A Six-Month Follow-Up Study of Participants With Coronavirus Disease 2019 (COVID-19) Previously Enrolled in a RO7496998 (AT-527) Study
- Conditions
- Long COVIDCOVID-19
- Registration Number
- NCT05059080
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 72
- Participant was diagnosed with COVID-19 and enrolled in a Phase III RO7496998 (AT-527) COVID-19 study
- 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
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants With COVID-19 Symptoms Assessed Through the COVID-19 Symptom Diary up to Month 6 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 Outcome Measures
Name Time Method 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 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. Each scale is scored from 0 to 100, and the total score represents the weighted average of these three subscores. Higher scores correspond to worse quality of life. The SGRQ had a recall specification of 4 weeks.
Percentage of Participants With COVID-19-Related Complications Up to 6 months COVID-19 related complications included pneumonia, acute respiratory failure, sepsis, coagulopathy, pericarditis and/or myocarditis, and cardiac failure.
Percentage of Participants With COVID-19 Related Medically-Attended Visits Up to 6 months COVID-19-related medically-attended visits were 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.
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 Reinfection was defined as any nasopharyngeal (NP) swab that was positive for SARS-CoV-2 infection via reverse-transcriptase polymerase chain reaction (RT-PCR), taken when clinically indicated based on symptoms.
Percentage of Participants With Adverse Events (AEs) Up to 6 months An AE is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any of the following: any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition not present at baseline or related to a protocol-mandated intervention.
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 The PROMIS-SF-Dyspnea Questionnaire is a 10-item questionnaire to evaluate the impact of dyspnea on specific activities. Participants self-assessed the severity of shortness of breath and difficulty of breathing in response to specific activities with a recall of the past 7 days. The PROMIS SF-Dyspnea Severity instrument is scored on a 4-point Likert scale, with an option to indicate that an activity had not been performed. Total score range is 0-30, where a higher score indicates a higher symptom severity of dyspnea.
Percentage of Participants With Any Post-Treatment Infection Up to 6 months Post-treatment infections were defined as any adverse event with a primary system organ class of infections and infestations.
Trial Locations
- Locations (35)
Instituto Ave Pulmo
🇦🇷Mar Del Plata, Argentina
Private Practice Dr Jean Benoit Martinot
🇧🇪Erpent, Belgium
Medif
🇧🇪Gozée, Belgium
L2IP -Instituto de Pesquisas Clínicas Ltda.
🇧🇷Brasilia, DF, Brazil
Chronos Pesquisa Clinica
🇧🇷Taguatinga, DF, Brazil
Hospital Agamenon Magalhães
🇧🇷Recife, PE, Brazil
Hospital Nossa Senhora das Graças
🇧🇷Curitiba, PR, Brazil
Conjunto Hospitalar do Mandaqui
🇧🇷Sao Paulo, SP, Brazil
Aalborg Universitetshospital
🇩🇰Aalborg, Denmark
Rigshospitalet Copenhagen University Hospital
🇩🇰Copenhagen, Denmark
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