Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)PRISMNCT04588363
COVID-19: Pediatric Research Immune Network on SARS-CoV-2 and MIS-C
An observational study of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Multisystem Inflammatory Syndrome in Children (MIS-C), run by National Institute of Allergy and Infectious Diseases (NIAID) at 20 sites in United States.
Trial summary
The primary objectives of this study are: To determine the proportion of children with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) related death, rehospitalization or major complications after infection with SARS-CoV-2 and/or Multisystem Inflammatory Syndrome in Children (MIS-C), and To determine… Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Multisystem Inflammatory Syndrome in Children (MIS-C), Coronavirus Disease 2019 (COVID-19)
- What is being tested?
- SARS-CoV-2 and/or MIS-C Exposure
- How many people
- 244 participants
- Where
- 20 sitesUnited States
- Study dates
- 19 Nov 2020to 3 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Individuals less than 21 years of age who fulfill one or more of the following criteria: * SARS-CoV-2 detection from a respiratory specimen, and/or * Meets criteria for MIS-C, and/or * Meets criteria for MIS-C, except has involvement of only 1 organ system
Who may be able to join
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) detection from a respiratory specimen, and/or
- Meets criteria for Multisystem Inflammatory Syndrome in Children (MIS-C), and/or
- Meets criteria for MIS-C, except has involvement of only 1 organ system
- Cases meeting clinical criteria for MIS-C but without known SARS-CoV-2 exposure, and who are being treated as MIS-C by the treating physician, but with negative SARS-CoV-2 PCR and pending or negative antibody testing, may be enrolled as subjects. If subsequent antibody testing is positive, cases will be labelled as confirmed MIS-C. If SARS-CoV-2 antibody testing is negative, subjects will be labeled at the end of the study as suspected/not confirmed MIS-C.
Who cannot join
- 1. Subject and/or parent/guardian who are not able to understand or be willing to provide informed consent and where applicable assent
- --Note, for this observational cohort study, participation in other COVID-19 studies is not an automatic exclusionary criterion.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215
Medical University of South Carolina, Pediatric Rheumatology
Charleston, South Carolina, 29425
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Duke University Children's Health Center
Durham, North Carolina, 27710
NewYork-Presbyterian Queens Hospital
Flushing, New York, 11355
Loma Linda University Health
Loma Linda, California, 92354
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Children's Hospital Los Angeles
Los Angeles, California, 91011
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
Cohen Children's Medical Center - Northwell Health
New Hyde Park, New York, 11040
Hassenfeld Children's Hospital at NYU Langone
New York, New York, 10016
NewYork-Presbyterian Komansky Children's Hospital
New York, New York, 10021
Mount Sinai Kravis Children's Hospital
New York, New York, 10029
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94303
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Mayo Clinic Rochester
Rochester, Minnesota, 55905
St. Louis Children's Hospital
St Louis, Missouri, 63110
Children's Hospital at Montefiore
The Bronx, New York, 10467
About this study
Official title: An Observational Cohort Study to Determine Late Outcomes and Immunological Responses After Infection With SARS-CoV-2 in Children With and Without Multisystem Inflammatory Syndrome (MIS-C)
The primary objectives of this study are:
- To determine the proportion of children with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) related death, rehospitalization or major complications after infection with SARS-CoV-2 and/or Multisystem Inflammatory Syndrome in Children (MIS-C), and
- To determine immunologic mechanisms and immune signatures associated with disease spectrum and subsequent clinical course during the year of follow-up.
Read the detailed description
This is a prospective, multicenter, observational cohort study to assess short and long-term clinical outcomes and immune responses after Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection and/or Multisystem Inflammatory Syndrome in Children (MIS-C) in children (e.g., defined as individuals who have not reached their 21st birthday at the time of enrollment). SARS-CoV-2 causes Coronavirus Disease 2019 (COVID-19)
Participants will be identified through active recruitment measures within hospitals and through ambulatory and laboratory-based databases of SARS-CoV-2 positive individuals <21 years of age. The study will enroll a minimum of 250 subjects from a diverse racial/ethnic background, from participating medical centers in the United States. The study period of participation is 1 year (12 months).
