Safety and Effectiveness of Placental Derived Exosomes and Umbilical Cord Mesenchymal Stem Cells in Moderate to Severe Acute Respiratory Distress Syndrome (ARDS) Associated With the Novel Corona Virus Infection (COVID-19)

NCT05387278 | Suspended Phase 1 FDA Drug

• 1 other identifier: EW-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. .

Conditions

COVID-19 Acute Respiratory Distress Syndrome; Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

• 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: 1. Discharged home on no supplemental oxygen 2. Discharged home on supplemental oxygen 3. Continued hospitalization on no oxygen 4. Continued hospitalization on oxygen but not in ICU 5. Continued hospitalization on oxygen in ICU (invasive and noninvasive ventilatory support) 6. Death

  3 Months

Secondary Outcomes (3)

• Time to clinical improvement

  3 months

• Overall Survival

  3 months

• COVID-19 polymerase chain reaction (PCR) test result as negative

  3 months

Study Arms (2)

Experimental/treatment arm

EXPERIMENTAL

Drug: EV-Pure™ and WJ-Pure™

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

EV-Pure™ and WJ-Pure™ DRUG

The treatment consists of administration of WJ-Pure™ and EV-Pure™ plus standard care

Experimental/treatment arm

Placebo DRUG

Cryopreservation media plus standard care

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be eligible for enrollment in the study only if they meet the following criteria:
• Male or female, aged at 18 years (including) to 75 years old.
• Patient with a confirmed SARS-CoV-2 infection (by positive reverse-transcription polymerase chain reaction (RT-PCR) from nasopharyngeal sample or any other sample)
• Hospitalized with moderate to severe ARDS.
• 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
• If childbearing age: agree to practice effective birth control from screening until 12 weeks after the last study treatment.

You may not qualify if:

• Subjects will be ineligible for enrollment in the study if they meet any of the following criteria:
• Patient under invasive mechanical ventilation for more than 48 hours
• Allergic or hypersensitive to any of the ingredients.
• Pneumonia caused by bacteria, mycoplasma, chlamydia, legionella, fungi or other viruses.
• Obstructive HABP/VABP induced by lung cancer or other known causes.
• Carcinoid syndrome.
• History of long-term use of immunosuppressive agents.
• History of Class III or IV pulmonary arterial hypertension.
• Patient with chronic respiratory disease under oxygen therapy.
• Undergoing hemodialysis or peritoneal dialysis.
• Estimated or actual rate of creatinine clearance \< 15 mL/min.
• History of moderate and severe liver disease (Child-Pugh score \>12).
• History of deep venous thrombosis or pulmonary embolism within the last 3 years.
• Undergoing extracorporeal membrane oxygenation (ECMO) or high-frequency oscillatory ventilation support.
• Patient included in another ongoing interventional therapeutic trial.

Sponsors & Collaborators

• Vitti Labs, LLC: lead

Study Sites (1)

Kit Bartalos

Liberty, Missouri, 64068, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 24, 2022
• Study Start: March 20, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)