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

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

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 Overview

• Status: Terminated
• Conditions: COVID-19; Long COVID

• Study Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• Argentina
  • Mar Del Plata, Argentina, B7602DCK
    • Instituto Ave Pulmo
• Belgium
  • Erpent, Belgium, 5101
    • Private Practice Dr Jean Benoit Martinot
  • Gozée, Belgium, 6534
    • Medif
• Brazil
  • DF
    • Brasilia, DF, Brazil, 70200-730
      • L2IP -Instituto de Pesquisas Clínicas Ltda.
    • Taguatinga, DF, Brazil, 72145-450
      • Chronos Pesquisa Clinica
  • PE
    • Recife, PE, Brazil, 52051-380
      • Hospital Agamenon Magalhaes
  • PR
    • Curitiba, PR, Brazil, 80810-040
      • Hospital Nossa Senhora Das Gracas
  • SP
    • Sao Paulo, SP, Brazil, 02401-400
      • Conjunto Hospitalar do Mandaqui
• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg Universitetshospital
  • Copenhagen, Denmark, DK-2100
    • Rigshospitalet Copenhagen University Hospital
  • Roskilde, Denmark, 4000
    • Sjællands Universitetshospital, Roskilde
• Germany
  • Köln, Germany, 50668
    • Praxis am Ebertplatz
• Mexico
  • Guadalajara, Mexico, 44100
    • Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
  • Mexico, Mexico
    • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Coahuila
    • Torreón, Coahuila, Mexico, 27000
      • CIMAB SA de CV
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44670
      • Panamerican Clinical Research S.A de C.V.
  • Mexico CITY (federal District)
    • Mexico City, Mexico CITY (federal District), Mexico, 06700
      • Clinstile S.A de C.V.
  • Queretaro
    • Queréaro, Queretaro, Mexico, 76230
      • PanAmerican Clinical Research, Querétaro
• Romania
  • Bucuresti, Romania, 021105
    • Prof. Dr. Matei Bals Institute of Infectious Diseases
  • Caracal, Romania, 235200
    • County Hospital Caracal
  • Sibiu, Romania, 550245
    • Sibiu Emergency Clinical County Hospital
• Switzerland
  • Zürich, Switzerland, 8091
    • Universitatsspital Zurich
• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University Medical Faculty
  • Ankara, Turkey, 06100
    • Gazi Universitesi Tip Fakultesi
  • Izmir, Turkey, 35100
    • Ege University Medical Faculty
  • Trabzon, Turkey, 61080
    • Karadeniz Technical University Faculty of Medicine
  • Çankaya, Turkey, 06590
    • Ankara University Medical Faculty - PPDS
• Ukraine
  • KIEV Governorate
    • Kyiv, KIEV Governorate, Ukraine, 01135
      • Medical Center LLC "Harmony of Beauty"
    • Kyiv, KIEV Governorate, Ukraine, 02091
      • CNE Kyiv City Clinical Hospital#1 of Exec. Body
    • Kyiv, KIEV Governorate, Ukraine, 03049
      • Kyiv Railway Clinical Hospital No2 of Branch Health Center of the JSC Ukrainian Rail
  • Katerynoslav Governorate
    • Ivano-Frankivsk, Katerynoslav Governorate, Ukraine, 76025
      • Municipal Non-profit Enterprise Central City Clinical Hospital of Ivano-Frankivsk City Council
  • Kharkiv Governorate
    • Kharkiv, Kharkiv Governorate, Ukraine, 61124
      • Municipal Non-profit Enterprise "City Clinical Hospital #13" of Kharkiv City Council
  • Kholm Governorate
    • Dnipro, Kholm Governorate, Ukraine, 49074
      • CNPE City Clinical Hospital #6 of DCC
  • Podolia Governorate
    • Vinnytsya, Podolia Governorate, Ukraine
      • Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1
  • Tavria Okruha
    • Zaporizhzhia, Tavria Okruha, Ukraine, 69118
      • Communal Non-Profit Enterprise City Hospital #7 of Zaporizhzhia City Council

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants Diagnosed with COVID-19; Participants were previously enrolled in a RO7496998 (AT-527) study (i.e. parent study NCT04889040 [CV43043]).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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)	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
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
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
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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Atea Pharmaceuticals, Inc.
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Actual): March 7, 2022
• Study Completion (Actual): March 16, 2022

Study Registration Dates

• First Submitted: September 24, 2021
• First Submitted That Met QC Criteria: September 24, 2021
• First Posted (Actual): September 28, 2021

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: September 9, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; Observational; Coronavirus Disease 2019; Mild to Moderate COVID-19; Long-COVID
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Chronic Disease; Post-Infectious Disorders; COVID-19; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: CV43140; 2021-000627-12 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No