Understanding the Long-term Impact of COVID on Children and Families

December 29, 2025 updated by: NYU Langone Health

NIH RECOVER: A Multi-site Observational Study of Post-acute Sequalae of SARS-CoV-2 Infection in Children

This is a combined retrospective and prospective, longitudinal, observational meta-cohort of individuals age 0-25 years who will enter the cohort with and without SARS-CoV-2 infection at varying stages before and after infection. Individuals with and without SARS-CoV-2 infection and with or without PASC symptoms will be followed to identify risk factors and occurrence of PASC. This study will be conducted in the United States and participants will be recruited through inpatient, outpatient, and community-based settings. Study data including age, demographics, social determinants of health, medical history, vaccination history, details of acute SARS-CoV-2 infection, overall health and physical function, and PASC symptoms will be reported by participants or collected from the electronic health record using a case report form at specified intervals. Biologic specimens will be collected at specified intervals, with some tests performed in local clinical laboratories and others performed by centralized research centers or banked in the Biospecimen Repository. Advanced clinical examinations and radiologic examinations will be performed at local study sites with cross-site standardization.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Ambidirectional longitudinal meta-cohort study (combined retrospective and prospective) with nested case-control studies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15028

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham (Pregnancy Cohort)
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital and Research Institute
    • California
      • La Jolla, California, United States, 92093
        • University of California San Diego
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles
      • San Diego, California, United States, 92123
        • University of California San Diego Health - Rady Children's Hospital
      • San Francisco, California, United States, 94143
        • University of California San Francisco
      • San Francisco, California, United States, 94115
        • University of California San Francisco (Pregnancy Cohort)
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Connecticut Children's Medical Center
      • New Haven, Connecticut, United States, 06510
        • Yale School of Medicine (YSM)
    • Delaware
      • Newark, Delaware, United States, 19718
        • ChristianaCare Health System
      • Wilmington, Delaware, United States, 19803
        • Nemours Children's Health
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20052
        • George Washington University
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Kapi'olani Medical Center for Women & Children
    • Illinois
      • Evanston, Illinois, United States, 60208
        • Northwestern University
      • Glenview, Illinois, United States, 60026
        • NorthShore University Healthsystem
      • Itasca, Illinois, United States, 60143
        • American Academy of Pediatrics
    • Kansas
      • Leawood, Kansas, United States, 66211
        • American Academy of Family Physicians
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville - Norton Children's Hospital
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Louisiana State University (LSU) - Pennington Biomedical Research Center
      • New Orleans, Louisiana, United States, 70118
        • Tulane University
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Harvard Medical School
      • Boston, Massachusetts, United States, 02115
        • Harvard School of Public Health
      • Boston, Massachusetts, United States, 02115
        • Northeastern University
      • Boston, Massachusetts, United States, 02114
        • Mass General Brigham - Harvard University
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Central Michigan University - College of Medicine
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • Dartmouth-Hitchcock
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • New Brunswick, New Jersey, United States, 08901
        • Saint Peter's University Hospital
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers University
      • West Orange, New Jersey, United States, 07052
        • The Pediatric Specialty Center at Saint Barnabas
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • University of New Mexico Health Sciences Center
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health
      • New York, New York, United States, 10027
        • Columbia University
      • New York, New York, United States, 10032
        • Columbia University (Pregnancy)
      • Queens, New York, United States, 11355
        • NewYork-Presbyterian Hospital
      • Valhalla, New York, United States, 10595
        • New York Medical College
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27516
        • University of North Carolina (UNC) at Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Raleigh, North Carolina, United States, 27610
        • WakeMed Health & Hospitals
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital
      • Cleveland, Ohio, United States, 44109
        • MetroHealth System
      • Cleveland, Ohio, United States, 44106
        • University Hospitals MacDonald's Women's Hospital
      • Cleveland, Ohio, United States, 44109
        • The MetroHealth System (Pregnancy Cohort)
      • Columbus, Ohio, United States, 43210
        • The Ohio State University - Wexner Medical Center
      • Dayton, Ohio, United States, 45409
        • Miami Valley Hospital
      • Fairfield, Ohio, United States, 45014
        • Children's Mercy Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center (OUHSC)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center (UPMC)
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
      • Providence, Rhode Island, United States, 02905
        • Women & Infants Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina (MUSC)
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Upstate
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Avera Research Institute
    • Texas
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch (UTMB) Galveston
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77024
        • University of Texas Health Science Center at Houston
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Health
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont (UVM) Children's Hospital
    • Virginia
      • Richmond, Virginia, United States, 23284
        • Virginia Commonwealth University
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 25 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Infected: Individuals less than 25 years of age meeting WHO criteria for suspected, probable or confirmed SARS-CoV-2 infection on or after March 1, 2020; or those born to a mother meeting these criteria during pregnancy.

