Nirmatrelvir plus ritonavir for 10 days for COVID-19

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Premium Medical Research Corp, Miami, FL
COVID-19
Ritonavir - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 19 Secondary · Reporting Duration: Day 1, Day 5, Day 10, and Day 15

Day 28
Proportion of participants with COVID-19-related hospitalization >24 hours, or death from any cause.
Day 44
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.
Week 24
Number of COVID-19-related medical visits through Day 44 and through Week 24.
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.
Day 15
Plasma concentration of nirmatrelvir
Plasma concentration of ritonavir
Day 44
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).
Day 44
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

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

Nirmatrelvir plus ritonavir for 10 days
1 of 3
Nirmatrelvir plus ritonavir for 5 days
1 of 3
Nirmatrelvir plus ritonavir for 15 days
1 of 3
Experimental Treatment

150 Total Participants · 3 Treatment Groups

Primary Treatment: Nirmatrelvir plus ritonavir for 10 days · Has Placebo Group · Phase 2

Nirmatrelvir plus ritonavir for 10 daysExperimental Group · 4 Interventions: Ritonavir, Placebo for nirmatrelvir, Placebo for ritonavir, Nirmatrelvir · Intervention Types: Drug, Drug, Drug, Drug
Nirmatrelvir plus ritonavir for 5 daysExperimental Group · 4 Interventions: Ritonavir, Placebo for nirmatrelvir, Placebo for ritonavir, Nirmatrelvir · Intervention Types: Drug, Drug, Drug, Drug
Nirmatrelvir plus ritonavir for 15 daysExperimental Group · 2 Interventions: Ritonavir, Nirmatrelvir · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ritonavir
2005
Completed Phase 4
~2200
Placebo for ritonavir
2009
Completed Phase 1
~130

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1, day 5, day 10, and day 15
Closest Location: Premium Medical Research Corp · Miami, FL
Photo of Miami  1Photo of Miami  2Photo of Miami  3
2022First Recorded Clinical Trial
4 TrialsResearching COVID-19
3 CompletedClinical Trials

Eligibility Criteria

Age Any Age · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a confirmed SARS-CoV-2 infection.
You have an immunocompromised condition.
You have been infected with COVID-19 within 5 days prior to screening and ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

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.