AzTrials
AzTrials

Immunocompromised PatientsCOV-IDNCT06683937

Evaluation of Direct Antiviral Treatments Against SARS-CoV-2 in Immunocompromised Patients With Covid-19.

An observational study of Immunocompromised Patients and SARS-CoV-2 Disease, run by Assistance Publique - Hôpitaux de Paris at 18 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Collection of data from the patient's medical file
How many people
327 participants
Where
18 sitesFrance
Study dates
14 Dec 2024to 18 Jul 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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)
Show all 35Show fewer
  • 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)

Who cannot join

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

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

France18 sites
  • CHU Angers

    Angers, 49000

  • Hôpital Pasteur, Colmar

    Colmar, 68000

  • Hôpital Henri Mondor

    Créteil, 94000

  • CHD Vendée (La Roche sur Yon)

    La Roche-sur-Yon, 85000

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270

  • CHRU Lille

    Lille, 59000

  • CHU Nord Marseille

    Marseille, 13000

  • CHU Nantes

    Nantes, 44000

  • CHU Nîmes Caremeau

    Nîmes, 30000

  • Hôpital Saint-Louis

    Paris, 75010

  • Hôpital Saint Antoine

    Paris, 75012

  • Hôpital Necker-Enfants Malades

    Paris, 75015

  • Hôpital Bichat

    Paris, 75018

  • CH Périgueux

    Périgueux, 24000

  • CHU Poitiers

    Poitiers, 86000

  • CHU Reims

    Reims, 51100

  • CHU Sud Réunion

    Saint-Pierre, 97410

  • CHU Toulouse

    Toulouse, 31000

Other trials in France

About this study

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

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.

Read the 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.

Being tested
Collection of data from the patient's medical file
Keywords
Immunocompromised patients, SARS-CoV-2 disease, Mono- or dual therapy with nirmatrelvir/ritonavir or remdesivir
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Collection of data from the patient's medical fileOther

    Collection of data from the patient's medical file

Study groups in NCT06683937
Study groupRoleWhat they receive
PatientsAdult patients at very high risk of severe SARS-CoV-2 disease, hospitalized for SARS-CoV-2 infection from June 2023 to April 2024.
Receives: Other: Collection of data from the patient's medical file

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 37 days

Secondary outcomes (7)
  1. Mortality at 30 days of diagnosis

    Mortality at 30 days of diagnosis

    Measured: 30 days

  2. Tolerance of antiviral treatments against SARS-CoV-2

    Rate of serious side effects within 6 months (grade 3 and 4 on adverse event scale).

    Measured: 6 months

  3. 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.

    Measured: 60 days

  4. Evaluate radiological evolution

    Reduction or disappearance of radiological lung lesions after the first line of therapy.

    Measured: 90 days

  5. Clinical relapse at discharge from hospital, at D30 and D60

    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.

    Measured: 90 days

  6. Identified factors associated with favorable evolution

    Description of clinical evolution adjusted for age and other variables of interest.

    Measured: 90 days

  7. Infectious complications and secondary non-infectious complications

    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)

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2024
  2. Study start14 Dec 2024
  3. Primary completion18 Jul 2025
  4. Study completion18 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
327 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06683937
Sponsor's protocol ID
APHP241194
Acronym
COV-ID
Status last verified
Sep 2026
First submitted
5 Nov 2024
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35561704
  • 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.

    PubMed 36182669
  • 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.

    PubMed 35698725
  • 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.

    PubMed 38115964

Questions about this trial

What is this clinical trial studying?

An observational study of Immunocompromised Patients and SARS-CoV-2 Disease, run by Assistance Publique - Hôpitaux de Paris at 18 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 35 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical evolution of immunocompromised patients receiving remdesivir and/or nirmatrelvir/ritonavir as curative treatment for COVID-19 (time frame: 37 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06683937, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in