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OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients
Sponsor: Calmy Alexandra
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).
Official title: OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial: the SWISS OPTICOV Study
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
256
Start Date
2023-04-27
Completion Date
2026-06-30
Last Updated
2026-02-18
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (4)
Basel University Hospital
Basel, Basel, Switzerland
Hôpitaux Universitaires de Genève
Geneva, Canton of Geneva, Switzerland
CHUV
Lausanne, Canton of Vaud, Switzerland
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland