Pilot Test of COVID-19 Related Clinical Outcome Assessment Methodology and Qualitative Evidence of Content Validity
Public ClinicalTrials.gov record NCT05207293. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Pilot Test of Clinical Outcome Assessment Methodology (Primarily the Ordinal Scale of Clinical Improvement) and Other Symptom Assessment Patient-reported Outcomes Scales) and Qualitative Evidence of Content Validity
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05207293
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 29 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 14, 2021
- Primary completion
- Jan 30, 2022
- Completion
- Jan 30, 2022
- Last update posted
- Jan 3, 2023
2021 – 2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05207293, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 3, 2023 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05207293 live on ClinicalTrials.gov.