Trial NCT04257656
Publication Wang Y, Lancet, 2020 (published paper)
Dates: 06feb2020 to 12mar2020
Funding: Mixed (Chinese Academy of Medical Sciences Emergency Project of COVID-19, National Key Research and Development Program of China, the Beijing Science and Technology Project)
Conflict of interest: Yes
| Methods | |
| RCT Blinding: double blinding | |
| Location :
Multicenter / China Follow-up duration (days): 28 | |
| Inclusion criteria | Men and non-pregnant women with COVID-19 who were aged at least 18 years and were RT-PCR positive for SARS-CoV-2, had pneumonia confirmed by chest imaging, had oxygen saturation of 94% or lower on room air or a ratio of arterial oxygen partial pressure to fractional inspired oxygen of 300 mm Hg or less, and were within 12 days of symptom onset. Eligible patients of child-bearing age (men and women) agreed to take effective contraceptive measures (including hormonal contraception, barrier methods, or abstinence) during the study period and for at least 7 days after the last study drug administration. |
| Exclusion criteria | Pregnancy or breast feeding; hepatic cirrhosis; alanine aminotransferase or aspartate aminotransferase more than five times the upper limit of normal; known severe renal impairment (estimated glomerular filtration rate <30 mL/min per 1·73 m²) or receipt of continuous renal replacement therapy, haemodialysis, or peritoneal dialysis; possibility of transfer to a non-study hospital within 72 h; and enrolment into an investigational treatment study for COVID-19 in the 30 days before screening. The use of other treatments, including lopinavir–ritonavir, was permitted. |
| Interventions | |
| Treatment
Remdesivir 200 mg IV infusion at day-1 followed by 100 mg IV infusion once a day for next 9 days |
|
| Control
Placebo Duration : 10 days | |
| Participants | |
| Randomized 237 participants (n1=158 / n2= 79) | |
| Characteristics of participants N=237 Mean age : 63.1 140 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=235 Critical: n=1 | |
| Primary outcome | |
| In the register Time to Clinical Improvement (TTCI) [Censored at Day 28] [ Time Frame: up to 28 days ] | |
| In the report Time to clinical improvement within 28 days after randomisation | |
| Documents available |
Protocol Yes. In English Statistical plan NR Data-sharing stated Yes |
| 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 the published article, the study registry and protocol were used in data extraction and risk of bias assessment. There was no a-priori statistical analysis plan. The study is underpowered, because recruitment was terminated early by the data safety and monitoring board, on the basis of the termination criteria specified in the protocol. With the actual number of participants (vs the target sample size), the statistical power was reduced from 80% to 58%. There is no change from the trial registration in the intervention and control treatments. The outcome adverse events is reported in the paper, but was not pre-specified in the trial registry/protocol. On July 15th 2020, we received additional information from authors on this study. |