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

NCT05212818 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: TF-TF0023-201
• Study Type: interventional
• Target: 19
• Locations: 2 countries
• Sites: 5

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).

Conditions

COVID-19 Pneumonia

Keywords

Pneumonia; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Time to not requiring oxygen support.

  28 days

• Cumulative incidence of SAEs, Grade 3 and 4 clinical and/or laboratory AEs

  28 days

• Changes of clinical status (9-point ordinal scale)

  15 days

• Number of supplemental oxygen-free days between Day 1 and Day 29.

  28 days

• Changes of chest x-ray, and computerized tomography (CT) scan

  28 days

Study Arms (4)

Low Dose of Active Drug

EXPERIMENTAL

80 patients will be randomly assigned to low dose, take active drug BID.

Drug: TF0023

Low Dose Placebo Control

EXPERIMENTAL

80 patients will be randomly assigned to Low dose placebo, take the placebo BID.

Drug: TF0023

High Dose of Active Drug

EXPERIMENTAL

160 patients will be randomly assigned to high dose, take the active drug BID.

Drug: TF0023

High Dose Placebo Control

EXPERIMENTAL

80 will be randomly assigned to high dose placebo, take the placebo BID.

Drug: TF0023

Interventions

TF0023 DRUG

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.

Also known as: IP, Active drug

High Dose Placebo Control; High Dose of Active Drug; Low Dose Placebo Control; Low Dose of Active Drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Techfields Inc: lead

Study Sites (5)

White Oak Medical Center LLC

Gaithersburg, Maryland, 20878, United States

Location

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

Lincoln Medical Center

The Bronx, New York, 10451, United States

Location

Worthwhile Clinical Trial

Benoni, Gauteng, South Africa

Location

Dr JM Engelbrecht Trials Site

Somerset West, Western Cape, South Africa

Location

MeSH Terms

Conditions

Pneumonia; COVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Chongxi Yu, Ph.D

  Techfields Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: January 28, 2022
• Study Start: May 10, 2022
• Primary Completion: February 3, 2023
• Study Completion: March 8, 2023
• Last Updated: January 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (2); US (3)