Covid-19 Living Data

Trial NCT04292899
Publication Goldman JD, N Engl J Med (2020) (published paper)
Dates: 06mar2020 to 26mar2020
Funding: Private (Gilead Sciences)
Conflict of interest: Yes

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / United States, Italy, Spain, Germany, Hong Kong, Singapore, South Korea, and Taiwan Follow-up duration (days): 40
Inclusion criteria	We enrolled hospitalized patients who were at least 12 years of age who had SARS-CoV-2 infection confirmed by polymerase-chain-reaction assay within 4 days before randomization. Eligible patients had radiographic evidence of pulmonary infiltrates and either had oxygen saturation of 94% or less while they were breathing ambient air or were receiving supplemental oxygen.
Exclusion criteria	Patients who were receiving mechanical ventilation and extracorporeal membrane oxygenation (ECMO) at screening were excluded, as were patients with signs of multiorgan failure. Exclusion criteria included alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 5 times the upper limit of the normal range or estimated creatinine clearance of less than 50 ml per minute (by the Cockcroft–Gault formula). Patients receiving concurrent treatment (within 24 hours before the start of trial treatment) with other agents with putative activity against Covid-19 were excluded.
Interventions
	Treatment Remdesivir 5 days 200 mg IV on day 1 followed by 100 mg once a day for the next 4 days.
	Control Remdesivir 10 days 200 mg IV on day 1 followed by 100 mg once a day for the next 9 days.
Participants
	Randomized participants : Remdesivir 10 days=200 Remdesivir 5 days=202
	Characteristics of participants N= 402 Mean age : NR 253 males Severity : Mild: n=0 / Moderate: n=275 / Severe: n=109 Critical: n=13 Number of vaccinated participants: NR
Primary outcome
	In the register The odds ratio for improvement on a 7 point ordinal scale on day 14
	In the report Clinical status assessed on day 14 on a 7-point ordinal scale consisting of the following categories: 1, death; 2, hospitalized, receiving invasive mechanical ventilation or ECMO; 3, hospitalized, receiving noninvasive ventilation or high-flow oxygen
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication:
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to all available versions of the published/pre-print article, the study registry, protocol, and statistical analysis plan were used in data extraction and risk of bias assessment. The primary outcome in the report reflects the primary outcome indicated in the registry. The trial registration describes additional trial arms as an extension to the study (the additional arms would enroll participants after enrollment to Part A, that includes the two arms presented in the published report, was complete). The extraction was updated on January 20th, 2021 based on results published on Clinicaltrials.gov on December 31st, 2020.