OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial
NCT ID: NCT05587894
Last Updated: 2024-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
256 participants
INTERVENTIONAL
2023-04-27
2025-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nirmatrelvir/r 5 days alone
Paxlovid 5 days
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 10 days alone
Paxlovid 10 days
Nirmatrelvir/r 300mg/100 mg bid will be given for 10 days, orally.
Nirmatrelvir/r 5 days + remdesivir s.d
Paxlovid 5 days
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.
Veklury
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.
Nirmatrelvir/r 10 days + remdesivir s.d
Paxlovid 10 days
Nirmatrelvir/r 300mg/100 mg bid will be given for 10 days, orally.
Veklury
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.
Interventions
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Paxlovid 5 days
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 days
Nirmatrelvir/r 300mg/100 mg bid will be given for 10 days, orally.
Veklury
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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)
3. ≥ 16 years of age;
4. 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)
* Severe immunosuppression (e.g., HIV infection with CD4 + T cell count \<350 / µl)
* Neutropenia (\<1000 neutrophils / µl) ≥1 week
* Lymphocytopenia (\<200 lymphocytes/µl)
* 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
5. Willing and able to comply with study requirements and restrictions as described in the informed consent form (ICF)
6. 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
7. Participant's or its legal representative's signature of the informed consent form
Exclusion Criteria
2. Hypersensitivity to study drugs (active substance(s) or excipients)
3. Body weight \< 40 kg
4. AST or ALT \> 5 times the upper limit
5. Cirrhosis Child-Pugh score C
6. Is taking or is anticipated to require any prohibited therapies\*
7. Participation in another interventional clinical study through Day 28 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
8. 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
9. 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.
10. Pregnant or breastfeeding female
* Study SOPs based on recommendations from the Liverpool COVID-19 interactions, French Society for Pharmacology and Therapeutics and French Speaking Transplantation society will be provided to guide investigators
16 Years
ALL
No
Sponsors
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University Hospital, Geneva
OTHER
ANRS, Emerging Infectious Diseases
OTHER_GOV
Responsible Party
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Alexandra Calmy
HIV/AIDS Unit Director
Locations
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Saint-André Hospital
Bordeaux, , France
Pellegrin Hospital
Bordeaux, , France
Francois Mitterrand Hospital
Dijon, , France
Croix Rousse Hospital
Lyon, , France
La Colombière Hospital
Montpellier, , France
Hotel Dieu Hospital
Nantes, , France
Laribosière Hospital
Paris, , France
Saint Antoine Hospital
Paris, , France
Pitié-Salpêtrière Hospital
Paris, , France
Saint Louis Hospital
Paris, , France
Bichat Claude-Bernard Hospital
Paris, , France
Robert Debré Hospital
Reims, , France
Purpan Hospital
Toulouse, , France
Tourcoing Hospital
Tourcoing, , France
Basel University Hospital
Basel, , Switzerland
University Hospitals of Geneva
Geneva, , Switzerland
University Hospital CHUV
Lausanne, , Switzerland
University Hospital Zurich
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CT-2022-501408-81-01
Identifier Type: REGISTRY
Identifier Source: secondary_id
ANRS 0176s OPTICOV
Identifier Type: -
Identifier Source: org_study_id
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