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

This is non-interventional, qualitative interview study. Patients will participate in a single one-on-one, semi-structured, 90-120 minute interview. The interviews will be audio/video-recorded. The interviews are non treatment-related, and no investigational drugs, devices, or invasive procedures will be administered or evaluated as part of this study.

Patients who have been hospitalized due to COVID-19 will be approached about the study by a dedicated clinician from the site the patient was hospitalized at. Eligible patients will be recruited via hospitals in the UK and the US. At that time, potential participants will be provided with the 'Consent to Contact' form, Patient Information Sheet and Informed Consent Form and if the patient is interested in the study the patient will be asked to sign 'Consent to Contact' form that will allow the clinical staff to pass the patient information to the research team at Parexel. All other research related activities will be conducted by the research team at Parexel.

Parexel research team will contact the potential participants to further confirm eligibility criteria, provide additional details of the study and explain the consent process. Participants will be given ample time to consider the study and the opportunity to ask the research team questions prior to deciding whether to participate or not.

If the participant agrees to take part in the study, the participant will be asked to provide signed consent by signing the Informed Consent Form.

Parexel research team will discuss the most suitable day and time for the interview and will assure that the participant has access to the required technology.

The interview is planned to last between 90-120 minutes and will be audio/video-recorded and transcribed to assure that all important information shared by the participants were captured and that data from the interview can be analysed in a qualitative manner with the use a qualitative data analysis software.

During the interview, the Parexel research team member with expertise in qualitative interviewing will conduct the interviews.

Before the interview begins, the interviewer will again explain the purpose of the study and the interview methodology to each participant. The semi-structured interviews will be conducted in four parts using a semi-structured interview guide.

The first part of the interview will include socio-demographic questions to collect data that can describe the participant interview sample. The following information will be collected: 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, hospitalisation length, oxygenation, perception of COVID-19 severity.

The second part of the interview will be structured to evaluate the validity of the COVID-19 symptom assessment instrument and discharge OSCI via pilot study. Participants will first be asked to complete the instruments as would happen in the SG018 clinical trial. Participants will be asked to complete the PRO instrument using a think-aloud method, whereby participants are encouraged to verbalize their thoughts, while completing the instrument.

In the next step participants will be asked how relevant, clear and easy to understand these instruments were. Ease of completion, comprehensiveness, and appropriateness of the format, response scales, and recall period within the PRO instrument will be evaluated.

The last part of the interview will consist of the concept confirmation exercises where participants will be asked open-ended questions about their experience with COVID-19 to encourage spontaneous responses. This section of the interview guide will include topics, questions, and probes designed to evaluate the concepts collected via other PRO measures used in the Phase III study to confirm their acceptability. The topics covered will include patients' experience of COVID-19 symptoms, fatigue, signs of depression and anxiety, physical pain, impact on physical functioning and daily activities.