Pilot Test of COVID-19 Related Clinical Outcome Assessment Methodology and Qualitative Evidence of Content Validity

Completed

Conditions studied: COVID-19

In brief

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 efficacy and safety in patients hospitalised due to COVID-19 that receive oxygen therapy. The primary endpoint in the Phase III trial (SG018) is to evaluate recovery in patients hospitalised due to COVID-19 that require oxygen therapy after administration of SNG001 compared to placebo. The primary endpoint will be determined using the World Health Organization Ordinal Scale of Clinical Improvement (OSCI) score, which will be assessed daily. The OSCI will be used in two different ways during SG018. When the patients are in hospital, the clinical study staff will assess the patient via observation using the OSCI. However, when patients have been discharged from hospital, the clinical study staff will assess the OSCI by asking two questions, one regarding the presence of COVID-19 symptoms and the other regarding usual activities returning to baseline levels. The patient will be required to answer both questions with either a 'yes' or 'no' answer. Daily assessments of the OSCI will be conducted via video call or telephone call after discharge from hospital. The two questions asked of patients when OSCI is assessed after discharge from hospital have been added to trial SG018 to allow assessment of OSCI to continue throughout the trial. As these are new questions and the data from these is being used to assess the primary endpoint in trial SG018, their relevance, ease of understanding and clarity needs to be shown, which is why this interview study is being conducted. Having patients comment on these questions will ensure that the way the benefit of treatment is being measured in SG018 is done in a robust and patient-centred way. The main aims of this qualitative pilot study are to: 1. To confirm how relevant, clear and easy to understand the two additional OSCI questions asked about COVID-19 symptoms and levels of usual activity are when patients have been discharged from hospital. 2. To find out what other symptoms and experiences patients hospitalised for COVID-19 might have had to see if these are reflected in the questionnaires used in SG018.

Key facts

Study ID: NCT05207293
Run by: Synairgen Research Ltd.
People needed: 29
Starts: 2021-11-15
Expected to finish: 2022-01-31
Last updated by the study team: 2023-01-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

≥ 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;
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.

You may not qualify if…

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.

Where it is running

Henry Ford Health System — Detroit, Michigan, United States
University Hospitals Dorset NHS Foundation Trust — Bournemouth, Dorset, United Kingdom
Hull Royal Infirmary — Hull, East Riding Of Yorkshire, United Kingdom
University Hospital Southampton NHS Foundation Trust — Southampton, Hampshire, United Kingdom
Queen Elizabeth Hospital Birmingham — Birmingham, United Kingdom

Full record on ClinicalTrials.gov

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