NIRMATRELVIR for Coronavirus disease 2019 (COVID-19) | Post-acute sequelae of SARS-CoV-2 infection (Long COVID)

Inclusion criteria

• {"criterion_text":"- Symptoms attributable to COVID-19 started within the past 5 days and ongoing."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Age between 18 and 65 years."}
• {"criterion_text":"- Participant is able and willing to provide informed consent."}
• {"criterion_text":"- Willingness to take a pregnancy test prior to starting study treatment (Participants of childbearing potential)."}

Exclusion criteria

• {"criterion_text":"- Patients that are not able to provide informed consent or comply with all study visits."}
• {"criterion_text":"- Use of concomitant medication contraindicated for the treatment of Paxlovid."}
• {"criterion_text":"- Pregnant and lactating woman."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Patient currently inpatient at hospital."}
• {"criterion_text":"- Comorbidity which requires active antiviral treatment as judged by the investigator."}
• {"criterion_text":"- Any chronic renal impairment."}
• {"criterion_text":"- Any chronic liver disease or liver impairment."}
• {"criterion_text":"- Previous randomisation in the PANORAMIC Norway trial."}
• {"criterion_text":"- Currently participating in a clinical trial of a therapeutic agent."}
• {"criterion_text":"- Currently taking Paxlovid."}
• {"criterion_text":"- Known allergy to Paxlovid."}

Primary endpoints

• {"endpoint_text":"- Continued symptoms of acute COVID-19 and new symptoms according to long-COVID illness.","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- A cause, non-elective hospitalisation and/or death, within 28 days of randomisation.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Participant reported symptoms daily for 7 days, weekly for 28 days and at 3 and 6 months.","definition_or_measurement_approach":"Participant-reported symptom diaries / electronic forms collected daily for 7 days, weekly to 28 days, and at 3 and 6 months."}
• {"endpoint_text":"- Contacts with health services reported by paticipants and/or captured by review for health registries.","definition_or_measurement_approach":""}
• {"endpoint_text":"- New infections in the household reported by the participants.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Evaluation of overall safety of drugs by the monitoring of adverse events (AEs as defined in the ISAs).","definition_or_measurement_approach":""}
• {"endpoint_text":"- Well-being, symptoms and health care utilisation.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Resource use and cost data.","definition_or_measurement_approach":""}

Methods

• Recruitment in the community in Norway (trial title: 'Paxlovid long covid-19 prevention trial with recruitment in the community in Norway').

Norway

Latest Decision Or Authorization Date

28-05-2025

Number Of Sites

3

Number Of Participants

2000

Primary sponsor

Full Name

Helse Bergen HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway

Third parties

• {"country":"Norway","full_name":"Ministry of Health and Care Services (Helse- og omsorgsdepartementet) (KlinBeForsk) Norway.","duties_or_roles":"Source of monetary support / funding","organisation_type":""}
• {"country":"Norway","full_name":"Helse Vest","duties_or_roles":"Source of monetary support / funding","organisation_type":""}