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

September 9, 2022 updated by: Hoffmann-La Roche

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 Graças
    • 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
        • Universitätsspital Zürich
  • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With COVID-19 Symptoms Assessed Through the COVID-19 Symptom Diary up to Month 6
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dyspnea Symptoms Assessment Score Through the Patient Reported Outcomes Measurement Information System - Short Form (PROMIS-SF) - Dyspnea Questionnaire
Time Frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
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)
Time Frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
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
Time Frame: Up to 6 months
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
Time Frame: Up to 6 months
Up to 6 months
Percentage of Participants Re-Infected With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)
Time Frame: Up to 6 months
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
Time Frame: Up to 6 months
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
Time Frame: Up to 6 months
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)
Time Frame: Up to 6 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Atea Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 7, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 16, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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