NIH RECOVER: A Multi-site Observational Study of Post-acute Sequalae of SARS-CoV-2 Infection in Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- NYU Langone Health
- Enrollment
- 15,028
- Locations
- 65
- Primary Endpoint
- Caregiver Severity of SARS-CoV-2 Infection
Study Overview
Brief 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. 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.
Detailed Description
Ambidirectional longitudinal meta-cohort study (combined retrospective and prospective) with nested case-control studies.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Other
Eligibility Criteria
- Ages
- — to 25 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •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
- +42 more not shown
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Caregiver Symptoms
Time Frame: Baseline, up to Month 48
Symptoms will be reported via remote patient report, in-person patient report, or EHR
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
Secondary Outcomes
No secondary outcomes reported