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

NCT05207293 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 29

Last updated 2023-01-04

No results posted yet for this study

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 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.

Conditions

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Synairgen Research Ltd.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2022-01-31
Completion
2022-01-31

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05207293 on ClinicalTrials.gov