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.

Inclusion Criteria:Age 7 to ≤21 yearsHistory of SARS-CoV-2 infection, documented by positive PCR and/or antigen testSARS-CoV-2 Antigenemia, defined as any detectable presence of full-length spike protein and/or Spike S1 subunit in plasmaOngoing, 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 enrollmentPregnancy and/or lactationFemale participant of childbearing age unwilling to use an acceptable method of birth control for the duration of the studyInability to tolerate drugUnstable medical conditions or significant co-morbid disease that, by the investigator's determination would make the participant unsuitable for enrollmentParticipation in any other clinical investigation using an experimental drug within 30 days prior to screeningIntent to participate in another clinical study while participating in this clinical trialBlood/plasma donation and or blood loss greater than 400 mL within 90 days, or greater than 200 mL within 30 days prior to screeningKnown 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 ageAbnormal baseline renal function, defined as glomerular filtration rate ≤50 mL/min/1.73m2