OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients
NCT07406217 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 256
Last updated 2026-02-18
Summary
The overall purpose of the trial is to evaluate the efficacy and safety of possible combination antiviral therapy direct antiviral agents (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 Coronavirus Disease 2019 (COVID-19).
Conditions
- COVID-19
- Immunodeficiency
Interventions
- DRUG
-
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.
- DRUG
-
Paxlovid 10 days
Nirmatrelvir/r 300mg/100 mg bid will be given for 10 days, orally.
Sponsors & Collaborators
-
ANRS, Emerging Infectious Diseases
collaborator OTHER_GOV -
Calmy Alexandra
lead OTHER
Principal Investigators
-
Alexandra Calmy, MD PhD · Hopitaux Universitaires de Genève
-
Nina Khanna, MD PhD · Basel University Hospital
-
Nicolas Muller, MD PhD · University of Zurich
-
Oriol Manuel, MD PhD · University Hospital CHUV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-27
- Primary Completion
- 2026-04-10
- Completion
- 2026-06-30
Countries
- Switzerland
Study Locations
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