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NCT Number: NCT07498504

Understanding the Long-term Impact of COVID-19 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.

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Key information

Conditions

Long COVID COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Long Covid19 Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

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

    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.

  2. Percentage of Participants with LC Remission

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

    Percentage of participants who experience remission from LC.

  3. Percentage of Participants with New Onset Conditions

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

    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).

Secondary outcomes

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

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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Leora Horwitz, MD

CONTACT

[email protected]

646-501-2685

Priscilla Short, CIP, CCRP

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

RECOVER-Adult Cycle 2: A Long-Term Follow Up Study of Post-Acute Sequelae of SARS-CoV-2 Infection in Adults

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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