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OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial

Study acronym: OPTICOV
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 23, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Mar 2025 to Jun 30, 2026v6 Show 4 more changesShow less
    • Study completion date: May 2025 to Jun 30, 2027
    • Eligibility criteria expanded, about 28 words
    • Study sites revised (18)
    • Collaborators shortened, about 3 words
  2. Primary completion date: May 2024 to Mar 2025v5 Show 4 more changesShow less
    • Study completion date: Jul 2024 to May 2025
    • Eligibility criteria expanded, about 112 words
    • Secondary endpoints revised (17)
    • Study description expanded, about 31 words
  3. Study sites: 1 to 18
    • Primary completion date: Jan 2024 to May 2024
    • Study completion date: Jan 2025 to Jul 2024
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of May 2023 to Apr 27, 2023
    v3
  5. Phase: Phase 2/3 to Phase 2v2 Show 6 more changesShow less
    • Start date: Oct 2022 to May 2023
    • Primary endpoint revised
    • Interventions: Paxlovid 10 days (Drug), Paxlovid 5 days (Drug), Tixagevimab and Cilgavimab (Drug) to Paxlovid 10 days (Drug), Paxlovid 5 days (Drug), Veklury (Drug)
    • Eligibility criteria shortened, about 40 words
    • Secondary endpoints: 18 to 17
    • Study description expanded, about 1 word
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The overall purpose of the trial is to evaluate the efficacy and safety of possible combination antiviral therapy DAA (remdesivir + nirmatrelvir/r)∞ versus the reference monotherapy (nirmatrelvir/r alone) and to assess the efficacy and safety of increasing the nirmatrelvir/r course from 5- to 10 days in immunocompromised patients diagnosed with asymptomatic or mild to moderate COVID-19.
Trial Details
NCT Number NCT05587894
Lead Sponsor ANRS, Emerging Infectious Diseases
Conditions
(from sponsor)		 COVID-19, Immunodeficiency
Related terms COVID-19, Immunologic Deficiency Syndromes
Enrollment 256 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov