Selective Trial Of Paxlovid for PASC (STOP-PASC): Randomized Double-Blind Placebo-Controlled Pilot Trial of Paxlovid for the Treatment of PASC

Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this study is to compare whether being treated with nirmatrelvir plus ritonavir for 15 days works better than being treated with placebo plus ritonavir to reduce severe symptoms of Long Covid. Participants will have 5 planned visits to the study clinic over 15 weeks and will take the drug (or placebo) for the first 15 days. This study uses the term post-acute sequelae of SARS-CoV-2 (PASC), which is another name for Long Covid.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Normal or near-normal kidney function

• History of confirmed COVID-19 infection that preceded the post-COVID symptoms

• Post-COVID-19 symptoms persisting greater than three months

• At least 2 post-COVID symptoms of moderate or severe intensity (fatigue, brain fog, shortness of breath, body aches, gastrointestinal symptoms, or cardiovascular symptoms)

• Willing to report all vaccinations

• Women of childbearing potential or men whose partners may become pregnant must use acceptable method of contraception during the treatment period and for 28 days after the last dose of the study drug

• Willing and able to adhere to study procedures and available for the duration of the study

Locations
United States
California
Stanford University
Stanford
Time Frame
Start Date: 2022-11-08
Completion Date: 2023-09-12
Participants
Target number of participants: 168
Treatments
Experimental: Nirmatrelvir plus ritonavir
Participants receive nirmatrelvir plus ritonavir (Paxlovid) for 15 days, and attend follow-up visits through week 15.
Placebo_comparator: Placebo plus ritonavir
Participants receive placebo to match nirmatrelvir plus ritonavir for 15 days, and attend follow-up visits through week 15.
Related Therapeutic Areas
Sponsors
Collaborators: Pfizer
Leads: Stanford University

This content was sourced from clinicaltrials.gov