Actively Recruiting
AT1001 for the Treatment of Long COVID
Led by Massachusetts General Hospital · Updated on 2025-07-28
150
Participants Needed
2
Research Sites
200 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
B
Boston Children's Hospital, Boston, MA, USA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
AT1001 for the Treatment of Long COVID
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 7 to 50 years
- Documented history of SARS-CoV-2 infection by positive PCR and/or antigen test
- Presence of ongoing, worsening, new, or recurrent symptoms at least 4 weeks after SARS-CoV-2 infection, including fatigue, headache, cognitive impairment, neuropsychiatric symptoms, decreased exercise tolerance, post-exertional malaise, respiratory symptoms, chest pain, palpitations, gastrointestinal symptoms, musculoskeletal symptoms, fever, sleep disturbances, sensory changes, pain, menstrual irregularities, or erectile dysfunction
You will not qualify if you...
- Age under 7 years or over 50 years at enrollment
- Pregnancy or lactation
- Female participants of childbearing age unwilling to use acceptable birth control during the study
- Inability to tolerate the study drug
- Unstable medical conditions or significant co-morbidities making participation unsuitable
- Participation in another experimental drug trial within 30 days prior to screening
- Intention to join another clinical study during this trial
- Recent blood or plasma donation or blood loss exceeding 400 mL within 90 days or 200 mL within 30 days before screening
- Known allergy to any components of AT1001
- Abnormal liver function indicated by AST or ALT greater than three times the upper limit of normal or total bilirubin greater than twice the upper limit for age
- Abnormal kidney function defined as glomerular filtration rate less than 50 mL/min/1.73m2
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
L
Lael M Yonker, MD
CONTACT
L
Lauren Guthrie, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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