Understanding the Long-term Impact of COVID-19 in Adults

N/ANot Yet RecruitingNCT07498504

NYU Langone Health5,205 enrolled

Overview

Long COVID (LC) affects an estimated 5-10% of individuals with SARS-CoV-2 causing a persistent physical, cognitive, and functional impairment with potentially severe socioeconomic consequences. While RECOVER-Adult cycle 1 established the largest, most comprehensive U.S. adult LC cohort (14,730 participants), key questions remain about long-term disease trajectories, biological mechanisms, and late-emerging complications. RECOVER-Adult cycle 2 will follow selected participants for two years each, focusing on neurocognitive, cardiopulmonary and infection-associated chronic conditions (IACC) such as Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and autonomic dysfunction. Using a case-cohort design, the study will investigate disease persistence versus resolution, biological mechanisms, and onset of new chronic illnesses, generating critical insights to guide prevention, treatment, and public health policy.

Study Type

OBSERVATIONAL

Enrollment

5,205

Conditions

Long COVID Long Covid19

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * RECOVER-Adult 2024 LCRI 11 or greater, as defined by Geng et al, 2024;1 or * At least 1 RECOVER-Adult LCRI symptom and either a) poor quality of life (QoL) as defined by a response of "poor" on the PROMIS-10 QoL question or b) "bother scale" is "quite a bit" or "very much" for corresponding LCRI symptom; or * At least 1 National Academies of Sciences, Engineering, and Medicine (NASEM) common symptom and either a) poor QoL, or b) "bother scale" is "quite a bit" or "very much" for corresponding NASEM symptom. Exclusion Criteria: * Individuals who have a known or documented hemoglobin lower than 8.5 g/dL, * Individuals who have not yet reached the age of majority, * Individuals who are unable to provide consent, * Individuals who are unwilling to consent to biospecimen collection or are unwilling to participate in the complete protocol, including all assessments and the cycle 2 visit schedule. Note that there are no exclusions related to blood volume collection. For healthy adults, the volume of blood collected (70.9 mL per visit and per year) is substantially lower than the federal minimal risk limit of 550 mL within 8 weeks, * Individuals in hospice care, * Individuals with a serious medical condition which would prevent in-person participation, * Individuals participating in the study NIH RECOVER-Pediatric: Understanding the long-term impact of COVID on children and families, unless enrolled only as caregiver, or * Long-term incarcerated individuals

Outcomes

Primary Outcomes

Percentage of Long COVID Research Index (LCRI) Score of 11 or Higher

The LCRI 11 assesses symptoms such as malaise, brain fog, and fatigue to classify individuals into likely LC, possible LC, or no LC. A score of 11 or greater indicates high-symptom cases of LC.

Time frame: Baseline, Month 6, Month 12, Month 18, Month 24

Percentage of Participants with LC Remission

Percentage of participants who experience remission from LC.

Time frame: Month 6, Month 12, Month 18, Month 24

Percentage of Participants with New Onset Conditions

New onset conditions include, but are not limited to, dementia, coronary artery disease, diabetes, renal disease, cancer, and myalgic encephalomyelitis (ME)/chronic fatigue syndrome (CFS).

Time frame: Month 6, Month 12, Month 18, Month 24

Secondary Outcomes

Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10) Score

is a 10-item, patient-reported survey assessing overall physical, mental, and social health-related quality of life (QOL). The raw score is converted to a standardized t-score ranging from 0-100 (with a mean of 50 and standard deviation of 10); higher scores indicate more of the concept being measured (i.e., higher quality of life).