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

Launched by HAUKELAND UNIVERSITY HOSPITAL · May 9, 2023

Keywords

ClinConnect Summary

The PAxlovid loNg cOvid-19 prevention trial is studying whether taking the medication Paxlovid can help prevent long-COVID in adults who have recently tested positive for COVID-19. This trial is looking for participants aged 18 to 65 years who have symptoms of COVID-19 that started within the last 5 days and have a positive test result. People who join the study will be randomly assigned to receive either Paxlovid or a placebo (a pill that looks the same but doesn't contain the active drug) while also receiving standard care for COVID-19. Throughout the study, participants will complete electronic questionnaires to track their symptoms over three months.

To be eligible, participants need to have current COVID-19 symptoms and a positive test, be able to provide consent, and, if applicable, agree to take a pregnancy test. However, those who are currently hospitalized, have certain medical conditions like chronic liver or kidney problems, or are pregnant or breastfeeding cannot participate. This trial is currently recruiting participants, and if you or someone you know fits the criteria, it could be an opportunity to contribute to important research on COVID-19.

Gender

ALL

Eligibility 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.