Actively Recruiting
OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients
Led by Calmy Alexandra · Updated on 2026-02-18
256
Participants Needed
4
Research Sites
165 weeks
Total Duration
On this page
Sponsors
C
Calmy Alexandra
Lead Sponsor
A
ANRS, Emerging Infectious Diseases
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Laboratory confirmed SARS-CoV-2 infection by real time RT-PCR or positive antigenic test
- Asymptomatic or mild to moderate COVID-19 (WHO progression scale less than 5; oxygen therapy allowed if for reasons other than COVID-19 lung disease)
- 16 years of age or older
- Immunocompromised with at least one risk factor for severe COVID-19 as defined by Federal Office of Public Health or other immunosuppression criteria including severe immunosuppression, neutropenia, lymphocytopenia, dialysis, hereditary immunodeficiencies, immunosuppressive drug use in last 12 months, active cancer under immunosuppressive therapy, certain hematologic malignancies, stem cell or bone marrow transplant, organ transplant or on waiting list
- Willing and able to comply with study requirements
- Enrolled in or beneficiary of a Social Security program or holder of health insurance
- Signed informed consent form by participant or legal representative
You will not qualify if you...
- SARS-CoV-2 PCR cycle threshold (CT) 30 or higher at screening
- Known hypersensitivity to study drugs or excipients
- Body weight less than 40 kg
- Elevated liver enzymes (AST and/or ALT more than 5 times upper limit)
- Cirrhosis with Child-Pugh score C
- Taking or expected to require prohibited therapies
- Participation in another interventional clinical study involving investigational treatments within 28 days before or 10 days after inclusion
- Any condition that in investigator's opinion would not be in participant's best interest or interfere with study assessments
- Received antiviral treatments against SARS-CoV-2 in 14 days before inclusion except limited recent nirmatrelvir/r use
- Pregnant or breastfeeding females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Basel University Hospital
Basel, Basel, Switzerland, 4031
Actively Recruiting
2
Hôpitaux Universitaires de Genève
Geneva, Canton of Geneva, Switzerland, 1205
Actively Recruiting
3
CHUV
Lausanne, Canton of Vaud, Switzerland, 10-549
Actively Recruiting
4
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland, 8091
Actively Recruiting
Research Team
A
Alexandra Calmy, MD PhD
CONTACT
C
Chiara Fedeli, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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