Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05387278
Other study ID # EW-01
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date March 20, 2023
Est. completion date December 2023

Study information

Verified date October 2022
Source Vitti Labs, LLC
Contact Mukesh Kumar
Phone 2407504893
Email mkumar@fdamap.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Recent advances have been made in prevention of the viral infection via vaccines but there is still need for effective treatment options for patients. Novel therapies need to be developed to further improve clinical outcomes. The biggest medical challenge in the response to COVID-19 is ARDS requiring hospitalization in an intensive care setting and ventilator dependence. Intravenously administered umbilical cord derived exosomes and stem cells have been reported in literature to alleviate pulmonary distress in such patients. The purpose of this study is to explore the safety and benefits of intravenous administration of WJPure and EVPure in the treatment of COVID-19 patients with moderate to severe ARDS. .


Description:

One of the hallmark features of the progression of COVID-19 is lung injury from the viral infection leading to potentially acute respiratory distress syndrome (ARDS) and respiratory failure requiring ventilator support. In patients who survive ARDS, regardless of the pathology, there is evidence that their long-term quality of life is adversely affected. The rationale for the dose and dosing regimen proposed in this study is based on the safe administration and benefits of this treatment regimen reported to us last year by physicians trying to treat moderate to severe COVID-19 patients. In those reports, the intravenous route of administration was used. It has been reported that dosing every 2 days amplified the benefit of the combination of exosomes and mesenchymal stem cells. It has been suggested based on clinical experience that the exosomes and MSCs are complementary to one another as well as enhancing the innate abilities of both. During the early days of the pandemic, intravenous infusion of a mixture of EV-Pure™ and WJ-Pure™ was reported to benefit hospitalized patients with moderate to severe COVID-19 related ARDS. This study is designed to systematically explore the risk and benefits of intravenous infusion of EV-Pure™ and WJ-Pure™ in the treatment of hospitalized COVID-19 patients with moderate to severe ARDS. This is a proof of concept, double-blind, placebo-controlled trial to evaluate the safety and efficacy of intravenous infusion of EV-Pure™ and WJ-Pure™, versus placebo, for use in the treatment of moderate to severe ARDS related to COVID-19. 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): 1. Experimental/treatment arm: EV-Pure™ and WJ-Pure™ plus standard care 2. Placebo: Cryopreservation media plus standard care The study duration would be 5 days of treatment plus 12 weeks follow up.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 2023
Est. primary completion date October 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Subjects will be eligible for enrollment in the study only if they meet the following criteria: 1. Male or female, aged at 18 years (including) to 75 years old. 2. Patient with a confirmed SARS-CoV-2 infection (by positive reverse-transcription polymerase chain reaction (RT-PCR) from nasopharyngeal sample or any other sample) 3. Hospitalized with moderate to severe ARDS. 4. Have ARDS or acute lung injury, comply with any of the following: i. Respiratory distress, Respiratory rate (RR) = 30 times/min ii. Pulse oxygen saturation (SpO2) at rest = 93% iii. Partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) = 300mmHg 5. 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: 1. Patient under invasive mechanical ventilation for more than 48 hours 2. Allergic or hypersensitive to any of the ingredients. 3. Pneumonia caused by bacteria, mycoplasma, chlamydia, legionella, fungi or other viruses. 4. Obstructive HABP/VABP induced by lung cancer or other known causes. 5. Carcinoid syndrome. 6. History of long-term use of immunosuppressive agents. 7. History of Class III or IV pulmonary arterial hypertension. 8. Patient with chronic respiratory disease under oxygen therapy. 9. Undergoing hemodialysis or peritoneal dialysis. 10. Estimated or actual rate of creatinine clearance < 15 mL/min. 11. History of moderate and severe liver disease (Child-Pugh score >12). 12. History of deep venous thrombosis or pulmonary embolism within the last 3 years. 13. Undergoing extracorporeal membrane oxygenation (ECMO) or high-frequency oscillatory ventilation support. 14. Patient included in another ongoing interventional therapeutic trial. 15. Pregnant or Lactating. 16. Any condition of unsuitable for the study determined by Principal Investigator (PI).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
EV-Pure™ and WJ-Pure™
The treatment consists of administration of WJ-Pure™ and EV-Pure™ plus standard care
Placebo
Cryopreservation media plus standard care

