Understanding the Long-term Impact of COVID-19 in Adults
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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,
Trial population
Subset of adults previously enrolled in RECOVER-Adult cycle 1, who did not withdraw consent to use their data, and are located proximate to a cycle 2 enrolling site.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
5,205 Participants
are grouped into 2 trial groupsGroup A: Case Group
Group B: Control Group
Trial outcomes
Primary outcomes
1
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 242
Percentage of Participants with LC Remission
Percentage of participants who experience remission from LC.
Time frame
Month 6, Month 12, Month 18, Month 243
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 24Secondary outcomes
1
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).
Time frame
Baseline, Month 6, Month 12, Month 18, Month 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
NYU Langone Health
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov
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