OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial
Launched by ANRS, EMERGING INFECTIOUS DISEASES · Oct 18, 2022
Trial Information
Current as of July 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called the OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients, is exploring how well certain antiviral treatments work for patients who have COVID-19 and are immunocompromised, meaning their immune systems are weakened. Specifically, the study is comparing a combination of two antiviral medications (remdesivir and nirmatrelvir/r) to the standard treatment of nirmatrelvir/r alone. It is also looking at whether extending the treatment period of nirmatrelvir/r from 5 days to 10 days can improve outcomes for these patients.
To be eligible for this trial, participants need to be at least 16 years old and have been diagnosed with COVID-19 through a test. They must also have mild to moderate symptoms and have one or more risk factors that compromise their immune system, such as certain cancers or ongoing treatments that weaken immunity. Participants will undergo regular check-ups during the trial to monitor their health and how well the treatments are working. This study is currently looking for volunteers, and it aims to provide valuable information on how to better treat COVID-19 in individuals with weakened immune systems.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Laboratory confirmed SARS-CoV-2 infection by RT-PCR or positive antigenic test
- • 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;
- • 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)
- • Severe immunosuppression (e.g., HIV infection with CD4 + T cell count \<350 / µl)
- • Neutropenia (\<1000 neutrophils / µl) ≥1 week
- • Lymphocytopenia (\<200 lymphocytes/µl)
- • 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
- • 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 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 through Day 28 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 and French Speaking Transplantation society will be provided to guide investigators
About Anrs, Emerging Infectious Diseases
ANRS, the French National Agency for Research on AIDS and Viral Hepatitis, is a prominent research organization dedicated to advancing scientific knowledge and public health responses to emerging infectious diseases. With a focus on enhancing understanding, prevention, and treatment of viral infections, ANRS conducts and supports innovative clinical trials that address urgent health challenges. By fostering collaboration among researchers, healthcare professionals, and institutions, ANRS aims to translate research findings into effective strategies that improve patient outcomes and inform public health policies. Their commitment to addressing the dynamic landscape of infectious diseases positions them as a leader in global health research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Paris, , France
Lyon, , France
Paris, , France
Basel, , Switzerland
Bordeaux, , France
Toulouse, , France
Bordeaux, , France
Nantes, , France
Zürich, , Switzerland
Tourcoing, , France
Geneva, , Switzerland
Dijon, , France
Montpellier, , France
Paris, , France
Paris, , France
Paris, , France
Reims, , France
Lausanne, , Switzerland
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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