- Conditions
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Multisystem Inflammatory Syndrome in Children (MIS-C), Coronavirus Disease 2019 (COVID-19)
- Being tested
- SARS-CoV-2 and/or MIS-C Exposure
- Keywords
- participants <21 years of age, observational cohort study, immunological responses post infection
- Medical subject headings
- pediatric multisystem inflammatory disease, COVID-19 related, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 and/or MIS-C ExposureOther
Also called Exposure: Severe Acute Respiratory Syndrome Coronavirus 2 Infection and/or Multisystem Inflammatory Syndrome in Children diagnosis
This is an observational cohort study.
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2 positive children | Individuals less than 21 years of age who fulfill one or more of the following criteria:
* SARS-CoV-2 detection from a respiratory specimen, and/or
* Meets criteria for MIS-C, and/or
* Meets criteria for MIS-C, except has involvement of only 1 organ system Receives: Other: SARS-CoV-2 and/or MIS-C Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Either COVID-19-Related Death, Rehospitalization, Major Complications after SARS-CoV-2 Illness and/or MIS-C at 6 Months Post Illness Presentation
Participants who experience Coronavirus Disease 2019 (COVID-19)-related death, rehospitalization or major complications after Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) illness and/or multisystem inflammatory syndrome in children (MIS-C).
Measured: 6 Months Post Illness Presentation (Enrollment)
Secondary outcomes (23)
Proportion of Participants with Coronavirus Disease 2019 (COVID-19)-Related Death after Multisystem Inflammatory Syndrome in Children (MIS-C) at 1 Year Post Illness Presentation
Participants who experience Coronavirus Disease 2019 (COVID-19)-related death, rehospitalization or major complications after Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) illness and/or multisystem inflammatory syndrome in children (MIS-C).
Measured: 1 Year Post Illness Presentation (Enrollment)
All-Cause Mortality
The occurrence of death in participants regardless of relationship to Coronavirus Disease 2019 (COVID-19) and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).
Measured: 1 Year Post Illness Presentation (Enrollment)
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Mortality
The occurrence of SARS-CoV-2 related death in participants.
Measured: 1 Year Post Illness Presentation (Enrollment)
Hospitalization for Participants Enrolled as an Outpatient or Rehospitalization after First Admission in Hospitalized Participants
Characterization of Participants who require:
- Hospitalization subsequent to enrollment as an outpatient for SARS-CoV-2/COVID-19 related illness and/or MIS-C, or
- Rehospitalization after discharge from their initial admission for SARS-CoV-2/COVID-19 related illness and/or MIS-C.
Abbreviations:
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
- Coronavirus Disease 2019 (COVID-19)
- Multisystem Inflammatory Syndrome in Children (MIS-C)
Measured: Up to 1 Year Post Illness Presentation (Enrollment)
Coagulation Abnormality by D-Dimer Biomarker
Characterization of dysregulation involving the coagulation system by D-dimer laboratory test.
Measured: Up to 1 Year Post Illness Presentation (Enrollment)
Coagulation Abnormality by Fibrinogen Biomarker
Characterization of dysregulation involving the coagulation system by fibrinogen laboratory test.
Measured: Up to 1 Year Post Illness Presentation (Enrollment)
Coagulation Abnormality by Prothrombin Time (PT) and Activated Partial Thromboplastin Time (PTT) Biomarkers
Characterization of dysregulation involving the coagulation system by PT and PTT laboratory tests.
Measured: Up to 1 Year Post Illness Presentation (Enrollment)
Coagulation Abnormality by International Normalised Ratio (INR) Biomarker
Characterization of dysregulation involving the coagulation system by INR laboratory test.
Measured: Up to 1 Year Post Illness Presentation (Enrollment)
Coronary Artery Abnormalities
Characterization of coronary artery abnormalities (e.g., by echocardiogram and, if performed for clinical indications, angiogram, as examples).
Measured: Up to 1 Year Post Illness Presentation (Enrollment)
Pulmonary Hypertension
Prevalence of pulmonary hypertension by echocardiogram and standard of care assessments.
