๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
* INCLUSION CRITERIA:
For Phase A Surveying:
1590 persons who are recovering or have recovered from an acute SARS/CoV2 infection will participate.
Inclusion criteria for Phase A:
Post-COVID-19 Convalescence (n=890)
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 in the past 5 years
a.For participants who don t have a known recovery date, a date of 6 weeks from infection will be imposed
5 Provides documentation of a positive COVID-19 Test. Approved test can include the following:
1. PCR, NAA, or other EUA Approved test to confirm active COVID infection.
2. 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.
3. A positive anti-Spike antibody test is accepted in unvaccinated individuals or those who had antibody testing prior to vaccination.
4. A positive anti-nucleocapsid 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, NAA, or other EUA Approved testing for the documented SARS/COV2 infection.
7. Provides documentation of a negative COVID-19 antibody test prior to vaccination.
OR
COVID-19 vaccine related medical conditions (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 a COVID 19 vaccination
5. Provides documentation of COVID-19 vaccination
6. Provides documentation of a COVID-19 vaccine related medical condition from a medical practitioner
OR
Participants with a history of multiple SARS-CoV-2 infections (N=600)
1. Participants 18 and older
2. Ability to provide informed consent
3. Stated willingness to complete telephone interviews
4. Reports having more than one SARS-CoV-2 infection
5. Provides documentation of at least one positive COVID-19 Test. Approved test can include the following:
5. PCR, NAA, or other EUA Approved test to confirm active COVID infection.
6. 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. Licensed Independent Practitioner documentation of viewing a positive home test results will also be acceptable.
7. A positive anti-Spike antibody test is accepted in unvaccinated individuals or those who had antibody testing prior to vaccination.
8. A positive anti-nucleocapsid antibody test
The elements of the 2020 CDC Interim Case Definition for Probable COVID-19 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:
* Clinical or radiographic evidence of pneumonia, OR
* Acute respiratory distress syndrome (ARDS).
AND
No alternative more likely diagnosis
For Phase B Evaluation:
240 persons who are recovering or have recovered from COVID-19 within the last five years will participate. The accrual ceiling is 120 PASC and 120 healthy volunteers, with a goal to identify 80 PASC participants and 80 post-COVID fully recovered healthy volunteers who may be eligible for Phase C. Time since infection (i.e. within first six months, six months to one year, one year to two years, and two years to five years) will also be considered, with a goal of recruiting at least 20 PASC participants and 20 post- COVID fully recovered participants within each of these four time frames.
Inclusion Criteria for all Phase B participants:
1. Adult participants aged 18 years and older
2. Self-reported completion of at least the 7th grade of school.
3. Fluency in English.
4. Willing and able to complete all study procedures
5. Participant has a primary care provider at the time of enrollment.
6. Able to provide informed consent
7. Participants must be at least six weeks out since the onset of COVID-19 symptoms with no fever for at least one week.
8. Participants must be within five years since starting to recover from acute COVID- 19 symptoms. The date of the start of recovery can be determined by:
* The date that fever broke for the first time
* The date the participant recalls starting to improve
* If a participant is unable to report a reliable date, a date of six weeks from the onset of COVID-19 symptoms may be imputed.
9. Does not have an active SARS-CoV-2 infection. The protocol will conform with NIH CC standards for documenting a participant does not have active SARS-CoV- 2 infection. This may include screening interviews and/or testing.
Additional Inclusion Criteria for Mild to Moderate Illness COVID-19 with severe PASC symptoms:
1. Licensed Independent Practitioner documentation of a stable state of general well- health and physical function prior to contracting SARS-CoV-2. This may include medical records, correspondence letters, or information gathered from telephone calls with study personnel.
2. A self-reported illness narrative of the development of persistent PASC symptoms after recovering from a SARS-CoV-2 inf