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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
19
Techfields Inc. is developing TF0023, a new investigational prodrug, indicated for relief of the signs and symptoms of ARDS and pneumonia caused by COVID-19 and other viruses.
White Oak Medical Center LLC
Gaithersburg, Maryland, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
Lincoln Medical Center
The Bronx, New York, United States
Worthwhile Clinical Trial
Benoni, Gauteng, South Africa
Percentage of patients able to maintain peripheral capillary oxygen saturation (SpO2) of >93% without oxygen support at Day 15.
To evaluate the clinical efficacy of Active drug relative to the control arm in patients hospitalized with respiratory impairment from acute COVID-19 as assessed by the ability to maintain peripheral capillary oxygen saturation (SpO2) of \>93% without supplemental oxygen.
Time frame: 15 days
Time to not requiring oxygen support.
To evaluate the clinical effect of Active drug as compared to placebo, as assessed by time to not require supplemental oxygen.
Time frame: 28 days
Cumulative incidence of SAEs, Grade 3 and 4 clinical and/or laboratory AEs
To evaluate the safety of Active drug compared to placebo.
Time frame: 28 days
Changes of clinical status (9-point ordinal scale)
To evaluate the clinical efficacy of Active drug as compared to placebo, as assessed by clinical status (9-point ordinal scale) at Day 15.
Time frame: 15 days
Number of supplemental oxygen-free days between Day 1 and Day 29.
To evaluate the clinical effect of Active drug compared to placebo, as assessed by supplemental oxygen requirements, and oxygenation.
Time frame: 28 days
Changes of chest x-ray, and computerized tomography (CT) scan
To evaluate the clinical effect of Active drug compared to placebo as assessed by chest x-ray, and computerized tomography (CT) scan.
Time frame: 28 days
Changes of clinical status (9-point ordinal scale)
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Dr JM Engelbrecht Trials Site
Somerset West, Western Cape, South Africa
To evaluate the clinical efficacy of Active drug as compared to placebo, as assessed by clinical status (9-point ordinal scale) at Day 15.
Time frame: 28 days
Percentage of patients reporting each severity rating on the 9-point ordinal scale
To evaluate the efficacy of Active drug compared to placebo as assessed by percentage of patients reporting each severity rating on the 9-point ordinal scale.
Time frame: 28 days
All-cause mortality
To evaluate the efficacy of Active drug compared to placebo on all-cause mortality (ACM).
Time frame: 28 days
Pattern score and volumetric score of the radiologic severity index.
To evaluate the efficacy of Active drug compared to placebo as assessed by pattern score and volumetric score of the radiologic severity index.
Time frame: 28 days
Duration of hospitalization and duration of Intensive Care Unit (ICU) treatment
To evaluate the efficacy of Active drug compared to placebo for patient clinical status on duration of hospitalization and duration of Intensive Care Unit (ICU) treatment.
Time frame: 28 days
Incidence and duration of new mechanical ventilation use and on respiratory failure-free days
To evaluate the efficacy of Active drug compared to placebo for patient clinical status on incidence and duration of new mechanical ventilation use and on respiratory failure-free days.
Time frame: 28 days