A Multicenter, Observational, 6-Month Follow-up Study of Patients With COVID-19 Previously Enrolled in a RO7496998 (AT-527) Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 72
- Locations
- 35
- Primary Endpoint
- Percentage of Participants With COVID-19 Symptoms Assessed Through the COVID-19 Symptom Diary up to Month 6
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
This study will evaluate the long-term sequelae of COVID-19 in patients diagnosed with COVID-19 who previously enrolled in a RO7496998 (AT-527) study (i.e. parent study NCT04889040 [CV43043]), for approximately 6 months after the end of the parent study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant was diagnosed with COVID-19 and enrolled in a Phase III RO7496998 (AT-527) COVID-19 study
Exclusion Criteria
- •Participation in an interventional study at the time of enrollment or plans to enroll in an interventional study during this study.
- •Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
Outcomes
Primary Outcomes
Percentage of Participants With COVID-19 Symptoms Assessed Through the COVID-19 Symptom Diary up to Month 6
Time Frame: Month 1 - Week 4, Month 2 - Week 4, Month 3 - Week 4, Month 4 - Week 4, Month 5 - Week 4, Month 6 - Week 4
COVID-19 symptoms were evaluated using the COVID-19 Symptom Diary. The COVID-19 Symptom Diary included the following 14 items: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills/sweats, feeling hot or feverish, nausea, vomiting, diarrhea, sense of smell over the past 7 days and sense of taste over the past 7 days. The severity of items 1-12 were recorded on a 4-point Likert scale (i.e none/mild/moderate/severe). Items 13-14 were recorded on a 3-point Likert scale (i.e. same as usual/less than usual/no sense). Reported here is the percentage of participants with COVID-19 symptoms (mild/moderate/severe or less than usual/no sense) recorded during week 4 of each month following the baseline assessment.
Secondary Outcomes
- Percentage of Participants With COVID-19-Related Complications(Up to 6 months)
- Respiratory-specific Health-related Quality of Life Score as Assessed by the St. George's Respiratory Questionnaire (SGRQ)(Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6)
- Percentage of Participants With COVID-19 Related Medically-Attended Visits(Up to 6 months)
- Percentage of Participants With Death Attributable to Progression of COVID-19(Up to 6 months)
- Percentage of Participants Re-Infected With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)(Up to 6 months)
- Percentage of Participants With Adverse Events (AEs)(Up to 6 months)
- Dyspnea Symptoms Assessment Score Through the Patient Reported Outcomes Measurement Information System - Short Form (PROMIS-SF) - Dyspnea Questionnaire(Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6)
- Percentage of Participants With Any Post-Treatment Infection(Up to 6 months)