PAxlovid loNg cOvid-19 pRevention triAl With recruitMent In the Community in Norway (PanoramicNOR)
Post COVID-19 Condition, Unspecified, SARS-CoV2 Infection, COVID-19
About this trial
This is an interventional prevention trial for Post COVID-19 Condition, Unspecified focused on measuring Nirmatrelvir ritonavir, Prevention
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.
Sites / Locations
- Haukeland University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Nirmatrelvir-ritonavir
Placebo
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.
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.