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NCT05747534

AT1001 for the Treatment of Long COVID

Completed
PHASE2Ages 7–50InterventionalTreatment
Massachusetts General Hospital
~107 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:Larazotide AcetatePlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Event Profiling and Time to Symptom Resolution
Measured over 8 weeks

Conditions

Long COVID
Long COVID-19
Post Acute COVID-19 Syndrome
Post Acute Sequelae of COVID-19

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NCT05747534

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Massachusetts General Hospital

    Boston, Massachusettsno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Adverse Event Profiling and Time to Symptom Resolution8 weeks

    The primary objective of this study is to evaluate the safety and efficacy of Larazotide (AT1001) versus placebo in children and young adults 7 to ≤50 years of age who present with symptoms of Long COVID. Safety will be assessed by means of adverse event monitoring, and efficacy will be evaluated using the Symptom Burden Questionnaire™ for Long COVID (SBQ™-LC) survey. Additional surveys will be used to monitor symptoms, quality of life and limitation of activities before, during and after treatment with Larazotide or Placebo.