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.
Study Type
OBSERVATIONAL
Enrollment
72
Percentage of Participants With COVID-19 Symptoms Assessed Through the COVID-19 Symptom Diary up to Month 6
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.
Time frame: Month 1 - Week 4, Month 2 - Week 4, Month 3 - Week 4, Month 4 - Week 4, Month 5 - Week 4, Month 6 - Week 4
Dyspnea Symptoms Assessment Score Through the Patient Reported Outcomes Measurement Information System - Short Form (PROMIS-SF) - Dyspnea Questionnaire
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.
Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Respiratory-specific Health-related Quality of Life Score as Assessed by the St. George's Respiratory Questionnaire (SGRQ)
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.
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Instituto Ave Pulmo
Mar del Plata, Argentina
Private Practice Dr Jean Benoit Martinot
Erpent, Belgium
Medif
Gozée, Belgium
L2IP -Instituto de Pesquisas Clínicas Ltda.
Brasília, Federal District, Brazil
Chronos Pesquisa Clinica
Taguatinga, Federal District, Brazil
Hospital Nossa Senhora das Graças
Curitiba, Paraná, Brazil
Hospital Agamenon Magalhães
Recife, Pernambuco, Brazil
Conjunto Hospitalar do Mandaqui
São Paulo, São Paulo, Brazil
Aalborg Universitetshospital
Aalborg, Denmark
Rigshospitalet Copenhagen University Hospital
Copenhagen, Denmark
...and 25 more locations
Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Percentage of Participants With COVID-19 Related Medically-Attended Visits
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.
Time frame: Up to 6 months
Percentage of Participants With Death Attributable to Progression of COVID-19
Time frame: Up to 6 months
Percentage of Participants Re-Infected With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)
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.
Time frame: Up to 6 months
Percentage of Participants With Any Post-Treatment Infection
Post-treatment infections were defined as any adverse event with a primary system organ class of infections and infestations.
Time frame: Up to 6 months
Percentage of Participants With COVID-19-Related Complications
COVID-19 related complications included pneumonia, acute respiratory failure, sepsis, coagulopathy, pericarditis and/or myocarditis, and cardiac failure.
Time frame: Up to 6 months
Percentage of Participants With Adverse Events (AEs)
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.
Time frame: Up to 6 months