NCT05567952

A Study to Learn About a Repeat 5-Day Treatment With the Study Medicines (Called Nirmatrelvir/Ritonavir) in People 12 Years Old or Older With Return of COVID-19 Symptoms and SARS-CoV-2 Positivity After Finishing Treatment With Nirmatrelvir/Ritonavir

AN INTERVENTIONAL, EFFICACY AND SAFETY, PHASE 2, RANDOMIZED, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE A REPEAT 5-DAY COURSE OF NIRMATRELVIR/RITONAVIR COMPARED TO PLACEBO/RITONAVIR IN PARTICIPANTS AT LEAST 12 YEARS OF AGE WITH REBOUND OF COVID-19 SYMPTOMS AND RAPID ANTIGEN TEST POSITIVITY

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 436 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to learn about the safety and effects of nirmatrelvir/ritonavir for the potential treatment of COVID-19 rebound. The study is seeking participants who: * Have completed treatment with nirmatrelvir/ritonavir * Have a rebound in COVID-19 symptoms * Are SARS-CoV-2 (COVID-19) positive All study medications will be taken 2 times a day by mouth for 5 days. The first dose of study medication is taken at the study clinic and the rest at home. We will examine the experiences of people receiving the study medicines to those who do not. This will help us determine if the study medicines are safe and effective. People taking part will be in this study for about 24 weeks. Enrolled participants will need to visit the study clinic at least 8 times during the study.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	nirmatrelvir	Participants will receive 2 tablets of nirmatrelvir every 12 hours
DRUG	ritonavir	Participants will receive 1 capsule of ritonavir every 12 hours
DRUG	placebo for nirmatrelvir	Participants will receive 2 tablets of placebo for nirmatrelvir every 12 hours. A placebo does not have any medicine in it but looks just like the medicine being studied.

Timeline

• Start date: 2022-10-19
• Primary completion: 2023-09-27
• Completion: 2024-02-09
• First posted: 2022-10-05
• Last updated: 2024-10-08
• Results posted: 2024-10-08

Locations

84 sites across 5 countries: United States, Canada, Greece, Italy, Taiwan

Regulatory

• FDA-regulated drug study