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
COV-ID
1 other identifier
observational
300
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2025
Shorter than P25 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2024
CompletedFirst Posted
Study publicly available on registry
November 12, 2024
CompletedStudy Start
First participant enrolled
December 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
September 12, 2025
September 1, 2025
6 months
November 5, 2024
September 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical evolution of immunocompromised patients receiving remdesivir and/or nirmatrelvir/ritonavir as curative treatment for COVID-19
Evolution of the patient's modified (suitable for immunocompromised patients) Ordinal Scale for Clinical Improvement (OSCI) of the World Health Organization (WHO) (score from 0 - non infected patient to 8 - deceased patient) from the initiation of treatment to 30 days (+7 days) following the first line of therapy.
37 days
Secondary Outcomes (7)
Mortality at 30 days of diagnosis
30 days
Tolerance of antiviral treatments against SARS-CoV-2
6 months
Evaluate virological evolution
60 days
Evaluate radiological evolution
90 days
Clinical relapse at discharge from hospital, at D30 and D60
90 days
- +2 more secondary outcomes
Study Arms (1)
Patients
Adult patients at very high risk of severe SARS-CoV-2 disease, hospitalized for SARS-CoV-2 infection from June 2023 to April 2024.
Interventions
Collection of data from the patient's medical file
Eligibility Criteria
Adult patients at very high risk of severe SARS-CoV-2 disease, hospitalized for SARS-CoV-2 infection from June 2023 to April 2024 in France.
You may qualify if:
- Adult patients with SARS-CoV-2 in France, treated in a center participating in the study
- Symptomatic patients for Covid-19 who have received mono- or dual therapy with nirmatrelvir/ritonavir or remdesivir
- SARS-CoV-2 positive by PCR on nasopharyngeal swab, ECBC or bronchoalveolar fluid
- Hospitalization in a ward or day hospital for SARS-CoV-2 infection
- Patients at very high risk of severe form of SARS-CoV-2
- Aggressive lymphomas (all types)
- Acute lymphocytic leukemia
- Acute myeloid leukemia
- Acute promyelocytic leukemia
- T-cell prolymphocytic leukemia
- Primary lymphoma of the central nervous system
- Stem cell transplant
- Light chain amyloidosis
- Chronic lymphocytic leukemia
- Multiple myeloma
- +20 more criteria
You may not qualify if:
- Opposition formulated (following receipt of the study information note)
- Patients who received convalescent plasma as first-line treatment for SARS-CoV-2 infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
CHU Angers
Angers, 49000, France
CHU Caen
Caen, 14000, France
Hôpital Pasteur, Colmar
Colmar, 68000, France
CHD Vendée (La Roche sur Yon)
La Roche-sur-Yon, 85000, France
CHRU Lille
Lille, 59000, France
CHU Nord Marseille
Marseille, 13000, France
CHU Nantes
Nantes, 44000, France
CHU Nîmes Caremeau
Nîmes, 30000, France
Hôpital Saint-Louis
Paris, 75010, France
Hôpital Necker-Enfants Malades
Paris, 75015, France
Hôpital Bichat
Paris, 75018, France
CH Périgueux
Périgueux, 24000, France
CHU Poitiers
Poitiers, 86000, France
CHU Reims
Reims, 51100, France
CHU Sud Réunion
Saint-Pierre, 97410, France
CHU Toulouse
Toulouse, 31000, France
Related Publications (4)
Bertagnolio S, Thwin SS, Silva R, Nagarajan S, Jassat W, Fowler R, Haniffa R, Reveiz L, Ford N, Doherty M, Diaz J. Clinical features of, and risk factors for, severe or fatal COVID-19 among people living with HIV admitted to hospital: analysis of data from the WHO Global Clinical Platform of COVID-19. Lancet HIV. 2022 Jul;9(7):e486-e495. doi: 10.1016/S2352-3018(22)00097-2. Epub 2022 May 10.
PMID: 35561704BACKGROUNDDeWolf S, Laracy JC, Perales MA, Kamboj M, van den Brink MRM, Vardhana S. SARS-CoV-2 in immunocompromised individuals. Immunity. 2022 Oct 11;55(10):1779-1798. doi: 10.1016/j.immuni.2022.09.006. Epub 2022 Sep 13.
PMID: 36182669BACKGROUNDMacKenna B, Kennedy NA, Mehrkar A, Rowan A, Galloway J, Matthewman J, Mansfield KE, Bechman K, Yates M, Brown J, Schultze A, Norton S, Walker AJ, Morton CE, Harrison D, Bhaskaran K, Rentsch CT, Williamson E, Croker R, Bacon S, Hickman G, Ward T, Davy S, Green A, Fisher L, Hulme W, Bates C, Curtis HJ, Tazare J, Eggo RM, Evans D, Inglesby P, Cockburn J, McDonald HI, Tomlinson LA, Mathur R, Wong AYS, Forbes H, Parry J, Hester F, Harper S, Douglas IJ, Smeeth L, Lees CW, Evans SJW, Goldacre B, Smith CH, Langan SM. Risk of severe COVID-19 outcomes associated with immune-mediated inflammatory diseases and immune-modifying therapies: a nationwide cohort study in the OpenSAFELY platform. Lancet Rheumatol. 2022 Jul;4(7):e490-e506. doi: 10.1016/S2665-9913(22)00098-4. Epub 2022 Jun 9.
PMID: 35698725BACKGROUNDEvans RA, Dube S, Lu Y, Yates M, Arnetorp S, Barnes E, Bell S, Carty L, Evans K, Graham S, Justo N, Moss P, Venkatesan S, Yokota R, Ferreira C, McNulty R, Taylor S, Quint JK. Impact of COVID-19 on immunocompromised populations during the Omicron era: insights from the observational population-based INFORM study. Lancet Reg Health Eur. 2023 Oct 13;35:100747. doi: 10.1016/j.lanepe.2023.100747. eCollection 2023 Dec.
PMID: 38115964BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cléa Melenotte, M.D.
Assistance Publique - Hôpitaux de Paris
- STUDY DIRECTOR
Clémentine de La Porte, M.D.
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2024
First Posted
November 12, 2024
Study Start
December 1, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
September 12, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share