Actively Recruiting
OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial
Led by ANRS, Emerging Infectious Diseases · Updated on 2026-02-23
256
Participants Needed
18
Research Sites
217 weeks
Total Duration
On this page
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 DAA (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 COVID-19.
CONDITIONS
Official Title
OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Laboratory confirmed SARS-CoV-2 infection by RT-PCR or positive antigenic test
- Asymptomatic or mild to moderate COVID-19 (WHO progression scale less than 5)
- At least 16 years old (18 years old for patients in Italy and Norway)
- Immunocompromised as defined by one or more risk factors for severe COVID-19 including diseases or treatments causing immune suppression
- Willing and able to comply with study requirements and restrictions as described in the informed consent form
- Enrolled in or beneficiary of a Social Security program or holder of health insurance
- Participant or legal representative has signed the informed consent form
You will not qualify if you...
- SARS-CoV-2 PCR with cycle threshold 30 or higher at screening
- Hypersensitivity to study drugs or their components
- Body weight under 40 kg
- Elevated liver enzymes (AST and/or ALT more than 5 times the upper limit)
- Cirrhosis with Child-Pugh score C
- Taking or expected to require prohibited therapies
- Participation in another interventional clinical study with investigational treatment within 28 days before or 10 days after inclusion
- Any condition that would prevent or limit study assessments or is not in the participant's best interest
- Received antiviral treatments against SARS-CoV-2 within 14 days before inclusion (except one or two doses of nirmatrelvir/ritonavir within 24 hours before inclusion)
- Pregnant or breastfeeding female
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Saint-André Hospital
Bordeaux, Bordeaux, France, 33075
Actively Recruiting
2
Pellegrin Hospital
Bordeaux, Bordeaux, France, 33076
Actively Recruiting
3
Francois Mitterrand Hospital
Dijon, Dijon, France, 21079
Actively Recruiting
4
Croix Rousse Hospital
Lyon, Lyon, France, 69317
Actively Recruiting
5
La Colombière Hospital
Montpellier, Montpellier, France, 34295
Actively Recruiting
6
Hotel Dieu Hospital
Nantes, Nantes, France, 44093
Actively Recruiting
7
Laribosière Hospital
Paris, Paris, France, 75010
Actively Recruiting
8
Saint Antoine Hospital
Paris, Paris, France, 75012
Actively Recruiting
9
Pitié-Salpêtrière Hospital
Paris, Paris, France, 75013
Actively Recruiting
10
Saint Louis Hospital
Paris, Paris, France, 75474
Actively Recruiting
11
Bichat Claude-Bernard Hospital
Paris, Paris, France, 75877
Actively Recruiting
12
Robert Debré Hospital
Reims, Reims, France, 51092
Actively Recruiting
13
Purpan Hospital
Toulouse, Toulouse, France, 31059
Actively Recruiting
14
Tourcoing Hospital
Tourcoing, Tourcoing, France, 59208
Actively Recruiting
15
Division of Infectious Diseases, Verona University Hospital
Verona, Italy
Actively Recruiting
16
Drammen Hospital, Vestre Viken Hospital
Drammen, Norway, 3004
Actively Recruiting
17
Oslo University Hospital and University of Oslo
Oslo, Norway, 0372
Actively Recruiting
18
Vestfold Hospital Trust
Tønsberg, Norway, 3103
Actively Recruiting
Research Team
D
Douae Ammour
CONTACT
C
Chiara Fedeli
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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