OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial
OPTICOV
2 other identifiers
interventional
256
3 countries
18
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 covid19
Started Apr 2023
Longer than P75 for phase_2 covid19
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2022
CompletedFirst Posted
Study publicly available on registry
October 20, 2022
CompletedStudy Start
First participant enrolled
April 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
February 23, 2026
February 1, 2026
3.2 years
October 17, 2022
February 19, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients with SARS-CoV-2 viral load (threshold cicle (Ct) <32) by real-time RT-PCR in nasopharyngeal swabs at Day 10 after treatment initiation.
SARS-CoV-2 viral load is measured in nasopharyngeal swabs by real-time RT-PCR
Day 10
Secondary Outcomes (17)
Percentage of patients with SARS-CoV-2 viral load (threshold cicle <32 CT) by real-time RT-PCR in nasopharyngeal swabs at Day5, Day14 and Day21 after treatment initiation
Day5, Day14 and Day21
Percentage of patients with detectable SARS-CoV-2 viremia at Day5, Day10 and Day14
Assessed for 14 days from the date of randomisation at Day5, Day10 and Day14
Decrease of SARS-CoV-2 viral load measured by copies/ml by nasopharyngeal swab at Day5, Day10, Day14, Day21 and in blood samples at Day5, Day10 and Day14 comparatively to screening
Day5, Day10, Day14, Day21
Number of de novo emergence of mutations on nasopharyngeal RT-PCR at Day5, Day10, Day14 and Day21 comparatively to screening
Day5, Day10, Day14 and Day21
Time to first negative SARS-CoV-2 RT-PCR (CT<32) until Day90
Day90
- +12 more secondary outcomes
Study Arms (4)
Nirmatrelvir/r 5 days alone
EXPERIMENTALNirmatrelvir/r 10 days alone
EXPERIMENTALNirmatrelvir/r 5 days + remdesivir s.d
EXPERIMENTALNirmatrelvir/r 10 days + remdesivir s.d
EXPERIMENTALInterventions
Nirmatrelvir/r 300mg/100 mg bid will be given for 5 days, orally. Nirmatrelvir/r is a combination of two molecules: nirmatrelvir which is a protease inhibitor (against 3CL) and ritonavir which has a booster role. Nirmatrelvir/r (marketed by Pfizer under the brand name Paxlovid®) is indicated for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk for progressing to severe COVID-19.
Nirmatrelvir/r 300mg/100 mg bid will be given for 10 days, orally.
Remdesivir "flash", 200mg, intravenous. Remdesivir (marketed by Gilead under de brand name Veklury®) is indicated in patients with pneumonia requiring supplemental oxygen (inpatients), as well as in outpatients who are at increased risk of progressing to severe COVID-19. The mode of action characterize remdesivir as a direct-acting antiviral compound.
Eligibility Criteria
You may qualify if:
- Laboratory confirmed SARS-CoV-2 infection by RT-PCR or positive antigenic test (commercialized assay)
- 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).
- ≥ 16 years of age (for patients recruited in Italy and in Norway, ≥ 18 years of age);
- 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) or other immunosuppression criteria such as Severe immunosuppression (e.g., 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
- Willing and able to comply with study requirements and restrictions as described in the informed consent form (ICF)
- 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 (LAF for participants recruited in Norway).
- Participant's or its legal representative's signature of the informed consent form
You may not qualify if:
- SARS-CoV-2 PCR ≥30 CT at screening
- Hypersensitivity to study drugs (active substance(s) or excipients)
- Body weight \< 40 kg
- AST and/or ALT \> 5 times the upper limit
- Cirrhosis Child-Pugh score C
- Is taking or is anticipated to require any prohibited therapies\*.
- 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
- Pregnant or breastfeeding female
- Study SOPs based on recommendations from the Liverpool COVID-19 interactions, French Society for Pharmacology and Therapeutics (https://sfpt-fr.org/recommandations-et-publications) and French Speaking Transplantation Society will be provided to guide investigators.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Saint-André Hospital
Bordeaux, Bordeaux, 33075, France
Pellegrin Hospital
Bordeaux, Bordeaux, 33076, France
Francois Mitterrand Hospital
Dijon, Dijon, 21079, France
Croix Rousse Hospital
Lyon, Lyon, 69317, France
La Colombière Hospital
Montpellier, Montpellier, 34295, France
Hotel Dieu Hospital
Nantes, Nantes, 44093, France
Laribosière Hospital
Paris, Paris, 75010, France
Saint Antoine Hospital
Paris, Paris, 75012, France
Pitié-Salpêtrière Hospital
Paris, Paris, 75013, France
Saint Louis Hospital
Paris, Paris, 75474, France
Bichat Claude-Bernard Hospital
Paris, Paris, 75877, France
Robert Debré Hospital
Reims, Reims, 51092, France
Purpan Hospital
Toulouse, Toulouse, 31059, France
Tourcoing Hospital
Tourcoing, Tourcoing, 59208, France
Division of Infectious Diseases, Verona University Hospital
Verona, Italy
Drammen Hospital, Vestre Viken Hospital
Drammen, 3004, Norway
Oslo University Hospital and University of Oslo
Oslo, 0372, Norway
Vestfold Hospital Trust
Tønsberg, 3103, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2022
First Posted
October 20, 2022
Study Start
April 27, 2023
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2027
Last Updated
February 23, 2026
Record last verified: 2026-02