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

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 Overview

• Status: Not yet recruiting
• Conditions: Long COVID; Long Covid19

• Study Type: Observational
• Enrollment (Estimated): 5205

Contacts and Locations

• Study Contact: Name: Leora Horwitz, MD; Phone Number: 646-501-2685; Email: RECOVER_CSC@nyulangone.org
• Study Contact Backup: Name: Priscilla Short, CIP, CCRP; Email: RECOVER_CSC@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline, Month 6, Month 12, Month 18, Month 24

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Leora Horwitz, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Post-Infectious Disorders; COVID-19; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Pathological Conditions, Signs and Symptoms; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: 25-01662

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No