deltatrials
Terminated PHASE3 INTERVENTIONAL 2-arm NCT05603143

Study of Obeldesivir in Participants With COVID-19 Who Have a High Risk of Developing Serious or Severe Illness (BIRCH)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5245 for the Treatment of COVID-19 in Participants With High-Risk for Disease Progression

Sponsor: Gilead Sciences

Conditions COVID-19
Interventions Obeldesivir Obeldesivir Placebo
Updated 17 times since 2022 Last updated: Dec 13, 2024 Started: Nov 5, 2022 Primary completion: Nov 7, 2023 Completion: Nov 7, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The study was stopped early as it was determined there would not be a statistically significant treatment effect associated with the primary endpoint due to the low number of events.

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A PHASE3 clinical study on COVID-19, this trial is terminated or withdrawn. The trial is conducted by Gilead Sciences and has accumulated 17 data snapshots since 2022. Infectious disease trials contribute critical data for public health response and treatment development.

Status Flow

~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Apr 2023 · 31 days · monthly snapshot~Apr 2023 – ~May 2023 · 30 days · monthly snapshot~May 2023 – ~Jun 2023 · 31 days · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshot~Aug 2023 – ~Sep 2023 · 31 days · monthly snapshot~Sep 2023 – ~Oct 2023 · 30 days · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Dec 2023 · 30 days · monthly snapshot~Dec 2023 – ~Jul 2024 · 7 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jan 2025 · 4 months · monthly snapshot~Jan 2025 – ~Sep 2025 · 8 months · monthly snapshot~Sep 2025 – present · 9 months · monthly snapshot

Change History

17 versions recorded

  1. Sep 2025 — Present [monthly]

    Terminated PHASE3

  2. Jan 2025 — Sep 2025 [monthly]

    Terminated PHASE3

  3. Sep 2024 — Jan 2025 [monthly]

    Terminated PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  5. Dec 2023 — Jul 2024 [monthly]

    Terminated PHASE3

    Status: Recruiting → Terminated

▶ Show 12 earlier versions

  1. Nov 2023 — Dec 2023 [monthly]

    Recruiting PHASE3

  2. Oct 2023 — Nov 2023 [monthly]

    Recruiting PHASE3

  3. Sep 2023 — Oct 2023 [monthly]

    Recruiting PHASE3

  4. Aug 2023 — Sep 2023 [monthly]

    Recruiting PHASE3

  5. Jul 2023 — Aug 2023 [monthly]

    Recruiting PHASE3

  6. Jun 2023 — Jul 2023 [monthly]

    Recruiting PHASE3

  7. May 2023 — Jun 2023 [monthly]

    Recruiting PHASE3

  8. Apr 2023 — May 2023 [monthly]

    Recruiting PHASE3

  9. Mar 2023 — Apr 2023 [monthly]

    Recruiting PHASE3

  10. Feb 2023 — Mar 2023 [monthly]

    Recruiting PHASE3

  11. Jan 2023 — Feb 2023 [monthly]

    Recruiting PHASE3

  12. Dec 2022 — Jan 2023 [monthly]

    Recruiting PHASE3

    First recorded

Nov 2022

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Gilead Sciences
Data source: Gilead Sciences

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

Study Locations

A Gudiña, Spain , Alicante, Spain , Badalona, Spain , Barcelona, Spain , Belfast, United Kingdom , Belo Horizonte - MG, Brazil , Blagoevgrad, Bulgaria , Brasília - DF, Brazil , Brits, South Africa , Bucharest, Romania and 63 more locations