PROLIFIC - A post-acute COVID syndrome study
Phase 1
- Conditions
- Patients with Post-Acute COVID syndrome (PACS) in which extensive clinical and biochemical examinations have been performed. PACS patients experience a wide variety of symptoms related to physical and cognitive function, including fatigue, dyspnea, brain fog” or other cognitive symptoms, pain, depression, and gastrointestinal issues which significantly impact quality of life.MedDRA version: 20.1Level: HLTClassification code 10047483Term: Viral upper respiratory tract infectionsSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2022-003855-32-SE
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Patients, =18 years of age, diagnosed with post-acute COVID-19 syndrome, with reported EQ-5D-5L VAS<50
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
Exclusion Criteria
Acute COVID-19 infection, other non-related conditions with post-acute COVID-19 syndrome like symptoms, previous treatment with Paxlovid
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of nirmatrelvir/ritonavir compared with that of placebo/ritonavir in patients with post-COVID-19 symptoms;Secondary Objective: To determine if nirmatrelvir/ritonavir improves secondary outcomes and selected biomarkers compared with placebo/ritonavir.;Primary end point(s): Change from baseline on the EQD5D functional scale at day 16, following a 15-day nirmatrelvir/ritonavir dosing regimen. ;Timepoint(s) of evaluation of this end point: Day 16
- Secondary Outcome Measures
Name Time Method