NCT05212818

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Techfields Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19 Pneumonia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-05-10
• Primary completion: 2023-02-03
• Completion: 2023-03-08
• First posted: 2022-01-28
• Last updated: 2024-01-08

Locations

5 sites across 2 countries: United States, South Africa

Regulatory

• FDA-regulated drug study