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An Adaptive Study of Favipiravir Compared to Standard of Care in Hospitalized Patients With COVID-19

NCT04434248 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2020-06-16

No results posted yet for this study

Summary

The study is Phase II/III and consists of pilot and pivotal stages. The objective of the pilot stage is to conduct a preliminary assessment of the efficacy and safety of Favipiravir, and to select the optimal dosing regimen to study during the pivotal stage. The objective of the pivotal stage is to assess the efficacy and safety of Favipiravir compared with the Standard of care (SOC) in hospitalized patients with moderate to severe COVID-19 pneumonia.

Conditions

Interventions

DRUG

Favipiravir

200 mg coated tablets

DRUG

Standard of Care

Standard of Care will be prescribed in accordance with the recommended treatment regimens presented in the Russian guidelines for the prevention, diagnosis and treatment of COVID-19 according to the decision of the Investigator.

Sponsors & Collaborators

  • Chemical Diversity Research Institute

    collaborator INDUSTRY

  • Chromis LLC

    lead INDUSTRY

Principal Investigators

  • Elena Pavlikova, MD,PhD,Prof · Moscow State University n.a. M.V. Lomonosov

  • Nikita Lomakin, MD,PhD · Central Clinical Hospital with Polyclinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-23
Primary Completion
2020-07-31
Completion
2020-07-31

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04434248 on ClinicalTrials.gov