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

NCT05852873 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2025-11-21

No results posted yet for this study

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.

Conditions

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

Interventions

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.

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.

Sponsors & Collaborators

  • University of Bergen

    collaborator OTHER

  • Oslo University Hospital

    collaborator OTHER

  • University of Oslo

    collaborator OTHER

  • St. Olavs Hospital

    collaborator OTHER

  • Norwegian University of Science and Technology

    collaborator OTHER

  • Haukeland University Hospital

    lead OTHER

Principal Investigators

  • Nina Langeland, MD, PhD · Haukeland University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-12
Primary Completion
2025-09-09
Completion
2027-06-11
FDA Drug
Yes

Countries

  • Norway

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05852873 on ClinicalTrials.gov