Favipiravir Therapy in Adults With Mild COVID-19

Study Overview
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Brief Summary
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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.

Official Title
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A Trial of Favipiravir Therapy in Adults With Mild Coronavirus Disease COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Favipiravir
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients must be eligible according to the following criteria for enrollment Should be at least 18 years of age Male or non-pregnant female (pregnancy testing is not mandatory. If the patient requests or is not sure, the study team will provide it) Diagnosed with mild COVID-19* confirmed by positive PCR test for SARS-CoV-2 at the time of recruitment, a result within the last five days Patients have to be enrolled within 5 days of disease onset. Exclusion criteria Patients meeting any of the following criteria will be excluded from trial enrolment: Patients with concomitant documented bacterial pneumonia established through positive sputum cultures Patients who are pregnant or breastfeeding Known sensitivity/allergy to Favipiravir (If Faviparavir was used for COVID-19 in the patient previously for influenza) Major comorbidities increasing the risk of study drug including Hematologic malignancy Advanced (stage 4-5) chronic kidney disease or dialysis therapy Severe liver damage (Child-Pugh score C, AST> 5 times the upper limit) HIV Gout/history of Gout or hyperuricemia (two times above the ULN) (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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Favipiravir<br>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<br>* 1800 mg twice daily for one day, followed by 800mg (4 tablets) twice daily<br>|
| Placebo Comparator: Placebo<br>9 tablets by mouth twice daily for one day, followed by 4 tablets twice daily (Maximum days of therapy is 7 days). | Drug: Placebo<br>* (9 tablets) by mouth twice daily for one day, followed by (4 tablets) twice daily (Maximum days of therapy is 7 days)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCR negative | Time from randomization to negativity in RT-PCR nucleic acid test for COVID-19 within 15 days of randomization | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 15 days | 
| Evaluate symptoms progression | Evaluate symptoms severity and the disease course progression in both arms till 28 days after starting the medicine. | 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. | 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 ) | 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 | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Favipiravir, COVID19, Mild illness, Saudi Arabia