NCT07406217 OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients
| NCT ID | NCT07406217 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Calmy Alexandra |
| Condition | COVID-19 |
| Study Type | INTERVENTIONAL |
| Enrollment | 256 participants |
| Start Date | 2023-04-27 |
| Primary Completion | 2026-04-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 256 participants in total. It began in 2023-04-27 with a primary completion date of 2026-04-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The overall purpose of the trial is to evaluate the efficacy and safety of possible combination antiviral therapy direct antiviral agents (remdesivir + nirmatrelvir/r) versus the reference monotherapy (nirmatrelvir/r alone) and to assess the efficacy and safety of increasing the nirmatrelvir/r course from 5- to 10 days in immunocompromised patients diagnosed with asymptomatic or mild to moderate Coronavirus Disease 2019 (COVID-19).
Eligibility Criteria
Inclusion Criteria: 1. Laboratory confirmed SARS-CoV-2 infection by real time 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; 4. Immunocompromised as defined by ≥ 1 risk factors for severe COVID-19 as assessed by the Federal Office of Public Health (FOPH) list (criteria 5: diseases/treatments leading to immune suppression) or other immunosuppression criteria such as: * Severe immunosuppression (e.g., human immunodeficiency virus (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. 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 (Aspartate transaminase) and/or alanine transaminase (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
Contact & Investigator
Alexandra Calmy, MD PhD
PRINCIPAL INVESTIGATOR
Hopitaux Universitaires de Genève
Frequently Asked Questions
Who can join the NCT07406217 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying COVID-19. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07406217 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07406217 currently recruiting?
Yes, NCT07406217 is actively recruiting participants. Contact the research team at alexandra.calmy@hug.ch for enrollment information.
Where is the NCT07406217 trial being conducted?
This trial is being conducted at Basel, Switzerland, Geneva, Switzerland, Lausanne, Switzerland, Zurich, Switzerland.
Who is sponsoring the NCT07406217 clinical trial?
NCT07406217 is sponsored by Calmy Alexandra. The principal investigator is Alexandra Calmy, MD PhD at Hopitaux Universitaires de Genève. The trial plans to enroll 256 participants.
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