Trial ChiCTR2000029853
Publication Ren Z, Adv Sci (2020) (published paper)
Dates: 18/02/2020 to 29/02/2020
Funding: Mixed (Henan Genuine Biotech Co. Ltd.; Henan province novel coronavirus control and prevention emergency science and technology tackling key project; National S&T Major Project of China)
Conflict of interest: No
Methods | |
RCT Blinding: Unblinded | |
Location :
Single center / China Follow-up duration (days): 18 | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
Azvudine 5 mg orally once a day |
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Control
Standard care | |
Participants | |
Randomized participants : Standard care=10 Azvudine=10 | |
Characteristics of participants N= 20 Mean age : NR 12 males Severity : Mild: n=3 / Moderate: n=17 / Severe: n=0 Critical: n=0 Number of vaccinated participants: NR | |
Primary outcome | |
In the register time and rate of temperature return to normal;time and rate of improvement of respiratory symptoms and signs (lung rhones, cough, sputum, sore throat, etc.); time and rate of improvement of diarrhea, myalgia, fatigue and other symptoms; time and rate | |
In the report Rate of nucleic acid negativity conversion of SARS-CoV-2 and the negativity conversion time. | |
Documents available |
Protocol Yes. In language other than English Statistical plan NR Data-sharing willing stated in the publication: 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 was used in data extraction and risk of bias assessment. This is a report on a pilot trial. The target sample size specified in the registry was achieved. There is no change from the trial registration in the intervention and control treatments. All secondary outcomes in the report are presented as primary outcomes in the trial registry. Some primary outcomes in the registry are not reported (e.g., rate of mild/moderate type to severe type, rate of severe type to critical type, improvement time and rate of CD4 count). Primary outcome in the registry and report is not the same.
On September 18th 2020, we received additional information from authors on this study. |