deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT04842747

VERU-111 in the Treatment of SARS-Cov-2 Infection by Assessing Its Effect on the Proportion of Patients Who Die on Study (VERU-111)

Phase 3, Randomized, Placebo-Controlled, Efficacy and Safety Study of VERU-111 for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS).

Sponsor: Veru Inc.

Conditions SARS-CoV Infection
Interventions VERU-111
Updated 19 times since 2021 Last updated: Mar 24, 2023 Started: May 18, 2021 Primary completion: Jul 6, 2022 Completion: Jul 6, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates SARS-CoV Infection and is currently completed. Veru Inc. leads this study, which shows 19 recorded versions since 2021 — indicating substantial longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Jan 2022 · 31 days · monthly snapshot~Jan 2022 – ~Feb 2022 · 31 days · monthly snapshot~Feb 2022 – ~Mar 2022 · 28 days · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~May 2023 · 8 months · monthly snapshot~May 2023 – ~Jul 2024 · 14 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – ~Nov 2025 · 2 months · monthly snapshot~Nov 2025 – present · 8 months · monthly snapshot

Change History

19 versions recorded

  1. Nov 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Nov 2025 [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 14 earlier versions

  1. Sep 2022 — May 2023 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  2. Jul 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE3

  3. Jun 2022 — Jul 2022 [monthly]

    Active Not Recruiting PHASE3

  4. May 2022 — Jun 2022 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  5. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE3

  6. Mar 2022 — Apr 2022 [monthly]

    Recruiting PHASE3

  7. Feb 2022 — Mar 2022 [monthly]

    Recruiting PHASE3

  8. Jan 2022 — Feb 2022 [monthly]

    Recruiting PHASE3

  9. Dec 2021 — Jan 2022 [monthly]

    Recruiting PHASE3

  10. Nov 2021 — Dec 2021 [monthly]

    Recruiting PHASE3

  11. Oct 2021 — Nov 2021 [monthly]

    Recruiting PHASE3

  12. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE3

  13. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  14. May 2021 — Jun 2021 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Veru Inc.
Data source: Veru Inc.

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

Study Locations

Atlántico, Colombia , Barranquilla, Colombia , Barretos, Brazil , Blagoevgrad, Bulgaria , Bogotá, Colombia , Botucatu, Brazil , Bragança Paulista, Brazil , Buenos Aires, Argentina , Cali, Colombia , Campinas, Brazil and 36 more locations