Favipiravir Therapy in Adults With Mild COVID-19

Phase 2

Completed

• Conditions: COVID-19
• Interventions: Drug: Placebo; Drug: Favipiravir

• Registration Number: NCT04464408
• Lead Sponsor: King Abdullah International Medical Research Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-28
• Study First Submitted QC: 2020-07-08
• Study First Posted: 2020-07-09
• Study Start: 2020-07-23
• Primary Completion: 2021-08-04
• Study Completion: 2021-08-04
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-04
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	9 tablets by mouth twice daily for one day, followed by 4 tablets twice daily (Maximum days of therapy is 7 days).
Favipiravir	Favipiravir	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)

Primary Outcome Measures

Name	Time	Method
PCR negative	15 days	Time from randomization to negativity in RT-PCR nucleic acid test for COVID-19 within 15 days of randomization

Secondary Outcome Measures

Name	Time	Method
Evaluate Faviparivirs effect	15 days	To evaluate Favipiravir's effect on the requirement of the use of antipyretics, analgesics, or antibiotics within 15 days after starting medicine.
Evaluate the safety of Favipiravir	28 days	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
Evaluate Favipiravir's effect	28 days	To evaluate Favipiravir's effect on disease complications within 28 days after starting medicine (hospitalization, ICU admission, or Mechanical ventilation )
Time from randomization to clinical recovery	15 days	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.
Evaluate symptoms progression	28 days	Evaluate symptoms severity and the disease course progression in both arms till 28 days after starting the medicine.

Trial Locations

Locations (7)

Prince Mohammed Bin Abdul Aziz Hospital - Al Madinah; 🇸🇦 Al Madinah, Saudi Arabia

King Abdulaziz Medical City - Riyadh; 🇸🇦 Riyadh, Saudi Arabia

Primary Health Care-Al Mansoura; 🇸🇦 Riyadh, Saudi Arabia

Primary Health Care-Al Urijah; 🇸🇦 Riyadh, Saudi Arabia

King Fahad Hospital - Madinah; 🇸🇦 Al Madīnah, Saudi Arabia

Primary Health Care-Safiyah; 🇸🇦 Al Madīnah, Saudi Arabia

King Abdullah Medical City - Makkah; 🇸🇦 Mecca, Saudi Arabia