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NCT05852873Active, not recruitingPhase 3

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

Source: ClinicalTrials.gov · Last updated 21 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
2000 (estimated)
First submitted
8 May 2023
Start date
12 May 2023
Primary completion date
9 Sept 2025
Lead sponsor
Haukeland University Hospital
NCT number
NCT05852873

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 2000
  • From 12 May 2023 to the primary completion date, 9 Sept 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous randomisation in the PANORAMIC Norway trial
  • Currently taking Paxlovid
  • Use of concomitant medication contraindicated for the treatment of Paxlovid\*
  • 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 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.

Other illness

  • Any chronic renal impairment
  • Any chronic liver disease or liver impairment
  • Known allergy to Paxlovid

Lab values

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

Other

  • 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
  • Currently participating in a clinical trial of a therapeutic agent
  • Pregnant and lactating women

Who the study is looking for

  • 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)

Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Haukeland University Hospital
Coordinator of this site? Confirm its status
BergenNorwayUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.