Clinical trial NCT05212818: Evaluate the Efficacy and Safety of TF0023 in Treatments for COVID-19 in Hospitalized Adults
Official title: A Phase 2, Multicenter, Randomized, Double-blind (Within Dose), Placebo-controlled, Parallel-group, and Dose-range-finding to Evaluate the Efficacy and Safety in Treatments for COVID-19 in Hospitalized Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID-19 Pneumonia
Keywords: Pneumonia
COVID-19
Lead sponsor: Techfields Inc
Sponsor class: INDUSTRY
First posted: 2022-01-28
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, Randomized, Double-blind (Within Dose), Placebo-controlled, Parallel-group, and Dose-range-finding Study to Evaluate the Efficacy and Safety of Active drug Versus Placebo in Treatments for COVID-19 in Hospitalized Adults, relieving of the signs and symptoms of acute respiratory distress syndrome (ARDS) and pneumonia caused by coronavirus disease 2019 (COVID-19).

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) 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 days (during the double-blind treatment period), starting immediately after all eligibility criteria (including test results) are confirmed. All patients will receive institutional standard of care (SOC) concurrently with their assigned IP. There will be a follow-up visit on Day 36+3 days.

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.

Primary outcomes:
measure: Percentage of patients able to maintain peripheral capillary oxygen saturation (SpO2) of >93% without oxygen support at Day 15.
timeFrame: 15 days
Secondary outcomes:
measure: Time to not requiring oxygen support.
timeFrame: 28 days
measure: Cumulative incidence of SAEs, Grade 3 and 4 clinical and/or laboratory AEs
timeFrame: 28 days
measure: Changes of clinical status (9-point ordinal scale)
timeFrame: 15 days
measure: Number of supplemental oxygen-free days between Day 1 and Day 29.
timeFrame: 28 days
measure: Changes of chest x-ray, and computerized tomography (CT) scan
timeFrame: 28 days
measure: Changes of clinical status (9-point ordinal scale)
timeFrame: 28 days
measure: Percentage of patients reporting each severity rating on the 9-point ordinal scale
timeFrame: 28 days
measure: All-cause mortality
timeFrame: 28 days
measure: Pattern score and volumetric score of the radiologic severity index.
timeFrame: 28 days
measure: Duration of hospitalization and duration of Intensive Care Unit (ICU) treatment
timeFrame: 28 days
measure: Incidence and duration of new mechanical ventilation use and on respiratory failure-free days
timeFrame: 28 days
Other outcomes:
Locations:
city: Gaithersburg
country: United States
facility: White Oak Medical Center LLC
state: Maryland
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Lincoln Medical Center
state: New York
city: Benoni
country: South Africa
facility: Worthwhile Clinical Trial
state: Gauteng
city: Somerset West
country: South Africa
facility: Dr JM Engelbrecht Trials Site
state: Western Cape
Study officials:
affiliation: Techfields Inc
name: Chongxi Yu, Ph.D
role: STUDY_CHAIR
References: