CompletedPhase 2

ImPROving Quality of LIFe in the Long COVID Patient

Sweden219 participantsStarted 2023-05-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. The subject has given written consent to participate in the study.
✓. ≥18 years of age at the time of the Screening Visit.
✓. Post-acute COVID-19 syndrome (PACS) according to the WHO definition.
✓. EQ-5D-5L VAS ≤ 50
✓. All fertile participants must agree to use a highly effective method of contraception for the duration of the study and 28 days after last intake of the IMP.

Exclusion criteria

✕. Other non-related conditions with PACS like symptoms.
✕. Renal function eGFR eGFRCysC \< 60 mL/min/1.73 m2.
✕. Not able to comply with the study protocol.
✕. Previous Paxlovid treatment.
✕. Pregnancy or breastfeeding.
✕. Drug-drug interaction with ongoing treatment, including concomitant use of any medications or substances that are strong inducers of CYP3A4 within 28 days prior to first dose of nirmatrelvir/ritonavir and during study treatment.
✕. Participants who are planning or considering vaccination (including boosters) through Study Day 45.
✕. Active COVID-19 infection as verified by SARS CoV-2 positive antigen test.

What they're measuring

Change from baseline in quality of life over time

Timeframe: Baseline and day 16

Trial details

NCT IDNCT05823896

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-28

View on ClinicalTrials.gov More Post-COVID-19 Syndrome trials