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

NCT05059080 | Terminated Results

• 2 other identifiers: CV431402021-000627-12
• Study Type: observational
• Target: 72
• Locations: 10 countries
• Sites: 35

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.

Conditions

COVID-19; Long COVID

Keywords

Coronavirus Disease 2019; COVID-19; SARS-CoV-2; Mild to Moderate COVID-19; Long-COVID; Observational

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• 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

• Percentage of Participants With COVID-19 Related Medically-Attended Visits

  Up to 6 months

• 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

Study Arms (1)

Participants Diagnosed with COVID-19

Participants were previously enrolled in a RO7496998 (AT-527) study (i.e. parent study NCT04889040 \[CV43043\]).

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants enrolled in a RO7496998 (AT-527) study.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Atea Pharmaceuticals, Inc.: collaborator

Study Sites (35)

Instituto Ave Pulmo

Mar del Plata, B7602DCK, Argentina

Location

Private Practice Dr Jean Benoit Martinot

Erpent, 5101, Belgium

Location

Medif

Gozée, 6534, Belgium

Location

L2IP -Instituto de Pesquisas Clínicas Ltda.

Brasília, Federal District, 70200-730, Brazil

Location

Chronos Pesquisa Clinica

Taguatinga, Federal District, 72145-450, Brazil

Location

Hospital Nossa Senhora das Graças

Curitiba, Paraná, 80810-040, Brazil

Location

Hospital Agamenon Magalhães

Recife, Pernambuco, 52051-380, Brazil

Location

Conjunto Hospitalar do Mandaqui

São Paulo, São Paulo, 02401-400, Brazil

Location

Aalborg Universitetshospital

Aalborg, 9000, Denmark

Location

Rigshospitalet Copenhagen University Hospital

Copenhagen, DK-2100, Denmark

Location

Sjællands Universitetshospital, Roskilde

Roskilde, 4000, Denmark

Location

Praxis am Ebertplatz

Cologne, 50668, Germany

Location

CIMAB SA de CV

Torreón, Coahuila, 27000, Mexico

Location

Panamerican Clinical Research S.A de C.V.

Guadalajara, Jalisco, 44670, Mexico

Location

Clinstile S.A de C.V.

Mexico City, Mexico CITY (federal District), 06700, Mexico

Location

PanAmerican Clinical Research, Querétaro

Queréaro, Querétaro, 76230, Mexico

Location

Instituto Jalisciense de Investigacion Clinica S.A. de C.V.

Guadalajara, 44100, Mexico

Location

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

México, Mexico

Location

Prof. Dr. Matei Bals Institute of Infectious Diseases

Bucharest, 021105, Romania

Location

County Hospital Caracal

Caracal, 235200, Romania

Location

Sibiu Emergency Clinical County Hospital

Sibiu, 550245, Romania

Location

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

Gazi Universitesi Tip Fakultesi

Ankara, 06100, Turkey (Türkiye)

Location

Hacettepe University Medical Faculty

Ankara, 06100, Turkey (Türkiye)

Location

Ankara University Medical Faculty - PPDS

Çankaya, 06590, Turkey (Türkiye)

Location

Ege University Medical Faculty

Izmir, 35100, Turkey (Türkiye)

Location

Karadeniz Technical University Faculty of Medicine

Trabzon, 61080, Turkey (Türkiye)

Location

Municipal Non-profit enterprise Central City Clinical Hospital of Ivano-Frankivsk City Council

Ivano-Frankivsk, Katerynoslav Governorate, 76025, Ukraine

Location

Municipal Non-profit Enterprise "City Clinical Hospital #13" of Kharkiv City Council

Kharkiv, Kharkiv Governorate, 61124, Ukraine

Location

CNPE City Clinical Hospital #6 of DCC

Dnipro, Kholm Governorate, 49074, Ukraine

Location

Medical Center LLC "Harmony of Beauty"

Kyiv, KIEV Governorate, 01135, Ukraine

Location

CNE Kyiv City Clinical Hospital#1 of Exec. Body

Kyiv, KIEV Governorate, 02091, Ukraine

Location

Kyiv Railway Clinical Hospital No2 of Branch Health Center of the JSC Ukrainian Rail

Kyiv, KIEV Governorate, 03049, Ukraine

Location

Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1

Vinnytsia, Podolia Governorate, Ukraine

Location

Communal Non-Profit Enterprise City Hospital #7 of Zaporizhzhia City Council

Zaporizhzhia, Tavria Okruha, 69118, Ukraine

Location

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: September 28, 2021
• Study Start: June 15, 2021
• Primary Completion: March 7, 2022
• Study Completion: March 16, 2022
• Last Updated: July 28, 2023
• Results First Posted: July 28, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share

Locations

AR (1); CH (1); TU (5); DE (1); RO (3); BR (5); BE (2); UA (8); ME (6); DK (3)