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Could a gut pill ease long COVID? new trial tests larazotide

NCT ID NCT05747534

Disease control Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times

Summary

This Phase 2a study tests whether larazotide, a drug that tightens the gut lining, can reduce long COVID symptoms in people aged 7 to 50. Participants take the drug or a placebo four times daily for 21 days. The goal is to see if it safely improves symptoms like fatigue, brain fog, and breathing trouble.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Larazotide (AT1001), a drug that tightens the gut lining to reduce inflammation
What this could lead to
If it works, this could point toward a treatment for long COVID by addressing gut-related inflammation.
What could go wrong
This is an early Phase 2a trial with only 150 participants, so results may not apply to everyone. The drug is taken four times daily for 21 days, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

107 people

The number who actually took part.

Started

May 2023

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

7 to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 7 to ≤50 years * History of SARS-CoV-2 infection, documented by positive PCR and/or antigen test * 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. Exclusion Criteria: * Age ≤6 years or \>50 years at time of enrollment * Pregnancy and/or lactation * Female participant of childbearing age unwilling to use an acceptable method of birth control for the duration of the study * Inability to tolerate drug * Unstable medical conditions or significant co-morbid disease that, by the investigator's determination would make the participant unsuitable for enrollment * Participation in any other clinical investigation using an experimental drug within 30 days prior to screening * Intent to participate in another clinical study while participating in this clinical trial * 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 * Known hypersensitivity to any of the formulation components of AT1001. * Abnormal baseline liver function as indicated by AST or ALT ≥3 times the upper limit of normal (ULN), or total bilirubin ≥2x ULN for age * Abnormal baseline renal function, defined as glomerular filtration rate ≤50 mL/min/1.73m2

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Conditions

The condition(s) this trial relates to.

long COVID-19

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Long COVID Long COVID-19 Post acute sequelae of COVID-19 Post-acute COVID-19 syndrome

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.