Actively Recruiting
OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial: the SWISS OPTICOV Study
Led by Calmy Alexandra · Updated on 2026-02-18
256
Participants Needed
4
Research Sites
11 weeks
Total Duration
On this page
Sponsors
C
Calmy Alexandra
Lead Sponsor
A
ANRS, Emerging Infectious Diseases
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of combining two antiviral drugs, remdesivir and nirmatrelvir/ritonavir (nirmatrelvir/r), compared to using nirmatrelvir/r alone. The study focuses on immunocompromised patients who have been diagnosed with asymptomatic or mild to moderate COVID-19. The goal is to see if the combination therapy or extending the duration of nirmatrelvir/r treatment from 5 to 10 days can better reduce the presence of the virus in patients. Participants in this randomized, controlled trial receive one of four treatment plans: nirmatrelvir/r for 5 days, nirmatrelvir/r for 10 days, nirmatrelvir/r for 5 days plus a single dose of remdesivir, or nirmatrelvir/r for 10 days plus a single dose of remdesivir. The oral nirmatrelvir/r is given twice daily, and remdesivir is administered as a single intravenous dose. The study is conducted in several European countries and also includes an exploratory cohort for patients who are not randomized or choose not to participate. During the study, participants are monitored through regular viral testing using PCR from nasal swabs at multiple time points including day 5, day 10, and beyond. Clinical evaluations occur up to day 90 to track symptoms and outcomes. The primary measurement is the viral positivity rate at day 10. Researchers assess safety and viral response throughout the study, which aims to last until mid-2026.
CONDITIONS
Brief Title
OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Laboratory confirmed SARS-CoV-2 infection by real time RT-PCR or positive antigenic test
- Asymptomatic or mild to moderate COVID-19 (WHO progression scale less than 5)
- Age 16 years or older
- Immunocompromised status defined by one or more risk factors for severe COVID-19 or immunosuppression criteria such as severe immunosuppression, neutropenia, lymphocytopenia, dialysis, hereditary immunodeficiencies, immunosuppressive drugs, active cancer treatments, certain blood cancers, organ or bone marrow transplants, sickle cell disease, or waiting list for organ transplant
- Willing and able to comply with study requirements and restrictions
- Enrolled in or beneficiary of a Social Security program or health insurance
- Signed informed consent form by participant or legal representative
You will not qualify if you...
- SARS-CoV-2 PCR cycle threshold greater than or equal to 30 at screening
- Hypersensitivity to study drugs or their components
- Body weight less than 40 kg
- Liver enzymes (AST or ALT) more than 5 times the upper limit
- Cirrhosis Child-Pugh score C
- Taking or expected to require prohibited therapies
- Participation in another interventional clinical study with investigational treatment within 28 days before or 10 days after inclusion
- Any condition that, in the investigator's opinion, would prevent safe participation or confound assessments
- Received antiviral treatments against SARS-CoV-2 in the 14 days before inclusion except one or two doses of nirmatrelvir/r within 24 hours before inclusion
- Pregnant or breastfeeding females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 to 10 days
Participants receive antiviral treatment with nirmatrelvir/ritonavir for either 5 or 10 days, with or without a single intravenous dose of remdesivir.
Visits on Day 1, Day 5, and Day 10 during treatment
Duration - Up to 90 days
Participants are monitored for virological and clinical outcomes after treatment ends.
Follow-up visits on Days 14, 21, 28, and 90
Trial Site Locations
Total: 4 locations
1
Basel University Hospital
Basel, Basel, Switzerland, 4031
Actively Recruiting
2
Hôpitaux Universitaires de Genève
Geneva, Canton of Geneva, Switzerland, 1205
Actively Recruiting
3
CHUV
Lausanne, Canton of Vaud, Switzerland, 10-549
Actively Recruiting
4
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland, 8091
Actively Recruiting
Research Team
A
Alexandra Calmy, MD PhD
C
Chiara Fedeli, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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