COVID-19Phase 2OPTICOVNCT05587894
OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial
A Phase 2 study testing Paxlovid 5 days, Paxlovid 10 days and Veklury in people with COVID-19 and Immunodeficiency, run by ANRS, Emerging Infectious Diseases at 18 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- COVID-19, Immunodeficiency
- What is being tested?
- Paxlovid 5 days, Paxlovid 10 days and Veklury
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 18 sitesin 3 countries
- Study dates
- 27 Apr 2023to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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*.
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- 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.
- 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
- 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.
- 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.
Trial locations and contacts
18 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 3 countries
France14 sites, 14 recruiting
- Recruiting
Saint-André Hospital
Bordeaux, Bordeaux, 33075
Fabrice Bonnet, Prof. MD, +33 5 56 79 58 23, fabrice.bonnet@chu-bordeaux.fr
- Recruiting
Pellegrin Hospital
Bordeaux, Bordeaux, 33076
Didier Neau, Prof. MD, +33 5 67 95 523, didier.neau@chu-bordeaux.fr
- Recruiting
Francois Mitterrand Hospital
Dijon, Dijon, 21079
Lionel Piroth, Prof. MD, +33 3 30 29 33 05, lionel.piroth@chu-dijon.fr
- Recruiting
Croix Rousse Hospital
Lyon, Lyon, 69317
Florence Ader, Prof. MD, +33 4 72 07 11 07, florence.ader@chu-lyon.fr
- Recruiting
La Colombière Hospital
Montpellier, Montpellier, 34295
Alain Makinson, Prof. MD, +33 4 67 33 95 10, a-makinson@chu-montpellier.fr
- Recruiting
Hotel Dieu Hospital
Nantes, Nantes, 44093
Francois Raffi, Prof. MD, +33 2 40 08 33 51, francois.raffi@chu-nantes.fr
- Recruiting
Laribosière Hospital
Paris, Paris, 75010
Sandra Devantine, Dr, +33 6 18 74 00 01, sandra.devantine@aphp.fr
- Recruiting
Saint Antoine Hospital
Paris, Paris, 75012
Karine Lacombe, Prof. MD, +33 1 49 28 24 38, karine.lacombe2@aphp.fr
- Recruiting
Pitié-Salpêtrière Hospital
Paris, Paris, 75013
Valérie Pourcher, Prof MD, +33 1 42 16 41 84, valerie.martinez@aphp.fr
- Recruiting
Saint Louis Hospital
Paris, Paris, 75474
Jean-Michel Molina, Prof. MD, +33 1 42 49 90 66, jean-michel.molina@aphp.fr
- Recruiting
Bichat Claude-Bernard Hospital
Paris, Paris, 75877
Jade Ghosn, Prof. MD, +33 14 02 58 860, jade.ghosn@aphp.fr
- Recruiting
Robert Debré Hospital
Reims, Reims, 51092
Maxime Hentzien, Prof. MD, +33 6 07 85 01 77, mhentzien@chu-reims.fr
- Recruiting
Purpan Hospital
Toulouse, Toulouse, 31059
Guillaume Martin Blondel, Prof. MD, +33 5 62 74 61 46, martin-blondel.g@chu-toulouse.fr
- Recruiting
Tourcoing Hospital
Tourcoing, Tourcoing, 59208
Olivier Robineau, +33 3 20 69 46 17, orobineau@ch-tourcoing.fr
Norway3 sites, 3 recruiting
- Recruiting
Drammen Hospital, Vestre Viken Hospital
Drammen, 3004
Lars Heggelund Medical Doctor, +47 48285882 ext. +47 32803000,, Lars.heggelund@vestreviken.no
- Recruiting
Oslo University Hospital and University of Oslo
Oslo, 0372
Øyvind Molberg Medical Doctor, +47 23 07 33 24, molberg@medisin.uio.no
- Recruiting
Vestfold Hospital Trust
Tønsberg, 3103
Oeyvind Misund Hernes MD, +47 40881602, Oyvind.misund.hernes@siv.no
Italy1 site, 1 recruiting
- Recruiting
Division of Infectious Diseases, Verona University Hospital
Verona
Fulvia Mazzaferri Medical Doctor, +39 0458128243, fulvia.mazzaferri@aovr.veneto.it
About this study
Official title: OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial: the OPTICOV Study
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.
Read the detailed description
This is a randomized, controlled, factorial, superiority trial to evaluate the viral efficacy of DAA (nirmatrelvir/r) + DAA (remdesivir)∞ versus nirmatrelvir/r alone and of 5 days versus 10 days of nirmatrelvir/r in immunocompromised patients diagnosed with asymptomatic or mild to moderate COVID-19.
The primary objective is to assess whether (i) a combination antiviral therapy of two DAA (nirmatrelvir/r + remdesivir)∞ And/or (ii) an increase in nirmatrelvir/r duration from 5 to 10 days improves viral efficacy by decreasing the SARS-CoV-2 positivity rate by real time RT-PCR (CT<32) in nasopharyngeal swabs at D10.
