NCT04981379

Clinical Trial For Early SARS-CoV-2 (COVID-19) Treatment

Efficacy and Safety of the Use of Hydroxychloroquine, Favipiravir or Hydroxychloroquine + Favipiravir in Early SARS-CoV-2 (COVID-19) Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,120 (actual)
• Sponsor: Health Institutes of Turkey · Other Government
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, double-blinded, and placebo controlled phase III clinical trial which aims to investigate the superiority of hydroxychloroquine, favipiravir or hydroxychloroquine + favipiravir treatment, initiated especially in the early period in the treatment of COVID-19, over the patients being followed up with placebo in adults aged 18\~59 Years.

Detailed description

This study is a randomized, double-blinded, and placebo controlled phase III clinical trial in in adults aged 18\~59 Years. The study was planned as a multicenter, randomized controlled, double-blind, parallel-arm drug study. The purpose of this study is to evaluate the efficacy and safety of hydroxychloroquine, favipiravir, or hydroxychloroquine + favipiravir treatments that were initiated early in patients who were caught during filiation or who were decided to be outpatient due to mild disease findings during hospital admission, after the diagnosis of COVID-19 against patients with placebo. It is planned that the study will be conducted with two separate arms. Study arms are planned as 2:2:2:1 for 320:320:320:160 patients as follows. The dose of Favipiravir has been determined as the standard dose. Hydroxychloroquine will also be given without a loading dose.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine	Hydroxychloroquine (200 mg), as two tablets per day for 5-day interval + Placebo \[Favipiravir (1600 mg)\], as two tablet per day at the first day and then Favipiravir (600 mg) as two tablet per day for the remaining 4-day interval.
DRUG	Favipiravir	Favipiravir (1600 mg), as two tablet per day at the first day and then Favipiravir (600 mg) as two tablet per day for the remaining 4-day interval + Placebo \[Hydroxychloroquine (200 mg)\], as two tablets per day for 5-day interval.
DRUG	Favipiravir + Hydroxychloroquine	Favipiravir (1600 mg), as two tablet per day at the first day and then Favipiravir (600 mg) as two tablet per day for the remaining 4-day interval + Hydroxychloroquine (200 mg), as two tablets per day for 5-day interval.
DRUG	Placebo	Placebo \[Favipiravir (1600 mg)\], as two tablet per day at the first day and then Placebo Favipiravir (600 mg) as two tablet per day for the remaining 4-day interval + Hydroxychloroquine (200 mg), as two tablets per day for 5-day interval.

Timeline

• Start date: 2020-11-16
• Primary completion: 2021-01-31
• Completion: 2021-02-16
• First posted: 2021-07-29
• Last updated: 2021-07-29

Locations

6 sites across 1 country: Turkey (Türkiye)