EUCTR2022-003855-32-SE
Active, not recruiting
Phase 1
An Interventional, Double-Blinded, 2-Arm Study to Investigate the Efficacy of Orally Administered Nirmatrelvir/Ritonavir Compared With Placebo/Ritanovir in Non-hospitalized Adult Participants suffering from post-COVID
ConditionsPatients 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]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- 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.
- Sponsor
- Karolinska Institutet
- Enrollment
- 400
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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