Measured: Up to 1 Year Post Illness Presentation (Enrollment)
Cardiovascular System Dysregulation by B-type natriuretic peptide (BNP) Biomarker
Characterization of cardiovascular system dysregulation by BNP laboratory test.
Measured: Up to 1 Year Post Illness Presentation (Enrollment)
Cardiovascular System Dysregulation by Troponin I Biomarker
Characterization of cardiovascular system dysregulation by Troponin I laboratory test.
Measured: Up to 1 Year Post Illness Presentation (Enrollment)
Cardiovascular System Dysregulation by Echocardiogram
Characterization of cardiac function by echocardiogram (Echo), a test that uses high frequency sound waves (ultrasound) to make pictures of the heart. The test is also referred to as a diagnostic cardiac ultrasound.
Measured: Up to 1 Year Post Illness Presentation (Enrollment)
Cardiovascular System Dysregulation by Electrocardiogram (ECG)
Characterization of cardiovascular system dysregulation(s) evaluated by standardized 12-lead electrocardiogram. ECG rhythms, intervals and voltages will be assessed. Cross reference: ECG and EKG are used interchangeably.
Measured: Up to 1 Year Post Illness Presentation (Enrollment)
Pulmonary Abnormalities
Pulmonary fibrosis (i.e., scarring) or other abnormalities detected by computerized tomography (CT) imaging.
Measured: Up to 1 Year Post Illness Presentation (Enrollment)
Pulmonary Function Characteristics
Characterization by pulmonary function tests (spirometry without bronchodilators).
Measured: Up to 1 Year Post Illness Presentation (Enrollment)
Renal/Metabolic Biomarkers: Serum Creatinine and Blood Urea Nitrogen (BUN)
Characterization of kidney/metabolic function by serum creatinine and blood urea nitrogen (BUN) laboratory tests
Measured: Up to 1 Year Post Illness Presentation (Enrollment)
Renal/Metabolic Biomarker: Estimated glomerular filtration rate (eGFR)
Characterization of kidney/metabolic function by the estimated glomerular filtration rate (eGFR) calculated value, using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
Measured: Up to 1 Year Post Illness Presentation (Enrollment)
Hepatic/Metabolic Biomarkers: Serum Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase ( ALT/SGPT)and Aspartate Aminotransferase (AST/SGOT)
Characterization of liver/metabolic function by the following laboratory tests:
- alkaline phosphatase
- alanine aminotransferase (ALT/SGPT) and
- aspartate aminotransferase (AST/SGOT).
Measured: Up to 1 Year Post Illness Presentation (Enrollment)
Hepatic/Metabolic Biomarker: Total Bilirubin
Characterization of liver/metabolic function by serum total bilirubin laboratory test.
Measured: Up to 1 Year Post Illness Presentation (Enrollment)
Neurologic Abnormalities
Characterization of neurologic sequelae of infection/disease.
Measured: Up to 1 Year Post Illness Presentation (Enrollment)
Other End Organ and/or functional abnormalities Occurring After Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection/ Coronavirus Disease 2019 (COVID-19) and/or Multisystem Inflammatory Syndrome in Children (MIS-C)
Identified by and characterized during standard of care assessments.
Measured: Up to 1 Year Post Illness Presentation (Enrollment)
Health Related Quality of Life
Assessment of health-related quality of life (HRQOL) after Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection/ Coronavirus Disease 2019 (COVID-19) and/or multisystem inflammatory syndrome in children (MIS-C).
The Pediatric Quality of Life Inventory is a series of assessment instruments designed to measure the health-related quality of life of children. The PedsQL 4.0 provides an opportunity for the assessment of both overall (generic) quality of life as well as disease-specific quality of life.
The PedsQL 4.0 Generic Core Scales are appropriate for assessing health-related quality of life in both healthy and chronically ill children. The four scales making up this generic battery include Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), and School Functioning (5 items).
