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Not yet recruiting NCT07498504

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

— Observational Long COVID Long Covid19

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Long COVID, Long Covid19. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Primary outcome measures

  • Percentage of Long COVID Research Index (LCRI) Score of 11 or Higher [Time frame: Baseline, Month 6, Month 12, Month 18, Month 24]
  • Percentage of Participants with LC Remission [Time frame: Month 6, Month 12, Month 18, Month 24]
  • Percentage of Participants with New Onset Conditions [Time frame: Month 6, Month 12, Month 18, Month 24]
Secondary outcome measures (1)
  • Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10) Score [Time frame: Baseline, Month 6, Month 12, Month 18, Month 24]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT07498504 · 25-01662

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