Status:
COMPLETED
Pilot Test of COVID-19 Related Clinical Outcome Assessment Methodology and Qualitative Evidence of Content Validity
Lead Sponsor:
Synairgen Research Ltd.
Collaborating Sponsors:
Parexel
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Brief Summary
COVID-19 is an acute respiratory disease caused by Severe Acute Respiratory Syndrome coronavirus (SARS-CoV). Synairgen is currently conducting a global Phase III clinical trial of SNG001 to determine...
Detailed Description
This is non-interventional, qualitative interview study. Patients will participate in a single one-on-one, semi-structured, 90-120 minute interview. The interviews will be audio/video-recorded. The in...
Eligibility Criteria
Inclusion
- ≥ 18 years at the time of consent
- Must have a confirmed diagnosis of COVID-19
- Must have been discharged from hospital due to COVID-19 infection in the last 35 days
- Must exhibit reliability and physiologic capability (e.g. sufficient hearing, vision etc.) to comply with all protocol procedures, in the investigator's opinion and must have educational level of minimum 8th grade or primary school;
- 6\. Must be able to read, write, and speak in a local language to complete the informed consent process and participate in an interview; 7. Must be willing to provide written informed consent to participate in the study; and, 8. Must be able to participate in a one-time interview for approximately 90-120 minute via video conference (e.g., Microsoft Teams, WebEx) AND has access to the necessary equipment and internet access.
Exclusion
- Signed the consent form to participate in the Synairgen SG018 clinical trial,
- Cognitive impairment, significant mental illness, or other disability impairing ability to participate in and/or complete research interview based on study coordinator's or clinician's judgement; or,
- Ongoing substance abuse disorders that may impact participation in this study.
Key Trial Info
Start Date :
November 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT05207293
Start Date
November 15 2021
End Date
January 31 2022
Last Update
January 4 2023
Active Locations (5)
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1
Henry Ford Health System
Detroit, Michigan, United States, 48202
2
University Hospitals Dorset NHS Foundation Trust
Bournemouth, Dorset, United Kingdom, BH7 7DW
3
Hull Royal Infirmary
Hull, East Riding Of Yorkshire, United Kingdom, HU3 2RW
4
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, SO16 6YD