Measured: Up to 1 Year Post Illness Presentation (Enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start19 Nov 2020
- Primary completion3 Mar 2023
- Study completion3 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)Studies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- 244 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Autoimmunity Centers of Excellence, Clinical Trials in Organ Transplantation in Children
- Responsible party
- Sponsor
- Investigators
- Steven A. Webber, MBChB, MRCP, Study chair, Department of Pediatrics, Monroe Carell Jr. Children's Hospital at VanderbiltJames D. Wilkinson, MD, MPH, Principal investigator, Vanderbilt Institute for Clinical and Translational Research (VICTR)Natasha B Halasa, MD, MPH, Principal investigator, Department of Pediatrics, Vanderbilt University Medical CenterVirginia Pascual, MD, Principal investigator, Gale and Ira Drukier Institute for Children's Health, Weill Cornell MedicineBetty Diamond, MD, Principal investigator, Institute of Molecular Medicine, The Feinstein Institute for Medical ResearchIgnacio Sanz, MD, Principal investigator, Division of Rheumatology, Emory UniversityOlivia Martinez, PhD, Principal investigator, Stanford UniversitySheri Krams, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588363
- Sponsor's protocol ID
- DAIT PRISM-01
- Other IDs
- NIAID CRMS ID#: 38772
- Acronym
- PRISM
- Status last verified
- Feb 2024
- First submitted
- 12 Oct 2020
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Cohort Study to Determine Late Outcomes and Immunological Responses After Infection With SARS-CoV-2 in Children With and Without Multisystem Inflammatory Syndrome (MIS-C)
- ClinicalTrials.gov ID
- NCT04588363
- Acronym / sponsor ID
- PRISM / DAIT PRISM-01
- Conditions
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Multisystem Inflammatory Syndrome in Children (MIS-C), Coronavirus Disease 2019 (COVID-19)
- Keywords
- participants <21 years of age, observational cohort study, immunological responses post infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Autoimmunity Centers of Excellence, Clinical Trials in Organ Transplantation in Children
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 19 Oct 2020 (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.
The primary objectives of this study are:
- To determine the proportion of children with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) related death, rehospitalization or major complications after infection with SARS-CoV-2 and/or Multisystem Inflammatory Syndrome in Children (MIS-C), and
- To determine immunologic mechanisms and immune signatures associated with disease spectrum and subsequent clinical course during the year of follow-up.
Detailed description
This is a prospective, multicenter, observational cohort study to assess short and long-term clinical outcomes and immune responses after Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection and/or Multisystem Inflammatory Syndrome in Children (MIS-C) in children (e.g., defined as individuals who have not reached their 21st birthday at the time of enrollment). SARS-CoV-2 causes Coronavirus Disease 2019 (COVID-19)
Participants will be identified through active recruitment measures within hospitals and through ambulatory and laboratory-based databases of SARS-CoV-2 positive individuals <21 years of age. The study will enroll a minimum of 250 subjects from a diverse racial/ethnic background, from participating medical centers in the United States. The study period of participation is 1 year (12 months).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 positive children | – | Other: SARS-CoV-2 and/or MIS-C ExposureIndividuals less than 21 years of age who fulfill one or more of the following criteria: * SARS-CoV-2 detection from a respiratory specimen, and/or * Meets criteria for MIS-C, and/or * Meets criteria for MIS-C, except has involvement of only 1 organ system |
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Individuals less than 21 years of age who fulfill one or more of the following criteria: * SARS-CoV-2 detection from a respiratory specimen, and/or * Meets criteria for MIS-C, and/or * Meets criteria for MIS-C, except has involvement of only 1 organ system
Key inclusion criteria (4 listed)
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) detection from a respiratory specimen, and/or
- Meets criteria for Multisystem Inflammatory Syndrome in Children (MIS-C), and/or
- Meets criteria for MIS-C, except has involvement of only 1 organ system
- Cases meeting clinical criteria for MIS-C but without known SARS-CoV-2 exposure, and who are being treated as MIS-C by the treating physician, but with negative SARS-CoV-2 PCR and pending or negative antibody testing, may be enrolled as subjects. If subsequent antibody testing is positive, cases will be labelled as confirmed MIS-C. If SARS-CoV-2 antibody testing is negative, subjects will be labeled at the end of the study as suspected/not confirmed MIS-C.
