COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05576662

Not reported

Not reported

2022-10-12

Completed

RCT

Randomized

Parallel

Blind label

single-center

Long covid

inclusion criteria: 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 of 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

suspected or confirmed pregnancy or breastfeeding severe liver disease prior use of study drug or other covid treatment within 30 days hypersensitivity or other contraindication to any components of the study drug current or expected use of any medication dependent on or inducer of cyp3a4 current or expected use of supplements or herbs (unless medically necessary) that cannot be temporarily held (period as determined necessary by investigators) hiv infection with viral load >50 copies/ml suspected or confirmed active covid infection within 30 days history of covid vaccine within 28 days prior to enrollment, or other vaccine (influenza, shingles, etc.) within 14 days of enrollment, or planned use of any vaccine until the primary endpoint has been met (10 weeks) other medical condition(s) or concomitant therapy that would compromise participant's safety or compliance with the study protocol or significantly confound interpretation of study results, as determined by study investigators current enrollment in, or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device inability to provide informed consent currently hospitalized

2

Stanford University

18

100

United States

Patients recovered from covid

N/A

168

Core Symptoms Severity Scale Score

None

Phase 2

[{"arm_notes": "nan", "treatment_id": 2421, "treatment_name": "Nirmatrelvir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]