RecruitingPhase 2NCT05587894

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

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


Sponsor

ANRS, Emerging Infectious Diseases

Enrollment

256 participants

Start Date

Apr 27, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The overall purpose of the trial is to evaluate the efficacy and safety of possible combination antiviral therapy DAA (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 COVID-19.


Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

Immunocompromised people — such as those undergoing cancer treatment, organ transplant recipients, or people with HIV — are at high risk of severe COVID-19 and can carry the virus for a long time. This randomized trial tests different combinations of antiviral medications to find out which strategy works best for treating COVID-19 in this vulnerable population. You may be eligible if: - You are 16 or older (18+ in Italy and Norway) with a confirmed COVID-19 infection - You have a mild to moderate case (not requiring oxygen specifically for COVID) - You are immunocompromised (e.g., on immunosuppressants, chemotherapy, transplant recipient, HIV with low CD4, or certain blood cancers) - You are willing and able to comply with study requirements You may NOT be eligible if: - Your COVID PCR CT value is 30 or above (meaning very low viral load) - You weigh less than 40 kg - You have severe liver disease (Child-Pugh C) or high liver enzymes (AST/ALT > 5x normal) - You have taken certain antiviral treatments for COVID in the 14 days before enrollment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

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.

DRUGVeklury

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.


Locations(18)

Saint-André Hospital

Bordeaux, Bordeaux, France

Pellegrin Hospital

Bordeaux, Bordeaux, France

Francois Mitterrand Hospital

Dijon, Dijon, France

Croix Rousse Hospital

Lyon, Lyon, France

La Colombière Hospital

Montpellier, Montpellier, France

Hotel Dieu Hospital

Nantes, Nantes, France

Laribosière Hospital

Paris, Paris, France

Saint Antoine Hospital

Paris, Paris, France

Pitié-Salpêtrière Hospital

Paris, Paris, France

Saint Louis Hospital

Paris, Paris, France

Bichat Claude-Bernard Hospital

Paris, Paris, France

Robert Debré Hospital

Reims, Reims, France

Purpan Hospital

Toulouse, Toulouse, France

Tourcoing Hospital

Tourcoing, Tourcoing, France

Division of Infectious Diseases, Verona University Hospital

Verona, Italy

Drammen Hospital, Vestre Viken Hospital

Drammen, Norway

Oslo University Hospital and University of Oslo

Oslo, Norway

Vestfold Hospital Trust

Tønsberg, Norway

View Full Details on ClinicalTrials.gov

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NCT05587894


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