Using Paxlovid to prevent long COVID in adults
PAxlovid loNg cOvid-19 pRevention triAl With recruitMent In the Community in Norway
This study is testing if taking Paxlovid soon after getting COVID-19 can help adults aged 18-64 avoid long COVID symptoms.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Haukeland University Hospital Academic / other |
| Locations | 1 site (Bergen, Vestland) |
| Trial ID | NCT05852873 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Paxlovid (nirmatrelvir/ritonavir) in preventing long COVID symptoms in adults aged 18-64 who have recently tested positive for COVID-19. Participants will be randomly assigned to receive either Paxlovid or a placebo, alongside standard care, within five days of symptom onset. The primary outcome will be assessed through electronic questionnaires over three months to determine the prevalence of long COVID symptoms. The study seeks to provide insights into early antiviral treatment's role in reducing long-term complications associated with COVID-19.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-64 who have experienced COVID-19 symptoms for no more than five days and have a positive SARS-CoV-2 test.
Not a fit: Patients currently hospitalized, those with certain comorbidities requiring antiviral treatment, or those with chronic liver or renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of long COVID symptoms in patients recovering from acute COVID-19.
How similar studies have performed: While the approach of using antiviral treatment for COVID-19 is being explored, this specific trial focusing on long COVID prevention with Paxlovid is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Bergen, Vestland
- Haukeland University Hospital — Bergen, Vestland, Norway (Recruiting)
Study contacts
- Principal investigator: Nina Langeland, MD, PhD — Haukeland University Hospital
- Study coordinator: Nina Langeland, MD, PhD
- Email: nina.langeland@uib.no
- Phone: +47-41616450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.