Evaluation of Direct Antiviral Treatments Against SARS-CoV-2 in Immunocompromised Patients With Covid-19.

Study acronym: COV-ID
StatusCompleted
PhaseNot specified
Started

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Record History

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  1. Notable Primary endpoints: details revised at 1 of 1 entry Show 10 more changesShow less
    • Completed without a posted recruiting period
    • Primary completion date changed from estimate of Jun 1, 2026 to Jul 18, 2025
    • Enrollment target: estimated 300 to confirmed 327
    • Study sites: 16 to 18
    • Start date changed from estimate of Dec 1, 2025 to Dec 14, 2024
    • Interventions: Collection of data from the patient's medical file (Other) to Collection of data from the patient's medical file (Other)
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 2 of 7 entries
    • Publications: details revised at 4 of 4 entries
    • Study title shortened, about 14 words
  2. Notable Primary and study completion dates: Jun 1, 2025 to Jun 1, 2026
    • Start date: Dec 1, 2024 to Dec 1, 2025
    • Collaborators expanded, about 5 words
    v2
  3. Minor Study First Submitted
  • 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.
Due to the lower virulence of circulating Omicron variants and the high seroprevalence of anti-SARS-CoV-2 antibodies, the incidence of cases and deaths related to the SARS-CoV-2 virus has significantly decreased in recent months worldwide. However, these infections remain a major public health problem in severely immunocompromised patients, who have decreased vaccine efficacy and are at higher risk of persistent SARS-CoV-2 viral shedding, relapses, secondary invasive fungal infection, intensive care unit hospitalization, and death than non-immunocompromised patients. The research concerns adult patients at very high risk of severe SARS-CoV-2 disease, suffering from SARS-CoV-2 having resulted in hospitalization in a center participating in the study in France between June 1, 2023 and April 1, 2024 and having received mono- or dual therapy with nirmatrelvir/ritonavir or remdesivir in order to carry out an evaluation of direct antiviral treatments against SARS-CoV-2 in these immunocompromised patients suffering from Covid-19. The study consists of collecting patient care data from the medical record. Patients will be identified by practitioners at each participating French center.
Trial Details
NCT Number NCT06683937
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators: URC-CIC Paris Descartes Necker Cochin
Conditions
(from sponsor)
Immunocompromised Patients, SARS-CoV-2 Disease
Related terms COVID-19
Enrollment 327 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov