NCT05823896

ImPROving Quality of LIFe in the Long COVID Patient

An Interventional, Double-Blinded, 2-Arm Study to Investigate the Efficacy of Orally Administered Nirmatrelvir/Ritonavir Compared with Placebo/Ritonavir in Non-hospitalized Adult Participants Suffering from Post-COVID

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the efficacy of orally administered nirmatrelvir/ritonavir compared with placebo/ritonavir to improve quality of life in non-hospitalized adult participants suffering from post-acute COVID-19 syndrome.

Detailed description

At present there is no curative treatment for post-acute COVID-19 syndrome (PACS). Treatment is focused on symptom management and individualized rehabilitation. There is data indicating SARS-CoV-2 viral persistence and chronic immune system activation in PACS. We are proposing an interventional, randomized and placebo-controlled clinical intervention trial of nirmatrelvir/ritonavir (300/100 mg) or placebo/ritonavir (100mg), twice daily for 15 days, in patients suffering from severe PACS and meeting the WHO definition of severe PACS. A total of 180 patients will be enrolled in this study and these will be randomized in a 2:1 ratio to receive either nirmatrelvir/ritonavir or placebo/ritonavir. The study will include deep exploratory systems-level analyses of the immune system in PACS patients, including changes induced by nirmatrelvir/ritonavir (Paxlovid®) treatment. The purpose of this study is to evaluate the efficacy of nirmatrelvir/ritonavir for its potential ability to provide sustained improvement in quality of life, in non-hospitalized patients with post-COVID, a patient group with high unmet medical needs. Hypothesis: Nirmatrelvir/ritonavir (Paxlovid®) improves health-related quality of life measured using the EQ-5D-5L VAS scale, as compared to placebo/ritonavir, in objective and pre-defined clinical phenotypes: postural orthostatic tachycardia syndrome (POTS), microvascular dysfunction, inappropriate sinus tachycardia, persistent fever, post exertional malaise (PEM), fatigue, brain fog, dyspnea, dysfunctional breathing patterns or inflammatory phenotypes (increased plasma D-dimer, CRP, ESR and ferritin).

Conditions

• Post-COVID-19 Syndrome
• Long COVID
• Long Covid19
• COVID-19
• POTS - Postural Orthostatic Tachycardia Syndrome
• Post COVID-19 Condition
• Post-COVID Syndrome
• Post COVID-19 Condition, Unspecified
• Postinfectious Inflammation
• Postinfectious Disorder

Interventions

Type	Name	Description
DRUG	Nirmatrelvir/ritonavir	300/100 mg tablet twice daily (q12h) administered orally for 15 days
DRUG	Placebo/ritonavir	100mg tablet twice daily (q12h) administered orally for 15 days

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-11-28
• Completion: 2024-11-28
• First posted: 2023-04-21
• Last updated: 2024-12-04

Locations

1 site across 1 country: Sweden

Regulatory

• FDA-regulated drug study