Study of ibuzatrelvir alone or combined with remdesivir in adults with COVID-19 who have severely compromised immune systems

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What is this study about?

This study focuses on treating people with COVID-19 who have severely weakened immune systems. The research evaluates two medications: ibuzatrelvir, which is taken as a tablet by mouth, and remdesivir, which is given through a vein as an infusion. Some participants will receive ibuzatrelvir alone, some will receive both medications together, and others will receive placebo.

The purpose of this research is to determine how well ibuzatrelvir works when used alone or combined with remdesivir in treating COVID-19 symptoms and reducing the amount of virus in people with weakened immune systems. The study includes people who have received organ transplants, those with blood cancers, individuals who have received certain cancer treatments, or those taking medications that affect their immune system.

During the study, participants will receive the study medication for up to three days. They will be monitored for changes in their COVID-19 symptoms and the amount of virus in their body. The study will track whether participants need emergency care, hospital treatment, or experience other health problems related to COVID-19. The total study period is 38 days, during which participants will have regular check-ups to monitor their health and any side effects.

1 Initial evaluation and confirmation

Your COVID-19 infection must be confirmed by a rapid antigen test (RAT) from a nasal sample taken within 2 days before starting the study

Your symptoms must have started no more than 5 days before joining the study

You must have at least one active COVID-19 symptom on the day of joining

2 Treatment assignment

You will be randomly assigned to receive one of three treatment options:

Option 1: Ibuzatrelvir tablets taken by mouth + saline solution by intravenous infusion

Option 2: Ibuzatrelvir tablets taken by mouth + Remdesivir given by intravenous infusion

Option 3: Placebo tablets + saline solution by intravenous infusion

3 Treatment period

The study will monitor your progress for 38 days

Regular nasal swabs will be collected to measure virus levels

Your COVID-19 symptoms will be tracked throughout the study period

4 Safety monitoring

Your health will be monitored for any side effects or adverse reactions

Emergency department visits related to COVID-19 will be recorded

Any need for additional treatments such as oxygen, antibiotics, or other medications will be documented

5 Final evaluation

The study will assess how quickly your symptoms improved

Final virus measurements will be taken from nasal samples

Any hospital visits or health complications during the study period will be recorded

Who Can Join the Study?

  • Must be 18 years or older
  • Must have a confirmed COVID-19 infection through a rapid antigen test (RAT) or other approved test from a nasal sample taken within 2 days before starting the study
  • Must have started experiencing COVID-19 symptoms within 5 days before joining the study and still have at least one symptom on the day of joining
  • Must be severely immunocompromised due to one of these conditions:
    • Having received an organ or islet cell transplant and currently taking medications that suppress the immune system
    • Having an active blood cancer (such as chronic lymphocytic lymphoma, non-Hodgkin lymphoma, multiple myeloma, or acute leukemia)
    • Having received special immune cell therapy (CAR-T-cell therapy) or stem cell transplant within the last 2 years, or currently taking medications that suppress the immune system
    • Currently receiving treatments that reduce B-cells (a type of immune cell) such as rituximab
  • Both men and women can participate in the study

Who Cannot Join the Study?

  • Patients under 18 years of age cannot participate
  • Individuals who have received COVID-19 antiviral treatment in the past 7 days
  • People with severe liver problems (defined as liver enzymes more than 5 times above normal levels)
  • Patients with severe kidney problems (requiring dialysis or with severely reduced kidney function)
  • Pregnant or breastfeeding women
  • Individuals with known allergies to ibuzatrelvir or remdesivir (the study medications)
  • Patients who are participating in other clinical trials
  • People who have received a COVID-19 vaccine within the last 14 days
  • Individuals with uncontrolled heart conditions
  • Patients with severe mental health conditions that could affect their ability to follow study procedures
  • People who cannot provide informed consent
  • Individuals with a history of severe reactions to similar medications
  • Patients taking medications that could interact with the study drugs
  • People with unstable medical conditions that could interfere with the study results

