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NCT05207293 · ClinicalTrials.gov registry record
Pilot Test of COVID-19 Related Clinical Outcome Assessment Methodology and Qualitative Evidence of Content Validity
A clinical trial, sponsored by Synairgen Research.
- Completed
- Registry status
- 29
- Enrollment target
NCT05207293: Completed study, sponsored by Synairgen Research.
NCT05207293 is a clinical trial that has completed, run by Synairgen Research. The registered enrollment target is 29 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05207293 has completed, sponsored by Synairgen Research.
- COMPLETED
- Registry status
- 29 participants
- Enrollment target
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
Primary Outcome
Confirm the content relevance, comprehensiveness and clarity of the Ordinal Scale of Clinical Improvement (OSCI) score Patient Reported Outcome assessment post hospital discharge. Two questions are answered 'Yes' or 'No' and these determine a score of either 0, 1 or 2, where the higher the score the worse the outcome.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2021-11-15 |
| Est. Completion | 2022-01-31 |
What the finished NCT05207293 record still lists
NCT05207293 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 29 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT05207293 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05207293 about?
NCT05207293 is a clinical study titled "Pilot Test of COVID-19 Related Clinical Outcome Assessment Methodology and Qualitative Evidence of Content Validity". 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 prima...
What is the current status of trial NCT05207293?
This trial is currently completed. The enrollment target is 29 participants. The study started on 2021-11-15. Estimated completion is 2022-01-31.
Who is sponsoring clinical trial NCT05207293?
This trial is sponsored by Synairgen Research, which has 3 total clinical trials registered on ClinicalTrials.gov.
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