Patients will be eligible if they are immunocompromised, have confirmed asymptomatic SARS-CoV-2 infection or mild to moderate COVID-19, regardless of symptoms onset, provided that they have no contra-indication to any of the study drugs.
A total of 256 patients will be included in France and Switzerland.
Participants not eligible for randomisation or who refuse to participate to the trial for any reason will be proposed to be included in an exploratory non comparative cohort (maximum 97 participants).
- Conditions
- COVID-19, Immunodeficiency
- Being tested
- Paxlovid 5 days, Paxlovid 10 days, Veklury
- Medical subject headings
- COVID-19, Immunologic Deficiency Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paxlovid 5 daysDrug
Also called Nirmatrevlir/ritonavir
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.
Paxlovid 10 daysDrug
Also called Nirmatrevlir/ritonavir
Nirmatrelvir/r 300mg/100 mg bid will be given for 10 days, orally.
VekluryDrug
Also called remdesivir
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.
| Study group | Role | What they receive |
|---|---|---|
| Nirmatrelvir/r 5 days alone | Experimental | Not described Receives: Drug: Paxlovid 5 days |
| Nirmatrelvir/r 10 days alone | Experimental | Not described Receives: Drug: Paxlovid 10 days |
| Nirmatrelvir/r 5 days + remdesivir s.d | Experimental | Not described Receives: Drug: Paxlovid 5 days; Drug: Veklury |
| Nirmatrelvir/r 10 days + remdesivir s.d | Experimental | Not described Receives: Drug: Paxlovid 10 days; Drug: Veklury |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
SARS-CoV-2 viral load is measured in nasopharyngeal swabs by real-time RT-PCR
Measured: Day5, Day14 and Day21
Percentage of patients with detectable SARS-CoV-2 viremia at Day5, Day10 and Day14
SARS-CoV-2 viremia is measured from plasma samples by real-time RT-PCR
Measured: 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
SARS-CoV-2 viral load is measured in nasopharyngeal swabs and in blood samples by real-time RT-PCR
Measured: Day5, Day10, Day14, Day21
Number of de novo emergence of mutations on nasopharyngeal RT-PCR at Day5, Day10, Day14 and Day21 comparatively to screening
Emergence of mutations is measured in nasopharyngeal swabs by genotyping techniques
Measured: Day5, Day10, Day14 and Day21
Time to first negative SARS-CoV-2 RT-PCR (CT<32) until Day90
SARS-CoV-2 viral load is measured in nasopharyngeal swabs by real-time RT-PCR
Measured: Day90
Absence of ability to cultivate virus from viral cultures from nasopharyngeal swabs at Day5, Day10 and Day21
Viral culture is performed from nasopharyngeal swabs samples
Measured: Day5, Day10 and Day21
Percentage of patients with sustained resolution or abatement of symptoms defined as a FLU-PRO-Plus score ≤1 at Day5, Day10, Day14, Day21 and Day28
FLU-PRO-Plus score is measured via an arithmetic formula
Measured: Day5, Day10, Day14, Day21 and Day28
All-cause hospitalization and/or death at Day28
Outcome measured during patients medical follow-up
Measured: Day28
Hospitalization at Day28
Outcome measured during patients medical follow-up
Measured: Day28
Death at Day28
Outcome measured during patients medical follow-up
Measured: Day28
Rate of Post-COVID19 condition at Day90 according to the WHO October 2021 definition
Rate of Post-COVID19 condition at Day90 according to the WHO October 2021 definition:
- Post COVID-19 condition occurs in individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis. Common symptoms include fatigue, shortness of breath, cognitive dysfunction but also others and generally have an impact on everyday functioning. Symptoms may be new onset following initial recovery from an acute COVID-19 episode or persist from the initial illness. Symptoms may also fluctuate or relapse over time.
Measured: Day 90
Percentage of participants with an adverse event (AE) or serious adverse event (SAE) or AE leading to treatment discontinuation up to Day28
Outcome measured during patients medical follow-up
Measured: Day 28
Adherence to nirmatrelvir/r with patient-reported adherence and nirmatrelvir/r residual plasma dosage at Day5 and Day10
Outcome measured by patient-reported adherence and drug residual dosage using dried spot (DBS)
Measured: Day5 and Day10
Number of DDIs who led to dosage adjustment of other patient's drugs
Outcome measured during patients medical follow-up
Measured: Assessed up to Day 10 from randomisation
Percentage of patients with specific retreatment patients (by antiviral antiinflammatory drugs or convalescent plasma through Day90
Outcome measured during patients medical follow-up
Measured: Day90
To assess the phenotypic resistance (IC50 increase) against treatment for viral strains cultured from nasopharyngeal swabs
Outcome measured in nasopharyngeal swabs by phenotyping techniques
Measured: Day5, Day10, Day14, Day21
Immunosuppressors residual concentrations, if applicable
Outcome measures in participants' blood samples
Measured: as needed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start27 Apr 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587894
- Sponsor's protocol ID
- ANRS 0176s OPTICOV
- Other IDs
- CT-2022-501408-81-01
- Acronym
- OPTICOV
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2022
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial: the OPTICOV Study
- ClinicalTrials.gov ID
- NCT05587894
- Acronym / sponsor ID
- OPTICOV / ANRS 0176s OPTICOV
- Conditions
- COVID-19, Immunodeficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized, controlled, factorial, superiority trial to evaluate the viral efficacy of DAA (nirmatrelvir/r) + DAA (remdesivir)∞ versus nirmatrelvir/r alone and of 5 days versus 10 days of nirmatrelvir/r in immunocompromised patients diagnosed with asymptomatic or mild to moderate COVID-19.
