What side effects are associated with this type of intervention?

Larazotide (AT1001), a zonulin receptor antagonist, is being studied for its safety and efficacy in treating Long COVID Syndrome. While specific side effects of Larazotide are not detailed, common treatments for Long COVID often include medications like steroids and immune modulators. These treatments can have side effects such as gastrointestinal issues (constipation, diarrhea, nausea), psychiatric symptoms (anxiety, insomnia), and increased risk of infections. It is important to consult with a healthcare provider to understand the potential risks and benefits of any treatment.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for Long COVID Syndrome. Larazotide, a Zonulin receptor antagonist, is currently being studied for its potential efficacy in treating Long COVID symptoms. This trial aims to evaluate its safety and effectiveness, but no similar drugs have received FDA approval for this condition yet.

What other types of research exist?

Promising novel alternatives to Larazotide for Long COVID Syndrome patients may include drugs that target immune modulation and inflammation, such as monoclonal antibodies or other small molecules currently under investigation for their efficacy in managing post-viral syndromes. Specific examples are not provided in the context, but patients should discuss with their healthcare providers about ongoing clinical trials and emerging treatments in this area.

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Peptide

Larazotide for Long COVID

Q: What is the mechanism of action of this treatment?

Larazotide, a Zonulin receptor antagonist, works by inhibiting the Zonulin pathway, which is involved in regulating intestinal permeability. By blocking this pathway, Larazotide helps to maintain the integrity of the gut barrier, potentially reducing systemic inflammation and immune dysregulation, which are thought to contribute to Long COVID symptoms. This is particularly important for Long COVID patients as it addresses underlying mechanisms that may perpetuate their symptoms, offering a targeted approach to alleviate their condition.

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

Ongoing, worsening, new, or recurrent symptoms present ≥4 weeks after SARS-CoV-2 infection.Symptoms include but are not limited to fatigue, malaise, headache, cognitive impairment, neuropsychiatric symptoms, decreased exercise tolerance, post exertional malaise, dyspnea, cough, chest pain, palpitations, tachycardia, gastrointestinal symptoms, musculoskeletal symptoms, fever, lightheadedness, insomnia and other sleep disturbances, anosmia or dysgeusia, pain, paresthesia, menstrual cycle irregularities, erectile dysfunction

Age 7 to ≤21 years

Must not have

Blood/plasma donation and or blood loss greater than 400 mL within 90 days, or greater than 200 mL within 30 days prior to screening

Female participant of childbearing age unwilling to use an acceptable method of birth control for the duration of the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 21 days

Summary

This trial is testing Larazotide, an oral medication, in young individuals with Long COVID symptoms. The medication aims to strengthen the gut barrier to help reduce these symptoms.

Who is the study for?

This trial is for children and young adults aged 7 to 21 with Long COVID symptoms persisting for at least 4 weeks post SARS-CoV-2 infection. Participants must have detectable spike protein in their blood, indicating ongoing antigenemia. Those with significant recent blood loss, liver or kidney dysfunction, pregnant or breastfeeding women, and those not using birth control are excluded.

What is being tested?

The study tests the safety and effectiveness of Larazotide (AT1001) compared to a placebo in managing Long COVID symptoms. Half of the participants will receive AT1001 while the other half will get a placebo, both taken orally four times daily for three weeks.

What are the potential side effects?

While specific side effects of Larazotide (AT1001) aren't listed here, common clinical trial side effects may include allergic reactions to ingredients, gastrointestinal issues like nausea or diarrhea, headaches, fatigue and potential impacts on liver or kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've had ongoing or new symptoms for over 4 weeks after a COVID-19 infection.

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I am between 7 and 21 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not donated more than 400 mL of blood in the last 3 months or more than 200 mL in the last month.

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I am a woman of childbearing age and agree to use birth control during the study.

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My liver tests are much higher than normal.

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My kidney function is reduced, with a filtration rate of 50 mL/min or less.

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I am either 6 years old or younger, or older than 22.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 21 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~21 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Adverse Event Profiling and Time to Symptom Resolution

Secondary study objectives

Cytokine profiling, Antigen Testing and Humoral and Cellular Responses

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Larazotide Acetate (AT1001)Experimental Treatment1 Intervention

Subjects will receive 250 or 500 µg of Larazotide Acetate orally four times a day (QID) for 21 days. Subjects \<25.0 kg will receive 250 µg dose of Larazotide Acetate (AT1001), and subjects ≥25.0 kg will receive 500 µg dose of Larazotide Acetate (AT1001).

Group II: PlaceboPlacebo Group1 Intervention

Subjects will receive 250 or 500 µg of placebo orally four times a day (QID) for 21 days. Subjects \<25.0 kg will receive 250 µg dose of placebo and subjects ≥25.0 kg will receive 500 µg dose of placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Larazotide Acetate

2011

Completed Phase 2

~350

0 / 7Eligibility criteria met

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

Larazotide, a Zonulin receptor antagonist, works by inhibiting the Zonulin pathway, which is involved in regulating intestinal permeability. By blocking this pathway, Larazotide helps to maintain the integrity of the gut barrier, potentially reducing systemic inflammation and immune dysregulation, which are thought to contribute to Long COVID symptoms. This is particularly important for Long COVID patients as it addresses underlying mechanisms that may perpetuate their symptoms, offering a targeted approach to alleviate their condition.

Evidence and the Main Adverse Effects Regarding Drug Therapies in the War Against COVID-19.