deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT05601167

Open Multicentre Study of the Safety and Efficacy Against COVID-19 of Nirmatrelvir/Ritonavir in the Adult Population

Open Multicentre Study for Assessment of the Safety and Efficacy Against COVID-19 of the Drug JTBC00201 (PROMOMED RUS LLC, Russia) in the Adult Population

Sponsor: Promomed, LLC

Conditions COVID-19
Updated 6 times since 2022 Last updated: Apr 6, 2023 Started: Feb 17, 2021 Primary completion: Jun 1, 2022 Completion: Jun 1, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT05601167, this PHASE3 trial focuses on COVID-19 and remains completed. Sponsored by Promomed, LLC, it has been updated 6 times since 2021, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Study Description(click to expand)

Upon signing the informed consent form and screening, 264 eligible outpatients with mild or moderate COVID-19 were randomized at a 1:1 ratio to receive either nirmatrelvir/ritonavir tablets, 300/100 mg, 2 times a day with 12 ±2 hours interval for 5 days, or SOC

Upon signing the informed consent form and screening, 264 eligible outpatients with mild or moderate COVID-19 were randomized at a 1:1 ratio to receive either nirmatrelvir/ritonavir tablets, 300/100 mg, 2 times a day with 12 ±2 hours interval for 5 days, or SOC

Status Flow

~Dec 2022 – ~May 2023 · 5 months · monthly snapshotCompleted~May 2023 – ~Jul 2024 · 14 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~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Present [monthly]

    Completed PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. May 2023 — Jul 2024 [monthly]

    Completed PHASE3

Show 1 earlier version
  1. Dec 2022 — May 2023 [monthly]

    Completed PHASE3

    First recorded

Feb 2021

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

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

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