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

NCT05852873 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: REC-SE-578741
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Nirmatrelvir ritonavir; Prevention

Outcome Measures

Primary Outcomes (1)

• Symptoms of long-COVID

  a dichotomous variable for presence of any of the three most important long-COVID symptoms: (i) fatigue, (ii) dyspnea and (iii) cognitive symptoms (defined as memory and/or concentration problems).

  Change in symptoms from baseline to 3, 6 and 12 months follow-up

Secondary Outcomes (9)

• Symptoms individually and grouped by organ system

  Change in symptoms from baseline to 3, 6, 12 and 24 months follow-up

• Graded responses for symptoms and symptom constellations

  Change in symptoms from baseline to 3, 6, 12 and 24 months follow-up

• Risk factors for long-COVID

  Up to 24 months

• Severity of acute disease

  28 days

• Hospitalisation

  28 days

Study Arms (2)

Nirmatrelvir-ritonavir

ACTIVE COMPARATOR

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.

Drug: Nirmatrelvir/ritonavir

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Nirmatrelvir/ritonavir DRUG

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

Also known as: Paxlovid tablets

Nirmatrelvir-ritonavir

Placebo DRUG

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.

Also known as: Placebo tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University of Bergen: collaborator
• Oslo University Hospital: collaborator
• University of Oslo: collaborator
• St. Olavs Hospital: collaborator
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, Vestland, 5021, Norway

Location

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  PMID: 41199272 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

nirmatrelvir and ritonavir drug combination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nina Langeland, MD, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blinded placebo-controlleded randomized clinical trial

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 10, 2023
• Study Start: May 12, 2023
• Primary Completion: September 9, 2025
• Study Completion (Estimated): June 11, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: After study completion and after the publication of the main outcomes of the trial.
• Access Criteria: Individual participant data may be shared with other researchers upon reasonable request, provided patient confidentiality is fully maintained

Locations

NO (1)