Trial NCT04402203
Publication Rahman SMA, Clin Infect Pract (2022) (published paper)
Dates: 2020-05-01 to 2020-07-30
Funding: Private (Beacon Pharmaceuticals Limited, Dhaka, Bangladesh.)
Conflict of interest: No

Methods
RCT
Blinding: double blinding
Location : Multicenter / Bangladesh
Follow-up duration (days): 22
Inclusion criteria
  • Male or female patients 18 -65 years old
  • Respiratory samples tested positive for the novel coronavirus
  • Initial symptoms within 7 days
  • Nonpregnant women (confirmed by urine human chorionic gonadotropin (HCG) test prior to enrollment)
Exclusion criteria
  • Severe clinical condition (meeting one of the following criteria: a resting respiratory rate greater than 30 per minute, oxygen saturation below 93%, oxygenation index (OI) < 300 mmHg (1 mmHg = 133.3 Pa), respiratory failure, shock, and/or combined failure of other organs that required ICU monitoring and treatment)
  • Chronic liver and kidney disease and reaching end stage. (Serum aspartate aminotransferase (AST) and Serum alanine aminotransferase (ALT) will be elevated over 5 times of normal upper range will excluded) (Normal upper limit of Serum AST = 40 units /L, ALT = 56 units /L)
  • Serum uric acid >7.0 mg/dL in Male and Serum uric acid >6.0 mg/dL in Female
  • ICU patient
  • Previous history of allergic reactions to Favipiravir
  • Pregnant or lactating women
  • Women of a childbearing age with a positive pregnancy test
  • Miscarriage, or within 2 weeks after delivery
  • Hypertensive patients, who are taking Calcium Channel Blockers
Interventions
Treatment
Favipiravir
Initial dose: 1600 mg orally twice daily on day 1 - Maintenance dose: 600 mg twice daily on days 2-10
Control
Placebo

Participants
Randomized
participants :
Favipiravir=29
Placebo=28
Characteristics of participants
N= 57
Mean age : NR
33 males
Severity : Mild: n=* / Moderate: n=* / Severe: n=0 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
1) Number of participants negative by RT-PCR for the virus at 4-10 days after initiation of therapy. [ Time Frame: at 4 to 10 days of therapy ] Negative by RT-PCR for the virus at 4-10 days after initiation of therapy. However, negative results for the viral presence should be with an interval of at least 24 hours. 2) Number of participants with lung condition change assessed with X-ray. [ Time Frame: at Day-4, Day-7 and Day-10 of therapy ] X-ray findings of lung condition improvement at Day-4, Day-7 and Day-10 of therapy.
In the report
Patient’s physical improvement with negative test results by RT-PCR and improvement by X-ray corresponding.
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
High
General comment In addition to the published article, the trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The primary and secondary outcomes in the article reflect those in the registry. The trial (n = 57) achieved its target sample size (n = 50).