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New treatment option for COVID-19
Official title OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial
ClinicalTrials.gov ID: NCT05587894
What this study is testing
What is Paxlovid 5 days?
Paxlovid 5 days is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for covid-19.
Also referred to as Nirmatrevlir/ritonavir.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join if
- Laboratory confirmed SARS-CoV-2 infection by RT-PCR or positive antigenic test (commercialized assay)
- Asymptomatic or mild to moderate COVID-19 (WHO progression scale \<5. Patients receiving oxygen therapy for reasons other than a pulmonary COVID-19...
- ≥ 16 years of age (for patients recruited in Italy and in Norway, ≥ 18 years of age);
- Immunocompromised as defined by ≥ 1 risk factors for severe COVID-19 as assessed by the FOPH list (criteria 5: diseases/treatments leading to immune...
- Willing and able to comply with study requirements and restrictions as described in the informed consent form (ICF)
You likely can't join if
- SARS-CoV-2 PCR ≥30 CT at screening
- Hypersensitivity to study drugs (active substance(s) or excipients)
- Body weight \< 40 kg
- AST and/or ALT \> 5 times the upper limit
- Cirrhosis Child-Pugh score C
- Is taking or is anticipated to require any prohibited therapies\ .
See the full eligibility criteria
- Laboratory confirmed SARS-CoV-2 infection by RT-PCR or positive antigenic test (commercialized assay)
- Asymptomatic or mild to moderate COVID-19 (WHO progression scale \<5. Patients receiving oxygen therapy for reasons other than a pulmonary COVID-19 are eligible).
- ≥ 16 years of age (for patients recruited in Italy and in Norway, ≥ 18 years of age);
- Immunocompromised as defined by ≥ 1 risk factors for severe COVID-19 as assessed by the FOPH list (criteria 5: diseases/treatments leading to immune suppression) or other immunosuppression criteria such as Severe...
- Willing and able to comply with study requirements and restrictions as described in the informed consent form (ICF)
- Enrolled in or a beneficiary of a Social Security program (State Medical Aid (AME) is not a Social Security program) or holders of health insurance (LAF for participants recruited in Norway).
- Participant's or its legal representative's signature of the informed consent form
- SARS-CoV-2 PCR ≥30 CT at screening
- Hypersensitivity to study drugs (active substance(s) or excipients)
- Body weight \< 40 kg
- AST and/or ALT \> 5 times the upper limit
- Cirrhosis Child-Pugh score C
- Is taking or is anticipated to require any prohibited therapies\ .
- Participation in another treatment clinical study with an investigational compound or device, including COVID-19 therapeutics, where the study intervention is performed in the 28 days preceding the inclusion and the 10...
- Presence of any condition for which, in the opinion of the investigator, participation would not be in participant's best interest or that could prevent, limit, or confound the protocol-specified assessments
- Having received antiviral treatments against SARS-CoV-2 in the 14 days before the inclusion with exception of those having received one or two doses of nirmatrevir/r in the 24h preceding the inclusion in the study.
- Pregnant or breastfeeding female
- Study SOPs based on recommendations from the Liverpool COVID-19 interactions, French Society for Pharmacology and Therapeutics (https://sfpt-fr.org/recommandations-et-publications) and French Speaking Transplantation...
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, Bordeaux, France
- Dijon, Dijon, France
- Lyon, Lyon, France
- Montpellier, Montpellier, France
- Nantes, Nantes, France
- Paris, Paris, France
- Reims, Reims, France
- Toulouse, Toulouse, France
- Tourcoing, Tourcoing, France
- Verona, Italy
- Drammen, Norway
- Oslo, Norway
- Tønsberg, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, Bordeaux, France; Dijon, Dijon, France; Lyon, Lyon, France; Montpellier, Montpellier, France; Nantes, Nantes, France; Paris, Paris, France and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.