OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16+
SponsorCalmy Alexandra
About this trial
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 criteria
Qualifiers
Laboratory confirmed SARS-CoV-2 infection by real time 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;
Severe immunosuppression (e.g., human immunodeficiency virus (HIV) infection with CD4 + T cell count <350 / μl)
Disqualifiers
SARS-CoV-2 PCR ≥30 CT at screening
Hypersensitivity to study drugs (active substance(s) or excipients)
Body weight < 40 kg
AST (Aspartate transaminase) and/or alanine transaminase (ALT) > 5 times the upper limit
Trial design
Treatments tested in this trial
- Paxlovid 5 days
- Paxlovid 10 days
Treatment groups
256 Participants
are divided into 4 treatment groupsSponsors and collaborators
Calmy Alexandra
Lead sponsor
University Hospital, Geneva
Sponsor institution
ANRS, Emerging Infectious Diseases
Collaborator
Source ClinicalTrials.gov