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

Exclusion Criteria:

1. Severe background disease like severe cardiac or pulmonary insufficiency (WHO grade
III or IV), severe liver and kidney diseases, severe COPD, severe neurological
disease, or concurrent malignancy (other than non-melanoma skin cancer) which is
uncontrolled or actively being treated

2. Severe asthma on chronic therapy with biologics or steroids.

3. Prior malignancy in which any thoracic radiotherapy was administered except for
partial or tangent breast irradiation for early-stage (stages I or II) breast cancer

4. D-dimer levels of >2,000 ng/mL at screening

5. Use of anti-pulmonary fibrosis drugs (e.g., imatinib, nintedanib, pirfenidone,
penicillamine, colchicine, tumor necrosis factor alpha blocker) within 5 days of the
first scheduled day of study intervention dosing

6. Use of anti-cytokine release syndrome drugs (e.g., anakinra, sarilumab, siltuximab,
tocilizumab and/or lenzilumab) within 5 days of the first scheduled day of study
intervention dosing

7. Use of systemic corticosteroids (e.g., prednisone, dexamethasone) within 5 days of the
first scheduled day of study intervention dosing

8. An active infection or infection with a fever ≥ 38.5°C within 3 days of the first
scheduled day of study intervention dosing

9. Poorly controlled intercurrent illnesses, such as interstitial lung disease,
uncontrolled hypertension; poorly controlled diabetes mellitus; unstable angina,
myocardial infarction, acute coronary syndrome or cerebrovascular event within 6
months of Screening; history of congestive heart failure (NYHA Class III or IV);
severe valvular heart disease; or poorly controlled cardiac arrhythmias not responding
to medical therapy or a pacemaker

10. QTc with Fridericia's correction that is unmeasurable, or ≥480 msec on screening ECG.
The average QTc from the screening ECG (completed in triplicate) must be <480 msec for
the patient to be eligible for the study

11. Patients taking any concomitant medication that may cause QTc prolongation, induce
Torsades de Pointes (www.crediblemeds.org) are not eligible if QTc ≥460 msec

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.