Key exclusion criteria (2 listed)
- 1. Subject and/or parent/guardian who are not able to understand or be willing to provide informed consent and where applicable assent
- --Note, for this observational cohort study, participation in other COVID-19 studies is not an automatic exclusionary criterion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-CoV-2 and/or MIS-C ExposureAlso: Exposure: Severe Acute Respiratory Syndrome Coronavirus 2 Infection and/or Multisystem Inflammatory Syndrome in Children diagnosisThis is an observational cohort study. | Other | SARS-CoV-2 positive children |
Primary outcome
Proportion of Participants With Either COVID-19-Related Death, Rehospitalization, Major Complications after SARS-CoV-2 Illness and/or MIS-C at 6 Months Post Illness Presentation
Time frame: 6 Months Post Illness Presentation (Enrollment)
Participants who experience Coronavirus Disease 2019 (COVID-19)-related death, rehospitalization or major complications after Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) illness and/or multisystem inflammatory syndrome in children (MIS-C).
23 secondary outcomes
Proportion of Participants with Coronavirus Disease 2019 (COVID-19)-Related Death after Multisystem Inflammatory Syndrome in Children (MIS-C) at 1 Year Post Illness Presentation
Time frame: 1 Year Post Illness Presentation (Enrollment)
All-Cause Mortality
Time frame: 1 Year Post Illness Presentation (Enrollment)
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Mortality
Time frame: 1 Year Post Illness Presentation (Enrollment)
Hospitalization for Participants Enrolled as an Outpatient or Rehospitalization after First Admission in Hospitalized Participants
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Coagulation Abnormality by D-Dimer Biomarker
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Coagulation Abnormality by Fibrinogen Biomarker
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Coagulation Abnormality by Prothrombin Time (PT) and Activated Partial Thromboplastin Time (PTT) Biomarkers
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Coagulation Abnormality by International Normalised Ratio (INR) Biomarker
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Coronary Artery Abnormalities
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Pulmonary Hypertension
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Cardiovascular System Dysregulation by B-type natriuretic peptide (BNP) Biomarker
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Cardiovascular System Dysregulation by Troponin I Biomarker
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Cardiovascular System Dysregulation by Echocardiogram
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Cardiovascular System Dysregulation by Electrocardiogram (ECG)
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Pulmonary Abnormalities
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Pulmonary Function Characteristics
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Renal/Metabolic Biomarkers: Serum Creatinine and Blood Urea Nitrogen (BUN)
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Renal/Metabolic Biomarker: Estimated glomerular filtration rate (eGFR)
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Hepatic/Metabolic Biomarkers: Serum Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase ( ALT/SGPT)and Aspartate Aminotransferase (AST/SGOT)
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Hepatic/Metabolic Biomarker: Total Bilirubin
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Neurologic Abnormalities
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Other End Organ and/or functional abnormalities Occurring After Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection/ Coronavirus Disease 2019 (COVID-19) and/or Multisystem Inflammatory Syndrome in Children (MIS-C)
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Health Related Quality of Life
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Clinical Trials in Organ Transplantation in ChildrenLink provided by the sponsor.
- Division of Allergy, Immunology and TransplantationLink provided by the sponsor.
- National Institute of Allergy and Infection DiseasesLink provided by the sponsor.
Related trials for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
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
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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. This study is not recruiting at the moment.
Steven A. Webber, MBChB, MRCP study chair
Department of Pediatrics, Monroe Carell Jr. Children's Hospital at Vanderbilt
James D. Wilkinson, MD, MPH principal investigator
Vanderbilt Institute for Clinical and Translational Research (VICTR)
Natasha B Halasa, MD, MPH principal investigator
Department of Pediatrics, Vanderbilt University Medical Center
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Multisystem Inflammatory Syndrome in Children (MIS-C), run by National Institute of Allergy and Infectious Diseases (NIAID) at 20 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of Participants With Either COVID-19-Related Death, Rehospitalization, Major Complications after SARS-CoV-2 Illness and/or MIS-C at 6 Months Post Illness Presentation (time frame: 6 Months Post Illness Presentation (Enrollment)). 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 29 Feb 2024.