Status:
TERMINATED
Evaluate the Efficacy and Safety of TF0023 in Treatments for COVID-19 in Hospitalized Adults
Lead Sponsor:
Techfields Inc
Conditions:
COVID-19 Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Techfields Inc. is developing a new investigational prodrug as a topical spray, indicated for relief of the signs and symptoms of ARDS and pneumonia caused by COVID-19. This is a Phase 2, Multicenter,...
Detailed Description
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) acc...
Eligibility Criteria
Inclusion
- Admitted to a hospital with pulmonary symptoms of active COVID-19.
- Patient (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
- Patient (or legally authorized representative) understands and agrees to comply with planned study procedures.
- Male or nonpregnant female adult ≥18 years of age at time of enrollment.
- 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:
- Laboratory confirmed SARS-CoV-2 infection by method as defined above, in sample collected \<72 hours prior to randomization; OR
- 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.
- 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.
- 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).
- 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
- 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:
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3 × the upper limit of normal (ULN) at screening.
- Total bilirubin or alkaline phosphatase level \>3.0 × the ULN at screening.
- Platelet count \<100 × 109/L.
- Extracorporeal membrane oxygenation required at baseline.
- Stage 3 or end stage renal disease (ESRD) patients with acute renal insufficiency may be considered only after discussion with medical monitor.
- Is at increased risk for bleeding events (e.g., had recent cerebral hemorrhage, gastrointestinal bleeding, serious trauma, recent surgery, or organ biopsy).
- Pregnant (patient has a positive pregnancy test result at screening) or breast-feeding.
- Anticipated discharge from the hospital or transfer to another hospital which is not a study site.
- Allergy to any study medication or known allergy to nonsteroidal anti-inflammatory drugs, including aspirin.
- 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.
Key Trial Info
Start Date :
May 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2023
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT05212818
Start Date
May 10 2022
End Date
March 8 2023
Last Update
January 8 2024
Active Locations (5)
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1
White Oak Medical Center LLC
Gaithersburg, Maryland, United States, 20878
2
Holy Name Medical Center
Teaneck, New Jersey, United States, 07666
3
Lincoln Medical Center
The Bronx, New York, United States, 10451
4
Worthwhile Clinical Trial
Benoni, Gauteng, South Africa