COPDPhase 1/2NCT05643729
Zofin to Treat Chronic Obstructive Pulmonary Disease (COPD)
A Phase 1/2 study testing Zofin in people with COPD, run by ZEO ScientifiX, Inc. at 1 site in United States.
Trial summary
A Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion (IV) of Zofin for the Treatment of Chronic Obstructive Pulmonary Disease (COPD). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- Zofin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2023to 31 Aug 2024
- Phase
- Phase 1/2
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject who can understand and are able to provide informed consent.
- Subject with moderate to severe COPD with normal cardiac, liver and renal function
- Subject must have a post-bronchodilator FEV1/FVC ratio of less than 0.7
- Subject must have a post-bronchodilator FEV1 percent predicted value <50%
- Subject must have a RV/TLC ratio of > 40%
- Subject must be either a non-smoker or an ex-smoker, with a cigarette smoking history of ≥ 10 packs per year.
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- Subject must have abstained from nicotine products for at least six months prior to enrollment in the study.
- Subject must be available for all specified assessments at the study site through the completion of the study.
- Subject must have oxyhemoglobin saturation on room air at rest equal or greater than 88% without oxygen
- Subject must be reasonably able to return for multiple follow-up visits.
- Adequate venous access
- For Women of Child-Bearing Potential (WOCBP) only, willingness to use FDA-recommended birth control until 6 months post treatment.
- Any male subject must agree to use contraceptives and not donate sperm during the study.
Who cannot join
- Subject with clinically significant illness with manifestations of significant organ dysfunction which in the judgment of the PI or co-investigator would render the study subject unlikely to tolerate the infusion or complete the study
- Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. Female subjects must undergo a blood pregnancy test at screening which will be within 72 hours of the IP infusion.
- Subject has been diagnosed with a pulmonary disease other than COPD (e.g. asthma, pulmonary, fibrosis, sarcoidosis, pulmonary hypertension, bronchiolitis, interstitial lung disease)
- Subject has been diagnosed with α1-Antitrypsin deficiency
- Subject has a body mass index greater than 42 kg/m2
- Subject has or had an active infection requiring systemic antibiotics within 12 weeks on enrollment in the study
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- Subject has or had exacerbation of COPD requiring hospitalization within 12 weeks of enrollment in the study.
- Subject has initiated pulmonary rehabilitation within 12 weeks of enrollment in the study
- Subject uses or used prednisone (or equivalent dose of another corticosteroid) within 12 weeks of enrollment in the study
- Subject has evidence or history of malignancy
- Subject has evidence or history of autoimmune disorders independent of COPD
- Subject is pregnant or breast-feeding
- Subject with pulmonary lobectomy or lung volume reduction surgery or lung transplantation. Subject with clinically significant bronchiectasis.
- Subject received an experimental therapy (drug or biologic) for any indication within 12 months of the study enrollment.
- Subject is unable to complete all the testing required for the study
- Subject who is on immunosuppressive medications.
- Subject who is unwilling to stop taking prescription or over the counter pain medication for 7 days prior to any visit.
- Subject with a history of bleeding disorders, anticoagulation therapy that cannot be stopped as prior to infusion.
- Active listing (or expected future listing) for transplant of any organ.
- Be a solid organ transplant recipient. This does not include prior cell-based therapy (>12 months prior to enrollment), bone, skin, ligament, tendon or corneal grafting. Have a history of organ or cell transplant rejection.
- History of drug abuse (illegal "street" drugs) except noninhalation use of marijuana (If it is legal use in states where patient resides), or prescription medications not being used appropriately for a pre-existing medical condition or alcohol abuse (≥ 5 drinks/day for ˃ 3 months), or documented medical, occupational, or legal problems arising from the use of alcohol or drugs withinthe past 24 months. Use of inhalation marijuana will be an exclusion criterion.
- Subject with untreated HIV infection. However, patients can be enrolled if they have been treated for HIV and test negative for HIV viral load but still test positive for antibodies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion (IV) of ZofinTM for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
A Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion (IV) of Zofin for the Treatment of Chronic Obstructive Pulmonary Disease (COPD).
Read the detailed description
Total of 20 adult patients will be chosen from population of adults between the age of 40 to 80 diagnosed with COPD to be randomized to 1 of 2 treatment arms including IV infusion of Zofin or IV infusion on sterile saline.
The subjects will be followed for 12 months to demonstrate safety and efficacy of Zofin.
