Evaluation of Direct Antiviral Treatments Against SARS-CoV-2 in Immunocompromised Patients With Covid-19. A G2i Study, National Multicenter Observational and Retrospective From June 2023 to April 2024
NCT06683937 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300
Last updated 2025-09-12
Summary
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.
Conditions
- Immunocompromised Patients
- SARS-CoV-2 Disease
Interventions
- OTHER
-
Collection of data from the patient's medical file
Collection of data from the patient's medical file
Sponsors & Collaborators
-
URC-CIC Paris Descartes Necker Cochin
collaborator OTHER -
Assistance Publique - Hôpitaux de Paris
lead OTHER
Principal Investigators
-
Cléa Melenotte, M.D. · Assistance Publique - Hôpitaux de Paris
-
Clémentine de La Porte, M.D. · Assistance Publique - Hôpitaux de Paris
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-01
- Primary Completion
- 2026-06-01
- Completion
- 2026-06-01
Countries
- France
Study Locations
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