Clinical trial for the treatment of COVID-19 and COVID-like illness in primary care

Not Applicable

• Conditions: Reducing illness duration, complications, and possibly transmission of COVID-19 (SARS-CoV-2 infection) and other respiratory pathogens; Infections and Infestations

• Registration Number: ISRCTN55471843
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-21
• Last Update Posted: 5 August 2024
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1700

Inclusion Criteria

In order to be eligible to participate in ECRAID-Prime, a participant must (at least) meet all the following criteria (there can be additional intervention-specific inclusion criteria):
1. Participant is =18 years of age on the day of inclusion; if people aged <18 years are suitable for inclusion in the evaluation of an investigational product, then this will be described and justified in the relevant, approved intervention-specific appendix
2. Presence of at least two symptoms suggestive of COVID-19 or COVID-like-illness, one respiratory (cough, sore throat, running or congested nose or sinuses, shortness of breath) and one systemic (fever, feeling feverish, sweats/chills or shivering, low energy or tiredness, headache, muscle, joint or body aches, loss of taste and/or smell)
3. Judged by recruiting a medically qualified clinician or research nurse that the illness is due to COVID-19 or COVID-like illness
4. Onset of symptoms less than 7 days (in case earlier treatment is required for a specific investigational product, this will be specified in the intervention-specific appendix)
5. Willing and able to give informed consent for participation in the study
6. Willing and able to comply with all trial procedures
7. Any additional eligibility criteria relevant to women of child-bearing potential including current pregnancy or breastfeeding will be specified in the intervention-specific appendix

Exclusion Criteria

A potential participant who meets any of the following criteria will be excluded from participation in ECRAID-Prime (there can be additional intervention-specific exclusion criteria).
1. Requiring admission to the hospital on the day of screening, or inclusion
2. Known allergies or hypersensitivities to any of the components used in the formulation of the investigational product, or the control product
3. Any disease, condition, or disorder that precludes participation in the trial, in the opinion of the person checking eligibility and taking consent
4. Any planned major surgery in the next 28 days
5. Currently participating in a trial of an investigational product

Study & Design

• Study Type: Interventional
• Study Design: Not specified