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Protease Inhibitor
Larazotide Acetate for Coronavirus
Phase 2
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presence of persistent fever/chills (>38.0°C for ≥24 hours, or report of subjective fever lasting ≥24 hours) and one or more laboratory parameters indicating inflammation (elevated C-reactive protein (CRP), elevated erythrocyte sedimentation rate (ESR), elevated ferritin, elevated lactic acid dehydrogenase (LDH), elevated d-dimer, elevated fibrinogen, elevated procalcitonin, elevated interleukin 6 (IL-6), increased neutrophils, reduced lymphocytes, low albumin)
Confirmed MIS-C by signs and symptoms as detailed by the CDC Health Advisory (https://www.cdc.gov/mis-c/hcp/; May 14, 2020)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
Study Summary
This trial is testing a new drug to see if it can help people with early signs of MIS-C who are at high risk of progression. The drug is given four times a day.
Who is the study for?
This trial is for children and young adults from 1 month to under 21 years old with MIS-C related to COVID-19. Participants must show early signs of MIS-C, have a fever, inflammation markers in the blood, severe illness needing hospitalization affecting multiple organs including the gut, and no other diagnosis that explains their symptoms. They also need proof of current or recent SARS-CoV-2 infection.Check my eligibility
What is being tested?
The study tests AT1001 (Larazotide Acetate) against a placebo given four times daily alongside standard care for MIS-C. The goal is to see if AT1001 can help pediatric patients who are at high risk of worsening symptoms due to early signs of MIS-C.See study design
What are the potential side effects?
Specific side effects for Larazotide Acetate aren't detailed here but generally could include digestive issues since it's taken orally, potential allergic reactions, or other common drug-related side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a fever for more than a day and tests show I have inflammation.
Select...
I have been diagnosed with MIS-C according to CDC guidelines.
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I've been hospitalized with severe illness affecting more than two organs and tested positive for COVID-19.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine proportion of participants with improvement in MIS-C related GI symptoms and no progression of disease
Evaluate the efficacy and safety of AT1001 versus placebo on mitigating symptoms of MIS-C
Secondary outcome measures
Determine the impact of AT1001 on change from baseline in additional organ system(s) involvement during acute presentation/hospitalization, as identified by clinical assessment and clinical laboratory tests.
Determine the impact of AT1001 on change from baseline in levels of IgM, IgG, and IgA antibodies against SARS CoV-2.
Determine the impact of AT1001 on change from baseline in levels of inflammatory markers (CRP, d-dimer, ferritin).
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Larazotide AcetateExperimental Treatment1 Intervention
AT1001 10 μg/kg/dose up to 500 μg/dose (rounded to the nearest 50 μg) will be administered orally four times a day (QID) to the standard of care for MIS-C.
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo will be administered orally four times a day (QID) to the standard of care for MIS-C.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Larazotide
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,924 Previous Clinical Trials
13,193,403 Total Patients Enrolled
Frequently Asked Questions
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