A Six-Month Follow-Up Study of Participants With Coronavirus Disease 2019 (COVID-19) Previously Enrolled in a RO7496998 (AT-527) Study

COVID-19 Clinical Trial

— MEADOWSPRING  

Official title:

A Multicenter, Observational, 6-Month Follow-up Study of Patients With COVID-19 Previously Enrolled in a RO7496998 (AT-527) Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05059080
• Other study ID #: CV43140
• Secondary ID: 2021-000627-12
• Status: Terminated
• Start date: June 15, 2021
• Est. completion date: March 16, 2022

Study information

• Verified date: September 2022
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. completion date: March 16, 2022
• Est. primary completion date: March 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Participant was diagnosed with COVID-19 and enrolled in a Phase III RO7496998 (AT-527) COVID-19 study

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

Related Conditions & MeSH terms

• COVID-19
• Long COVID

Locations

Country	Name	City	State
Argentina	Instituto Ave Pulmo	Mar Del Plata
Belgium	Private Practice Dr Jean Benoit Martinot	Erpent
Belgium	Medif	Gozée
Brazil	L2IP -Instituto de Pesquisas Clínicas Ltda.	Brasilia	DF
Brazil	Hospital Nossa Senhora das Graças	Curitiba	PR
Brazil	Hospital Agamenon Magalhães	Recife	PE
Brazil	Conjunto Hospitalar do Mandaqui	Sao Paulo	SP
Brazil	Chronos Pesquisa Clinica	Taguatinga	DF
Denmark	Aalborg Universitetshospital	Aalborg
Denmark	Rigshospitalet Copenhagen University Hospital	Copenhagen
Denmark	Sjællands Universitetshospital, Roskilde	Roskilde
Germany	Praxis am Ebertplatz	Köln
Mexico	Instituto Jalisciense de Investigacion Clinica S.A. de C.V.	Guadalajara
Mexico	Panamerican Clinical Research S.A de C.V.	Guadalajara	Jalisco
Mexico	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Mexico
Mexico	Clinstile S.A de C.V.	Mexico City	Mexico CITY (federal District)
Mexico	PanAmerican Clinical Research, Querétaro	Queréaro	Queretaro
Mexico	CIMAB SA de CV	Torreón	Coahuila
Romania	Prof. Dr. Matei Bals Institute of Infectious Diseases	Bucuresti
Romania	County Hospital Caracal	Caracal
Romania	Sibiu Emergency Clinical County Hospital	Sibiu
Switzerland	Universitätsspital Zürich	Zürich
Turkey	Gazi Universitesi Tip Fakultesi	Ankara
Turkey	Hacettepe University Medical Faculty	Ankara
Turkey	Ankara University Medical Faculty - PPDS	Çankaya
Turkey	Ege University Medical Faculty	Izmir
Turkey	Karadeniz Technical University Faculty of Medicine	Trabzon
Ukraine	CNPE City Clinical Hospital #6 of DCC	Dnipro	Kholm Governorate
Ukraine	Municipal Non-profit enterprise Central City Clinical Hospital of Ivano-Frankivsk City Council	Ivano-Frankivsk	Katerynoslav Governorate
Ukraine	Municipal Non-profit Enterprise "City Clinical Hospital #13" of Kharkiv City Council	Kharkiv	Kharkiv Governorate
Ukraine	CNE Kyiv City Clinical Hospital#1 of Exec. Body	Kyiv	KIEV Governorate
Ukraine	Kyiv Railway Clinical Hospital No2 of Branch Health Center of the JSC Ukrainian Rail	Kyiv	KIEV Governorate
Ukraine	Medical Center LLC "Harmony of Beauty"	Kyiv	KIEV Governorate
Ukraine	Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1	Vinnytsya	Podolia Governorate
Ukraine	Communal Non-Profit Enterprise City Hospital #7 of Zaporizhzhia City Council	Zaporizhzhia	Tavria Okruha

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Atea Pharmaceuticals, Inc.

Countries where clinical trial is conducted

Argentina,  Belgium,  Brazil,  Denmark,  Germany,  Mexico,  Romania,  Switzerland,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Month 1 - Week 4, Month 2 - Week 4, Month 3 - Week 4, Month 4 - Week 4, Month 5 - Week 4, Month 6 - Week 4
Secondary	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.	Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Secondary	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.	Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Secondary	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.	Up to 6 months
Secondary	Percentage of Participants With Death Attributable to Progression of COVID-19		Up to 6 months
Secondary	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.	Up to 6 months
Secondary	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.	Up to 6 months
Secondary	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.	Up to 6 months
Secondary	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.	Up to 6 months