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
NCT ID: NCT06683937
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
300 participants
OBSERVATIONAL
2025-12-01
2026-06-01
Brief Summary
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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.
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Detailed Description
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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.
Identifying an effective anti-SARS-CoV-2 therapeutic strategy is a real challenge in severely immunocompromised patients because clinicians are faced with chronic carriage and serious complications in these patients, as well as drug interactions with immunosuppressive treatments, the emergence of resistance and the absence of recommendations.
The data currently available in the literature remain heterogeneous and sometimes without sufficient level of evidence. However, some teams have reported in this population the efficacy of repeated or prolonged treatment with nirmatrelvir/ritonavir or even multitherapies combining several antiviral treatments and/or combinations of monoclonal antibodies on persistent carriage of the virus. Thus, some centers recommend prolonged antiviral treatments combining 5 to 10 days of remdesivir with 10 days of nirmatrelvir/ritonavir.
Nirmatrelvir/ritonavir and remdesivir are the currently available antiviral therapies that are still effective against circulating Omicron virus subvariants. It therefore seems important to have more data on their efficacy in monotherapy, dual therapy, or in the case of prolonged treatment.
The study consists of collecting patient care data from the medical record. Patients will be identified by practitioners at each participating French center.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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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.
Collection of data from the patient's medical file
Collection of data from the patient's medical file
Interventions
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Collection of data from the patient's medical file
Collection of data from the patient's medical file
Eligibility Criteria
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Inclusion Criteria
* 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
* Hematopoietic stem cell transplant
* Solid organ transplant
* Being on the waiting list for an organ transplant
* Primary immunodeficiency;
* HIV patients with CD4 \<200/mm3 or with a detectable viral load
* Lymphopenia \<200/mm3
* Neutropenia \<1000/mm3 for \> 1 week
* Patients receiving long-term immunosuppressive treatment (period of at least 3 months during treatment during infection) with:
* anti-CD20 antibodies
* anti-JAK
* BTK inhibitors
* azathioprine
* cyclophosphamide
* methotrexate
* mycophenolate mofetil
* CAR-T cell gene therapy
* bi-phenotypic therapeutic antibodies
* tacrolimus
* sirolimus
* long-term corticosteroids (prednisone equivalent dose \>5mg for 3 months)
Exclusion Criteria
* Patients who received convalescent plasma as first-line treatment for SARS-CoV-2 infection
18 Years
ALL
No
Sponsors
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URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Cléa Melenotte, M.D.
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Clémentine de La Porte, M.D.
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Locations
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CHU Angers
Angers, , France
CHU Caen
Caen, , France
Hôpital Pasteur, Colmar
Colmar, , France
CHD Vendée (La Roche sur Yon)
La Roche-sur-Yon, , France
CHRU Lille
Lille, , France
CHU Nord Marseille
Marseille, , France
CHU Nantes
Nantes, , France
CHU Nîmes Caremeau
Nîmes, , France
Hôpital Saint-Louis
Paris, , France
Hôpital Necker-Enfants Malades
Paris, , France
Hôpital Bichat
Paris, , France
CH Périgueux
Périgueux, , France
CHU Poitiers
Poitiers, , France
CHU Reims
Reims, , France
CHU Sud Réunion
Saint-Pierre, , France
CHU Toulouse
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
DeWolf 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.
MacKenna 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.
Evans 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.
Other Identifiers
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APHP241194
Identifier Type: -
Identifier Source: org_study_id
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