COVID-19 PneumoniaPhase 2NCT05212818
Evaluate the Efficacy and Safety of TF0023 in Treatments for COVID-19 in Hospitalized Adults
A Phase 2 study testing TF0023 in people with COVID-19 Pneumonia, run by Techfields Inc at 5 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- TF0023
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 10 May 2022to 8 Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States3 sites
White Oak Medical Center LLC
Gaithersburg, Maryland, 20878
Holy Name Medical Center
Teaneck, New Jersey, 07666
Lincoln Medical Center
The Bronx, New York, 10451
South Africa2 sites
Worthwhile Clinical Trial
Benoni, Gauteng
Dr JM Engelbrecht Trials Site
Somerset West, Western Cape
About this study
Official title: 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).
Read the 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
- Being tested
- TF0023
- Keywords
- Pneumonia, COVID-19
- Medical subject headings
- Pneumonia, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TF0023Drug
Also called IP, Active 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.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose of Active Drug | Experimental | 80 patients will be randomly assigned to low dose, take active drug BID. Receives: Drug: TF0023 |
| Low Dose Placebo Control | Experimental | 80 patients will be randomly assigned to Low dose placebo, take the placebo BID. Receives: Drug: TF0023 |
| High Dose of Active Drug | Experimental | 160 patients will be randomly assigned to high dose, take the active drug BID. Receives: Drug: TF0023 |
| High Dose Placebo Control | Experimental | 80 will be randomly assigned to high dose placebo, take the placebo BID. Receives: Drug: TF0023 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 days
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 28 days
All-cause mortality
To evaluate the efficacy of Active drug compared to placebo on all-cause mortality (ACM).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start10 May 2022
- Primary completion3 Feb 2023
- Study completion8 Mar 2023
Why it stopped: Low patient accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Techfields Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chongxi Yu, Ph.D, Study chair, Techfields Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212818
- Sponsor's protocol ID
- TF-TF0023-201
- Status last verified
- Jan 2024
- First submitted
- 20 Jan 2022
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05212818
- Acronym / sponsor ID
- TF-TF0023-201
- Conditions
- COVID-19 Pneumonia
- Keywords
- Pneumonia, COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low patient accrual.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Techfields IncIndustry (pharma, biotech, devices)
- Study start
- 10 May 2022 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low Dose of Active Drug | Experimental | Drug: TF002380 patients will be randomly assigned to low dose, take active drug BID. |
| Low Dose Placebo Control | Experimental | Drug: TF002380 patients will be randomly assigned to Low dose placebo, take the placebo BID. |
| High Dose of Active Drug | Experimental | Drug: TF0023160 patients will be randomly assigned to high dose, take the active drug BID. |
| High Dose Placebo Control | Experimental | Drug: TF002380 will be randomly assigned to high dose placebo, take the placebo BID. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (11 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TF0023Also: IP, Active drugTechfields 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. | Drug | High Dose Placebo Control, High Dose of Active Drug, Low Dose Placebo Control, Low Dose of Active Drug |
Primary outcome
Percentage of patients able to maintain peripheral capillary oxygen saturation (SpO2) of >93% without oxygen support at Day 15.
Time frame: 15 days
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.
11 secondary outcomes
Time to not requiring oxygen support.
Time frame: 28 days
Cumulative incidence of SAEs, Grade 3 and 4 clinical and/or laboratory AEs
Time frame: 28 days
Changes of clinical status (9-point ordinal scale)
Time frame: 15 days
Number of supplemental oxygen-free days between Day 1 and Day 29.
Time frame: 28 days
Changes of chest x-ray, and computerized tomography (CT) scan
Time frame: 28 days
Changes of clinical status (9-point ordinal scale)
Time frame: 28 days
Percentage of patients reporting each severity rating on the 9-point ordinal scale
Time frame: 28 days
All-cause mortality
Time frame: 28 days
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
Time frame: 28 days
Incidence and duration of new mechanical ventilation use and on respiratory failure-free days
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Low patient accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chongxi Yu, Ph.D study chair
Techfields Inc
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TF0023 in people with COVID-19 Pneumonia, run by Techfields Inc at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low patient accrual.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients able to maintain peripheral capillary oxygen saturation (SpO2) of >93% without oxygen support at Day 15. (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.