Uninfected: Individuals less than 25 years of age who have never met any of the WHO criteria for suspected, probable or confirmed SARS-CoV-2 infection.

Description

Inclusion Criteria:

Infected Cohort:

Patients will be eligible for inclusion according to the following criteria:

  1. Ages newborn-25 years
  2. Infected individuals will have suspected, probable, or confirmed SARS-CoV-2 infection as defined by WHO criteria within 24 months of enrollment or have been born to a mother meeting these criteria during pregnancy (congenitally exposed)
  3. Children/young adults with or without history of MIS-C are eligible
  4. Children/young adults with or without history of SARS-CoV-2 vaccination are eligible
  5. Children/young adults with evidence of past SARS-CoV-2 infection based on serum antibody profile are eligible (with or without history of acute symptoms)
  6. Children/young adults with recurrent SARS-CoV-2 infections and those with post-vaccination (breakthrough) infections are eligible to participate
  7. Participants are eligible without exclusion related to sex, race/ethnicity, geography, nationality, severity of disease, or underlying health conditions

Children/Young Adults with Suspected SARS-Cov-2 Infection

Children/young adults who meet these clinical criteria:

At least one of these clinical criteria:

  • Acute onset of fever and cough OR
  • Acute onset of ANY THREE OR MORE of the following signs or symptoms: fever, cough, general weakness /fatigue, headache, myalgia, sore throat, coryza, dyspnea, anorexia/nausea/vomiting, diarrhea, altered mental status.

AND at least one of these epidemiological criteria:

  1. Residing or working in an area with a high risk of transmission of virus: closed residential, school or camp settings anytime within the 14 days before symptom onset; OR
  2. Residing or travel to an area with community transmission anytime within the 14 days before symptom onset; OR
  3. Any known household contact or any member of the household working in any health care setting, including within health facilities or within the community; anytime within the 14 days before symptom onset.

  4. A patient with history of severe acute respiratory illness (SARI):

    - SARI: acute respiratory infection with history of fever or measured fever of ≥ 38 C°; and cough; with onset within the last 10 days; and requires hospitalization

  5. An asymptomatic person not meeting epidemiologic criteria with a positive SARS-CoV-2 Antigen-RDT.

Children/Young Adults with Probable SARS-Cov-2 Infection

  1. A patient who meets clinical criteria above AND is a contact of a probable or confirmed case or linked to a COVID-19 cluster; OR
  2. A suspect case with chest imaging showing findings suggestive of COVID-19 disease; OR
  3. A person with recent onset of anosmia (loss of smell) or ageusia (loss of taste) in the absence of any other identified cause

Children/Young Adults with Confirmed SARS-Cov-2 Infection

  1. A person with a positive Nucleic Acid Amplification Test (NAAT); OR
  2. A person with a positive SARS-CoV-2Antigen-RDT AND meeting either the probable case definition or suspect criteria A OR B; OR
  3. An asymptomatic person with a positive SARS-CoV-2 Antigen-RDT who is a contact of a probable or confirmed case

Children/Young Adults with Asymptomatic SARS-CoV-2 Infection

  1. A person without history of acute COVID-19 symptoms who has one or more of the epidemiological exposures for suspected infection and who also meets criteria b or c for suspected or probable infection, or who meets any of the criteria for confirmed infection
  2. A person without history of acute COVID-19 symptoms who has positive nucleocapsid antibody test result in medical history or Tier 1 testing with or without NAAT or RDT testing or known contact to a probable or confirmed case.

