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

Inclusion Criteria

• •For Phase A Surveying:
• •1590 persons who are recovering or have recovered from an acute SARS/CoV2 infection will participate.
• •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.
• •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.
• •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.
• •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 infection. These include symptoms such as fatigue, cognitive difficulties, orthostatic intolerance, unrefreshing sleep, neuropathic pain, mood change, and post-exertional malaise.
• •3. Laboratory documentation of a positive COVID-19 PCR, NAA, or other EUA Approved test to confirm active COVID infection at the time of the SARS-CoV-2 infection. Participants with positive home tests during Phase A will be required to have a positive anti-SARS nucleocapsid antibody test.
• •4. Meets WHO Clinical Progression Scale of 2 - 6:
• •* 2: Ambulatory; symptomatic, independent
• •* 3: Ambulatory; symptomatic, assistance needed
• •* 4: Hospitalized; no oxygen therapy
• •* 5: Hospitalized; oxygen by mask or nasal prongs
• •* 6: Hospitalized; oxygen by non-invasive ventilation or high flow oxygen
• •5. Functional Criteria: Substantial symptom severity as determined using SF-36v2: score of \<=70 physical function subscale, or \<=50 on role physical subscale, or \<=75 on social function subscale.
• •OR
• •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 recovery to prior health after a SARS/CoV2 infection.
• •3. Laboratory documentation of a positive COVID-19 PCR, NAA, or other EUA Approved test to confirm active COVID infection at the time of the SARS-CoV-2 infection. Participants with positive home tests during Phase A will be required to have a positive anti-SARS nucleocapsid antibody test.
• •4. Meets WHO Clinical Progression Scale of 2 - 6:
• •* 2: Ambulatory; symptomatic, independent
• •* 3: Ambulatory; symptomatic, assistance needed
• •* 4: Hospitalized; no oxygen therapy
• •* 5: Hospitalized; oxygen by mask or nasal prongs
• •* 6: Hospitalized; oxygen by non-invasive ventilation or high flow oxygen
• •Functional Criteria: No substantial symptom severity as determined using SF-36v2: score of \>=85 physical function subscale, and \>= 85 on role physical subscale, and \>= 85 on social function subscale.
• •OR
• •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. Either a self-reported illness narrative of near recovery to prior health or a narrative of the development of persistent PASC symptoms after recovering from a SARS-CoV-2 infection. These include symptoms such as fatigue, cognitive difficulties, orthostatic intolerance, unrefreshing sleep, neuropathic pain, mood change, and post-exertional malaise.
• •3. Laboratory documentation of a positive COVID-19 PCR, NAA, or other EUA Approved test to confirm active COVID infection at the time of the SARS-CoV-2 infection. Participants with positive home tests during Phase A will be required to have a positive Anti-SARS nucleocapsid antibody test.
• •4. Meets WHO Clinical Progression Scale of 2 - 6:
• •* 2: Ambulatory; symptomatic, independent
• •* 3: Ambulatory; symptomatic, assistance needed
• •* 4: Hospitalized; no oxygen therapy
• •* 5: Hospitalized; oxygen by mask or nasal prongs
• •* 6: Hospitalized; oxygen by non-invasive ventilation or high flow oxygen
• •5. Functional Criteria: Mild to moderate symptom severity as determined using SF-36v2: score of between 71 and 84 on the physical function subscale, or between 51 and 84 on role physical subscale, or between 76 and 84 on social function subscale.
• •For Phase C Deep Phenotyping: