AT1001 for the Treatment of Long COVID

Prior treatment

• Inability to tolerate drug
• Participation in any other clinical investigation using an experimental drug within 30 days prior to screening
• 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

Other illness

• Unstable medical conditions or significant co-morbid disease that, by the investigator's determination would make the participant unsuitable for enrollment
• Known hypersensitivity to any of the formulation components of AT1001.

Lab values

• 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

Age

• Age ≤6 years or \>50 years at time of enrollment
• Female participant of childbearing age unwilling to use an acceptable method of birth control for the duration of the study

Other

• Pregnancy and/or lactation
• Intent to participate in another clinical study while participating in this clinical trial
• Abnormal baseline renal function, defined as glomerular filtration rate ≤50 mL/min/1.73m2

• 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.