Trial IRCT20211004052664N1
Publication Tehrani S, Mediterr J Infect Microbes Antimicrob (2022) (published paper)
Dates: 2021-04-01 to 2021-09-30
Funding: No specific funding (The authors declared that this study received no financial support.)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Single center / Iran
Follow-up duration (days): 6
Inclusion criteria
  • Laboratory confirmation of SARS-CoV-2 by reverse transcription-polymerase chain reaction (RT-PCR) or imaging findings highly suggestive of COVID-19
  • Outpatients with moderate severity (respiratory rate <30/min, oxygen saturation >94%, or pulmonary infiltration <50% in both lungs)
  • Age of at least 18 y
  • Agreed to participate in this study
  • oral tolerance to the medication. Additionally, an expert radiologist read the lung computed tomography (CT) scan of the patients. Unilateral and bilateral multilobular infiltrations, especially peripheral, and ground-glass opacities in lung CT scan were considered highly suggestive of COVID-19.
Exclusion criteria
  • Immunocompromised patients defined as receiving immunosuppressive medications, solid organ transplant, hematopoietic stem cell transplant, infection with human immunodeficiency virus, and active cancer
  • Pregnancy
  • Consumption of other antiviral therapies from symptom onset
  • Severe hypersensitivity or anaphylactic shock after taking favipiravir
Interventions
Treatment
Favipiravir
Initial dose: 1600 mg favipiravir orally 2 times a day for the first 24 hours -Maintenance dose: 600 mg orally 2 times a day for the next 4 days.
Control
Standard care

Participants
Randomized
participants :
Standard care=40
Favipiravir=38
Characteristics of participants
N= 78
Mean age : NR
43 males
Severity : Mild: n= 78/ Asymptomatic: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
1) Body temperature; Timepoint: Days 1 (start of treatment), 3, 5 and 7; Method of measurement: Thermometer. 2) Respiratory rate (per minute); Timepoint: Days 1 (start of treatment), 3, 5 and 7; Method of measurement: Physical examination by physician. 3) Oxygen saturation; Timepoint: Days 1 (start of treatment), 3, 5 and 7; Method of measurement: Pulseoxymeter.
In the report
Hospitalization rate during the seven-days follow-up period.
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Not reported
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. The study achieved the target sample size specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome does not reflect the reported primary outcome. Adverse events did not seem to be completely reported. The study duration was short.