Pilot Interview Study- COVID19 Clinical Outcome Assessment methodology
Research type
Research Study
Full title
Pilot test of Clinical Outcome Assessment (COA) methodology (primarily the World Health Organization Ordinal Scale of Clinical Improvement (OSCI)) and other symptom assessment patient-reported outcomes (PRO) scales) and qualitative evidence of content validity for Synairgen SPRINTER COVID-19 Study.
IRAS ID
303873
Contact name
Tom Wilkinson
Contact email
Sponsor organisation
Synairgen Research Ltd
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
Summary of Research
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 its product SNG001 to determine its 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 them 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 they are reflected in the questionnaires used in SG018.Summary of Results
Clinical Study Summary
Trial Title:
‘Pilot test of Clinical Outcome Assessment (COA) methodology (primarily the World Health Organization Ordinal Scale of Clinical Improvement (OSCI)) and other symptom assessment patient-reported outcomes (PRO) scales) and qualitative evidence of content validity for Synairgen SPRINTER COVID-19 Study’Trial Number: SG019
This is a summary of the SG019 research trial results.
Synairgen Research Ltd (‘Synairgen’) was the sponsor of this trial and would like to share this study summary with participating sites and NHS ethics/HRA.Thank you!
Synairgen would like to send a huge thank you to all research participants, participating hospitals, and their staff for their invaluable contribution to this study.
COVID-19 can be a very debilitating disease, greatly affecting the daily lives of patients with this condition even after discharge from hospital. Despite having gone through hospitalisation for COVID-19, participants in this research study showed an incredible level of engagement and dedication in undertaking these research activities.Why was the research needed?
The COVID-19 pandemic created an urgent clinical need for new treatments for COVID-19. Synairgen was developing an inhaled antiviral drug, SNG001, that showed promising results in an early phase study in COVID-19 conducted in 2020. This led to further research being planned, the Phase III SPRINTER Trial. It was hoped that SNG001 would help patients hospitalised due to COVID-19 to quickly return to their usual day-to-day activities.
The main objective of the pilot study was to evaluate the patient reported version (PRO) of the World Health Organization (WHO) Ordinal Scale for Clinical Improvement (OSCI) and assess how easy patients found it to understand and to complete the scale.Who participated in the study?
A total of 27 participants were interviewed for this study. 26 interviews were analysed as the data from one participant was excluded from the study due to not meeting the study eligibility criteria.
This research took place across 5 hospital sites, 4 in the UK and 1 in the US.
The trained hospital site staff were asked to identify and screen eligible patients with a patient information sheet and a consent to contact form, which gave permission for Parexel study team to contact the patients directly, obtain full consent and conduct the interviews. The study was conducted between 10 November 2021 and 31 January 2022. All participants were interviewed within 35 days from the day of discharge from hospital where they were admitted due to COVID-19.What interventions did the participants take/receive?
Trained and experienced Parexel study personnel contacted patients to arrange their participation in the study. The interviews were conducted remotely via video conferencing. The interview lasted approximately 90 to 120 minutes for each participant and consisted of 4 parts.
Part 1: Comprised of general questions about the participant such as age, gender, nationality, place of residence, race, work status, level of education, general health status, chronic conditions, COVID-19 history including details regarding date of diagnosis, hospitalization length, need for oxygen therapy and perception of COVID-19 severity.
Part 2: Participants were asked to test two specific questions about their COVID-19 symptoms and level of function/any limitations of their usual activities that have occurred as a consequence of COVID-19. This will simply involve answering two questions as ‘yes/no’ responses and verbally selecting ‘yes/no’ answers on a COVID-19 symptoms scale.
Part 3: Participants were asked if the two questions from Part 2 are relevant, clear and easy to understand in their opinion.
Part 4: Participants were asked some further questions about their overall experience of COVID-19, the symptoms they experienced when they had COVID-19 and the impact on their daily life.What were the results of this study?
The study results confirmed that, overall, the questionnaires assessing COVID-19 symptoms and recovery included in this study were relevant to the experiences of patients hospitalised for COVID-19. Most questions were easily understood by the majority of the study participants and answered without any issues. One question, however, which assessed if patients were back to their normal activity levels was difficult to answer for 42% of patients, which might limit its use in assessing recovery in patients with COVID-19.How has this research helped patients and researchers?
The results of this research have helped researchers understand more about the symptoms and impact of COVID-19 on daily activities on patients. It also described patients’ experience of recovery to normal levels of activity following a hospitalisation due to COVID-19. It provided information about the relevance and validity of patient reported instruments, assessing symptomatology and impact of COVID-19 in hospitalised patients.Where can I learn more about the study?
If you want to learn more about this study or about Synairgen Research, please follow these links:
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Synairgen plc / Synairgen Research Ltd
Mailpoint 810
Southampton General Hospital
Tremon Road
Southampton
SO16 6YD
United Kingdom
Tel: +44 (0) 23 8051 2800
Fax: +44 (0)23 8051 2800REC name
South Central - Oxford B Research Ethics Committee
REC reference
21/SC/0325
Date of REC Opinion
3 Nov 2021
REC opinion
Further Information Favourable Opinion