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. 2021 Jan 7;101:106272. doi: 10.1016/j.cct.2021.106272

Table 1.

Characteristics of included trials.

Wang [5] Beigel [7] Spinner [8] Pan (Solidarity) [9]
Centers 10 sites in Wuhan, China 60 sites and 13 subsites in the United States, Mexico, Europe, and Asia 105 sites in the United States, Europe, and Asia 405 sites in 30 countries (all over the world)
Number of patients 236 1063 584 5451
Enrollment initiation February 2020 February 2020 March 2020 March 2020
Enrollment completion March 2020 April 2020 April 2020 October 2020
Date of publication April 2020 May 2020 August 2020 November 2020 (preprint)
Population Patients hospitalized with SARS-CoV-2 infection with an interval from symptom onset to enrolment of 12 days or less, and evidence of pneumonia Patients hospitalized with SARS-CoV-2 infection with evidence of lower respiratory tract involvement Patients hospitalized with severe SARS-CoV-2 infection and moderate COVID-19 pneumonia (pulmonary infiltrates and room-air oxygen saturation > 94%) Patients hospitalized with SARS-CoV-2 infection
Trial type Double-blind; multicenter; RCT Double-blind; multicenter; RCT Open-label; multicenter; RCT Open-label; multicenter; RCT
Inclusion criteria
  • Aged ≥ 18 years old

  • SARS-CoV-2 infection confirmed by PCR

  • Radiographic infiltrates

  • SpO2 ≤ 94% on room air or a ratio of arterial oxygen partial pressure to fractional inspired oxygen of 300 mmHg or less,

  • Interval from symptom onset to enrolment of 12 days or less

  • Practicing heterosexual abstinence or using study-specified contraception during the study period and for at least 7 days after the last study drug administration

  • Aged ≥ 18 years old

  • SARS-CoV-2 infection confirmed by PCR ≤ 3 days before randomization (then expanded due to limitation in testing capacity)

  • Radiographic infiltrates

  • SpO2 ≤ 94% on room air, or requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

  • Practicing heterosexual abstinence or using study-specified contraception

  • Aged ≥ 18 or aged ≥ 12 and < 18 years of age but weighing ≥ 40 kg (parents to sign the consent) SARS-CoV-2 infection confirmed by PCR ≤ 4 days before randomization

  • Radiographic infiltrates

  • SpO2 > 94% on room air at screening

    Radiographic infiltrates

  • Hospitalized and requiring medical care for COVID-19

  • Practicing heterosexual abstinence or using study-specified contraception

  • Aged ≥ 18 years old

  • SARS-CoV-2 infection confirmed by PCR

  • Hospitalized and requiring medical care for COVID-19

  • Not anticipated to be transferred within 72 h

Exclusion criteria
  • Enrollment into an investigational treatment study for COVID-19 in the 30 days before screening.

  • Hepatic cirrhosis

  • ALT or AST > 5 × ULN

  • Glomerular filtration rate < 30 mL/min per 1.73 m or receipt of renal replacement therapy

  • Pregnant woman

  • Breastfeeding woman

  • Anticipated discharge or transfer to another hospital within 72 h

  • Concurrent treatment with other agents with antiviral activity against SARS-CoV-2

  • ALT or AST > 5 x ULN

  • Impaired renal function or need for hemodialysis or hemofiltration

  • Pregnant woman

  • Breastfeeding woman

  • Hypersensitivity to the study drug

  • Anticipated discharge or transfer to another hospital within 72 h

  • Concurrent treatment with other agents with antiviral activity against SARS-CoV-2

  • Requiring mechanical ventilation at screening

  • ALT or AST > 5 × ULN

  • Creatinine clearance < 50 mL/min

  • Pregnant woman

  • Breastfeeding woman

  • Hypersensitivity to the study drug

  • Patients without clear consent to follow-up

  • Contraindication per physician's evaluation

  • Received hydroxychloroquine, Lopinavir-Ritonavir or Interferon

Randomization sequence SAS software, version 9.4 (Stratified) Interactive web response system Interactive web response system Cloud-based GCP-compliant clinical data management system)
Treatments
  • Remdesivir (10-day course)

  • Standard care (placebo)

  • Remdesivir (10-day course)

  • Standard care (placebo)

  • Remdesivir (5-day course)

  • Remdesivir (10-day course)

  • Standard care

  • Remdesivir (10-day course)

  • Standard care

Primary outcome Time to clinical improvement (two-point reduction in patients' admission status on a six-point ordinal scale, or live discharge from the hospital, whichever came first) within 28 days after randomization The time to recovery, defined by either discharge from the hospital or hospitalization for infection control purposes only Clinical status assessed on the 7-point ordinal scale on study day 11 All-cause mortality
Results of the primary outcome Remdesivir was not superior to placebo in shortening time to clinical improvement Remdesivir was superior to placebo in shortening the time to recovery Remdesivir (5-day course) was superior to standard care in terms of care associated with higher odds of better clinical status Remdesivir was not superior to standard care in reducing all-cause mortality
Follow up 28 days 29 days 28 days 28 days
Funding National Key Research and Development Program of China National Institute of Allergy and Infectious Diseases and others Gilead Sciences World health organization and participating countries

ALT = Alanine aminotransferase; AST = Aspartate aminotransferase; COVID-19 = Coronavirus Disease 2019; PCR = Polymerase chain reaction; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2; ULN=Upper limit of normal.