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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05059080
Recruitment Status : Completed
First Posted : September 28, 2021
Last Update Posted : April 18, 2022
Sponsor:
Collaborator:
Atea Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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), for approximately 6 months after the end of the parent study.

Condition or disease
COVID-19 Long COVID

Study Design
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Study Type : Observational
Actual Enrollment : 73 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter, Observational, 6-Month Follow-up Study of Patients With COVID-19 Previously Enrolled in a RO7496998 (AT-527) Study
Actual Study Start Date : June 15, 2021
Actual Primary Completion Date : March 7, 2022
Actual Study Completion Date : March 16, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Participants Diagnosed with COVID-19
Participants were previously enrolled in a RO7496998 (AT-527) study


Outcome Measures
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Primary Outcome Measures :
  1. COVID-19 Symptoms Assessment through the COVID-19 Symptom Diary (Items 1-14) [ Time Frame: Up to 6 months ]
    COVID-19 symptoms will be evaluated using the COVID-19 Symptom Diary (items 1-14). The severity of each COVID-19 symptom will be recorded on a Likert scale (i.e none/mild/moderate/severe).


Secondary Outcome Measures :
  1. Dyspnea Symptoms Assessment through the Patient Reported Outcomes Measurement Information System (PROMIS) - Dyspnea Questionnaire [ Time Frame: Up to 6 months ]
    The PROMIS-Dyspnea Questionnaire will be used to evaluate the impact of Dyspnea on specific activities. The severity of impact on each activity will be recorded on a Likert scale with a recall period over the last 7 days (i.e no shortness of breath, mild/moderate/severe shortness of breath or not applicable)

  2. Respiratory Symptoms Assessment through the St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: Up to 6 months ]
    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. The SGRQ had a recall specification of 4 weeks.

  3. Proportion of Participants with COVID-19 Related Medically-Attended Visits [ Time Frame: Up to 6 months ]
    COVID-19-related medically-attended visits are 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.

  4. Proportion of Participants with Death Attributable to Progression of COVID-19 [ Time Frame: Up to 6 months ]
  5. Proportion of Participants Re-Infected with Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) [ Time Frame: Up to 6 months ]
  6. Proportion of Participants with any Post-Treatment Infection [ Time Frame: Up to 6 months ]
  7. Frequency of COVID-19 Related Complications [ Time Frame: Up to 6 months ]
    Examples of COVID-19 related complications include death, hospitalization, radiologically confirmed pneumonia, acute respiratory failure, sepsis, coagulopathy, pericarditis, myocarditis and cardiac failure.

  8. Proportion of Participants with Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: Up to 6 months ]
    Event severity will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5 (NCI CTCAE v5.0)


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants enrolled in a RO7496998 (AT-527) study.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05059080


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Atea Pharmaceuticals, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT05059080    
Other Study ID Numbers: CV43140
2021-000627-12 ( EudraCT Number )
First Posted: September 28, 2021    Key Record Dates
Last Update Posted: April 18, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hoffmann-La Roche:
Coronavirus Disease 2019
COVID-19
SARS-CoV-2
 Mild to Moderate COVID-19
Long-COVID
Observational
Additional relevant MeSH terms:
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COVID-19
Post-Acute COVID-19 Syndrome
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