Actively Recruiting
OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial: the OPTICOV Study
Led by ANRS, Emerging Infectious Diseases · Updated on 2026-02-23
256
Participants Needed
18
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of combination antiviral therapy using remdesivir plus nirmatrelvir/ritonavir compared to nirmatrelvir/ritonavir alone in immunocompromised patients diagnosed with asymptomatic or mild to moderate COVID-19. The study also assesses whether extending the duration of nirmatrelvir/ritonavir treatment from 5 to 10 days improves viral control. This randomized, controlled, factorial trial focuses on reducing the presence of the virus in the nose as measured by real-time RT-PCR testing. Participants receive one of four treatments: nirmatrelvir/ritonavir for 5 days, nirmatrelvir/ritonavir for 10 days, a combination of nirmatrelvir/ritonavir for 5 days plus a single dose of remdesivir, or the combination with nirmatrelvir/ritonavir for 10 days plus remdesivir. Nirmatrelvir/ritonavir is taken orally twice daily, while remdesivir is given as a one-time intravenous infusion. The trial includes an exploratory cohort for patients who do not qualify or choose not to be randomized. During the study, participants will have nasopharyngeal swabs and blood samples taken at multiple time points to measure viral load and presence of the virus. Researchers will monitor symptoms, hospitalizations, adverse events, and treatment adherence. The main outcome is the percentage of patients with a significant viral load at day 10. Follow-up visits will assess longer-term viral presence, symptom resolution, and post-COVID conditions up to day 90. The study aims to gather detailed data on antiviral treatment effects in this vulnerable population over several weeks.
CONDITIONS
Brief 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)
- Age 16 years or older (18 years or older for patients recruited in Italy and Norway)
- Immunocompromised as defined by at least one risk factor for severe COVID-19 including diseases or treatments leading to immune suppression
- Willing and able to comply with study requirements and restrictions as described in the informed consent form
- Enrolled in or a beneficiary of a Social Security program or holders of health insurance
- Signed informed consent form by participant or legal representative
You will not qualify if you...
- SARS-CoV-2 PCR cycle threshold 30 or higher at screening
- Hypersensitivity to study drugs or their components
- Body weight less than 40 kg
- Liver enzyme levels (AST and/or ALT) more than 5 times the upper limit
- Cirrhosis with Child-Pugh score C
- Use or anticipated need for prohibited therapies
- Participation in another interventional clinical study with investigational compounds within 28 days before and 10 days after inclusion
- Any condition that investigator believes would not be in participant's best interest or limit study assessments
- Received antiviral treatments against SARS-CoV-2 in the 14 days before inclusion except one or two doses of nirmatrelvir/ritonavir within 24 hours before inclusion
- Pregnant or breastfeeding female
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 to 10 days
Participants receive antiviral treatment with nirmatrelvir/ritonavir for 5 or 10 days, with or without a single dose of remdesivir.
1 baseline visit and up to 3 follow-up visits at Day 5, Day 10, and Day 14
Duration - Up to 90 days after treatment initiation
Participants are monitored for viral load, symptoms resolution, safety, and adverse events after treatment completion.
Visits at Day 14, Day 21, Day 28, and Day 90
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
C
Chiara Fedeli
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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