Evaluate the Efficacy and Safety of TF0023 in Treatments for COVID-19 in Hospitalized Adults

Inclusion Criteria

• •1. Admitted to a hospital with pulmonary symptoms of active COVID-19.
• •2. Patient (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
• •3. Patient (or legally authorized representative) understands and agrees to comply with planned study procedures.
• •4. Male or nonpregnant female adult ≥18 years of age at time of enrollment.
• •5. Has laboratory confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay (serology is not acceptable) in any specimen, as documented by either of the following:
• •1. Laboratory confirmed SARS-CoV-2 infection by method as defined above, in sample collected \<72 hours prior to randomization; OR
• •2. Laboratory confirmed SARS-CoV-2 infection by method as defined above, in sample collected ≥72 hours prior to randomization, documented inability to obtain a repeat sample (e.g., due to lack of testing supplies, limited testing capacity, results taking \>24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection.
• •6. Has a score of 4 (hospitalized, oxygen by mask or nasal prongs), 5 (hospitalized, noninvasive ventilation or high-flow oxygen), or 6 (hospitalized, intubation and mechanical ventilation) in the ordinal scale.
• •7. Women of childbearing potential must agree to either abstinence or use at least 1 primary form of contraception not including hormonal contraception from the time of screening through Day 29. (Double-barrier method \[condoms, sponge, diaphragm, with spermicidal jellies, or cream\] is acceptable).
• •8. Agrees to not participate in another clinical study for the treatment of COVID-19 or SARS-CoV-2 through Day 29. However, Food and Drug Administration (FDA)-approved or under an emergency use authorization antivirus or other drugs may be allowed, and that should be judged by the patient's physician.