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

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

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).

Study Overview

• Status: Terminated
• Conditions: COVID-19 Pneumonia
• Intervention / Treatment: Drug: TF0023

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2

Contacts and Locations

Study Locations

• South Africa
  • Gauteng
    • Benoni, Gauteng, South Africa
      • Worthwhile Clinical Trial
  • Western Cape
    • Somerset West, Western Cape, South Africa
      • Dr JM Engelbrecht Trials Site
• United States
  • Maryland
    • Gaithersburg, Maryland, United States, 20878
      • White Oak Medical Center LLC
  • New Jersey
    • Teaneck, New Jersey, United States, 07666
      • Holy Name Medical Center
  • New York
    • Bronx, New York, United States, 10451
      • Lincoln Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Dose of Active Drug; 80 patients will be randomly assigned to low dose, take active drug BID.	Drug: TF0023; 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.; Other Names: IP, Active drug
Experimental: Low Dose Placebo Control; 80 patients will be randomly assigned to Low dose placebo, take the placebo BID.	Drug: TF0023; 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.; Other Names: IP, Active drug
Experimental: High Dose of Active Drug; 160 patients will be randomly assigned to high dose, take the active drug BID.	Drug: TF0023; 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.; Other Names: IP, Active drug
Experimental: High Dose Placebo Control; 80 will be randomly assigned to high dose placebo, take the placebo BID.	Drug: TF0023; 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.; Other Names: IP, Active drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	28 days
All-cause mortality	To evaluate the efficacy of Active drug compared to placebo on all-cause mortality (ACM).	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.	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.	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.	28 days

Collaborators and Investigators

• Sponsor: Techfields Inc
• Investigators: Study Chair: Chongxi Yu, Ph.D, Techfields Inc

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Actual): February 3, 2023
• Study Completion (Actual): March 8, 2023

Study Registration Dates

• First Submitted: January 20, 2022
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Pneumonia; COVID-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; COVID-19; Pneumonia
• Other Study ID Numbers: TF-TF0023-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No