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Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health

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ClinicalTrials.gov Identifier: NCT04573062
Recruitment Status : Recruiting
First Posted : October 5, 2020
Last Update Posted : July 23, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Brief 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.


Condition or disease
Post-Coronavirus Disease 19

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 1540 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health
Estimated Study Start Date : July 28, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Group/Cohort
Post COVID patients
Individuals whom have previously had COVID-19 infection.



Primary Outcome Measures :
  1. Screening Phase [ Time Frame: End of Study ]
    The number and severity of persistent symptoms associated with COVID-19 convalescence. Collected data will be used to characterize different narratives of COVID-19 convalescence.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
1000 persons who are recovering from an acute COVID-19 infection will participate. Individuals in the community who are within six months of their convalescence from an acute COVID-19 infection.
Criteria
  • INCLUSION CRITERIA:

For Phase A:

1540 persons who are recovering from an acute SARS/CoV2 infection will participate.

Inclusion criteria for Phase A:

Post-COVID-19 Convalescence (n=1000)

  1. Participants 18 and older
  2. Ability to provide informed consent
  3. Stated willingness to complete telephone interviews
  4. Reports having begun recovery from an acute SARS/CoV2 infection within the last six months
  5. Provides documentation of a positive COVID-19 PCR or antibody test

OR

Post-COVID-19 Neurological Sequelae (n=250)

  1. Participants 18 and older
  2. Ability to provide informed consent
  3. Stated willingness to complete telephone interviews
  4. Reports having developed neurological symptoms as a consequence of an acute SARS/CoV2 infection
  5. Provides documentation of a positive COVID-19 PCR or antibody test

OR

Test-Negative COVID-19 with Persistent Symptoms (n=50)

  1. Participants 18 and older
  2. Ability to provide informed consent
  3. Stated willingness to complete telephone interviews
  4. Reports having developed persistent symptoms as a consequence of an acute SARS/CoV2 infection
  5. Provides documentation of a clinical diagnosis of an acute SARS/CoV2 infection from a medical practitioner OR meets the Clinical Criteria of the 2020 CDC Interim Case Definition for Probable SARS/CoV2 infection.
  6. Has either negative or absent COVID-19 PCR testing for the documented SARS/CoV2 infection.
  7. Provides documentation of a negative COVID-19 antibody test.

OR

Participants enrolled in protocol 20CC0113: Cardiopulmonary Inflammation and Multi- System Imaging During the Clinical Course of COVID-19 Infection in Asymptomatic and Symptomatic Persons (N=150)

  1. Participants 18 and older
  2. Ability to provide informed consent
  3. Stated willingness to complete telephone interviews
  4. Provides documentation of a positive COVID-19 PCR or antibody test 5. Co-enrollment in 20CC0113

OR

Participants enrolled in protocol 000102-CC: COVID-19, Chronic Adaptation, and Response to Exercise (COVID-CARE) (N=90)

  1. Participants 18 and older
  2. Ability to provide informed consent
  3. Stated willingness to complete telephone interviews
  4. Provides documentation of a positive COVID-19 PCR or antibody test
  5. Co-enrollment in 000102-CC

The elements of the 2020 CDC Interim Case Definition for Probable COVID-19 Infection used for this protocol will be the Clinical Criteria:

Clinical Criteria:

At least two of the following symptoms: fever (measured or subjective), chills, rigors, myalgia, headache, sore throat, new olfactory and taste disorder(s)

OR

At least one of the following symptoms: cough, shortness of breath, or difficulty breathing

OR

Severe respiratory illness with at least one of the following:

  1. Clinical or radiographic evidence of pneumonia, OR
  2. Acute respiratory distress syndrome (ARDS).

AND

No alternative more likely diagnosis.

EXCLUSION CRITERIA:

Exclusion criteria for Phase A:

  • Not willing to provide personal identifying information to investigative team
  • Cognitive impairment that is severe enough to limit consent capacity

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): NCT04573062


Contacts
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Contact: Angelique Gavin (301) 402-0880 angelique.gavin@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Avindra Nath, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
Additional Information:
Publications:
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Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT04573062    
Other Study ID Numbers: 10000089
000089-N
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: July 23, 2021
Last Verified: June 23, 2021
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Post-COVID-19
Convalescence
COVID-19
COVID
Additional relevant MeSH terms:
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Coronavirus Infections
Convalescence
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Disease Attributes
Pathologic Processes