Randomized Multicenter Study on the Efficacy and Safety of Favipiravir for Parenteral Administration Compared to Standard of Care in Hospitalized Patients With COVID-19
NCT05185284 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 217
Last updated 2022-01-11
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.
Conditions
Interventions
- 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
Sponsors & Collaborators
-
Solyur Pharmaceuticals Group
collaborator UNKNOWN -
Promomed, LLC
lead OTHER
Principal Investigators
-
Dmitriy Pushkar, MD, Academic · Moscow State Clinical Hospital №50
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-08-11
- Primary Completion
- 2021-12-30
- Completion
- 2021-12-30
Countries
- Russia
Study Locations
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