Locations

Country Name City State
United States Kit Bartalos Liberty Missouri

Sponsors (1)

Lead Sponsor Collaborator
Vitti Labs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To Assess the safety of EV-Pure™ and WJ-Pure™ administration in patients exhibiting moderate to severe ARDS associated with COVID-19, compared to placebo. Evaluate incidences of Treatment-Emergent Adverse Events following EV-Pure™ and WJ-Pure™ administeration in patients exhibiting moderate to severe ARDS associated with COVID-19 compared to placebo. Presence of adverse events in less than 10% of the study population, as a measure of safety 3 months
Primary To assess the efficacy of EV-Pure™ and WJ-Pure™ compared to placebo, in patients with moderate to severe ARDS assoociated with COVID-19 Clinical data will be evaluated to determine if there were any significant changes in the COVID-19 symptoms in patients in the treated versus placebo groups. The following information will be collected to evaluate the effectiveness of the treatment at 4 weeks post- treatment:
Discharged home on no supplemental oxygen
Discharged home on supplemental oxygen
Continued hospitalization on no oxygen
Continued hospitalization on oxygen but not in ICU
Continued hospitalization on oxygen in ICU (invasive and noninvasive ventilatory support)
Death
3 Months
Secondary Time to clinical improvement The following information will be collected from the subjects during the follow-up visits or calls:
Medical history review
Physical exam and vital signs
Assessment for delayed adverse reactions
3 months
Secondary Overall Survival Survival of the subjects in the 2 arms of the study 3 months
Secondary COVID-19 polymerase chain reaction (PCR) test result as negative COVID-19 polymerase chain reaction (PCR) test result as negative in the subjects in the 2 arms of the study 3 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06168149 - The Relationship of Fetal Lung Elastography Values With the Development of Respiratory Distress in Cases of Preterm Labor
Recruiting NCT03670732 - CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure N/A
Recruiting NCT02901652 - NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome N/A
Completed NCT02249143 - Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants N/A
Suspended NCT01852916 - NHFOV Versus NCPAP to Prevent Exubation Failure N/A
Completed NCT00208039 - Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates N/A
Recruiting NCT03510169 - Use of Gentle Synchronized Negative Pressure in Helping Babies Breathe N/A
Completed NCT00004494 - Phase I Study of Vasoactive Intestinal Peptide in Patients With Acute Respiratory Distress Syndrome and Sepsis Phase 1
Completed NCT00006058 - Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns N/A
Completed NCT00004805 - Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents With Infants at Risk of Sudden Death N/A
Completed NCT03292562 - A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation N/A
Completed NCT05948332 - Definition and Management of Right Ventricular Injury in Adult Patients Receiving Extracorporeal Membrane Oxygenation
Completed NCT05038514 - The Effect of Music Therapy in COVID-19 Patients Given Prone Position N/A
Active, not recruiting NCT04079829 - Postoperative Respiratory Abnormalities
Completed NCT05462509 - Feasibility of Use of the PATH bCPAP and Oxygen Blenders Device With Neonates in Uganda N/A
Active, not recruiting NCT03808402 - The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS
Completed NCT01812681 - Cord Blood 25(oh)-Vitamin D Level in Preterm Infants and Associated Morbidities N/A
Completed NCT01517958 - Lung Ultrasound to Diagnose Transient Tachypnea of the Newborn (TTN) Versus Respiratory Distress Syndrome (RDS) in Neonates N/A
Not yet recruiting NCT01440868 - Sustained Lung Inflation in the Delivery Room in Preterm Infants at High Risk of Respiratory Distress Syndrome N/A
Completed NCT01222247 - Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial Phase 3