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

Launched by TECHFIELDS INC · Jan 25, 2022

Keywords

ClinConnect Summary

A total of approximately 400 eligible patients will be randomly assigned to receive Active Drug low dose (n=80), placebo low dose (n=80), Active Drug high dose (n=160), or placebo high dose (n=80) according to a 1:1:2:1 ratio. The study will be stopped when the last patient completes the double-blind treatment period (end of treatment \[EOT\]/early termination visit \[ETV\] on Day 29 + 3 days) and follow-up period. Screening will start when the patient is hospitalized. Each patient enrolled will receive an investigational product (IP; Active Drug or placebo) in a double-blind manner for 28 ...

Gender

ALL

Eligibility criteria

• 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.
• Exclusion Criteria:
• 1. Any condition, including any significant medical or neuropsychiatric condition, including the presence of laboratory abnormalities, which in the judgment of the investigator places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study including, but not limited to:
• • 1. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3 × the upper limit of normal (ULN) at screening.
• • 2. Total bilirubin or alkaline phosphatase level \>3.0 × the ULN at screening.
• • 3. Platelet count \<100 × 109/L.
• • 2. Extracorporeal membrane oxygenation required at baseline.
• • 3. Stage 3 or end stage renal disease (ESRD) patients with acute renal insufficiency may be considered only after discussion with medical monitor.
• • 4. Is at increased risk for bleeding events (e.g., had recent cerebral hemorrhage, gastrointestinal bleeding, serious trauma, recent surgery, or organ biopsy).
• • 5. Pregnant (patient has a positive pregnancy test result at screening) or breast-feeding.
• • 6. Anticipated discharge from the hospital or transfer to another hospital which is not a study site.
• • 7. Allergy to any study medication or known allergy to nonsteroidal anti-inflammatory drugs, including aspirin.
• • 8. Patient must agree to refrain from taking oral aspirin or any orally administered acetylsalicylic acid medications until PK sampling is completed to be eligible to participate in the PK sub-study.