deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT04542694

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

Open-label Randomized Multicenter Comparative Study on the Efficacy and Safety of Areplivir Film-coated Tablets (PROMOMED RUS LLC, Russia) in Patients Hospitalized With COVID-19

Sponsor: Promomed, LLC

Conditions COVID-19
Updated 6 times since 2020 Last updated: Nov 3, 2020 Started: May 21, 2020 Primary completion: Aug 10, 2020 Completion: Aug 20, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on COVID-19, this trial is completed. The trial is conducted by Promomed, LLC and has accumulated 6 data snapshots since 2020. Infectious disease trials contribute critical data for public health response and treatment development.

Study Description(click to expand)

Upon signing the informed consent form and screening, 200 eligible patients with polymerase chain reaction (PCR) confirmed COVID-19 are randomized at a 1:1 ratio to receive either Favipiravir 1600 mg twice a day (BID) on Day 1 followed by 600 mg BID on Days 2-14 (1600/600 mg), or SOC. The course of treatment by Favipiravir is 14 days.

Upon signing the informed consent form and screening, 200 eligible patients with polymerase chain reaction (PCR) confirmed COVID-19 are randomized at a 1:1 ratio to receive either Favipiravir 1600 mg twice a day (BID) on Day 1 followed by 600 mg BID on Days 2-14 (1600/600 mg), or SOC. The course of treatment by Favipiravir is 14 days.

Status Flow

~Oct 2020 – ~Dec 2020 · 2 months · monthly snapshotCompleted~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

  5. Dec 2020 — Jan 2021 [monthly]

    Completed PHASE3

Show 1 earlier version
  1. Oct 2020 — Dec 2020 [monthly]

    Completed PHASE3

    First recorded

May 2020

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Promomed, LLC
Data source: Promomed, LLC

For direct contact, visit the study record on ClinicalTrials.gov .