Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health
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- STATUS
- Recruiting
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- End date
- Dec 31, 2024
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- participants needed
- 1540
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- sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
Summary
- Background
People who get COVID-19 have a wide range of symptoms. They also recover from COVID-19 in different ways. In this study, researchers will use survey data to describe the different ways people experience and recover from COVID-19. They will also use the data to help create future studies to understand why some people do not fully recover.
- Objective
To learn more about the range and timing of symptoms that people have before, during, and after COVID-19 infection.
- Eligibility
People ages 18 and older who can give documentation of a positive COVID-19 or antibody test.
- Design
Participants will be screened with a telephone interview. It will take 15 minutes. They will provide their COVID-19 test results and medical records.
Participants will complete a second telephone interview. It will take 30 60 minutes. They will also take online surveys every 3 months for 3 years.
The interview and surveys will ask participants about their health before they got COVID-19, what happened while they had COVID-19, and what their recovery has been like.
Participants will get log-in data to take the online surveys. Completing all of the surveys the first time may take up to 3 hours. Follow-up surveys will take up to 30 minutes. Participants do not have to complete the surveys in one sitting. They will be able to save their progress and finish the surveys later.
Participants may be contacted to take part in other research studies.
Description
Study Description: In late 2019, the novel coronavirus SARS/CoV2 appeared in Wuhan, China. The various ways that humans will recover from COVID-19 is just starting to be observed and it is clear there will be a wide range of convalescent experiences. A year into the pandemic, the post-acute sequelae of SARS/CoV2 infection (PASC) is known to be common and includes a broad range of symptoms and potential pathologies. This phased protocol is designed to observe and study the convalescence and recoveries from acute SARS/CoV2 infections.
Phase A Phase A Surveying (Phase A) will enable people in the community that are convalescing from COVID-19 to be studied using telephone interviews and internet-based questionnaires. The objective of Phase A Surveying is to observe and describe the range of medical syndromes that occur in the wake of an acute SARS/CoV2 infection.
Participants are required to be within the first six months of their recovery and have documentation of a positive laboratory test for COVID-19. .Additional cohorts of persons with neurological sequelae, persons with a clinical diagnosis of COVID-19 with negative testing, and participants co-enrolled in other research studies within the Division of Intramural Research will also be studied. The data collected during Phase A will describe the range of symptoms and patterns of symptom clustering of PASC. This data will also characterize the patient populations which have been or will be evaluated at the NIH Clinical Center in more detail.
Phase B Evaluation (Phase B) will allow surveyed participants of research interest from Phase A to be invited to the NIH Clinical Center for a medical evaluation and to undergo a panel of standard research measurements. Each participant will be medically and psychologically characterized to best understand if their complaints can be attributed to known disorders. The observations made during Phase B will provide insights into the range, character, and subtypes of PASC. Individuals found to have disorders being studied within the Division of Intramural Research at NIH will be appropriately referred.
Evaluated individuals with persistent symptoms in the absence of demonstrable medical disease and individuals who fully recovered from SARS/CoV2 will be invited back to the NIH Clinical Center for broad and deep research measurements.
Phase C Deep Phenotyping (Phase C)employed will be synchronized with other NIH-approved deep phenotyping protocols to foster crossphenotype comparison research with other medical syndromes, such as Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Gulf War Illness (GWI). Deep phenotyping characterizations would be used to generate scientific hypotheses for testing in future studies and for cross-comparisons with other fatiguing disorders.
Evaluated individuals with PASC may be invited to participate in Phase D Longitudinal Evaluation phase (Phase D). This would enable the observation of the natural history of PASC and allow for exploration of the biological mechanisms underlying successful
recovery and how recovery can go away.
Previous epidemics have created unique medical syndromes in the past. Data from this protocol may be used to characterize PASC and any Post-COVID 19 Syndrome subtypes that may be discovered. If warranted, a Criteria Development phase will develop data-driven research consensus criteria for defining PASC and any Post-COVID 19 Syndromes.
The results of this protocol will provide novel insights into COVID- 19 convalescence and its potential outcomes.
This current version of the protocol provides the details for Phase A, Phase B, and Phase C. Additional phases will be detailed in planned protocol amendments.
Details
| Condition | Post-Coronavirus Disease 19 |
|---|---|
| Clinical Study Identifier | NCT04573062 |
| Sponsor | National Institute of Neurological Disorders and Stroke (NINDS) |
| Last Modified on | 11 May 2022 |
Eligibility
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