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

A MULTICENTER, OBSERVATIONAL, 6 MONTH FOLLOW-UP STUDY OF PATIENTS WITH COVID 19 PREVIOUSLY ENROLLED IN A RO7496998 (AT-527) STUDY - MEADOWSPRING

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000627-12-BE

Enrollment

1040

Registered

2021-05-05

Start date

2021-06-01

Completion date

Unknown

Last updated

2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus disease 2019 (COVID-19) MedDRA version: 23.1 Level: LLT Classification code 10084401 Term: COVID-19 respiratory infection System Organ Class: 100000004862

Interventions

Product Name: RO7496998 hemisulfate (AT-527) Product Code: RO7496998 Pharmaceutical Form: Tablet INN or Proposed INN: Not available yet CAS Number: 2241337-84-6 Current Sponsor code: RO7496998 Other d

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age >=18 years (regardless of weight) at the time of signing Informed Consent Form or age >=12 to =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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: • To evaluate the long-term symptoms of patients diagnosed with COVID-19 ;Secondary Objective: • To evaluate health-related quality of life (HRQoL) of patients diagnosed with COVID-19 • To evaluate medical resource utilization for patients diagnosed with COVID-19 • To evaluate the long-term outcomes of COVID-19 in patients diagnosed with COVID-19 • To evaluate adverse events in patients diagnosed with COVID-19 who previously enrolled in a RO7496998 (AT-527) study ;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)	—

Measure

Time frame

Main Objective: • To evaluate the long-term symptoms of patients diagnosed with COVID-19 ;Secondary Objective: • To evaluate health-related quality of life (HRQoL) of patients diagnosed with COVID-19 • To evaluate medical resource utilization for patients diagnosed with COVID-19 • To evaluate the long-term outcomes of COVID-19 in patients diagnosed with COVID-19 • To evaluate adverse events in patients diagnosed with COVID-19 who previously enrolled in a RO7496998 (AT-527) study ;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)

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Secondary

Measure	Time frame
Secondary end point(s): 1. Impact of dyspnea symptoms on specific activities, as assessed through use of Patient Reported Outcomes Measurement Information System (PROMIS)-Dyspnea Questionnaire at Day 1 and Months 1, 2, 3, 4, 5, and 6 2. Respiratory-specific HRQoL, as assessed through use of St. George's Respiratory Questionnaire (SGRQ) at Day 1 and Months 1, 2, 3, 4, 5, and 6 3. Proportion of patients with COVID-19 related medically attended visits through to study end (defined as hospitalization, emergency room visit, urgent care visit, physician’s office visit, or telemedicine visit with the primary reason for the visit being COVID-19 or COVID-19 related symptoms) 4. Proportion of patients with all-cause mortality 5. Proportion of patients with death attributable to progression of COVID-19 6. Proportion of patients re-infected with Severe Acute Respiratory Syndrome coronavirus-2 (SARS-CoV-2) 7. Proportion of patients with any post-treatment infection including but not limited to bacterial, viral, or fungal pneumonia or sepsis 8. Frequency of COVID-19 related complications (e.g. death, hospitalization, radiologically confirmed pneumonia, acute respiratory failure sepsis, coagulopathy, pericarditis, myocarditis, cardiac failure) 9. Incidence and severity of adverse events and serious adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) ;Timepoint(s) of evaluation of this end point: 1-2. At Day 1 and Months 1, 2, 3, 4, 5, and 6 3-9. Up to approximately 6 months	—

Measure

Time frame

Secondary end point(s): 1. Impact of dyspnea symptoms on specific activities, as assessed through use of Patient Reported Outcomes Measurement Information System (PROMIS)-Dyspnea Questionnaire at Day 1 and Months 1, 2, 3, 4, 5, and 6 2. Respiratory-specific HRQoL, as assessed through use of St. George's Respiratory Questionnaire (SGRQ) at Day 1 and Months 1, 2, 3, 4, 5, and 6 3. Proportion of patients with COVID-19 related medically attended visits through to study end (defined as hospitalization, emergency room visit, urgent care visit, physician’s office visit, or telemedicine visit with the primary reason for the visit being COVID-19 or COVID-19 related symptoms) 4. Proportion of patients with all-cause mortality 5. Proportion of patients with death attributable to progression of COVID-19 6. Proportion of patients re-infected with Severe Acute Respiratory Syndrome coronavirus-2 (SARS-CoV-2) 7. Proportion of patients with any post-treatment infection including but not limited to bacterial, viral, or fungal pneumonia or sepsis 8. Frequency of COVID-19 related complications (e.g. death, hospitalization, radiologically confirmed pneumonia, acute respiratory failure sepsis, coagulopathy, pericarditis, myocarditis, cardiac failure) 9. Incidence and severity of adverse events and serious adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) ;Timepoint(s) of evaluation of this end point: 1-2. At Day 1 and Months 1, 2, 3, 4, 5, and 6 3-9. Up to approximately 6 months

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Countries

Argentina, Belgium, Brazil, Colombia, Denmark, France, Germany, Hungary, Italy, Japan, Mexico, Peru, Poland, Portugal, Romania, Russian Federation, Serbia, Spain, Switzerland, Turkey, Ukraine, United Kingdom, United States

Contacts

Public ContactTrial Information Support Line-TISL

F. Hoffmann La Roche Ltd.

global.rochegenentechtrials@roche.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026