Zofin to Treat Chronic Obstructive Pulmonary Disease (COPD)
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ClinicalTrials.gov Identifier: NCT05643729 |
Recruitment Status :
Suspended
(Study is on hold)
First Posted : December 9, 2022
Last Update Posted : November 1, 2023
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Sponsor:
ZEO ScientifiX, Inc.
Information provided by (Responsible Party):
ZEO ScientifiX, Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | November 1, 2022 | ||||
First Posted Date ICMJE | December 9, 2022 | ||||
Last Update Posted Date | November 1, 2023 | ||||
Estimated Study Start Date ICMJE | November 15, 2023 | ||||
Estimated Primary Completion Date | May 30, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Zofin to Treat Chronic Obstructive Pulmonary Disease (COPD) | ||||
Official Title ICMJE | 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) | ||||
Brief 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). | ||||
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention 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 (Participant, Care Provider, Investigator)Masking Description: The study will be double blinded such that neither the patients nor the researchers will know who is getting a placebo and who is getting the treatment. Only product manufacturing staff will be un-blinded. Primary Purpose: Treatment
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Condition ICMJE | COPD | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Suspended | ||||
Estimated Enrollment ICMJE |
20 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | August 31, 2024 | ||||
Estimated Primary Completion Date | May 30, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 40 Years to 80 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05643729 | ||||
Other Study ID Numbers ICMJE | 27198 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | ZEO ScientifiX, Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | ZEO ScientifiX, Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | ZEO ScientifiX, Inc. | ||||
Verification Date | October 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |