NCT04588363: PRISM

COVID-19: Pediatric Research Immune Network on SARS-CoV-2 and MIS-C

Completed Last updated 29 February 2024

What this trial tests

trial testing SARS-CoV-2 and/or MIS-C Exposure in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in 244 participants. Completed in 3 March 2023.

Timeline

19 November 2020

Primary endpoint
3 March 2023

3 March 2023

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	244
Start date	19 November 2020
Primary completion	3 March 2023
Estimated completion	3 March 2023
Sites	20 locations across United States

Drugs / interventions tested

• SARS-CoV-2 and/or MIS-C Exposure

Conditions studied

• Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) — all drugs for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) →
• Multisystem Inflammatory Syndrome in Children (MIS-C) — all drugs for Multisystem Inflammatory Syndrome in Children (MIS-C) →
• Coronavirus Disease 2019 (COVID-19) — all drugs for Coronavirus Disease 2019 (COVID-19) →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Under 20, any sex, with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) or Multisystem Inflammatory Syndrome in Children (MIS-C). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Hemophagocytic Lymphohistiocytosis Gene Variants in Multisystem Inflammatory Syndrome in Children.
   Vagrecha A, Zhang M, Acharya S, Lozinsky S, et al · · 2022 · cited 32× · PMID 35336791 · DOI 10.3390/biology11030417
2. Neurologic Manifestations of COVID-19 in Children: Emerging Pathophysiologic Insights.
   Schober ME, Pavia AT, Bohnsack JF. · · 2021 · cited 28× · PMID 33965992 · DOI 10.1097/pcc.0000000000002774
3. Immune profiling of COVID-19: preliminary findings and implications for the pandemic.
   Maecker HT. · · 2021 · cited 15× · PMID 33963016 · DOI 10.1136/jitc-2021-002550
4. The Trilogy of SARS-CoV-2 in Pediatrics (Part 2): Multisystem Inflammatory Syndrome in Children.
   Tran VL, Parsons S, Nuibe A. · · 2021 · cited 7× · PMID 34035676 · DOI 10.5863/1551-6776-26.4.318