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 ofanti-SARS-CoV-2 antibodies, the incidence of cases and deaths related to the SARS-CoV-2virus has significantly decreased in recent months worldwide. However, these infectionsremain a major public health problem in severely immunocompromised patients, who havedecreased vaccine efficacy and are at higher risk of persistent SARS-CoV-2 viralshedding, relapses, secondary invasive fungal infection, intensive care unithospitalization, 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 inthe study in France between June 1, 2023 and April 1, 2024 and having received mono- ordual therapy with nirmatrelvir/ritonavir or remdesivir in order to carry out anevaluation of direct antiviral treatments against SARS-CoV-2 in these immunocompromisedpatients suffering from Covid-19.The study consists of collecting patient care data from the medical record. Patients willbe 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.

Not yet recruiting
Immunocompromised Patients
SARS-CoV-2 Disease

Other: Collection of data from the patient's medical file

Collection of data from the patient's medical file

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
France
Locations

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

CHU Poitiers
Poitiers, France

CH Périgueux
Périgueux, France

CHU Reims
Reims, France

CHU Sud Réunion
Saint-Pierre, France

CHU Toulouse
Toulouse, France

Contacts

Cléa Dr Melenotte, M.D.
33142192826
clea.melenotte@aphp.fr

Hélène Morel
33171196346
helene.morel@aphp.fr

Assistance Publique - Hôpitaux de Paris
NCT Number
Keywords
Immunocompromised Patients
SARS-CoV-2 disease
Mono- or dual therapy with nirmatrelvir/ritonavir or remdesivir
MeSH Terms
COVID-19