Antiviral treatment for long covid.

Phase 3

Not yet recruiting

• Conditions: Virus Diseases

• Registration Number: 2023-510337-29-00
• Lead Sponsor: Helse Bergen HF

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-06-24
• Last Update Posted: 2025-05-28

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 2000

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 provide informed consent or comply with all study visits.

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.

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Continued symptoms of acute COVID-19 and new symptoms according to long-COVID illness.		Continued symptoms of acute COVID-19 and new symptoms according to long-COVID illness.

Secondary Outcome Measures

Name	Time	Method
A cause, non-elective hospitalisation and/or death, within 28 days of randomisation.		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.		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.		Contacts with health services reported by paticipants and/or captured by review for health registries.
New infections in the household reported by the participants.		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).		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.		Well-being, symptoms and health care utilisation.
Resource use and cost data.		Resource use and cost data.

Trial Locations

Locations (3)

Helse Moere Og Romsdal HF; 🇳🇴 Aalesund, Norway

Oslo University Hospital HF; 🇳🇴 Oslo, Norway

Helse Bergen HF; 🇳🇴 Bergen, Norway

Helse Moere Og Romsdal HF

🇳🇴Aalesund, Norway

Dag Arne Lihaug Hoff

Site contact

70106192

Dag.Arne.Lihaug.Hoff@helse-mr.no