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.
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
Opposition formulated (following receipt of the study information note)
Patients who received convalescent plasma as first-line treatment for SARS-CoV-2 infection
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.
Case-only
Retrospective
Collection of data from the patient's medical file
Other interventionCollection of data from the patient's medical file
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.
Mortality at 30 days of diagnosis
Mortality at 30 days of diagnosis
Tolerance of antiviral treatments against SARS-CoV-2
Rate of serious side effects within 6 months (grade 3 and 4 on adverse event scale).
Evaluate virological evolution
Decrease or negativity of PCR between D2 and D30 following the first line of anti-SARS-CoV-2 therapy, then at D60.
Evaluate radiological evolution
Reduction or disappearance of radiological lung lesions after the first line of therapy.
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Assistance Publique - Hôpitaux de Paris
Lead sponsor
URC-CIC Paris Descartes Necker Cochin
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
