Clinical trial NCT05059080: A Six-Month Follow-Up Study of Participants With Coronavirus Disease 2019 (COVID-19) Previously Enrolled in a RO7496998 (AT-527) Study
Official title: A Multicenter, Observational, 6-Month Follow-up Study of Patients With COVID-19 Previously Enrolled in a RO7496998 (AT-527) Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: COVID-19
Long COVID
Keywords: Coronavirus Disease 2019
COVID-19
SARS-CoV-2
Mild to Moderate COVID-19
Long-COVID
Observational
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Atea Pharmaceuticals, Inc.
First posted: 2021-09-28
Enrollment: 72
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants enrolled in a RO7496998 (AT-527) study.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With COVID-19 Symptoms Assessed Through the COVID-19 Symptom Diary up to Month 6
timeFrame: 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 outcomes:
measure: Dyspnea Symptoms Assessment Score Through the Patient Reported Outcomes Measurement Information System - Short Form (PROMIS-SF) - Dyspnea Questionnaire
timeFrame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
measure: Respiratory-specific Health-related Quality of Life Score as Assessed by the St. George's Respiratory Questionnaire (SGRQ)
timeFrame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
measure: Percentage of Participants With COVID-19 Related Medically-Attended Visits
timeFrame: Up to 6 months
measure: Percentage of Participants With Death Attributable to Progression of COVID-19
timeFrame: Up to 6 months
measure: Percentage of Participants Re-Infected With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)
timeFrame: Up to 6 months
measure: Percentage of Participants With Any Post-Treatment Infection
timeFrame: Up to 6 months
measure: Percentage of Participants With COVID-19-Related Complications
timeFrame: Up to 6 months
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Mar Del Plata
country: Argentina
facility: Instituto Ave Pulmo
city: Erpent
country: Belgium
facility: Private Practice Dr Jean Benoit Martinot
city: Gozée
country: Belgium
facility: Medif
city: Brasilia
country: Brazil
facility: L2IP -Instituto de Pesquisas Clínicas Ltda.
state: DF
city: Taguatinga
country: Brazil
facility: Chronos Pesquisa Clinica
state: DF
city: Recife
country: Brazil
facility: Hospital Agamenon Magalhães
state: PE
city: Curitiba
country: Brazil
facility: Hospital Nossa Senhora das Graças
state: PR
city: Sao Paulo
country: Brazil
facility: Conjunto Hospitalar do Mandaqui
state: SP
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet Copenhagen University Hospital
city: Roskilde
country: Denmark
facility: Sjællands Universitetshospital, Roskilde
city: Köln
country: Germany
facility: Praxis am Ebertplatz
city: Torreón
country: Mexico
facility: CIMAB SA de CV
state: Coahuila
city: Guadalajara
country: Mexico
facility: Panamerican Clinical Research S.A de C.V.
state: Jalisco
city: Mexico City
country: Mexico
facility: Clinstile S.A de C.V.
state: Mexico CITY (federal District)
city: Queréaro
country: Mexico
facility: PanAmerican Clinical Research, Querétaro
state: Queretaro
city: Guadalajara
country: Mexico
facility: Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
city: Mexico
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
city: Bucuresti
country: Romania
facility: Prof. Dr. Matei Bals Institute of Infectious Diseases
city: Caracal
country: Romania
facility: County Hospital Caracal
city: Sibiu
country: Romania
facility: Sibiu Emergency Clinical County Hospital
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
city: Ankara
country: Turkey
facility: Gazi Universitesi Tip Fakultesi
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
city: Trabzon
country: Turkey
facility: Karadeniz Technical University Faculty of Medicine
city: Çankaya
country: Turkey
facility: Ankara University Medical Faculty - PPDS
city: Ivano-Frankivsk
country: Ukraine
facility: Municipal Non-profit enterprise Central City Clinical Hospital of Ivano-Frankivsk City Council
state: Katerynoslav Governorate
city: Kharkiv
country: Ukraine
facility: Municipal Non-profit Enterprise "City Clinical Hospital #13" of Kharkiv City Council
state: Kharkiv Governorate
city: Dnipro
country: Ukraine
facility: CNPE City Clinical Hospital #6 of DCC
state: Kholm Governorate
city: Kyiv
country: Ukraine
facility: Medical Center LLC "Harmony of Beauty"
state: KIEV Governorate
city: Kyiv
country: Ukraine
facility: CNE Kyiv City Clinical Hospital#1 of Exec. Body
state: KIEV Governorate
city: Kyiv
country: Ukraine
facility: Kyiv Railway Clinical Hospital No2 of Branch Health Center of the JSC Ukrainian Rail
state: KIEV Governorate
city: Vinnytsya
country: Ukraine
facility: Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1
state: Podolia Governorate
city: Zaporizhzhia
country: Ukraine
facility: Communal Non-Profit Enterprise City Hospital #7 of Zaporizhzhia City Council
state: Tavria Okruha
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: