Antiviral treatment for long covid.

Phase 1

• Conditions: MedDRA version: 23.1Level: LLTClassification code 10084401Term: COVID-19 respiratory infectionSystem Organ Class: 100000004862; COVID-19SARS-CoV-2; MedDRA version: 23.1Level: LLTClassification code 10084355Term: COVID-19 virus test positiveSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2022-003244-27-NO
• Lead Sponsor: Helse Bergen HF

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-19
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• 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)

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

•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.

Study & Design

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