Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
2,000
Countries
1
Sites
3
Virus Diseases
The primary objective is to invesigate 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)
Key facts
- Sponsor
- Helse Bergen HF
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 11 Apr 2023 → ongoing
- Decision date (initial)
- 2024-06-24
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Ministry of Health and Care Services (Helse- og omsorgsdepartementet) (KlinBeForsk) Norway. · Helse Vest
External identifiers
- EU CT number
- 2023-510337-29-00
- EudraCT number
- 2022-003244-27
- ClinicalTrials.gov
- NCT05852873
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
The primary objective is to invesigate 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 objectives 1
- 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 coummunity safely reduces new infections in houshold., 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.
Conditions and MedDRA coding
Virus Diseases
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | LLT | 10084382 | Coronavirus disease 2019 | 10021881 |
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screening and Randomisation A randomisation list will be generated by a qualified person not involved in the trial and forwarded directly to the company producing placebo capsules. Prior to the initiation of the study, the pharmaceutical company performing the encapsulation of the IMPs (Paxlovid and placebo) will assign study IDs to the medicinal packages based on the randomisation list. At inclusion, the trial team will allocate the participants to the next available study ID number and the corresponding Paxlovid/placebo medicinal package. No study procedures will occur until informed consent is signed.
|
Randomised Controlled | Double | [{"id":119013,"code":5,"name":"Carer"},{"id":119010,"code":1,"name":"Subject"},{"id":119012,"code":4,"name":"Analyst"},{"id":119011,"code":2,"name":"Investigator"},{"id":119009,"code":3,"name":"Monitor"}] | Testing arm: Healthy adults (P) will be treated with Paxlovid (I) for 5 days for acute Covid Placebo arm: Healthy adults (P) will be treated with Placebo (I) for acute Covid. |
| 2 | Treatment phase 5 days treatment with either Paxlovid or 5 days treatment with placebo
|
Randomised Controlled | Double | [{"id":119016,"code":3,"name":"Monitor"},{"id":119017,"code":1,"name":"Subject"},{"id":119019,"code":5,"name":"Carer"},{"id":119015,"code":2,"name":"Investigator"},{"id":119018,"code":4,"name":"Analyst"}] | Testing arm: Healthy adults (P) will be treated with Paxlovid (I) for 5 days for acute Covid Placebo arm: Healthy adults (P) will be treated with Placebo for 5 days for acute Covid |
| 3 | Follow up phase Electronic forms filled out by patients per sms daily for 7 days, weekly for 28 days and at 3 and 6 months.
|
Randomised Controlled | Double | [{"id":119021,"code":1,"name":"Subject"},{"id":119023,"code":2,"name":"Investigator"},{"id":119024,"code":3,"name":"Monitor"},{"id":119022,"code":4,"name":"Analyst"},{"id":119025,"code":5,"name":"Carer"}] | Testing arm: Healthy adults (P) will be treated with Paxlovid (I) for 5 days for acute Covid Placebo arm: Healthy adults (P) will be treated with Placebo (I) for 5 days for acute Covid |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 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 12
- 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 woman.
- Participants of childbearing potential (participants who are anatomically and psysiologically capable of becoming pregnant), or have a partner of childbearing potential, not willing to use highly effective contraceptive until 7 days after completing Paxlovid.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Continued symptoms of acute COVID-19 and new symptoms according to long-COVID illness.
Secondary endpoints 7
- A cause, non-elective hospitalisation and/or death, within 28 days of randomisation.
- Participant reported symptoms daily for 7 days, weekly for 28 days and at 3 and 6 months.
- Contacts with health services reported by paticipants and/or captured by review for health registries.
- New infections in the household reported by the participants.
- Evaluation of overall safety of drugs by the monitoring of adverse events (AEs as defined in the ISAs).
- Well-being, symptoms and health care utilisation.
- Resource use and cost data.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB220919 · Substance
- Active substance
- Nirmatrelvir
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 3000 mg milligram(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Encapsulation for blinding to placebo, Capsugel DB-caps AAel Swedish Orange
SUB10342MIG · Substance
- Active substance
- Ritonavir
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 1000 mg milligram(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Encapsulation for blinding to placebo, Capsugel DB-caps AAel Swedish Orange
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Helse Bergen HF
- Sponsor organisation
- Helse Bergen HF
- Address
- Haukelandsveien 22
- City
- Bergen
- Postcode
- 5021
- Country
- Norway
Scientific contact point
- Organisation
- Helse Bergen HF
- Contact name
- Nina Langeland
Public contact point
- Organisation
- Helse Bergen HF
- Contact name
- Nina Langeland
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ongoing, recruitment ended | 2,000 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Norway | 2023-04-11 | 2023-05-12 | 2025-08-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol EU CT 2023-510337-29-00 | 2.4 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 2.0 |
| Subject information and informed consent form (for publication) | Informed consent form Panoramic Norway track changes | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Panoramic Norway | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Generel biobanking | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF MR Panoramic Norway | 1.3 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Paxlovid Nirmatrelvir and Ritonavir | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NO 2023-510337-29-00 | 2.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-22 | Norway | Acceptable 2024-06-24
|
2024-06-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-19 | Norway | Acceptable 2025-05-06
|
2025-05-28 |