Non-Infected Cohort

A person who meets the following criteria will qualify for enrollment as a non-infected control subject:

  1. Does not meet WHO criteria for a suspected, probable, or confirmed case of SARS-CoV-2 infection AND
  2. Does not have serological evidence of past asymptomatic SARS-CoV-2 infection in medical history or Tier 1 testing, AND
  3. Lives in the same communities or recruited from the same sources as those in the SARS-CoV-2 infected cohort, AND
  4. Either not hospitalized for any reason in prior 3 months, or hospitalized (with or without ICU stay) within the prior 3 months
  5. Uninfected individuals may participate independent of their vaccination status
  6. Uninfected individuals who develop SARS-CoV-2 infection during the study period will be reassigned to the SARS-Cov-2 infected group and will be considered to have been enrolled prior to SARS-CoV-2 infection.

Children (≤3 years of age) born in and out of the context of maternal SARS-CoV-2 infection during pregnancy.

  1. Children ≤3 years of age born to a childbearing parent with history of suspected, probable, or confirmed SARS-COV-2 infection during pregnancy (according the same criteria listed for the infected child cohort) will be enrolled in the study from existing research cohorts at the maternal fetal medicine sites in the RECOVER. network.
  2. Children ≤3 years of age born to a childbearing parent without history of SARS-COV-2 infection during pregnancy (according to the same criteria listed for the non-infected child cohort) will also be enrolled from the same existing research cohorts at maternal fetal medicine sites in the RECOVER network.

Children with MIS-C

Children/young adults with SARS-CoV-2 infection who have history of MIS-C meeting the CDC definition:

  1. An individual aged <21 years presenting with fever*, laboratory evidence of inflammation**, and evidence of clinically severe illness requiring hospitalization, with multisystem (>2) organ involvement (cardiac, renal, respiratory, hematologic, gastrointestinal, dermatologic or neurological); AND
  2. No alternative plausible diagnoses; AND

  3. Positive for current or recent SARS-CoV-2 infection by RT-PCR, serology, or antigen test; or exposure to a suspected or confirmed COVID-19 case within the 4 weeks prior to the onset of symptoms.

    • Fever >38.0°C for ≥24 hours, or report of subjective fever lasting ≥24 hours **Including, but not limited to, one or more of the following: an elevated C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), fibrinogen, procalcitonin, d-dimer, ferritin, lactic acid dehydrogenase (LDH), or interleukin 6 (IL-6), elevated neutrophils, reduced lymphocytes and low albumin Young adults with past history of MIS-C with current ages 22-25 years are eligible to participate.

Children/Young Adults with Post-Vaccine Myocarditis

  1. Age 3-25 years
  2. Recipient of mRNA COVID-19 vaccination within last 4 weeks
  3. Children or young adults with or without history of SARS-CoV-2 infection are eligible
  4. Children or young adults with or without history of MIS-C are eligible (if any prior MIS-C-related cardiac abnormalities are known to have resolved pre-vaccination)
  5. No other known auto-immune or other immune dysregulation disease
  6. Participants are eligible without exclusion related to sex, race/ethnicity, geography, nationality, severity of disease, or underlying health conditions
  7. Clinical evidence of probable or confirmed myocarditis based on the following criteria:

Children and young adults ages 3-25 years with presence of ≥1 new or worsening of the following clinical symptoms:

  • chest pain, pressure, or discomfort
  • dyspnea, shortness of breath, or pain with breathing
  • palpitations
  • syncope

OR, children aged 3-12 years might instead have ≥2 of the following symptoms:

  • irritability
  • vomiting
  • poor feeding
  • tachypnea

  • lethargy AND

    ≥1 new finding of:

  • troponin level above upper limit of normal (any type of troponin)
  • abnormal electrocardiogram (ECG or EKG) or rhythm monitoring findings consistent with myocarditis
  • abnormal cardiac function or wall motion abnormalities on echocardiogram
  • cardiac MRI findings consistent with myocarditis
  • histopathologic confirmation of myocarditis (Definite myocarditis)¶ AND
  • No other identifiable cause of the symptoms and finding

Entry criteria are adapted from the CDC definition based on the assumptions that COVID-19 vaccines will be available in the future to children <5 years of age.

