Trials / Completed
CompletedNCT05576662
Paxlovid for Treatment of Long Covid
Selective Trial Of Paxlovid for PASC (STOP-PASC): Randomized Double-Blind Placebo-Controlled Pilot Trial of Paxlovid for the Treatment of PASC
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 168 (actual)
- Sponsor
- Stanford University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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."
Detailed description
An exploratory sub-study will investigate the correlation of physical activity and biometric parameters from digital wearable devices with the subjective symptom severity and other patient-reported outcomes in the main study. All participants with iPhone 6S Plus or newer will be offered an opportunity to opt-in to this sub-study. An Apple Watch and Bluetooth-enabled blood pressure monitor will be provided to participants and data will be collected for the duration of the main study to track participants' physiological and behavioral trends in the Paxlovid versus placebo groups.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nirmatrelvir | Two 150 mg tablets taken by mouth every 12 hours |
| DRUG | Placebo | Two tablets containing placebo matching nirmatrelvir taken by mouth every 12 hours |
| DRUG | Ritonavir | One 100 mg capsule taken by mouth every 12 hours |
Timeline
- Start date
- 2022-11-08
- Primary completion
- 2023-08-14
- Completion
- 2023-09-12
- First posted
- 2022-10-12
- Last updated
- 2025-09-04
- Results posted
- 2024-09-25
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05576662. Inclusion in this directory is not an endorsement.