RECRUITING

AT1001 for the Treatment of Long COVID

Conditions

Long COVID Long COVID-19 Post Acute COVID-19 Syndrome Post Acute Sequelae of COVID-19 SARS-CoV-2 Pediatrics

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-05-31

Study Completion:2027-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05747534

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:7 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Lael M Yonker, MD

CONTACT

617-724-2890

lyonker@mgh.harvard.edu

Lauren Guthrie, MPH

CONTACT

6176437175

lauren.guthrie@mgh.harvard.edu

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Boston Children's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

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

Study Start Date2023-05-31

Study Completion Date2027-03-31

Study Record Updates

Study Start Date2023-05-31

Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

SARS-CoV-2
Long COVID
Pediatrics

Additional Relevant MeSH Terms

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