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ClinicalTrials.gov ID

NCT06683937

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

300Estimated

Last Update Posted

Sep 12, 2025Actual

Start Date

Dec 1, 2025Estimated

Primary Completion Date

Jun 1, 2026Estimated

Completion Date

Jun 1, 2026Estimated

Official Title

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

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.

Detailed Description

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.

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.

• Immunocompromised Patients
• SARS-CoV-2 Disease

• Collection of data from the patient's medical file

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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
  • 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:

• Opposition formulated (following receipt of the study information note)
• Patients who received convalescent plasma as first-line treatment for SARS-CoV-2 infection

Observational Model

Case-Only

Time Perspective

Retrospective

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Collaborators

URC-CIC Paris Descartes Necker CochinOTHER

riviere-f@chu-caen.fr

martin.martinot@ch-colmar.fr

sophie.leautez@ght85.fr

emmanuel.faure2@chu-lille.fr

carole.eldin@ap-hm.fr

benjamin.gaborit@chu-nantes.fr

Paul.loubet@chu-nimes.fr

laura.levi@aphp.fr

clea.melenotte@aphp.fr33142192826

nathan.peiffer-smadja@aphp.fr

claire.aguilar@ch-perigueux.fr

gwenael.le-moal@chu-poitiers.fr

mhentzien@chu-reims.fr

kevin.diallo@chu-reunion.fr

martin-blondel.g@chu-toulouse.fr