Trial ChiCTR2000030001
Publication Wu X, Engineering, 2020 (published paper)
Dates: 2020-02-14 to 2020-03-06
Funding: Public/non profit (Chinese Academy of Engineering Projects for COVID-19; Heilongjiang Province Urgent Project-6 for COVID-19)
Conflict of interest: No

Methods
RCT
Blinding: double blinding
Location : Multicenter / China
Follow-up duration (days): 28
Inclusion criteria1) laboratory-confirmed SARS-CoV-2 infection by RT-PCR;
2) chest CT imaging-confirmed lung damage—namely, multiple small plaques and stromal changes in the lungs, manifested in the outer lung, or with multiple ground glass shadows and infiltration shadows in both lungs (although these changes might not be present in mild patients);
3) hospitalized patients with fever (axillary temperature >=37.0 C) or respiratory symptoms;
4) a time from symptom onset to randomization of less than 12 d;
5) not having participated in other clinical research within the past three months;
6) 18 years or older;
7) not participating in other antiviral studies within 28 d of follow-up; and
8) written informed consent
Exclusion criteria1) patients who were unsuitable or who could not participate safely in the study, as judged by the principle investigators;
2) patients with serious grade C liver disease, according to the Child-Pugh score;
3) patients with severe renal impairment (glomerular filtration rate <= 30 mL min 1.73-1 m-2) or continuous renal replacement therapy, hemodialysis, or peritoneal dialysis;
4) patients with severe anemia (hemoglobin < 60 g L-1);
5) pregnant or breastfeeding women;
6) patients with a history of allergy to TZV or its metabolic components;
7) patients with the possibility of being transferred to another hospital within 72 h of randomization; and
8) patients who participated in other clinical trials for COVID-19 within 30 d prior to our screening
Interventions
Treatment
Triazavirin
250 mg orally 3 times a day (or 4 times if severe or critical patient) for 7 days
Control
Placebo
Duration : 7 days
Participants
Randomized
52 participants (n1=26 / n2= 26)
Characteristics of participants
N=52
Mean age : NR
26 males
Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=*
Primary outcome
In the register
Time to Clinical recovery
In the report
Time to clinical improvement
Documents
available

Protocol

Yes. In English

Statistical plan

NR

Data-sharing stated

NR
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 protocol and the study registry were used for data extraction and risk of bias assessment (neither registered before initiation of study). The trial was terminated ahead of schedule by the decision of the data and safety monitoring board because the COVID-19 outbreak in China was under control at the time, and there had been no new cases for one week. As a result, the target sample size specified in the registry/protocol was not achieved (planned sample size was 240). There is no change from the trial registration in the intervention and control treatments. The primary outcome indicated in registry/protocol reflects the primary outcome reported in the paper.