Remdesivir for 5 or 10 Days in Patients with Severe Covid-19.N Engl J Med. 2020 11 05; 383(19):1827-1837.NEJM
Abstract
BACKGROUND
Remdesivir is an RNA polymerase inhibitor with potent antiviral activity in vitro and efficacy in animal models of coronavirus disease 2019 (Covid-19).
METHODS
We conducted a randomized, open-label, phase 3 trial involving hospitalized patients with confirmed SARS-CoV-2 infection, oxygen saturation of 94% or less while they were breathing ambient air, and radiologic evidence of pneumonia. Patients were randomly assigned in a 1:1 ratio to receive intravenous remdesivir for either 5 days or 10 days. All patients received 200 mg of remdesivir on day 1 and 100 mg once daily on subsequent days. The primary end point was clinical status on day 14, assessed on a 7-point ordinal scale.
RESULTS
In total, 397 patients underwent randomization and began treatment (200 patients for 5 days and 197 for 10 days). The median duration of treatment was 5 days (interquartile range, 5 to 5) in the 5-day group and 9 days (interquartile range, 5 to 10) in the 10-day group. At baseline, patients randomly assigned to the 10-day group had significantly worse clinical status than those assigned to the 5-day group (P = 0.02). By day 14, a clinical improvement of 2 points or more on the ordinal scale occurred in 64% of patients in the 5-day group and in 54% in the 10-day group. After adjustment for baseline clinical status, patients in the 10-day group had a distribution in clinical status at day 14 that was similar to that among patients in the 5-day group (P = 0.14). The most common adverse events were nausea (9% of patients), worsening respiratory failure (8%), elevated alanine aminotransferase level (7%), and constipation (7%).
CONCLUSIONS
In patients with severe Covid-19 not requiring mechanical ventilation, our trial did not show a significant difference between a 5-day course and a 10-day course of remdesivir. With no placebo control, however, the magnitude of benefit cannot be determined. (Funded by Gilead Sciences; GS-US-540-5773 ClinicalTrials.gov number, NCT04292899.).
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Authors+Show Affiliations
From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).No affiliation info available
MeSH
Pub Type(s)
Clinical Trial, Phase III
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Language
eng
PubMed ID
32459919
Clinical Trial Links
Citation
Goldman, Jason D., et al. "Remdesivir for 5 or 10 Days in Patients With Severe Covid-19." The New England Journal of Medicine, vol. 383, no. 19, 2020, pp. 1827-1837.
Goldman JD, Lye DCB, Hui DS, et al. Remdesivir for 5 or 10 Days in Patients with Severe Covid-19. N Engl J Med. 2020;383(19):1827-1837.
Goldman, J. D., Lye, D. C. B., Hui, D. S., Marks, K. M., Bruno, R., Montejano, R., Spinner, C. D., Galli, M., Ahn, M. Y., Nahass, R. G., Chen, Y. S., SenGupta, D., Hyland, R. H., Osinusi, A. O., Cao, H., Blair, C., Wei, X., Gaggar, A., Brainard, D. M., ... Subramanian, A. (2020). Remdesivir for 5 or 10 Days in Patients with Severe Covid-19. The New England Journal of Medicine, 383(19), 1827-1837. https://doi.org/10.1056/NEJMoa2015301
Goldman JD, et al. Remdesivir for 5 or 10 Days in Patients With Severe Covid-19. N Engl J Med. 2020 11 5;383(19):1827-1837. PubMed PMID: 32459919.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR
T1 - Remdesivir for 5 or 10 Days in Patients with Severe Covid-19.
AU - Goldman,Jason D,
AU - Lye,David C B,
AU - Hui,David S,
AU - Marks,Kristen M,
AU - Bruno,Raffaele,
AU - Montejano,Rocio,
AU - Spinner,Christoph D,
AU - Galli,Massimo,
AU - Ahn,Mi-Young,
AU - Nahass,Ronald G,
AU - Chen,Yao-Shen,
AU - SenGupta,Devi,
AU - Hyland,Robert H,
AU - Osinusi,Anu O,
AU - Cao,Huyen,
AU - Blair,Christiana,
AU - Wei,Xuelian,
AU - Gaggar,Anuj,
AU - Brainard,Diana M,
AU - Towner,William J,
AU - Muñoz,Jose,
AU - Mullane,Kathleen M,
AU - Marty,Francisco M,
AU - Tashima,Karen T,
AU - Diaz,George,
AU - Subramanian,Aruna,
AU - ,,
Y1 - 2020/05/27/
PY - 2020/5/28/pubmed
PY - 2020/12/2/medline
PY - 2020/5/28/entrez
SP - 1827
EP - 1837
JF - The New England journal of medicine
JO - N Engl J Med
VL - 383
IS - 19
N2 - BACKGROUND: Remdesivir is an RNA polymerase inhibitor with potent antiviral activity in vitro and efficacy in animal models of coronavirus disease 2019 (Covid-19). METHODS: We conducted a randomized, open-label, phase 3 trial involving hospitalized patients with confirmed SARS-CoV-2 infection, oxygen saturation of 94% or less while they were breathing ambient air, and radiologic evidence of pneumonia. Patients were randomly assigned in a 1:1 ratio to receive intravenous remdesivir for either 5 days or 10 days. All patients received 200 mg of remdesivir on day 1 and 100 mg once daily on subsequent days. The primary end point was clinical status on day 14, assessed on a 7-point ordinal scale. RESULTS: In total, 397 patients underwent randomization and began treatment (200 patients for 5 days and 197 for 10 days). The median duration of treatment was 5 days (interquartile range, 5 to 5) in the 5-day group and 9 days (interquartile range, 5 to 10) in the 10-day group. At baseline, patients randomly assigned to the 10-day group had significantly worse clinical status than those assigned to the 5-day group (P = 0.02). By day 14, a clinical improvement of 2 points or more on the ordinal scale occurred in 64% of patients in the 5-day group and in 54% in the 10-day group. After adjustment for baseline clinical status, patients in the 10-day group had a distribution in clinical status at day 14 that was similar to that among patients in the 5-day group (P = 0.14). The most common adverse events were nausea (9% of patients), worsening respiratory failure (8%), elevated alanine aminotransferase level (7%), and constipation (7%). CONCLUSIONS: In patients with severe Covid-19 not requiring mechanical ventilation, our trial did not show a significant difference between a 5-day course and a 10-day course of remdesivir. With no placebo control, however, the magnitude of benefit cannot be determined. (Funded by Gilead Sciences; GS-US-540-5773 ClinicalTrials.gov number, NCT04292899.).
SN - 1533-4406
UR - https://www.unboundmedicine.com/medline/citation/32459919/full_citation
DB - PRIME
DP - Unbound Medicine
ER -
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