The primary objective is to assess whether (i) a combination antiviral therapy of two DAA (nirmatrelvir/r + remdesivir)∞ And/or (ii) an increase in nirmatrelvir/r duration from 5 to 10 days improves viral efficacy by decreasing the SARS-CoV-2 positivity rate by real time RT-PCR (CT<32) in nasopharyngeal swabs at D10.
Patients will be eligible if they are immunocompromised, have confirmed asymptomatic SARS-CoV-2 infection or mild to moderate COVID-19, regardless of symptoms onset, provided that they have no contra-indication to any of the study drugs.
A total of 256 patients will be included in France and Switzerland.
Participants not eligible for randomisation or who refuse to participate to the trial for any reason will be proposed to be included in an exploratory non comparative cohort (maximum 97 participants).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nirmatrelvir/r 5 days alone | Experimental | Drug: Paxlovid 5 days |
| Nirmatrelvir/r 10 days alone | Experimental | Drug: Paxlovid 10 days |
| Nirmatrelvir/r 5 days + remdesivir s.d | Experimental | Drug: Paxlovid 5 days, Drug: Veklury |
| Nirmatrelvir/r 10 days + remdesivir s.d | Experimental | Drug: Paxlovid 10 days, Drug: Veklury |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paxlovid 5 daysAlso: Nirmatrevlir/ritonavirNirmatrelvir/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. | Drug | Nirmatrelvir/r 5 days + remdesivir s.d, Nirmatrelvir/r 5 days alone |
| Paxlovid 10 daysAlso: Nirmatrevlir/ritonavirNirmatrelvir/r 300mg/100 mg bid will be given for 10 days, orally. | Drug | Nirmatrelvir/r 10 days + remdesivir s.d, Nirmatrelvir/r 10 days alone |
| VekluryAlso: remdesivirRemdesivir "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. | Drug | Nirmatrelvir/r 10 days + remdesivir s.d, Nirmatrelvir/r 5 days + remdesivir s.d |
Primary outcome
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.
Time frame: Day 10
SARS-CoV-2 viral load is measured in nasopharyngeal swabs by real-time RT-PCR
17 secondary outcomes
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
Time frame: Day5, Day14 and Day21
Percentage of patients with detectable SARS-CoV-2 viremia at Day5, Day10 and Day14
Time frame: 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
Time frame: Day5, Day10, Day14, Day21
Number of de novo emergence of mutations on nasopharyngeal RT-PCR at Day5, Day10, Day14 and Day21 comparatively to screening
Time frame: Day5, Day10, Day14 and Day21
Time to first negative SARS-CoV-2 RT-PCR (CT<32) until Day90
Time frame: Day90
Absence of ability to cultivate virus from viral cultures from nasopharyngeal swabs at Day5, Day10 and Day21
Time frame: Day5, Day10 and Day21
Percentage of patients with sustained resolution or abatement of symptoms defined as a FLU-PRO-Plus score ≤1 at Day5, Day10, Day14, Day21 and Day28
Time frame: Day5, Day10, Day14, Day21 and Day28
All-cause hospitalization and/or death at Day28
Time frame: Day28
Hospitalization at Day28
Time frame: Day28
Death at Day28
Time frame: Day28
Rate of Post-COVID19 condition at Day90 according to the WHO October 2021 definition
Time frame: Day 90
Percentage of participants with an adverse event (AE) or serious adverse event (SAE) or AE leading to treatment discontinuation up to Day28
Time frame: Day 28
Adherence to nirmatrelvir/r with patient-reported adherence and nirmatrelvir/r residual plasma dosage at Day5 and Day10
Time frame: Day5 and Day10
Number of DDIs who led to dosage adjustment of other patient's drugs
Time frame: Assessed up to Day 10 from randomisation
Percentage of patients with specific retreatment patients (by antiviral antiinflammatory drugs or convalescent plasma through Day90
Time frame: Day90
To assess the phenotypic resistance (IC50 increase) against treatment for viral strains cultured from nasopharyngeal swabs
Time frame: Day5, Day10, Day14, Day21
Immunosuppressors residual concentrations, if applicable
Time frame: as needed
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paxlovid 5 days, Paxlovid 10 days and Veklury in people with COVID-19 and Immunodeficiency, run by ANRS, Emerging Infectious Diseases at 18 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France, Norway, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Douae Ammour (+33782960531, douae.ammour@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.