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Lille Lille France
Universitaetsmedizin Goettingen Goettingen Germany
Rostock University Medical Center Rostock Germany
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
Institut Jules Bordet Anderlecht Belgium
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Hospital Del Mar Barcelona Spain
Fakultna Nemocnica Trnava Trnava Slovakia
University General Hospital Of Heraklion Heraklion Greece
Nemocnica s poliklinikou Stefana Kukuru Michalovce a.s. Michalovce Slovakia
Narodny Ustav Detskych Chorob Bratislava Slovakia
Region Skane Skanes Universitetssjukhus Lund Sweden
Hippokration Hospital Athens Greece
Evangelismos S.A. Athens Greece
Odense University Hospital Odense Denmark
Alexandra Hospital Athens Greece
Karolinska University Hospital Solna Sweden
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Stichting Radboud University Medical Center Nijmegen The Netherlands
Narodny Onkologicky Ustav Bratislava Slovakia
Aalborg University Hospital Aalborg Denmark
Hospital Universitario Virgen De Valme Sevilla Spain
General University Hospital Of Patras Patras Greece
University General Hospital Of Alexandroupoli Alexandroupoli Greece
Region Midtjylland Aarhus Denmark
Rigshospitalet Copenhagen Denmark
Hospital Alvaro Cunqueiro Vigo Spain
Hopital Beaujon Clichy France
Vrije Universiteit Brussel Jette Belgium
Evangelisches Klinikum Bethel gGmbH Bielefeld Germany
Helios Universitaetsklinikum Wuppertal Wuppertal Germany
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH Villingen-Schwenningen Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH Trier Germany
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Umataptfkz Mmvmruf Cbpbvp Hknmtdevrwvzdkhxm Hamburg Germany
Unbnbaxhajormvipygzxq Artxlkgk Augsburg Germany
Lkzbc Gmnmjbi Hntmdrpf Om Akzmen Athens Greece
Ugwrxqfbjn Hxtngnvw Cjeucwo Cologne Germany
Ceelfv Hwxfdgipopp Uscljryrhicsc Dn Dcaej Dijon France
Eculoic Uniavmkfgmcv Mtjcoqi Cvgcnjm Rqjqhbiom (gzdptzs Mee Rotterdam The Netherlands
Hcczpgcn De Lc Slupo Cvlo I Stwh Pjo Barcelona Spain
Fmfivjjyb Pvab Lh Iknpkvphnygim Byrnrlecy Dyy Hnkokrei Umugoebjicscq Lb Pwc Madrid Spain
Hhrjyrtz Uvhzocdzbaido Heuvngnn Twcfq y Pgpcxz Ijxddazt Cwktlj dqicldbsbksrnbgkf (wvdv Badalona Spain
Hmjynjxa Vjql dgxwpfcw Barcelona Spain
Hfthgrga Uvsrlcwvuyehl dt A Cmrbja A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
25.09.2025
Denmark Denmark
Recruiting
25.09.2025
France France
Recruiting
25.09.2025
Germany Germany
Recruiting
25.09.2025
Greece Greece
Recruiting
25.09.2025
Slovakia Slovakia
Recruiting
25.09.2025
Spain Spain
Recruiting
25.09.2025
Sweden Sweden
Recruiting
25.09.2025
The Netherlands The Netherlands
Recruiting
25.09.2025

Trial locations

Investigated drugs:

Ibuzatrelvir is an antiviral medication being studied for treating COVID-19 in people with weakened immune systems. It works by blocking a protein that the virus needs to multiply in the body. This medication is taken orally to help fight the coronavirus infection.

Remdesivir is an established antiviral medication that is already approved for treating COVID-19. It works by interfering with the virus’s ability to copy itself. This medication is given through an intravenous (IV) line directly into the bloodstream.

The study also includes a combination therapy of ibuzatrelvir and remdesivir together, to see if using both medications provides better results than using either medication alone in people with severely compromised immune systems who have COVID-19.

COVID-19 – A respiratory disease caused by the SARS-CoV-2 virus that primarily affects the lungs and respiratory system. The infection typically begins with symptoms such as fever, cough, fatigue, and loss of taste or smell. The virus spreads mainly through respiratory droplets when infected people breathe, talk, cough, or sneeze. The disease can range from mild to severe, with some people experiencing difficulty breathing and decreased oxygen levels. In immunocompromised individuals, the infection may last longer and symptoms can be more persistent.

Trial ID:
2024-517671-21-00
Protocol code:
C5091018
Trial Phase:
Therapeutic confirmatory (Phase III)

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