Long COVIDNCT07498504
Understanding the Long-term Impact of COVID-19 in Adults
An observational study of Long COVID and Long Covid19, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Long COVID, Long Covid19
- How many people
- 5,205 participants
- Where
- 1 siteUnited States
- Study dates
- May 2026to Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Priscilla Short, CIP, CCRP contact
About this study
Official title: 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.
- Conditions
- Long COVID, Long Covid19
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Month 6, Month 12, Month 18, Month 24
Percentage of Participants with LC Remission
Percentage of participants who experience remission from LC.
Measured: 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).
Measured: Month 6, Month 12, Month 18, Month 24
Secondary 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).
Measured: Baseline, Month 6, Month 12, Month 18, Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study startMay 2026 (estimated)
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Leora Horwitz, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498504
- Sponsor's protocol ID
- 25-01662
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECOVER-Adult Cycle 2: A Long-Term Follow Up Study of Post-Acute Sequelae of SARS-CoV-2 Infection in Adults
- ClinicalTrials.gov ID
- NCT07498504
- Acronym / sponsor ID
- 25-01662
- Conditions
- Long COVID, Long Covid19
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,205 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2026 (estimated)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Percentage of Participants with LC Remission
Time frame: Month 6, Month 12, Month 18, Month 24
Percentage of participants who experience remission from LC.
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).
1 secondary outcome
Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10) Score
Time frame: Baseline, Month 6, Month 12, Month 18, Month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Long COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Priscilla Short, CIP, CCRP contact
Leora Horwitz, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long COVID and Long Covid19, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leora Horwitz, MD (646-501-2685, RECOVER_CSC@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Long COVID Research Index (LCRI) Score of 11 or Higher (time frame: Baseline, Month 6, Month 12, Month 18, Month 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.