Treatment of Long COVID with Larazotide
Phase 2a Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Larazotide (AT1001) for the Treatment of Long COVID in Children and Adults
This study is testing if a new medication called Larazotide can help children and adults aged 7 to 50 who have Long COVID symptoms feel better compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 7 Years to 50 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT05747534 on ClinicalTrials.gov |
What this trial studies
This Phase 2a clinical trial evaluates the safety and efficacy of Larazotide (AT1001) compared to a placebo in children and adults aged 7 to 50 years who exhibit symptoms of Long COVID associated with SARS-CoV-2 antigenemia. Participants will receive either the active drug or placebo orally four times a day for 21 days. The study includes a baseline screening visit to confirm eligibility and assess symptom severity, followed by a treatment phase where the drug's effects will be monitored. The trial aims to gather data on the potential benefits of Larazotide in alleviating Long COVID symptoms.
Who should consider this trial
Good fit: Ideal candidates are children and adults aged 7 to 50 years with a documented history of SARS-CoV-2 infection and ongoing symptoms of Long COVID.
Not a fit: Patients outside the age range of 7 to 50 years, those who are pregnant or lactating, or those unwilling to use birth control may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from Long COVID symptoms.
How similar studies have performed: While there have been various studies on Long COVID, the specific use of Larazotide for this condition is novel and has not been extensively tested in prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts and 1 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Lael M Yonker, MD
- Email: lyonker@mgh.harvard.edu
- Phone: 617-724-2890
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.