Primary Caregiver Entry Criteria

  1. A primary caregiver is defined as an individual, such as a family member (biological or nonbiological) or legal guardian, who is responsible for the care of the enrolled child and resides in the same household as the child. When possible, the primary caregiver identified at study entry will remain in the same role throughout the study.
  2. The primary caregiver is the caregiver who spends the most time with the child or young adult, has substantial responsibility for taking care of him/her on a daily basis, and is most knowledgeable about him/her.
  3. If two or more persons share equally in the caregiver responsibilities for the child or young adult, the person selected by the family to fill out study forms both about themselves and the child will be considered the primary caregiver.
  4. If a biological family member primary caregiver has not reached the legal age of majority in their jurisdiction, the parent/legal guardian for the minor primary caregiver will provide consent for participation, with assent provided by the minor caregiver.
  5. A nonbiological primary caregiver or legal guardian serving as primary caregiver must be above the legal age of majority in their jurisdiction.
  6. The primary caregiver cannot be a babysitter or other childcare provider who receives money to care for the child.

Biological Parent Entry Criteria

- If the primary caregiver is a biological parent of the child or young adult who is participating in the study, the other biological parent may be enrolled to provide a home sample of saliva for DNA analysis.

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Any child, young adult, caregiver, or other biological parent who in the opinion of the site investigator may be at increased risk of adverse events during participation in the study, or who may not be able to complete study procedures due to co-morbid disease or disability.
  2. Any young adult age above the age of majority who lacks capacity to provide consent
  3. Nonviable neonates and neonates of uncertain viability as determined by the treating physician
  4. Any child, young, adult, or caregiver with co-morbid illness with expected survival <2 years
  5. Any child who is being given up for adoption or is a ward of the state
  6. Any caregiver or other biological parent who is incarcerated, or who lacks capacity to provide consent
  7. Currently enrolled in the study Understanding the Long-term Impact of COVID-19 in Adults

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Extant, Clinical and De Novo Cohort -- INFECTED
SARS-CoV-2 infected children and young adults with and without current or prior PASC-like symptoms, including infected individuals with history of multisystem inflammatory syndrome in children (MIS-C), and infants born in the context of maternal SARS-CoV-2 infection during pregnancy
Extant, Clinical and De Novo Cohort -- UNINFECTED
SARS-CoV-2 uninfected children and infants born to uninfected mothers
Acute Cohort -- INFECTED
Newly SARS-CoV-2 infected individuals (≤4 weeks since onset of symptoms or positive laboratory testing)
Acute Cohort -- UNINFECTED
Contemporaneous SARS-CoV-2 uninfected individuals selected from the same population as newly SARS-CoV-2 infected individuals
Post-acute cohort -- INFECTED
Post-acute infected individuals (>4 weeks after initial symptoms or positive laboratory testing) in the extant, clinical and de novo cohorts, including infants born in the context of maternal SARS-CoV-2 infection during pregnancy, will be enrolled 1-24 months after initial SARS-CoV-2 infection.
Post-acute cohort -- UNINFECTED
Uninfected individuals will be derived from a similar population with respect to age, sex, race and ethnicity, geographic origin, sociodemographics, and time of enrollment as the infected individuals.
Post-COVID Vaccine Myocarditis
Individuals with history of myocarditis after receiving COVID-19 vaccine.
Primary Caregivers
The primary caregiver of the child or young adult may optionally participate in the study.
Biological Parent
If the primary caregiver is a biological parent, the other biological parent may optionally participate in the study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Caregiver SARS-CoV-2 Infection Status
Time Frame: Baseline
Initial SARS-CoV-2 infection is reported via remote patient report (electronic, paper or telephone assessments) and EHR. Infection categories include: SARS CoV 2 PCR result, SARS CoV 2 antigen result, SARS CoV 2 antibody result, SARS CoV 2 sequencing performed, diagnosed by a doctor based on symptoms, suspected by participant but not diagnosed by a doctor.
Baseline
Child SARS-CoV-2 Infection Status
Time Frame: Baseline
Initial SARS-CoV-2 infection is reported via remote patient report (electronic, paper or telephone assessments) and EHR. Infection categories include: SARS CoV 2 PCR result, SARS CoV 2 antigen result, SARS CoV 2 antibody result, SARS CoV 2 sequencing performed, diagnosed by a doctor based on symptoms, suspected by participant but not diagnosed by a doctor.
Baseline
Caregiver Severity of SARS-CoV-2 Infection
Time Frame: Baseline
Severity levels are reported via remote patient report (electronic, paper or telephone assessments) and EHR. NIH severity levels include: asymptomatic or presymptomatic, mild illness, moderate illness, severe illness, and critical illness.
Baseline
Child Severity of SARS-CoV-2 Infection
Time Frame: Baseline
Severity levels are reported via remote patient report (electronic, paper or telephone assessments) and EHR. NIH severity levels include: asymptomatic or presymptomatic, mild illness, moderate illness, severe illness, and critical illness.
Baseline
Caregiver Previous In-Hospital SARS-CoV-2 Treatment Record
Time Frame: Baseline
Treatments will be reported via remote patient report (electronic, paper, or telephone assessment) and EHR -- Treated with corticosteroids , Treated with hydroxychloroquine, Treated with lopinavir, ritonavir, other antiviral, Treated with monoclonal antibody, Treated with therapeutic anticoagulation, Treated with antibiotics.
Baseline
Child Previous In-Hospital SARS-CoV-2 Treatment Record
Time Frame: Baseline
Treatments will be reported via remote patient report (electronic, paper, or telephone assessment) and EHR -- Treated with corticosteroids , Treated with hydroxychloroquine, Treated with lopinavir, ritonavir, other antiviral, Treated with monoclonal antibody, Treated with therapeutic anticoagulation, Treated with antibiotics.
Baseline
Caregiver Symptoms
Time Frame: Baseline, up to Month 48
Symptoms will be reported via remote patient report, in-person patient report, or EHR
Baseline, up to Month 48
Child Symptoms
Time Frame: Baseline, up to Month 48
Symptoms will be reported via remote patient report, in-person patient report, or EHR -- symptoms include: Nasal Congestion, Trouble breathing, Pain when breathing, Chest pain, Palpitations/heart racing, Dizziness/lightheadedness, Fainting, Change in hearing/ringing in ears, Blurred vision, Change in smell, Change in taste, Problems with teeth or gums, Tremors/shakiness, Feeling off-balance or unsteady, Feeling tingling or "pins and needles", Seizures/fits, Muscle weakness, Difficulty sleeping, Excessive sleepiness, Fatigue/Low energy, Feeling exhausted after walking, Poor appetite, Stomach pains/cramps, Nausea, Vomiting, Diarrhea, Constipation, Problems with urination, Skin rash, Problems with memory, Problems with concentration, Speech difficulty, Anxiety, Depression, Body pain, Headache, Problems swallowing or chewing, Change in menstruation
Baseline, up to Month 48
Caregiver SARS-CoV-2 Vaccination Status
Time Frame: Baseline, up to Month 48
Vaccination in status will be reported via remote patient report, in-person patient report, or EHR.
Baseline, up to Month 48
Change in Child SARS-CoV-2 Vaccination Status
Time Frame: Week 8, up to Month 48
Vaccination in status will be reported via remote patient report, in-person patient report, or EHR.
Week 8, up to Month 48
Change in Caregiver SARS-CoV-2 Treatment Record
Time Frame: Month 12, up to Month 48
Treatments will be reported via remote patient report, in-person patient report, or EHR -- Treated with corticosteroids, Treated with hydroxychloroquine, Treated with lopinavir, ritonavir, other antiviral, Treated with monoclonal antibody, Treated with therapeutic anticoagulation, Treated with antibiotics.
Month 12, up to Month 48
Change in Child SARS-CoV-2 Treatment Record
Time Frame: Week 8, up to Month 48
Treatments will be reported via remote patient report, in-person patient report, or EHR -- Treated with corticosteroids, Treated with hydroxychloroquine, Treated with lopinavir, ritonavir, other antiviral, Treated with monoclonal antibody, Treated with therapeutic anticoagulation, Treated with antibiotics.
Week 8, up to Month 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stuart Katz, MD, MS, NYU Langone Health
  • Principal Investigator: Leora Horwitz, MD, NYU Langone Health
  • Principal Investigator: Andrea Troxel, ScD, NYU Langone Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 23, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21-01231

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial, after deidentification will be shared upon reasonable request.

IPD Sharing Time Frame

Data will become available beginning 9 months with no end date.

IPD Sharing Access Criteria

The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to RECOVER_CSC@NYULangone.org To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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