Trial ChiCTR2000030894, NCT04310228
Publication Zhao H, Biomed Pharmacother, 2020 (published paper)
Dates: 2/2/2020 to 3/15/2020
Funding: Public/non profit ( Chinese COVID-19 scientific research emergency project, China Mega-Project for Infectious Diseases, and China Mega-Project for Innovative Drugs)
Conflict of interest: No conflicts of interest
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Multicenter / China Follow-up duration (days): 60 | |
| Inclusion criteria | Laboratory-confirmed cases according to Chinese guidelines of COVID-19; Male or female more than 18 years old; Increased interleukin-6; Sign the informed consent |
| Exclusion criteria | Allergic to favipiravir or tocilizumab; Pregnant or lactating woman; ALT or AST > 5 times of upper limit of normal; Patients with active hepatitis, tuberculosis, and definite bacterial or fungal infections; Other conditions judged by the investigators |
| Interventions | |
| Treatment 1 Favipiravir (600 mg) Co-Intervention: Standard care Duration : 7 days | |
| Control Favipiravir+Tocilizumab (600 mg/400 mg) Co-Intervention: Standard care Duration : 7 days | |
| Treatment 3 Tocilizumab (400 mg) Co-Intervention: Standard care Duration : 1 day | |
| Participants | |
| Randomized 26 participants n1=7/ n2=14/ n3=5 | |
| Characteristics of participants N=26 Mean age : NR 14 males Severity : Mild: n=0 / Moderate: n=12/ Severe: n=13 Critical: n=1 | |
| Primary outcome | |
| In the register Clinical cure rate [Time Frame: 3 months ] Definition of clinical cure: The viral load of the respiratory specimen was negative for two consecutive times (the interval between the two tests was greater than or equal to one day), the lung image improved, and the body temperature returned to normal for more than 3 days, and the clinical manifestation improved. | |
| In the report cumulative lung lesion remission rate (lung CT (lung CTexamination indicated absorption of lung inflammation) | |
| Documents available |
Protocol NR 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 available pre-proof published version of the article, the study registries were used in data extraction and risk of bias assessment. The protocol and the statistical analysis plan were not available. The target sample size of n=150 specified in the registry was not achieved (actual sample size n=26). There is no change from the trial registries in the intervention and control treatments. Some efficacy outcomes specified in the registries were not reported in the paper,and the primary outcome reported differs in the report and registries. Both adverse events and serious adverse events were not stated as outcomes in the trial registries. |