Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04573062
Recruitment Status : Recruiting
First Posted : October 5, 2020
Last Update Posted : July 30, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Tracking Information
First Submitted Date October 1, 2020
First Posted Date October 5, 2020
Last Update Posted Date July 30, 2021
Estimated Study Start Date August 4, 2021
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 1, 2020)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health
Official Title Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health
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.

Detailed 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 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 would 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 Intermural Research at NIH will be appropriately referred. Evaluated individuals of research interest may be invited back to the NIH Clinical Center from broad and deep research measurement during Phase C Deep Phenotyping (Phase C). The deep phenotyping methods employed will be synchronized with other NIH-approved deep phenotyping protocols to foster cross-phenotype comparison research with other medical syndromes, such as Myalgic Encephalomyelitis/Chronic Fatigue Syndrome and Gulf War Illness. Deep phenotyping characterizations would be used to generate scientific hypotheses for testing in future studies.

Evaluated individuals with Post-COVID-19 syndromes of research interest may be invited to participate in Phase D Longitudinal Evaluation phase (Phase D). This would enable the observation of the natural history of Post-COVID convalescence and allow for exploration of the biological mechanisms underlying successful recovery and how recovery can go awry.

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.

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 of the study only. Additional phases will be detailed in planned protocol Amendments.

Objectives:

Primary Objective:

Phase A: to observe and describe the range of medical syndromes that occur in the wake of acute SARS/CoV2.

Secondary Objectives:

Phase A: To observe and describe recovery trajectories following an acute SARS/CoV2 infection.

Endpoints:

Outcome measures

Phase A: 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.

Study Populations: Phase A:

  • Total of 1540 Participants Comprised of the following:
  • 1000 adults who are within six months of their convalescence from an acute SARS/CoV2infection with documentation of a positive COVID-19 test. A subset of these individuals may be eligible for participation in Protocol 000466 Procedural Motor Memory in Long Haul COVID-19
  • 250 adults recovering from neurological sequelae from a SARS/CoV2 infection that may be eligible for participation in Protocol 00094 An Observational Study of Neurological Function After COVID 19 Infection .
  • 50 adults with medical documentation supporting a clinical diagnosis of a COVID-19 with negative or absent PCR testing and negative antibody testing.
  • Up to 150 participants enrolled in protocol 20CC0113: Cardiopulmonary Inflammation and Multi-System Imaging During the Clinical Course of COVID-19 Infection in Asymptomatic and Symptomatic Persons
  • Up to 90 participants enrolled in protocol 000102-CC: COVID-19, Chronic Adaptation, and Response to Exercise (COVID-CARE)

Description of Sites/Facilities Enrolling Participants: Study Duration:

Phase A: All activities will be done using telephone interviews and internet-based questionnaires that participants will complete offsite.

Participant Duration:

Phase A: Participants will be invited to complete questionnaires for a period of three years.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Post-Coronavirus Disease 19
Intervention Not Provided
Study Groups/Cohorts Post COVID patients
Individuals whom have previously had COVID-19 infection.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 13, 2021)
1540
Original Estimated Enrollment
 (submitted: October 1, 2020)
1000
Estimated Study Completion Date December 31, 2024
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Angelique Gavin (301) 402-0880 angelique.gavin@nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04573062
Other Study ID Numbers 10000089
000089-N
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
Study Sponsor National Institute of Neurological Disorders and Stroke (NINDS)
Collaborators Not Provided
Investigators
Principal Investigator: Avindra Nath, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date June 23, 2021