BIO 300 Oral Suspension in Previously Hospitalized Long COVID Patients

Inclusion Criteria

• •1. Age ≥ 18
• •2. Patients hospitalized for COVID-19-related complications ready to be discharged and those within 365 days of discharge (even if the patient was referred to subacute or acute respiratory rehabilitation after discharge)
• •3. Radiographic signs of lung injury after standard treatment of COVID-19 such as, ground glass opacity, consolidation, or fibrotic shadows at screening
• •4. Able to perform a PFT and have a DLCO \<70% of predicted at screening
• •5. Able to perform a 6-minute walk test
• •6. Blood routine, liver and kidney function test values are within the controllable range
• •1. Adequate hepatic function as evidenced by ALT, AST and LDH \< 2X ULN and bilirubin \< 1.5X ULN for the reference lab
• •2. Adequate renal function as evidenced by a serum creatinine ≤ 1.5 X ULN for the reference laboratory OR a calculated creatinine clearance of ≥ 60 mL/min by the Cockcroft-Gault Equation
• •3. Adequate hematopoietic function as evidenced by white blood cells ≥ 3x10\^9 / L and platelets ≥ 100x10\^9 / L
• •7. Female patients of childbearing potential must have a negative pregnancy test at screening
• •8. Female patients of childbearing potential and male participants with female sexual partners of childbearing potential must agree to use an effective method of non-estrogen-based contraception (e.g., condom and a diaphragm, condom and intrauterine device, condom and Depo-Provera, condom and Nexplanon, or condom and progesterone mini-pill) during the 12-week portion of the study that they are receiving study medication and for 30 days following the last dose of study medication, or to abstain from sexual intercourse during these time periods. Women who have been off estrogen contraceptives for a minimum of 5 days prior to the first scheduled day of study intervention dosing are eligible. A woman not of childbearing potential is one who has undergone bilateral oophorectomies or who is post-menopausal, defined as no menstrual periods for 12 consecutive months
• •9. Ability of the patient or the patient's legal representative to read and provide written informed consent
• •12. Patients who have undergone thoracotomy within 4 weeks of Day 1 of protocol therapy
• •13. Patients that have a known allergy to any of the placebo components
• •14. Psychiatric conditions, social situations or substance abuse that precludes the ability of the study participant to cooperate with the requirements of the trial and protocol therapy
• •15. Pregnancy or currently on estrogen-based contraceptives
• •16. Women who are breastfeeding
• •17. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.