Trial ChiCTR2000030254
Publication Chen C, medRxiv, 2020
Dates: 20feb2020 to 12-mars-20
Funding: Public/non profit (National Key Research and Development Program of China (2020YFC0844400) )
| Methods | |
| RCT | |
| Location :
Multicenter / China Follow-up duration (days): 7 | |
| Inclusion criteria | Patients were assessed for eligibility on the basis of: (1) aged 18 years or older; (2)voluntarily provided informed consent; (3) initial symptoms were within 12 days; (4)Diagnosed as COVID-19 pneumonia. According to the Chinese Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia at that moment, COVID-19 could be diagnosed without a positive SARS-CoV-2 nucleic acid test result by: (1) a positive chest CT scan; (2) significant clinical manifestation including pyrexia, cough,breath difficulty and other indications of viral infection of lower respiratory tract; and (3) laboratory results indicating lymphopenia and (optional) leukopenia. Hence, male and female adult patients with clinically confirmed COVID-19 including moderate,severe or critical types of COVID-19 were eligible. |
| Exclusion criteria | Patients were excluded if they meet any of following criteria: (1) allergic to Favipiravir or Umifénovir; (2) with elevated ALT/AST (>6x upper limit of normal range) or with chronic liver disease (cirrhosis at grade Child-Pugh C); (3) severe/critical patients whose expected survival time were <48 hours; (4) female in pregnancy; (5) HIV infection; or (6) considered unsuitableby researchers for the patient’s best interest. |
| Interventions | |
| Treatment
Favipiravir (1600mg initial 600mg maintenance) Co-Intervention: Standard care Duration : 7 |
|
| Control
Umifenovir (200mg) Duration : 7 | |
| Participants | |
| Randomized 240 participants (n1=120 / n2= 120) | |
| Characteristics of participants N=240 Mean age : NR 110 males Severity : Mild: n=0 / Moderate: n=209/ Severe: n=24 Critical: n=3 | |
| Primary outcome | |
| In the register Clinical recovery rate of day 7 | |
| In the report Clinical recovery rate at 7 days or end of treatment | |
| Documents avalaible |
Protocol No Statistical plan No 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 |
High |
| General comment | In addition to all available versions of the published/pre-print article, the study registry and protocol were used in data extraction and risk of bias assessment. The study achieved the target sample size specified in the trial registry. There is no change from the registry in the intervention and control treatments, nor in the primary outcome. Some outcomes from the registry are not reported in the paper (e.g., mortality). The outcome adverse events is reported in the paper, but was not pre-specified in the trial registry/protocol. Of note: the report text states « The cases of respiratory failure in the two group were both 4 », but the table shows 1 case for the Favipirivir group and 4 cases for the Umifenovir group. |