Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health (NCT04573062) | Clinical Trial Compass
RecruitingNot Applicable
Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health
United States1,590 participantsStarted 2022-01-02
Plain-language 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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants 18 and older
. Ability to provide informed consent
. Stated willingness to complete telephone interviews
. PCR, NAA, or other EUA Approved test to confirm active COVID infection.
. A positive home Antigen test is acceptable when documentation of a photograph of the test with a phone-based date and time stamp is provided.
. A positive anti-Spike antibody test is accepted in unvaccinated individuals or those who had antibody testing prior to vaccination.
. A positive anti-nucleocapsid antibody test
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Screening Phase
Timeframe: End of Study
2
Phase C: Deep Phenotyping
Timeframe: End of Study
3
Phase B: Evaluation
Timeframe: End of Study
Trial details
NCT IDNCT04573062
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
. No alternative explanation for PASC symptoms identified by adjudication committee during Phase B.
. Fluency in English
. Met inclusion and exclusion criteria for Mild to Moderate Illness COVID-19 without post-acute COVID-19 symptoms after completing Phase B.
. Fluency in English
. Not willing to provide personal identifying information to investigative team
. Cognitive impairment that is severe enough to limit consent capacity
. Current or past psychotic disorder including depression with psychosis, bipolar disorder with psychotic symptoms and schizophrenia
. Major depression disorder, generalized anxiety disorder, post-traumatic stress disorder, panic disorder, or obsessive-compulsive disorder unless managed for more than six months with a stable treatment regimen