A Six-Month Follow-Up Study of Patients with COVID-19 Previously Enrolled in a RO7496998 (AT-527) Study

Phase 1

• Conditions: Coronavirus disease 2019 (COVID-19); MedDRA version: 23.1Level: LLTClassification code 10084401Term: COVID-19 respiratory infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-000627-12-RO
• Lead Sponsor: F. Hoffmann La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-27
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1040

Inclusion Criteria

•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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified