Understanding the Long-term Impact of COVID-19 in Adults
RECOVER-Adult Cycle 2: A Long-Term Follow Up Study of Post-Acute Sequelae of SARS-CoV-2 Infection in Adults
1 other identifier
observational
5,205
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2026
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2026
CompletedFirst Posted
Study publicly available on registry
March 27, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2030
March 27, 2026
March 1, 2026
3.9 years
March 23, 2026
March 23, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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.
Baseline, Month 6, Month 12, Month 18, Month 24
Percentage of Participants with LC Remission
Percentage of participants who experience remission from LC.
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).
Month 6, Month 12, Month 18, Month 24
Secondary Outcomes (1)
Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10) Score
Baseline, Month 6, Month 12, Month 18, Month 24
Study Arms (2)
Case Group
Individuals who met LC enrichment criteria in RECOVER-Adult cycle 1.
Control Group
Individuals who did not meet LC enrichment criteria in RECOVER-Adult cycle 1.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leora Horwitz, MD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2026
First Posted
March 27, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
April 1, 2030
Study Completion (Estimated)
April 1, 2030
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Immediately following publication. No end date.
- Access Criteria
- Data will be stored in registries housed by NHLBI BioData Catalyst® (BDC). Data will be available in three forms: 1) identified line-level, in a private data repository (RECOVER Data Gateway; RDG) maintained by BDC and accessible only to RECOVER Consortium investigators upon approval by a RECOVER PI and the RECOVER publications committee following established policies and procedures; 2) fully deidentified line-level, in a data repository at BDC accessible upon request to the public, for which access is managed by the Database of Genotypes and Phenotypes (dbGaP); and 3) publicly available, grouped, anonymized data for exploration and cohort-building through BDC using the Patient-centered Information Commons: Standardized Unification of Research Elements (BDC-PICSURE) tool. No permissions are required to access PIC-SURE because it is fully anonymized count data.
Data will be stored in registries housed by NHLBI BioData Catalyst® (BDC). Data will be available in three forms: 1) identified line-level, in a private data repository (RECOVER Data Gateway; RDG) maintained by BDC and accessible only to RECOVER Consortium investigators upon approval by a RECOVER PI and the RECOVER publications committee following established policies and procedures; 2) fully deidentified line-level, in a data repository at BDC accessible upon request to the public, for which access is managed by the Database of Genotypes and Phenotypes (dbGaP); and 3) publicly available, grouped, anonymized data for exploration and cohort-building through BDC using the Patient-centered Information Commons: Standardized Unification of Research Elements (BDC-PICSURE) tool. No permissions are required to access PIC-SURE because it is fully anonymized count data.