PAxlovid loNg cOvid-19 pRevention triAl With recruitMent In the Community in Norway

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The goal of this clinical trial is to compare treatment with oral Paxlovid (nirmatrelvir/ritonavir) and placebo for acute COVID-19 as an intervention to prevent long-COVID (post-COVID-19 condition) in adults aged 18-64 years old. The main question it aims to answer is: Does treatment with Paxlovid for acute COVID-19 reduce the prevalence of long-COVID compared to placebo. Participants with acute COVID-19, documented with positive lateral flow test or PCR, within the last 5 days will be randomised to take either Paxlovid or placebo. All participants will receive standard of care in addition. Participants will respond to electronic questionnaires at 14 time points during follow-up. The primary outcome is presence of long-COVID symptoms at 3 months follow-up. Researchers will compare participants who received Paxlovid and placebo to see if Paxlovid treatment can prevent the occurrence of long-COVID.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:

• Symptoms attributable to COVID-19 started within the past 5 days and ongoing

• Positive PCR or lateral flow SARS-CoV-2 test. Any positive PCR test or a lateral flow test taken between two days before symptom onset and randomisation qualifies.

• Age between 18 and 65 years

• Participant is able and willing to provide informed consent

• Willingness to take a pregnancy test prior to starting study treatment (Participants of childbearing potential)

Locations
Other Locations
Norway
Haukeland University Hospital
RECRUITING
Bergen
Contact Information
Primary
Nina Langeland, MD, PhD
nina.langeland@uib.no
+47-41616450
Backup
Bjorn Blomberg, MD, PhD
bjorn.blomberg@uib.no
+47-93262119
Time Frame
Start Date: 2023-05-12
Estimated Completion Date: 2026-04
Participants
Target number of participants: 2000
Treatments
Active_comparator: Nirmatrelvir-ritonavir
Participants will receive a standard 5-day treatment course nirmatrelvir plus ritonavir in addition to standard of care. The participants will receive 2 tablets nirmatrelvir 150 mg twice daily and 1 tablet ritonavir 100mg twice daily, both for a duration of 5 days. The tablets have been encapsulated to maintain blinding.
Placebo_comparator: Placebo
Participants in the control arm will receive a 5-day course of placebo tablets in addition to standard of care. The participants will receive 3 tablets twice daily for 5 days. The placebo tablets have the same shape and appearance as the active comparator product. The tablets containing placebo and active comparato have both been encapsulated in the same way to maintain blinding.
Related Therapeutic Areas
Sponsors
Collaborators: St. Olavs Hospital, University of Bergen, University of Oslo, Oslo University Hospital, Norwegian University of Science and Technology
Leads: Haukeland University Hospital

This content was sourced from clinicaltrials.gov