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Could longer or stronger antivirals beat COVID in vulnerable patients?

NCT ID NCT05587894

Disease control Sponsor: ANRS, Emerging Infectious Diseases Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether giving a longer course (10 days instead of 5) or adding another antiviral (remdesivir) to the standard Paxlovid treatment helps immunocompromised people clear COVID-19 faster. About 256 adults with mild or no symptoms will be randomly assigned to different treatment plans. The main goal is to see if the virus is gone by day 10.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Paxlovid (nirmatrelvir/ritonavir) and remdesivir
What this could lead to
If successful, this could show that a longer course or combination of antivirals helps immunocompromised people clear COVID-19 faster and avoid severe illness.
What could go wrong
This is a Phase 2 trial with only 256 participants, so results are preliminary. The added drugs may cause more side effects or not improve outcomes significantly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 256 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Laboratory confirmed SARS-CoV-2 infection by RT-PCR or positive antigenic test (commercialized assay) 2. Asymptomatic or mild to moderate COVID-19 (WHO progression scale \<5. Patients receiving oxygen therapy for reasons other than a pulmonary COVID-19 are eligible). 3. ≥ 16 years of age (for patients recruited in Italy and in Norway, ≥ 18 years of age); 4. Immunocompromised as defined by ≥ 1 risk factors for severe COVID-19 as assessed by the FOPH list (criteria 5: diseases/treatments leading to immune suppression) or other immunosuppression criteria such as Severe immunosuppression (e.g., HIV infection with CD4 + T cell count \<350 / µl) Neutropenia (\<1000 neutrophils / µl) ≥1 week Lymphocytopenia (\<200 lymphocytes/µl) On dialysis treatment Hereditary immunodeficiencies Intake of drugs which suppress the immune system (e.g. glucocorticoids for a long time \[an equivalent dose of prednisone \>20 mg/day \> 3 months\], monoclonal antibodies, cytostatics, biological products, everolimus, mTOR inhibitors etc.) in the last 12 months Active cancer under cytostatics or targeted therapy known to be immunosuppressive (e.g., platinum salts, cyclophosphamide, anthracyclines, taxanes, 5-fluorouracil, gemcitabine, purine inhibitors, proteasome inhibitors) or associated with hematologic toxicity (neutropenia, lymphopenia), for example sunitinib, imatinib, regorafenib. Aggressive lymphomas (all types) Acute lymphatic leukemia Acute myeloid leukemia Acute promyelocytic leukemia T prolymphocytic leukemia Primary central nervous system lymphoma Stem cell transplantation Light chain amyloidosis Chronic lymphoid leukemia Multiple myeloma Sickle cell disease Bone marrow transplant Organ transplant Being on the waiting list for an organ transplant 5. Willing and able to comply with study requirements and restrictions as described in the informed consent form (ICF) 6. Enrolled in or a beneficiary of a Social Security program (State Medical Aid (AME) is not a Social Security program) or holders of health insurance (LAF for participants recruited in Norway). 7. Participant's or its legal representative's signature of the informed consent form Exclusion Criteria: 1. SARS-CoV-2 PCR ≥30 CT at screening 2. Hypersensitivity to study drugs (active substance(s) or excipients) 3. Body weight \< 40 kg 4. AST and/or ALT \> 5 times the upper limit 5. Cirrhosis Child-Pugh score C 6. Is taking or is anticipated to require any prohibited therapies\*. 7. Participation in another interventional clinical study with an investigational compound or device, including COVID-19 therapeutics, where the study intervention is performed in the 28 days preceding the inclusion and the 10 days after the inclusion. Investigators of the different clinical studies should agree on participant's inclusion. 8. Presence of any condition for which, in the opinion of the investigator, participation would not be in participant's best interest or that could prevent, limit, or confound the protocol-specified assessments 9. Having received antiviral treatments against SARS-CoV-2 in the 14 days before the inclusion with exception of those having received one or two doses of nirmatrevir/r in the 24h preceding the inclusion in the study. 10. Pregnant or breastfeeding female * Study SOPs based on recommendations from the Liverpool COVID-19 interactions, French Society for Pharmacology and Therapeutics (https://sfpt-fr.org/recommandations-et-publications) and French Speaking Transplantation Society will be provided to guide investigators.

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Conditions

The condition(s) this trial relates to.

COVID-19 immunodeficiency disease inborn error of immunity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID-19 Immunodeficiency

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bichat Claude-Bernard Hospital

    RECRUITING

    Paris, Paris, 75877, France

  • Croix Rousse Hospital

    RECRUITING

    Lyon, Lyon, 69317, France

  • Division of Infectious Diseases, Verona University Hospital

    RECRUITING

    Verona, Italy

  • Drammen Hospital, Vestre Viken Hospital

    RECRUITING

    Drammen, 3004, Norway

  • Francois Mitterrand Hospital

    RECRUITING

    Dijon, Dijon, 21079, France

  • Hotel Dieu Hospital

    RECRUITING

    Nantes, Nantes, 44093, France

  • La Colombière Hospital

    RECRUITING

    Montpellier, Montpellier, 34295, France

  • Laribosière Hospital

    RECRUITING

    Paris, Paris, 75010, France

  • Oslo University Hospital and University of Oslo

    RECRUITING

    Oslo, 0372, Norway

  • Pellegrin Hospital

    RECRUITING

    Bordeaux, Bordeaux, 33076, France

  • Pitié-Salpêtrière Hospital

    RECRUITING

    Paris, Paris, 75013, France

  • Purpan Hospital

    RECRUITING

    Toulouse, Toulouse, 31059, France

  • Robert Debré Hospital

    RECRUITING

    Reims, Reims, 51092, France

  • Saint Antoine Hospital

    RECRUITING

    Paris, Paris, 75012, France

  • Saint Louis Hospital

    RECRUITING

    Paris, Paris, 75474, France

  • Saint-André Hospital

    RECRUITING

    Bordeaux, Bordeaux, 33075, France

  • Tourcoing Hospital

    RECRUITING

    Tourcoing, Tourcoing, 59208, France

  • Vestfold Hospital Trust

    RECRUITING

    Tønsberg, 3103, Norway

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