A Six-Month Follow-Up Study of Patients with COVID-19 Previously Enrolled in a RO7496998 (AT-527) Study
- Conditions
- Coronavirus disease 2019 (COVID-19)MedDRA version: 23.1Level: LLTClassification code 10084401Term: COVID-19 respiratory infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2021-000627-12-BE
- Lead Sponsor
- F. Hoffmann La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1040
•Age >=18 years (regardless of weight) at the time of signing Informed Consent Form or age >=12 to <18 years (weight >=40 kg) at the time of signing Informed Consent Form (and Assent Form)
•Ability, judged by the investigator, to comply with the study protocol
•Patient was diagnosed with COVID-19 and enrolled in a Phase III RO7496998 (AT-527) COVID-19 study. Patients who completed all study assessments in the parent study are eligible, regardless of whether patients completed or discontinued early from the study drug
Are the trial subjects under 18? yes
Number of subjects for this age range: 150
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 940
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: •To evaluate the long-term symptoms of patients diagnosed with COVID-19<br><br>;Secondary Objective: •To evaluate health-related quality of life (HRQoL) of patients diagnosed with COVID-19<br>•To evaluate medical resource utilization for patients diagnosed with COVID-19<br>•To evaluate the long-term outcomes of COVID-19 in patients diagnosed with COVID-19<br>•To evaluate adverse events in patients diagnosed with COVID-19 who previously enrolled in a RO7496998 (AT-527) study<br>;Primary end point(s): 1.Descriptive summaries, over time, of COVID-19 symptoms, as assessed through the COVID-19 Symptom Diary (Items 1-14);Timepoint(s) of evaluation of this end point: 1. From Day 1 up to approximately 6 months (Weekly)<br><br>
- Secondary Outcome Measures
Name Time Method