E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10084355 |
E.1.2 | Term | COVID-19 virus test positive |
E.1.2 | System Organ Class | 100000004848 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10084401 |
E.1.2 | Term | COVID-19 respiratory infection |
E.1.2 | System Organ Class | 100000004862 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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). |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
1. Study on brain damage in long COVID 2. Immune profiling of COVID-19 patients with no or long COVID sequalae. |
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E.3 | Principal 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)
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Continued symtoms of acute COVID-19 and new symptoms according to long-COVID illness |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
3 months after randomization |
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E.5.2 | 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
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E.5.2.1 | 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
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial will be the timepoint for last controlled data capture of last participant. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |