Nirmatrelvir plus ritonavir for 10 days for COVID-19
Phase-Based Progress Estimates
Premium Medical Research Corp, Miami, FL
Ritonavir - Drug
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What conditions do you have?
What conditions do you have?
Patients with COVID-19 who are immunocompromised have a higher chance of severe illness. Such patients may benefit from longer treatment durations compared to the standard treatment regimen. The purpose of the clinical trial is to evaluate the efficacy (how well a study treatment works in the clinical trial) and safety when taking the study medicine for either 5, 10, or 15 days.
All the study medication will be taken by mouth. The first dose of study medication is taken at the study site and the rest at home. People taking part will be in this study for about 24 weeks. Enrolled participants will need to visit the study site at least 10 times during the study.
1 Primary · 19 Secondary · Reporting Duration: Day 1, Day 5, Day 10, and Day 15
Proportion of participants with COVID-19-related hospitalization >24 hours, or death from any cause.
Duration of each targeted COVID-19 signs/symptoms.
Proportion of participants with SARS-CoV-2 RNA level in nasopharyngeal swabs <2.0 log10 copies/mL at each study visit.
Proportion of participants with severe signs/symptoms attributed to COVID-19.
Time to sustained nasopharyngeal swab SARS-CoV-2 RNA <LLOQ (<2.0 log10 copies/mL) for participants with nasopharyngeal swab SARS-CoV-2 RNA ≥LLOQ at baseline.
Number of COVID-19-related medical visits through Day 44 and through Week 24.
Change from baseline in SARS-CoV-2 RNA level in nasopharyngeal swabs and in plasma over time.
Incidence of serious adverse events and adverse events leading to discontinuations.
Incidence of treatment emergent adverse events.
Number of days in hospital and ICU stay in participants with COVID-19-related hospitalization.
Proportion of participants requiring invasive mechanical ventilation or Extracorporeal membrane oxygenation.
Proportion of participants with COVID-19-related hospitalization of any duration.
Proportion of participants with COVID-19-related intensive care unit (ICU) admission of any duration.
Proportion of participants with SARS-CoV-2 RNA <LLOQ in plasma over time.
Proportion of participants with death (all cause).
Time to first nasopharyngeal swab SARS-CoV-2 RNA<LLOQ (<2.0 log10 copies/mL) for participants with nasopharyngeal swab SARS-CoV-2 RNA ≥LLOQ at baseline.
Plasma concentration of nirmatrelvir
Plasma concentration of ritonavir
Proportion of participants with sustained nasopharyngeal swab SARS-CoV-2 ribonucleic acid (RNA) <lower limit of quantitation (LLOQ) (defined as <2.0 log10 copies/mL).
Rebound in SARS-CoV-2 RNA level in nasopharyngeal swabs at follow up, defined as a half (0.5) log10 copies/mL increase or greater in SARS-CoV-2 RNA level, with a follow-up viral RNA level ≥2.5 log10 copies/mL
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.