A Phase 2/3 interventional study of Favipiravir and Placebo in COVID-19, sponsored by King Abdullah International Medical Research Center. Completed at 7 sites in Saudi Arabia. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-11-05.
Sponsored by King Abdullah International Medical Research Center · Phase 2/3, Interventional, and Treatment
Favipiravir is a selective and potent inhibitor of influenza viral RNA polymerase. It acts as a purine analogue, which selectively inhibits viral RNA-dependent RNA polymerase (RdRps). It has the characteristic of acting on RNA viruses including Ebola and Coronaviruses especially novel coronavirus (2019-nCoV). The purpose of this study is to evaluate the clinical efficacy and safety of Favipiravir in comparison to placebo in the treatment of mild COVID-19 cases. It is a Multicenter, randomized double-blinded, parallel-group trial.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 231 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →King Abdullah International Medical Research Center is the lead sponsor of 44 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients must be eligible according to the following criteria for enrollment
Exclusion criteria
Patients meeting any of the following criteria will be excluded from trial enrolment:
Major comorbidities increasing the risk of study drug including
(6) Having used Favipiravir or participated in any other interventional drug clinical study within 30 days before the first dose of study drug (i.e., the patient received it for influenza previously) (7) The investigator believes that participating in the trial is not in the best interests of the patient, or the investigator considers unsuitable for enrollment (such as unpredictable risks or subject compliance issues) (8) Clinical prognostic non-survival, palliative care, or in a deep coma and have no response to supportive treatment within three hours of admission.
(9) Hospitalized patients for mild, moderate, or severe COVID-19
Favipiravir: 1800 mg (9 tablets) by mouth twice daily for one day, followed by 800mg (4 tablets) twice daily (Maximum days of therapy is 7 days)
Drug: Favipiravir
9 tablets by mouth twice daily for one day, followed by 4 tablets twice daily (Maximum days of therapy is 7 days).
Drug: Placebo
1800 mg twice daily for one day, followed by 800mg (4 tablets) twice daily
(9 tablets) by mouth twice daily for one day, followed by (4 tablets) twice daily (Maximum days of therapy is 7 days)
PCR negative
Time from randomization to negativity in RT-PCR nucleic acid test for COVID-19 within 15 days of randomization
Time frame: 15 days
Time from randomization to clinical recovery
The duration from start of treatment (Favipiravir or placebo) to normalization of pyrexia, respiratory symptoms, and relief of cough (or other relevant symptoms at enrollment) that is maintained for at least 72 hours.
Time frame: 15 days
Evaluate symptoms progression
Evaluate symptoms severity and the disease course progression in both arms till 28 days after starting the medicine.
Time frame: 28 days
Evaluate Faviparivirs effect
To evaluate Favipiravir's effect on the requirement of the use of antipyretics, analgesics, or antibiotics within 15 days after starting medicine.
Time frame: 15 days
Evaluate Favipiravir's effect
To evaluate Favipiravir's effect on disease complications within 28 days after starting medicine (hospitalization, ICU admission, or Mechanical ventilation )
Time frame: 28 days
Evaluate the safety of Favipiravir
Evaluate the safety of investigational drug compared to the control arm within 15 days after starting the medicine. This is assessed by allergic reactions, medication intolerance, liver toxicity, and hyperuricemia in subjects
Time frame: 28 days
Plan to share: No
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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King Abdullah International Medical Research Center