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)

September 5, 2025 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Collection of data from the patient's medical file
Collection of data from the patient's medical file

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical evolution of immunocompromised patients receiving remdesivir and/or nirmatrelvir/ritonavir as curative treatment for COVID-19
Time Frame: 37 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality at 30 days of diagnosis
Time Frame: 30 days
Mortality at 30 days of diagnosis
30 days
Tolerance of antiviral treatments against SARS-CoV-2
Time Frame: 6 months
Rate of serious side effects within 6 months (grade 3 and 4 on adverse event scale).
6 months
Evaluate virological evolution
Time Frame: 60 days
Decrease or negativity of PCR between D2 and D30 following the first line of anti-SARS-CoV-2 therapy, then at D60.
60 days
Evaluate radiological evolution
Time Frame: 90 days
Reduction or disappearance of radiological lung lesions after the first line of therapy.
90 days
Clinical relapse at discharge from hospital, at D30 and D60
Time Frame: 90 days
Modified (suitable for immunocompromised patients ) OSCI score (Ordinal Scale for Clinical Improvement of the World Health Organization, score from 0 - non infected patient to 8 - deceased patient)at hospital discharge, D30 and D60. Maximum modified OSCI score between H48 and D30.
90 days
Identified factors associated with favorable evolution
Time Frame: 90 days
Description of clinical evolution adjusted for age and other variables of interest.
90 days
Infectious complications and secondary non-infectious complications
Time Frame: 90 days

Incidence of infectious complications (aspergillosis and bacterial infections) and secondary non-infectious complications.

Collection of the following elements:

  • Use of a second line of therapy (antivirals and plasma therapy) specifying the time after the first line
  • occurrence of complications during the initial hospitalization after the first line of therapy: pulmonary embolism, hospitalization in the Intensive Care Unit, probable or proven invasive fungal infections (aspergillosis, mucormycosis with initiation of antifungal treatment), bacterial infection (antibiotics initiated)
  • persistence of viral carriage (> 3 weeks and >8 weeks)
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC Necker Cochin, France

Investigators

  • Principal Investigator: Cléa Melenotte, M.D., Assistance Publique - Hopitaux de Paris
  • Study Director: Clémentine de La Porte, M.D., Assistance Publique - Hopitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

November 5, 2024

First Submitted That Met QC Criteria

November 9, 2024

First Posted (Actual)

November 12, 2024

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 5, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP241194

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Immunocompromised Patients

Clinical Trials on Collection of data from the patient's medical file

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe