AzTrials
AzTrials

SARS-CoV-2 InfectionNCT05172011

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

An observational study of SARS-CoV-2 Infection, run by NYU Langone Health at 65 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages Up to 25 yearsHealthy volunteers can take part
Conditions the study is for
SARS-CoV-2 Infection
Type of treatment
Vaccines
How many people
15,028 participants
Where
65 sitesUnited States
Study dates
1 Mar 2022to 23 May 2027
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 Up to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

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.

Who may be able to join

  • Infected Cohort:
  • Patients will be eligible for inclusion according to the following criteria:
  • Ages newborn-25 years
  • 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)
  • Children/young adults with or without history of MIS-C are eligible
  • Children/young adults with or without history of SARS-CoV-2 vaccination are eligible
Show all 85Show fewer
  • 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)
  • Children/young adults with recurrent SARS-CoV-2 infections and those with post-vaccination (breakthrough) infections are eligible to participate
  • 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:
  • 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
  • Residing or travel to an area with community transmission anytime within the 14 days before symptom onset; OR
  • 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.
  • 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
  • An asymptomatic person not meeting epidemiologic criteria with a positive SARS-CoV-2 Antigen-RDT.
  • Children/Young Adults with Probable SARS-Cov-2 Infection
  • 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
  • A suspect case with chest imaging showing findings suggestive of COVID-19 disease; OR
  • 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
  • A person with a positive Nucleic Acid Amplification Test (NAAT); OR
  • A person with a positive SARS-CoV-2Antigen-RDT AND meeting either the probable case definition or suspect criteria A OR B; OR
  • 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
  • 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
  • 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:
  • Does not meet WHO criteria for a suspected, probable, or confirmed case of SARS-CoV-2 infection AND
  • Does not have serological evidence of past asymptomatic SARS-CoV-2 infection in medical history or Tier 1 testing, AND
  • Lives in the same communities or recruited from the same sources as those in the SARS-CoV-2 infected cohort, AND
  • Either not hospitalized for any reason in prior 3 months, or hospitalized (with or without ICU stay) within the prior 3 months
  • Uninfected individuals may participate independent of their vaccination status
  • 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.
  • 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.
  • 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:
  • 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
  • No alternative plausible diagnoses; AND
  • 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
  • Age 3-25 years
  • Recipient of mRNA COVID-19 vaccination within last 4 weeks
  • Children or young adults with or without history of SARS-CoV-2 infection are eligible
  • 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)
  • No other known auto-immune or other immune dysregulation disease
  • Participants are eligible without exclusion related to sex, race/ethnicity, geography, nationality, severity of disease, or underlying health conditions
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • A nonbiological primary caregiver or legal guardian serving as primary caregiver must be above the legal age of majority in their jurisdiction.
  • 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.

Who cannot join

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • 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.
  • Any young adult age above the age of majority who lacks capacity to provide consent
  • Nonviable neonates and neonates of uncertain viability as determined by the treating physician
  • Any child, young, adult, or caregiver with co-morbid illness with expected survival <2 years
  • Any child who is being given up for adoption or is a ward of the state
  • Any caregiver or other biological parent who is incarcerated, or who lacks capacity to provide consent
  • Currently enrolled in the study Understanding the Long-term Impact of COVID-19 in Adults

Trial locations and contacts

65 sites in 1 country.

65 sites in 1 country

United States65 sites

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, 87102

  • Johns Hopkins University

    Baltimore, Maryland, 21218

  • Louisiana State University (LSU) - Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808

  • University of Alabama at Birmingham (Pregnancy Cohort)

    Birmingham, Alabama, 35294

  • Mass General Brigham - Harvard University

    Boston, Massachusetts, 02114

  • Harvard Medical School

    Boston, Massachusetts, 02115

  • Harvard School Of Public Health

    Boston, Massachusetts, 02115

  • Northeastern University

    Boston, Massachusetts, 02115

  • University of Vermont (UVM) Children's Hospital

    Burlington, Vermont, 05401

  • University of North Carolina (UNC) at Chapel Hill

    Chapel Hill, North Carolina, 27516

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

  • Good Samaritan Hospital

    Cincinnati, Ohio, 45220

  • University Hospitals MacDonald's Women's Hospital

    Cleveland, Ohio, 44106

  • Metrohealth System

    Cleveland, Ohio, 44109

  • The MetroHealth System (Pregnancy Cohort)

    Cleveland, Ohio, 44109

  • The Ohio State University - Wexner Medical Center

    Columbus, Ohio, 43210

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Central Michigan University - College of Medicine

    Detroit, Michigan, 48201

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Northwestern University

    Evanston, Illinois, 60208

  • Children's Mercy Hospital

    Fairfield, Ohio, 45014

  • University of Texas Medical Branch (UTMB) Galveston

    Galveston, Texas, 77555

  • Northshore University HealthSystem

    Glenview, Illinois, 60026

  • Prisma Health Upstate

    Greenville, South Carolina, 29605

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106

  • Kapi'olani Medical Center for Women & Children

    Honolulu, Hawaii, 96826

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77024

  • Baylor College of Medicine

    Houston, Texas, 77030

  • American Academy of Pediatrics

    Itasca, Illinois, 60143

  • University of California San Diego

    La Jolla, California, 92093

  • American Academy of Family Physicians

    Leawood, Kansas, 66211

  • Dartmouth-Hitchcock

    Lebanon, New Hampshire, 03766

  • Arkansas Children's Hospital and Research Institute

    Little Rock, Arkansas, 72202

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

  • University of Louisville - Norton Children's Hospital

    Louisville, Kentucky, 40202

  • Medical College Of Wisconsin

    Milwaukee, Wisconsin, 53226

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Rutgers University

    New Brunswick, New Jersey, 08901

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08901

  • Yale School of Medicine (YSM)

    New Haven, Connecticut, 06510

  • Tulane University

    New Orleans, Louisiana, 70118

  • NYU Langone Health

    New York, New York, 10016

  • Columbia University

    New York, New York, 10027

  • Columbia University (Pregnancy)

    New York, New York, 10032

  • ChristianaCare Health System

    Newark, Delaware, 19718

  • University of Oklahoma Health Sciences Center (OUHSC)

    Oklahoma City, Oklahoma, 73104

  • University Of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh Medical Center (UPMC)

    Pittsburgh, Pennsylvania, 15213

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Women & Infants Hospital

    Providence, Rhode Island, 02905

  • NewYork-Presbyterian Hospital

    Queens, New York, 11355

  • WakeMed Health & Hospitals

    Raleigh, North Carolina, 27610

  • Virginia Commonwealth University

    Richmond, Virginia, 23284

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Utah Health

    Salt Lake City, Utah, 84132

  • University of California San Diego Health - Rady Children's Hospital

    San Diego, California, 92123

  • University of California San Francisco (Pregnancy Cohort)

    San Francisco, California, 94115

  • University of California San Francisco

    San Francisco, California, 94143

  • Avera Research Institute

    Sioux Falls, South Dakota, 57108

  • New York Medical College

    Valhalla, New York, 10595

  • George Washington University

    Washington D.C., District of Columbia, 20052

  • The Pediatric Specialty Center at Saint Barnabas

    West Orange, New Jersey, 07052

  • Nemours Children's Health

    Wilmington, Delaware, 19803

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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

Keywords
Post Acute Sequalae of SARS-CoV-2 (PASC)
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05172011
Study groupRoleWhat they receive
Extant, Clinical and De Novo Cohort -- INFECTEDSARS-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 -- UNINFECTEDSARS-CoV-2 uninfected children and infants born to uninfected mothers
Acute Cohort -- INFECTEDNewly SARS-CoV-2 infected individuals (≤4 weeks since onset of symptoms or positive laboratory testing)
Acute Cohort -- UNINFECTEDContemporaneous SARS-CoV-2 uninfected individuals selected from the same population as newly SARS-CoV-2 infected individuals
Post-acute cohort -- INFECTEDPost-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 -- UNINFECTEDUninfected 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 MyocarditisIndividuals with history of myocarditis after receiving COVID-19 vaccine.
Primary CaregiversThe primary caregiver of the child or young adult may optionally participate in the study.
Biological ParentIf the primary caregiver is a biological parent, the other biological parent may optionally participate in the study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Caregiver SARS-CoV-2 Infection Status

    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.

    Measured: Baseline

  2. Child SARS-CoV-2 Infection Status

    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.

    Measured: Baseline

  3. Caregiver Severity of SARS-CoV-2 Infection

    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.

    Measured: Baseline

  4. Child Severity of SARS-CoV-2 Infection

    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.

    Measured: Baseline

  5. Caregiver Previous In-Hospital SARS-CoV-2 Treatment Record

    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.

    Measured: Baseline

  6. Child Previous In-Hospital SARS-CoV-2 Treatment Record

    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.

    Measured: Baseline

  7. Caregiver Symptoms

    Symptoms will be reported via remote patient report, in-person patient report, or EHR

    Measured: Baseline, up to Month 48

  8. Child Symptoms

    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

    Measured: Baseline, up to Month 48

  9. Caregiver SARS-CoV-2 Vaccination Status

    Vaccination in status will be reported via remote patient report, in-person patient report, or EHR.

    Measured: Baseline, up to Month 48

  10. Change in Child SARS-CoV-2 Vaccination Status

    Vaccination in status will be reported via remote patient report, in-person patient report, or EHR.

    Measured: Week 8, up to Month 48

  11. Change in Caregiver SARS-CoV-2 Treatment Record

    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.

    Measured: Month 12, up to Month 48

  12. Change in Child SARS-CoV-2 Treatment Record

    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.

    Measured: Week 8, up to Month 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2021
  2. Study start1 Mar 2022
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion23 May 2027 (estimated)

Resources

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
Other
Time perspective
Other
Enrolment
15,028 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05172011
Sponsor's protocol ID
21-01231
Status last verified
Dec 2025
First submitted
27 Dec 2021
Last updated
31 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All of the individual participant data collected during the trial, after deidentification will be shared upon reasonable request.

Publications

  • Gross RS, Thaweethai T, Rosenzweig EB, Chan J, Chibnik LB, Cicek MS, Elliott AJ, Flaherman VJ, Foulkes AS, Gage Witvliet M, Gallagher R, Gennaro ML, Jernigan TL, Karlson EW, Katz SD, Kinser PA, Kleinman LC, Lamendola-Essel MF, Milner JD, Mohandas S, Mudumbi PC, Newburger JW, Rhee KE, Salisbury AL, Snowden JN, Stein CR, Stockwell MS, Tantisira KG, Thomason ME, Truong DT, Warburton D, Wood JC, Ahmed S, Akerlundh A, Alshawabkeh AN, Anderson BR, Aschner JL, Atz AM, Aupperle RL, Baker FC, Balaraman V, Banerjee D, Barch DM, Baskin-Sommers A, Bhuiyan S, Bind MC, Bogie AL, Bradford T, Buchbinder NC, Bueler E, Bukulmez H, Casey BJ, Chang L, Chrisant M, Clark DB, Clifton RG, Clouser KN, Cottrell L, Cowan K, D'Sa V, Dapretto M, Dasgupta S, Dehority W, Dionne A, Dummer KB, Elias MD, Esquenazi-Karonika S, Evans DN, Faustino EVS, Fiks AG, Forsha D, Foxe JJ, Friedman NP, Fry G, Gaur S, Gee DG, Gray KM, Handler S, Harahsheh AS, Hasbani K, Heath AC, Hebson C, Heitzeg MM, Hester CM, Hill S, Hobart-Porter L, Hong TKF, Horowitz CR, Hsia DS, Huentelman M, Hummel KD, Irby K, Jacobus J, Jacoby VL, Jone PN, Kaelber DC, Kasmarcak TJ, Kluko MJ, Kosut JS, Laird AR, Landeo-Gutierrez J, Lang SM, Larson CL, Lim PPC, Lisdahl KM, McCrindle BW, McCulloh RJ, McHugh K, Mendelsohn AL, Metz TD, Miller J, Mitchell EC, Morgan LM, Muller-Oehring EM, Nahin ER, Neale MC, Ness-Cochinwala M, Nolan SM, Oliveira CR, Osakwe O, Oster ME, Payne RM, Portman MA, Raissy H, Randall IG, Rao S, Reeder HT, Rosas JM, Russell MW, Sabati AA, Sanil Y, Sato AI, Schechter MS, Selvarangan R, Sexson Tejtel SK, Shakti D, Sharma K, Squeglia LM, Srivastava S, Stevenson MD, Szmuszkovicz J, Talavera-Barber MM, Teufel RJ 2nd, Thacker D, Trachtenberg F, Udosen MM, Warner MR, Watson SE, Werzberger A, Weyer JC, Wood MJ, Yin HS, Zempsky WT, Zimmerman E, Dreyer BP; RECOVER-Pediatric Consortium. Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design. PLoS One. 2024 May 7;19(5):e0285635. doi: 10.1371/journal.pone.0285635. eCollection 2024.

    PubMed 38713673

  • Metz TD, Clifton RG, Gallagher R, Gross RS, Horwitz LI, Jacoby VL, Martin-Herz SP, Peralta-Carcelen M, Reeder HT, Beamon CJ, Chan J, Chang AA, Costantine MM, Fitzgerald ML, Foulkes AS, Gibson KS, Guthe N, Habli M, Hackney DN, Hoffman MK, Hoffman MC, Hughes BL, Katz SD, Laleau V, Mallett G, Mendez-Figueroa H, Monzon V, Palatnik A, Palomares KTS, Parry S, Pettker CM, Plunkett BA, Poppas A, Reddy UM, Rouse DJ, Saade GR, Sandoval GJ, Schlater SM, Sciurba FC, Simhan HN, Skupski DW, Sowles A, Thaweethai T, Thomas GL, Thorp JM Jr, Tita AT, Weiner SJ, Weigand S, Yee LM, Flaherman VJ; RECOVER Initiative. Researching COVID to enhance recovery (RECOVER) pregnancy study: Rationale, objectives and design. PLoS One. 2023 Dec 21;18(12):e0285351. doi: 10.1371/journal.pone.0285351. eCollection 2023.

    PubMed 38128008

  • Gross R, Thaweethai T, Rosenzweig EB, Chan J, Chibnik LB, Cicek MS, Elliott AJ, Flaherman VJ, Foulkes AS, Witvliet MG, Gallagher R, Gennaro ML, Jernigan TL, Karlson EW, Katz SD, Kinser PA, Kleinman LC, Lamendola-Essel MF, Milner JD, Mohandas S, Mudumbi PC, Newburger JW, Rhee KE, Salisbury AL, Snowden JN, Stein CR, Stockwell MS, Tantisira KG, Thomason ME, Truong DT, Warburton D, Wood JC, Ahmed S, Akerlundh A, Alshawabkeh AN, Anderson BR, Aschner JL, Atz AM, Aupperle RL, Baker FC, Balaraman V, Banerjee D, Barch DM, Baskin-Sommers A, Bhuiyan S, Bind MC, Bogie AL, Buchbinder NC, Bueler E, Bukulmez H, Casey BJ, Chang L, Clark DB, Clifton RG, Clouser KN, Cottrell L, Cowan K, D'Sa V, Dapretto M, Dasgupta S, Dehority W, Dummer KB, Elias MD, Esquenazi-Karonika S, Evans DN, Faustino EVS, Fiks AG, Forsha D, Foxe JJ, Friedman NP, Fry G, Gaur S, Gee DG, Gray KM, Harahsheh AS, Heath AC, Heitzeg MM, Hester CM, Hill S, Hobart-Porter L, Hong TKF, Horowitz CR, Hsia DS, Huentelman M, Hummel KD, Iacono WG, Irby K, Jacobus J, Jacoby VL, Jone PN, Kaelber DC, Kasmarcak TJ, Kluko MJ, Kosut JS, Laird AR, Landeo-Gutierrez J, Lang SM, Larson CL, Lim PPC, Lisdahl KM, McCrindle BW, McCulloh RJ, Mendelsohn AL, Metz TD, Morgan LM, Muller-Oehring EM, Nahin ER, Neale MC, Ness-Cochinwala M, Nolan SM, Oliveira CR, Oster ME, Payne RM, Raissy H, Randall IG, Rao S, Reeder HT, Rosas JM, Russell MW, Sabati AA, Sanil Y, Sato AI, Schechter MS, Selvarangan R, Shakti D, Sharma K, Squeglia LM, Stevenson MD, Szmuszkovicz J, Talavera-Barber MM, Teufel RJ 2nd, Thacker D, Udosen MM, Warner MR, Watson SE, Werzberger A, Weyer JC, Wood MJ, Yin HS, Zempsky WT, Zimmerman E, Dreyer BP. Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design. medRxiv [Preprint]. 2023 May 12:2023.04.27.23289228. doi: 10.1101/2023.04.27.23289228.

    PubMed 37214806

Questions about this trial

What is this clinical trial studying?

An observational study of SARS-CoV-2 Infection, run by NYU Langone Health at 65 sites 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 85 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: under way, not looking for participants, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Caregiver SARS-CoV-2 Infection Status (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05172011, which also lists 3 linked publications.

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 31 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in