Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT05852873

PHASE3

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

Sponsor: Haukeland University Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

2000

Start Date

2023-05-12

Completion Date

2027-06-11

Last Updated

2025-11-21

Healthy Volunteers

Conditions

Post COVID-19 Condition, Unspecified SARS-CoV2 Infection COVID-19

Interventions

DRUG

Nirmatrelvir/ritonavir

Participants in the intervention arm will receive a standard 5-day treatment course Paxlovid (nirmatrelvir plus ritonavir) in addition to standard of care.

DRUG

Placebo

Participants in the control arm will receive a 5-day course of placebo tablets, with the same appearance and quantity, in addition to standard of care.

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 such 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.

Locations (1)

Haukeland University Hospital

Bergen, Vestland, Norway