Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04898231
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2021-05-13
Brief Title:
MIS-C Comparative Effectiveness Study
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Multisystem Inflammatory Syndrome Therapies in Children MISTIC Comparative Effectiveness Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MISTIC
Brief Summary:
In March 2020 children exposed to the virus that causes the COVID-19 illness SARS-CoV-2 presented with fever and significant inflammation about a month after exposure to the virus Some children were sick enough to require care in the intensive care unit for what came to be known as Multisystem Inflammatory Syndrome-Children MIS-CThe clinical presentation shared many features with Kawasaki disease KD a self-limited inflammation that can cause ballooning of the arteries of the heart Thus physicians reached for many of the therapies used to treat children with KD Despite the surge of COVID-19 cases and children continuing to present with MIS-C there are no data that guide the choice of therapy Thus the investigators have designed a study to determine which combination of therapies is most effective in helping children with MIS-C recover quickly
Detailed Description:
This study is a multi-site randomized pragmatic comparative effectiveness study of children with MIS-C The current standard of care is that all MIS-C patients are initially treated with IVIG and receive additional therapy if they are severely ill or do not improve clinically This study design will randomize subjects who have received IVIG but clinically warrant further anti-inflammatory therapy to one of three treatment arms infliximab steroids or anakinra and allow for re-randomization to one of the two remaining arms if clinically warranted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None