AT1001 for the Treatment of Long COVID
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 ≤21 years of age who present with symptoms of Long COVID in the presence of SARS-CoV-2 antigenemia. AT1001 (n=32) or placebo (n=16) will be administered orally four times a day (QID) for 21 days.
Conditions:
🦠 Long COVID 🦠 Long COVID-19 🦠 Post Acute COVID-19 Syndrome 🦠 Post Acute Sequelae of COVID-19
🗓️ Study Start (Actual) 31 May 2023
🗓️ Primary Completion (Estimated) 31 March 2025
✅ Study Completion (Estimated) 31 March 2026
👥 Enrollment (Estimated) 48
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Age 7 to ≤21 years
    • * History of SARS-CoV-2 infection, documented by positive PCR and/or antigen test
    • * SARS-CoV-2 Antigenemia, defined as any detectable presence of full-length spike protein and/or Spike S1 subunit in plasma
    • * 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 \>22 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 direct bilirubin ≥2x ULN for age
    • * Abnormal baseline renal function, defined as glomerular filtration rate ≤50 mL/min/1.73m2
Ages Eligible for Study: 7 Years to 21 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 24 February 2023
  • First Submitted that Met QC Criteria 24 February 2023
  • First Posted 28 February 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 March 2024
  • Last Update Posted 6 March 2024
  • Last Verified March 2024