What side effects are associated with this type of intervention?

Common treatments for COVID-19, particularly anti-inflammatory or immunomodulatory agents like tocilizumab and baricitinib, have several known side effects. Tocilizumab can cause constipation, diarrhea, nausea, anxiety, insomnia, hypertension, and superinfection. Baricitinib may lead to nausea, vomiting, and elevated transaminase levels. Remdesivir, another commonly used treatment, can cause nausea, vomiting, transaminase elevations, and bradycardia. These treatments are used cautiously, especially in immunocompromised patients.

What prior FDA approvals exist?

The FDA has approved several treatments for COVID-19 that focus on modulating the immune response or reducing inflammation. Notably, tocilizumab, an anti-IL-6 receptor antibody, has been approved for use in severely to critically ill COVID-19 patients, often in combination with corticosteroids. Additionally, dexamethasone, a corticosteroid, has been widely used to reduce inflammation in hospitalized patients with severe COVID-19. These treatments aim to mitigate the cytokine storm and excessive inflammatory response associated with severe COVID-19.

What other types of research exist?

Promising alternatives to AT1001 for coronavirus patients include: 1) Remdesivir, an antiviral that has shown efficacy in reducing hospitalization risk in children and adults with mild-to-moderate COVID-19. 2) Molnupiravir, a nucleoside analogue available through EUA for high-risk nonpregnant adults. 3) Inhaled corticosteroids like budesonide, which have demonstrated benefits in early COVID-19 treatment. 4) Monoclonal antibodies such as casirivimab-imdevimab and sotrovimab, which have been effective in high-risk populations.

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Protease Inhibitor

Larazotide Acetate for Coronavirus

Phase 2

Waitlist Available

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Summary

This trial tests AT1001, an oral medication, in children with COVID-19 and early signs of MIS-C. It aims to see if AT1001 can help manage symptoms and prevent the condition from worsening.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Determine the impact of AT1001 on infectious and inflammatory markers of MIS-C

Determine the impact of AT1001 on need for escalation of care (eg, transfer from hospital ward to ICU; supplemental oxygen; mechanical ventilation).

Trial 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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Coronavirus, particularly anti-inflammatory and immunomodulatory agents like AT1001, work by reducing the excessive inflammatory response and modulating the immune system. These mechanisms are vital for Coronavirus patients as they help prevent severe complications, such as cytokine storms, which can cause significant organ damage and increase the risk of death. By controlling inflammation and immune response, these treatments aim to improve patient outcomes and reduce the severity of the disease.

A bibliometric analysis of research related Chinese Medicine in the prevention and treatment of corona virus disease 2019.The potential insights of Traditional Chinese Medicine on treatment of COVID-19.