COVID-19 SARS-CoV-2 MedDRA version: 23.1 Level: LLT Classification code 10084355 Term: COVID-19 virus test positive System Organ Class: 100000004848 MedDRA version: 23.1 Level: LLT Classification code 10084401 Term: COVID-19 respiratory infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Paxlovid
Product Name: Paxlovid
Product Code: J0SAE30
Pharmaceutical Form: Capsule, hard + tablet
Pharmaceutical form of the placebo: Capsule, hard + tablet
Route of administration of the
Sponsors
Helse Bergen HF
Eligibility
Sex/Gender
All
Inclusion 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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2000 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients that are not able to provide informed consent or 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to to investigate if early treatment with Paxlovid (nirmatrelvir plus ritonavir) for patients with acute COVID (confirmed PCR or lateral flow test) can reduce long term complications (long COVID). ;Secondary Objective: To determine whether antiviral treatment in the community safely reduces non-elective overnight hospitalisations/ deaths in symptomatic patients with confirmed COVID-19 within 28 days of randomisation. By investigating antiviral treatment effects on; 1) Time to recovery (defined as the first instance that a participant report of feeling recovered from the illness) 2) Participant reported illness severity, reported by daily rating of how well participant feels, enabling identification of sustained recovery. 3) Duration of severe symptoms and symptom recurrence 4) To determine whether antiviral treatment in the community safely reduces contacts with the health services 5) To determine whether antiviral treatment in the community safely reduces new infections in household 6) To investigate the safety outcomes and cost-effectiveness outcomes 7) to investigate symptoms and well-being at six months (with determination of proportion with Long Covid) from randomisation;Primary end point(s): Continued symtoms of acute COVID-19 and new symptoms according to long-COVID illness;Timepoint(s) of evaluation of this end point: 3 months after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): All cause, non-elective hospitalisation and/or death, within 28 days of randomisation 1-3) Participant reported symptoms daily for 7 days, weekly for 28 days and at 3 and 6 months. 4) Contacts with health services reported by participants and/or captured by review for health registries 5) New infections in the household reported by the participants 6) Evaluation of overall safety of drugs by the monitoring of adverse events 7) Well-being, symptoms and health care utilisation 8) Resource use and cost data ;Timepoint(s) of evaluation of this end point: Within 28 days of randomisation: Participant report, review of health registry data for up to 1 year (Norwegian Patient Registry, Norwegian Pandemic Registry and Norwegian Cause of Death Registry) 1-4) Online participant report daily for 7 days, weekly for 28 days and at 3 and 6 months. Review of health registry data for up to 1 year (Norwegian Patient Registry, Norwegian Pandemic Registry and Norwegian Registry for Primary Health Care) 5) Online participant report day 0 – 6, weekly for 28 days 6) For the duration of the antiviral course and 3 months after inclusion 7) Online participant report at six months, health registry search for up to one year 8) Baseline, Day 28 and at 3 months | — |
Countries
Norway
Contacts
Public ContactDepartment of Clinical Science
University of Bergen
Outcome results
None listed