NCT05185284

Randomized Multicenter Study on the Efficacy and Safety of Favipiravir for Parenteral Administration Compared to Standard of Care in Hospitalized Patients With COVID-19

Open-label Randomized Multicenter Comparative Study on the Efficacy and Safety of AREPLIVIR® (Favipiravir) for Parenteral Administration (PROMOMED RUS LLC, Russia) in Hospitalized Patients With COVID-19

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: Promomed, LLC · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is open-labe randomized multicenter comparative Phase III study conducted in 7 medical facilities. The objective of the study is to assess the efficacy and safety of Favipiravir for parenteral administration compared with the Standard of care (SOC) in hospitalized patients with moderate COVID-19 pneumonia.

Detailed description

Upon signing the informed consent form and screening, 217 eligible patients hospitalized with COVID-19 pneumonia were randomized at a 1:1 ratio to receive either Favipiravir intravenously by drip infusion for 2 hours 1600 mg twice a day (BID) on Day 1 followed by 800 mg BID on Days 2-14 (1600/800 mg), or SOC. The course of treatment by Favipiravir is 10 days.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Favipiravir	400 mg, lyophilizate for preparation of concentrate for solution for infusion
DRUG	Favipiravir	200 mg coated tablets
DRUG	Remdesivir	100 mg, lyophilizate for preparation of concentrate for solution for infusion

Timeline

• Start date: 2021-08-11
• Primary completion: 2021-12-30
• Completion: 2021-12-30
• First posted: 2022-01-11
• Last updated: 2022-01-11

Locations

6 sites across 1 country: Russia