RecruitingPhase 2NCT07406217

OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients

OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial: the SWISS OPTICOV Study

Sponsor

Calmy Alexandra

Enrollment

256 participants

Start Date

Apr 27, 2023

Study Type

INTERVENTIONAL

Conditions

COVID-19 Immunodeficiency

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).

Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Paxlovid 10 days and a drug called Paxlovid 5 days for people with covid-19 and immunodeficiency. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 16 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPaxlovid 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.

DRUGPaxlovid 10 days

Nirmatrelvir/r 300mg/100 mg bid will be given for 10 days, orally.