AT1001 for the Treatment of Long COVID

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Long COVID, Long COVID-19, Post Acute COVID-19 Syndrome, Post Acute Sequelae of COVID-19

In brief

The primary objective of this study is to evaluate the safety and efficacy of Larazotide (AT1001) versus placebo in children and adults 7 to ≤50 years of age who present with symptoms of Long COVID in the presence of SARS-CoV-2 antigenemia. AT1001 (n=100) or placebo (n=50) will be administered orally four times a day (QID) for 21 days.

Key facts

Study ID

NCT05747534

Run by

Massachusetts General Hospital

People needed

107

Starts

2023-05-31

Expected to finish

2026-09-30

Last updated by the study team

2026-05-22

Who can join

Age: 7 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston Children's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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