Trial NCT04333589
Publication Zhao H, Int Immunopharmacol (2021) (published paper)
Dates: 2020-03-27 to 2020-05-09
Funding: Public/non profit (Chinese COVID-19 scientific research emergency; China Mega-Project for Infectious Diseases; China Mega-Project for Innovative Drugs)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / China
Follow-up duration (days): 30
Inclusion criteria
  • Over 18 years of age
  • both male and female
  • After the first diagnosis and treatment of COVID-19, the SARS-CoV-2 RNA test of respiratory specimens such as sputum or nasopharyngeal swabs, has been negative for two consecutive times (sampling time interval of at least 24 h), in accordance with China COVID-19 guidelines (7th Edition), discharged
  • During screening visit (follow-up after discharge), the SARS-CoV-2 RNA test of COVID-19 is positive in any one of the following samples: sputum, nasopharyngeal swabs, blood, feces or other specimens. Regardless of whether or not they had symptoms and the severity of symptoms
  • Volunteer to participate in the research and sign the Informed Consent Form.
Exclusion criteria
  • Allergic to favipiravir
  • Pregnant or lactating women
  • The researchers considered the patient was not suitable to participate in this clinical trial.
Interventions
Treatment
Favipiravir
Initial dose: 1600 mg twice a day orally on day 1 -Maintenance dose: 600 mg twice a day orally on days 2-7. Day 8-14 according to clinician's judgement, but no more than 14 days of treatment.

Control
Standard care

Participants
Randomized
participants :
Favipiravir=36
Standard care=19
Characteristics of participants
N= 55
Mean age : NR
25 males
Severity : Mild: n= */ Asymptomatic: n=*
Number of vaccinated participants: NR
Primary outcome
In the register
Viral nucleic acid test negative conversion rate [ Time Frame: 5 months ]
In the report
The primary outcome was time to achieve a consecutive twice (at intervals of more than 24 h) negative RT-PCR result for SARS-CoV-2 RNA in nasopharyngeal swab and sputum sample.
Documents
available

Protocol

Yes. In English

Statistical plan

NR

Data-sharing willing stated in the publication:
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 trial registry and published protocol summary were used in data extraction and assessment of risk of bias. The study was registered retrospectively and did not achieve the target sample size. There are some differences in outcomes reported and follow-up timepoints in the published article and registry and protocol summary.