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

Conditions

• COVID-19

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• nirmatrelvir — DRUG
  Participants will receive 2 tablets of nirmatrelvir every 12 hours
• ritonavir — DRUG
  Participants will receive 1 capsule of ritonavir every 12 hours
• placebo for nirmatrelvir — DRUG
  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.

Study Details

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.

Key Dates

First listed

Oct 5, 2022

Start date

Oct 19, 2022

Status verified

Sep 2024

Primary completion

Sep 27, 2023

Completion

Feb 9, 2024

Study Design

Enrollment

436 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: nirmatrelvir plus ritonavir for 5 days
  Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 5 days
• Other: placebo plus ritonavir for 5 days
  placebo (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 5 days

Primary Outcome Measure

Change From Baseline to Day 5 in Viral Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Ribonucleic Acid (RNA) Level in Nasopharyngeal (NP) Swabs: mITT Population [ Time Frame: Baseline, Day 5 ]

Locations (67)

Find similar trials in Mesa, AZ

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