- Conditions
- COPD
- Being tested
- Zofin, Placebo
- Keywords
- Zofin, Human Amniotic Fluid
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZofinDrug
Intravenous Infusion (IV) of Zofin
PlaceboOther
Intravenous Infusion of sterile saline
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Zofin | Experimental | Group 1 Treatment Arm (10 subjects): Zofin + Standard of care (SOC) Ten subjects will receive 1 mL of Zofin on Day 0, Day 4, and Day 8, containing 1-5 x 10^11 particles/ml. The Zofin dose will be diluted in 100 mL of sterile saline at subject's bedside. In addition to Zofin all subjects in this trial will receive SOC throughout the study period. Receives: Drug: Zofin |
| Group 2: Placebo | Placebo comparator | Group 2 Control Arm (10 subjects): Placebo + SOC Ten subjects will receive placebo on Day 0, Day 4, and Day 8, containing 101 mL of sterile saline at subject's bedside. In addition to placebo all subjects in this trial will receive SOC throughout the study period. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Zofin
To demonstrate the safety of Zofin administered intravenously in subjects with COPD by measuring incidence of any of the following treatment-emergent serious adverse events (TE-SAEs) within the first 30 days of infusion:
- Life-threatening event (e.g., stroke or non-fatal pulmonary embolism).
- Event requiring inpatient hospitalization or prolongation of existing hospitalization (e.g., for worsening dyspnea).
- Event resulting in persistent or significant disability/incapacity.
- Event resulting in death. Frequency and severity of any adverse events from Day 0 (day of treatment) up to 12 months of treatment will similarly be observed.
Measured: first 30 days
Safety of Zofin
To monitor the frequency and severity of adverse events
Measured: day 0 to 12 months
Secondary outcomes (19)
FVC
FVC from resting PFT
Measured: Screen, day 4, day 8, 4 months, 8 months and 12 months
FEV1
FEV1 from resting PFT
Measured: Screen, day 4, day 8, 4 months, 8 months and 12 months
FEV1 to FVC ratio
FEV1 to FVC ratio on resting pulmonary function test
Measured: Screen, day 4, day 8, 4 months, 8 months and 12 months
FEF25-75
FEF25-75 on resting pulmonary function test
Measured: Screen, day 4, day 8, 4 months, 8 months and 12 months
Lung Volume Changes
Change in lung volumes (in body plethysmograph), including SGAW (specific airway conductance) and RV (to calculate gas trapping)
Measured: Screen, day 4, day 8, 4 months, 8 months and 12 months
DLCO
Change in single breath diffusing capacity of lung for carbon monoxide (DLCO)
Measured: Screen, day 4, day 8, 4 months, 8 months and 12 months
HU of CT Scan
Change in the average of Hounsfield Unit (HU) - a relative quantitative measurement of radio density in CT images.
Measured: Screen and 12 months
% air in lung on CT Scan
Change in the percentage of air in the lung
Measured: Screen and 12 months
CPET
Cardiopulmonary Exercise Testing (CPET) with peak VO2 and measures of dynamic hyperinflation
Measured: Screen, 4 months, and 12 months
Peak VO2
Cardiopulmonary Exercise Testing (CPET) with peak VO2
Measured: Screen, 4 months, and 12 months
Dynamic Hyperinflation
Cardiopulmonary Exercise Testing (CPET) with measures of dynamic hyperinflation
Measured: Screen, 4 months, and 12 months
Pulmonary Exacerbation
Incidence of investigator-defined pulmonary exacerbation: decrease in exacerbation-related hospitalization
Measured: Screening through 12 months
TNF-α
Change in serum inflammatory markers: TNF-α
Measured: Day 0, Day14, 4 months, 8 months, and 12 months
CRP
Change in serum inflammatory markers: CRP
Measured: Day 0, Day14, 4 months, 8 months, and 12 months
IL-1
Change in serum inflammatory markers: IL-1
Measured: Day 0, Day14, 4 months, 8 months, and 12 months
D-Dimer
Change in serum inflammatory markers: D-dimer
Measured: Day 0, Day14, 4 months, 8 months, and 12 months
Fibrinogen
Change in serum inflammatory markers: Fibrinogen
Measured: Day 0, Day14, 4 months, 8 months, and 12 months
SF-36 ot SGRQ
Change in SF-36 questionnaire or St. George's Respiratory Questionnaire (SGRQ)
Measured: Screen, 14 days, 1.5 months, 4 months, 8 months, and 12 months
CAT Assessment
Change in quality of life (QOL) assessments via COPD Assessment Test (CAT)
Measured: Screen, 14 days, 1.5 months, 4 months, 8 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start15 Nov 2023 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Why it stopped: Study is on hold
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a phase I/II randomized, double blinded and placebo control. The ratio between groups is 1:1 for total 20 subjects. Each subject will be randomized to receive either treatment or placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ZEO ScientifiX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natasha Phrsai, Study director, Proxima Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643729
- Sponsor's protocol ID
- 27198
- Status last verified
- Oct 2022
- First submitted
- 1 Nov 2022
- Last updated
- 1 Nov 2023
- 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 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion (IV) of ZofinTM for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT05643729
- Acronym / sponsor ID
- 27198
- Conditions
- COPD
- Keywords
- Zofin, Human Amniotic Fluid
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study is on hold
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ZEO ScientifiX, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2023 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 9 Dec 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.
A Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion (IV) of Zofin for the Treatment of Chronic Obstructive Pulmonary Disease (COPD).
Detailed description
Total of 20 adult patients will be chosen from population of adults between the age of 40 to 80 diagnosed with COPD to be randomized to 1 of 2 treatment arms including IV infusion of Zofin or IV infusion on sterile saline.
The subjects will be followed for 12 months to demonstrate safety and efficacy of Zofin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a phase I/II randomized, double blinded and placebo control. The ratio between groups is 1:1 for total 20 subjects. Each subject will be randomized to receive either treatment or placebo.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Zofin | Experimental | Drug: ZofinGroup 1 Treatment Arm (10 subjects): Zofin + Standard of care (SOC) Ten subjects will receive 1 mL of Zofin on Day 0, Day 4, and Day 8, containing 1-5 x 10^11 particles/ml. The Zofin dose will be diluted in 100 mL of sterile saline at subject's bedside. In addition to Zofin all subjects in this trial will receive SOC throughout the study period. |
| Group 2: Placebo | Placebo comparator | Other: PlaceboGroup 2 Control Arm (10 subjects): Placebo + SOC Ten subjects will receive placebo on Day 0, Day 4, and Day 8, containing 101 mL of sterile saline at subject's bedside. In addition to placebo all subjects in this trial will receive SOC throughout the study period. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject who can understand and are able to provide informed consent.
- Subject with moderate to severe COPD with normal cardiac, liver and renal function
- Subject must have a post-bronchodilator FEV1/FVC ratio of less than 0.7
- Subject must have a post-bronchodilator FEV1 percent predicted value <50%
- Subject must have a RV/TLC ratio of > 40%
Key exclusion criteria (22 listed)
- Subject with clinically significant illness with manifestations of significant organ dysfunction which in the judgment of the PI or co-investigator would render the study subject unlikely to tolerate the infusion or complete the study
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 |
|---|---|---|
| ZofinIntravenous Infusion (IV) of Zofin | Drug | Group 1: Zofin |
| PlaceboIntravenous Infusion of sterile saline | Other | Group 2: Placebo |
Primary outcome
Safety of Zofin
Time frame: first 30 days
To demonstrate the safety of Zofin administered intravenously in subjects with COPD by measuring incidence of any of the following treatment-emergent serious adverse events (TE-SAEs) within the first 30 days of infusion: * Life-threatening event (e.g., stroke or non-fatal pulmonary embolism). * Event requiring inpatient hospitalization or prolongation of existing hospitalization (e.g., for worsening dyspnea). * Event resulting in persistent or significant disability/incapacity. * Event resulting in death. Frequency and severity of any adverse events from Day 0 (day of treatment) up to 12 months of treatment will similarly be observed.
Safety of Zofin
Time frame: day 0 to 12 months
To monitor the frequency and severity of adverse events
19 secondary outcomes
FVC
Time frame: Screen, day 4, day 8, 4 months, 8 months and 12 months
FEV1
Time frame: Screen, day 4, day 8, 4 months, 8 months and 12 months
FEV1 to FVC ratio
Time frame: Screen, day 4, day 8, 4 months, 8 months and 12 months
FEF25-75
Time frame: Screen, day 4, day 8, 4 months, 8 months and 12 months
Lung Volume Changes
Time frame: Screen, day 4, day 8, 4 months, 8 months and 12 months
DLCO
Time frame: Screen, day 4, day 8, 4 months, 8 months and 12 months
HU of CT Scan
Time frame: Screen and 12 months
% air in lung on CT Scan
Time frame: Screen and 12 months
CPET
Time frame: Screen, 4 months, and 12 months
Peak VO2
Time frame: Screen, 4 months, and 12 months
Dynamic Hyperinflation
Time frame: Screen, 4 months, and 12 months
Pulmonary Exacerbation
Time frame: Screening through 12 months
TNF-α
Time frame: Day 0, Day14, 4 months, 8 months, and 12 months
CRP
Time frame: Day 0, Day14, 4 months, 8 months, and 12 months
IL-1
Time frame: Day 0, Day14, 4 months, 8 months, and 12 months
D-Dimer
Time frame: Day 0, Day14, 4 months, 8 months, and 12 months
Fibrinogen
Time frame: Day 0, Day14, 4 months, 8 months, and 12 months
SF-36 ot SGRQ
Time frame: Screen, 14 days, 1.5 months, 4 months, 8 months, and 12 months
CAT Assessment
Time frame: Screen, 14 days, 1.5 months, 4 months, 8 months, and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- 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.
Natasha Phrsai study director
Proxima Health, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Zofin in people with COPD, run by ZEO ScientifiX, Inc. at 1 site in United States.
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 13 inclusion and 22 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: paused, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Safety of Zofin (time frame: first 30 days). The study lists 2 primary outcomes in all. 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 1 Nov 2023.