A Six-Month Follow-Up Study of Participants With Coronavirus Disease 2019 (COVID-19) Previously Enrolled in a RO7496998 (AT-527) Study (MEADOWSPRING)
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|ClinicalTrials.gov Identifier: NCT05059080|
Recruitment Status : Completed
First Posted : September 28, 2021
Last Update Posted : April 18, 2022
|Condition or disease|
|COVID-19 Long COVID|
|Study Type :||Observational|
|Actual Enrollment :||73 participants|
|Official Title:||A Multicenter, Observational, 6-Month Follow-up Study of Patients With COVID-19 Previously Enrolled in a RO7496998 (AT-527) Study|
|Actual Study Start Date :||June 15, 2021|
|Actual Primary Completion Date :||March 7, 2022|
|Actual Study Completion Date :||March 16, 2022|
Participants Diagnosed with COVID-19
Participants were previously enrolled in a RO7496998 (AT-527) study
- COVID-19 Symptoms Assessment through the COVID-19 Symptom Diary (Items 1-14) [ Time Frame: Up to 6 months ]COVID-19 symptoms will be evaluated using the COVID-19 Symptom Diary (items 1-14). The severity of each COVID-19 symptom will be recorded on a Likert scale (i.e none/mild/moderate/severe).
- Dyspnea Symptoms Assessment through the Patient Reported Outcomes Measurement Information System (PROMIS) - Dyspnea Questionnaire [ Time Frame: Up to 6 months ]The PROMIS-Dyspnea Questionnaire will be used to evaluate the impact of Dyspnea on specific activities. The severity of impact on each activity will be recorded on a Likert scale with a recall period over the last 7 days (i.e no shortness of breath, mild/moderate/severe shortness of breath or not applicable)
- Respiratory Symptoms Assessment through the St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: Up to 6 months ]The SGRQ is a 50-item respiratory-specific health-related quality of life instrument that measures health impairment. The questionnaire contains 3 domains: symptoms, activity, and impacts. Items were assessed on various response scales, including a 5-point Likert scale and True/False scale. The SGRQ had a recall specification of 4 weeks.
- Proportion of Participants with COVID-19 Related Medically-Attended Visits [ Time Frame: Up to 6 months ]COVID-19-related medically-attended visits are defined as hospitalization, ER 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.
- Proportion of Participants with Death Attributable to Progression of COVID-19 [ Time Frame: Up to 6 months ]
- Proportion of Participants Re-Infected with Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) [ Time Frame: Up to 6 months ]
- Proportion of Participants with any Post-Treatment Infection [ Time Frame: Up to 6 months ]
- Frequency of COVID-19 Related Complications [ Time Frame: Up to 6 months ]Examples of COVID-19 related complications include death, hospitalization, radiologically confirmed pneumonia, acute respiratory failure, sepsis, coagulopathy, pericarditis, myocarditis and cardiac failure.
- Proportion of Participants with Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: Up to 6 months ]Event severity will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5 (NCI CTCAE v5.0)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05059080
|Study Director:||Clinical Trials||Hoffmann-La Roche|