AT1001 for the Treatment of Long COVID

NCTNCT05747534Other id2023P000240

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 107 participants (actual)
Sponsor: Massachusetts General Hospital · Other
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: 31 May 2023
Primary completion: 18 Jun 2026
Completion: 18 Jun 2026
First posted: 28 Feb 2023
Last update posted: 18 Aug 2026
Conditions: Long COVID · Long COVID-19 · Post Acute COVID-19 Syndrome · Post Acute Sequelae of COVID-19

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20232024202520262027

Ph 2
AT1001 for the Treatment of Long COVID
NCT05747534
31 May 2023 to 18 Jun 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Larazotide AcetateDrug
PlaceboDrug

Arms2

Experimental
Larazotide Acetate (AT1001)
Subjects will receive 250 or 500 µg of Larazotide Acetate orally four times a day (QID) for 21 days. Subjects \<25.0 kg will receive 250 µg dose of Larazotide Acetate (AT1001), and subjects ≥25.0 kg will receive 500 µg dose of Larazotide Acetate (AT1001).
Placebo comparator
Placebo
Subjects will receive 250 or 500 µg of placebo orally four times a day (QID) for 21 days. Subjects \<25.0 kg will receive 250 µg dose of placebo and subjects ≥25.0 kg will receive 500 µg dose of placebo.

Primary outcomes1

Outcomes the sponsor listed as primary.

Adverse Event Profiling and Time to Symptom Resolution
Time frame · 8 weeks
Registry description
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 ≤50 years of age who present with symptoms of Long COVID. Safety will be assessed by means of adverse event monitoring, and efficacy will be evaluated using the Symptom Burden Questionnaire™ for Long COVID (SBQ™-LC) survey. Additional surveys will be used to monitor symptoms, quality of life and limitation of activities before, during and after treatment with Larazotide or Placebo.

Secondary outcomes(1)

Cytokine profiling, Antigen Testing and Humoral and Cellular Responses
Time frame · 21 days
Registry description
The secondary objective of this study is to characterize the inflammatory response observed in children and young adults 7 to ≤21 years of age with Long COVID and SARS-CoV-2 antigenemia. To assess inflammatory responses, blood, stool and nasal epithelial specimens will be obtained at baseline prior to treatment with Larazotide or Placebo, and at completion of the study's treatment phase (21 days). Inflammatory responses will be evaluated by means of antigen testing, cytokine profiling, among others.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 7 Years up to 50 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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