TF0023 for Coronavirus Pneumonia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Coronavirus PneumoniaTF0023 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to see if it can help relieve symptoms of ARDS and pneumonia caused by COVID-19.

Eligible Conditions
  • Coronavirus Pneumonia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: 28 days

15 days
Percentage of patients able to maintain peripheral capillary oxygen saturation (SpO2) of >93% without oxygen support at Day 15.
28 days
All-cause mortality
Changes of chest x-ray, and computerized tomography (CT) scan
Changes of clinical status (9-point ordinal scale)
Cumulative incidence of SAEs, Grade 3 and 4 clinical and/or laboratory AEs
Duration of hospitalization and duration of Intensive Care Unit (ICU) treatment
Incidence and duration of new mechanical ventilation use and on respiratory failure-free days
Number of supplemental oxygen-free days between Day 1 and Day 29.
Pattern score and volumetric score of the radiologic severity index.
Percentage of patients reporting each severity rating on the 9-point ordinal scale
Time to not requiring oxygen support.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

Trial Design

4 Treatment Groups

Low Dose Placebo Control
1 of 4
Low Dose of Active Drug
1 of 4
High Dose of Active Drug
1 of 4
High Dose Placebo Control
1 of 4

Experimental Treatment

400 Total Participants · 4 Treatment Groups

Primary Treatment: TF0023 · No Placebo Group · Phase 2

Low Dose Placebo Control
Drug
Experimental Group · 1 Intervention: TF0023 · Intervention Types: Drug
Low Dose of Active Drug
Drug
Experimental Group · 1 Intervention: TF0023 · Intervention Types: Drug
High Dose of Active Drug
Drug
Experimental Group · 1 Intervention: TF0023 · Intervention Types: Drug
High Dose Placebo Control
Drug
Experimental Group · 1 Intervention: TF0023 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 28 days

Who is running the clinical trial?

Techfields IncLead Sponsor
1 Previous Clinical Trials
225 Total Patients Enrolled
Chongxi Yu, Ph.DStudy ChairTechfields Inc
1 Previous Clinical Trials
225 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are admitted to a hospital with pulmonary symptoms of active COVID-19.
You understand and agree to comply with the study's planned procedures.
You agree to not participate in another clinical study for the treatment of COVID-19 or SARS-CoV-2 through Day 29.
You are of childbearing potential and you agree to either abstinence or use at least 1 primary form of contraception from the time of screening through Day 29.

Who else is applying?

What state do they live in?
Virginia100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%