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

• Status: Not yet recruiting
• Trial end date: 2026-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Haukeland University Hospital
• Collaborator: University of Bergen
• Treatments: Ritonavir

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• • Patients that are not able to comply with all study visits

• Patient currently inpatient at hospital

• Comorbidity which requires active antiviral treatment as judged by the investigator

• Any chronic renal impairment

• Any chronic liver disease or liver impairment

• Previous randomisation in the PANORAMIC Norway trial

• Currently participating in a clinical trial of a therapeutic agent

• Currently taking Paxlovid

• Known allergy to Paxlovid

• Use of concomitant medication contraindicated for the treatment of Paxlovid*

• Pregnant and lactating women

• Participants of childbearing potential (participants who are anatomically and physiologically capable of becoming pregnant), or have a partner of childbearing potential, not willing to use highly effective contraceptive until 7 days after completing Paxlovid.

• Concomitant medications that are contraindicated for the treatment of Paxlovid

• Medicinal products that are highly dependent on CYP3A for clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions.

• Medicinal products that are potent CYP3A inducers where significantly reduced nirmatrelvir/ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance.

• Paxlovid cannot be started immediately after discontinuation of any of the following medicinal products due to the delayed offset of the recently discontinued CYP3A inducer.

More information is available in the study protocol on medicinal products that are contraindicated with concomitant use of Paxlovid.