Back to resultsSafety and Effectiveness of EV-Pure + WJ-Pure Treatment on Pulmonary Fibrosis Secondary to Covid-19
Primary Purpose
Pulmonary Fibrosis, COVID-19 Respiratory Infection
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EV-Pure™ and WJ-Pure™ plus standard care
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Fibrosis
Eligibility Criteria
Inclusion Criteria:
Subjects will be eligible for enrollment in the study only if they meet the following criteria:
- Male or female, aged between 25 years (including) to 90 years old
- Confirmed and documented COVID-19 infection history with confirmed diagnosis of Pulmonary Fibrosis
- Negative to current Covid-19 infection as tested by RT-PCR tests
- Able to perform a 6-minute walk test
Blood routine, liver and kidney functions test values are within controllable range
- Adequate hepatic function as evidenced by ALT, AST and LDH < 2X ULN and bilirubin < 1.5X ULN for the reference lab
- Adequate renal function as evidenced by a serum creatinine ≤ 1.5 X ULN for the reference laboratory OR a calculated creatinine clearance of ≥ 60 mL/min by the Cockcroft-Gault Equation
- Adequate hematopoietic function as evidenced by white blood cells ≥ 3x109 / L and platelets ≥ 100x109 / L
- If childbearing age: agree to practice effective birth control from screening until 12 weeks after the last study treatment.
Exclusion Criteria:
Subjects will be ineligible for enrollment in the study if they meet any of the following criteria:
- Clinically relevant heart condition such as, but not limited to, uncontrolled heart failure, severe pulmonary hypertension, atrial fibrillation or significant congenital heart disease
- Severe asthma on chronic therapy with biologics or steroids
- Active smokers as defined as individuals who currently smokes at least one cigarette or equivalent product a day. (Ex-smokers who had regularly smoked but who had not smoked the previous month are eligible)
- Evidence of active malignancy, or prior history of active malignancy not in remission.
- Life expectancy of < 6 months
- Patient included in another ongoing interventional therapeutic trial.
- Pregnant or Lactating.
- Serious or life-threatening co-morbidities, that in the opinion of the investigators, may compromise the safety or compliance with the study guidelines and tracking.
Sites / Locations
- Kit BartalosRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental/treatment arm
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Evaluate incidences of Treatment-Emergent Adverse Events following following EV-Pure™ and WJ-Pure™ administeration to patients exhibiting Covid induced Pulmonary Fibrosis.
Presence of adverse events in less than 10% of the study population, as a measure of safety
To evaluate the efficacy of EV-Pure™ and WJ-Pure™ administration in alleviating long term symptoms of Covid induced Pulmonary Fibrosis, compared to placebo
Change in distance walked on the six-minute walk test (6MWT). The 6MWT is a validated endpoint commonly used in clinical trial research.
Secondary Outcome Measures
Change in Pulse Oximetry at Rest and During the 6MWT
Oxygen saturation (pulse oximetry) at rest and during the 6-minute walk test (6MWT)
Incidence of Re-Hospitalization
Incidence of hospitalization after initial discharge and initiating treatment
Quality of Life assessment as collected using the SF-36
The SF-36 (v2) is a self-administered questionnaire containing 36 items that measures functional status, well-being, and overall evaluation of health in 8 domains.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05387239
Brief Title
Safety and Effectiveness of EV-Pure + WJ-Pure Treatment on Pulmonary Fibrosis Secondary to Covid-19
Official Title
Safety and Effectiveness of EV-Pure + WJ-Pure Treatment on Pulmonary Fibrosis Secondary to Covid-19
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2022 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vitti Labs, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The COVID-induced fibrotic lung damage continues long after viral infection has subsided and is exhibited by severe respiratory pathology and concomitant symptoms. The long-lasting sequelae in patients who have recovered from severe COVID indicate that there is a 30% chance of developing a persistent respiratory system pathology and a 10% chance of developing a severe pathology. The symptoms of lung fibrosis include a severe disruption of respiration, reduction of exercise tolerance, and concomitant development of persistent fibrotic lung damage. This study intends to evaluate benefits of a combination of WJPure and EVPure in Covid-19 patients exhibiting pulmonary fibrosis.
Detailed Description
Multiple clinical trials are underway to explore options for treatment of pulmonary fibrosis in patients with history of COVID. Mesenchymal stem cell (MSC)-based therapies have been used worldwide for various pulmonary diseases. A recent review of over 110 reports of clinical trials worldwide with MSC-based therapies in pulmonary diseases found that these therapies have been reported to be safe and effective in the treatment of acute/viral pulmonary disease, community-acquired pneumonia (CAP), chronic obstructive pulmonary disease (COPD), bronchopulmonary dysplasia (BPD), interstitial lung diseases (ILD), chronic pulmonary fibrosis, bronchiolitis obliterans syndrome (BOS) and lung cancer. A phase 2 clinical trial in 101 severe Covid-19 patients with lung damage using human umbilical cord derived MSCs found that the treatment exerted numerical improvement in whole lung lesion volume and the 6-minute walk test from baseline to day 28 compared with the placebo.
This proof of concept, double-blind, placebo-controlled trial will evaluate the safety and efficacy of intravenous infusion of EV-Pure™ and WJ-Pure™, versus placebo, for use in the treatment of Covid induced Pulmonary Fibrosis. This is an add-on treatment study; subjects will be allowed to take standard of care treatments available.
The study will have two arms (n=10 each):
Experimental/treatment arm: EV-Pure™ and WJ-Pure™ plus standard care
Placebo: Saline plus standard care
The study duration would be 5 days of treatment plus 12 weeks follow up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Fibrosis, COVID-19 Respiratory Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental/treatment arm
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
EV-Pure™ and WJ-Pure™ plus standard care
Intervention Description
The treatment consists of administration of WJ-Pure™ and EV-Pure™ plus standard care
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Saline plus standard care
Primary Outcome Measure Information:
Title
Evaluate incidences of Treatment-Emergent Adverse Events following following EV-Pure™ and WJ-Pure™ administeration to patients exhibiting Covid induced Pulmonary Fibrosis.
Description
Presence of adverse events in less than 10% of the study population, as a measure of safety
Time Frame
3 months
Title
To evaluate the efficacy of EV-Pure™ and WJ-Pure™ administration in alleviating long term symptoms of Covid induced Pulmonary Fibrosis, compared to placebo
Description
Change in distance walked on the six-minute walk test (6MWT). The 6MWT is a validated endpoint commonly used in clinical trial research.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in Pulse Oximetry at Rest and During the 6MWT
Description
Oxygen saturation (pulse oximetry) at rest and during the 6-minute walk test (6MWT)
Time Frame
3 months
Title
Incidence of Re-Hospitalization
Description
Incidence of hospitalization after initial discharge and initiating treatment
Time Frame
3 months
Title
Quality of Life assessment as collected using the SF-36
Description
The SF-36 (v2) is a self-administered questionnaire containing 36 items that measures functional status, well-being, and overall evaluation of health in 8 domains.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects will be eligible for enrollment in the study only if they meet the following criteria:
Male or female, aged between 25 years (including) to 90 years old
Confirmed and documented COVID-19 infection history with confirmed diagnosis of Pulmonary Fibrosis
Negative to current Covid-19 infection as tested by RT-PCR tests
Able to perform a 6-minute walk test
Blood routine, liver and kidney functions test values are within controllable range
Adequate hepatic function as evidenced by ALT, AST and LDH < 2X ULN and bilirubin < 1.5X ULN for the reference lab
Adequate renal function as evidenced by a serum creatinine ≤ 1.5 X ULN for the reference laboratory OR a calculated creatinine clearance of ≥ 60 mL/min by the Cockcroft-Gault Equation
Adequate hematopoietic function as evidenced by white blood cells ≥ 3x109 / L and platelets ≥ 100x109 / L
If childbearing age: agree to practice effective birth control from screening until 12 weeks after the last study treatment.
Exclusion Criteria:
Subjects will be ineligible for enrollment in the study if they meet any of the following criteria:
Clinically relevant heart condition such as, but not limited to, uncontrolled heart failure, severe pulmonary hypertension, atrial fibrillation or significant congenital heart disease
Severe asthma on chronic therapy with biologics or steroids
Active smokers as defined as individuals who currently smokes at least one cigarette or equivalent product a day. (Ex-smokers who had regularly smoked but who had not smoked the previous month are eligible)
Evidence of active malignancy, or prior history of active malignancy not in remission.
Life expectancy of < 6 months
Patient included in another ongoing interventional therapeutic trial.
Pregnant or Lactating.
Serious or life-threatening co-morbidities, that in the opinion of the investigators, may compromise the safety or compliance with the study guidelines and tracking.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mukesh Kumar
Phone
2407504893
Email
mkumar@fdamap.com
Facility Information:
Facility Name
Kit Bartalos
City
Liberty
State/Province
Missouri
ZIP/Postal Code
64068
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kit Bartalos, DO
12. IPD Sharing Statement
Learn more about this trial
Safety and Effectiveness of EV-Pure + WJ-Pure Treatment on Pulmonary Fibrosis Secondary to Covid-19
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