Status:
SUSPENDED
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)
Lead Sponsor:
Vitti Labs, LLC
Conditions:
COVID-19 Acute Respiratory Distress Syndrome
Respiratory Distress Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 i...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Pregnant or Lactating.
- Any condition of unsuitable for the study determined by Principal Investigator (PI).
Key Trial Info
Start Date :
March 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05387278
Start Date
March 20 2025
End Date
December 1 2025
Last Update
September 19 2024
Active Locations (1)
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1
Kit Bartalos
Liberty, Missouri, United States, 64068