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Bone Marrow Mesenchymal Stem Cell for COVID-19 related ARDS

Alpesh Amin


A Study On:

  • Other

Status:

Interested in joining this trial?

Official Title

Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles as Early Goal Directed Therapy for COVID-19 Moderate-to-Severe Acute Respiratory Distress Syndrome (ARDS): A Phase III Clinical Trial


Eligibility

You can join if...

Inclusion Criteria

To be eligible to participate in this study, a patient must meet all of the following criteria:

  1. Admitted to hospital with symptoms suggestive of COVID-19 infection.
  2. Subject (or legally authorized representative) provides informed consent prior to the
    initiation of any study procedures.
  3. Subject (or legally authorized representative) understands and agrees to comply with
    planned study procedures.
  4. Male or nonpregnant female aged 18-85 of age at time of enrollment.
  5. Women of childbearing potential must agree to either abstinence or use at least one primary
    form of contraception not including hormonal contraception from time of screening
    through Day 61.
  6. Meets criteria for either severe or critical COVID-19 as evidenced by
    a. Severe COVID-19:
    i. SARS-CoV-2 PCR positive in sample collected within one week prior to
    randomization
    ii. Severe symptoms suggestive of severe systemic illness with COVID-19,
    which could include any symptom of moderate illness or shortness of breath
    at rest, or respiratory distress
    iii. Clinical signs indicative of severe systemic illness with COVID-19, such as
    respiratory rate ≥ 30 per minute, heart rate ≥ 125 per minute, SpO2 ≤ 93%
    on room air at sea level
    b. Critical COVID-19:
    i. SARS-CoV-2 PCR positive in sample collected within one week prior to
    randomization
    ii. Evidence of critical illness, defined by at least one of the following:
  7. Respiratory failure defined based on resource utilization requiring
    at least one of the following:
    Endotracheal intubation and mechanical ventilation, oxygen
    delivery by high flow nasal cannula (heated, humidified, oxygen
    delivered via reinforced nasal cannula at flow rates > 20 L/min with
    fraction of delivered oxygen ≥ 0.5), oxygen delivery by high flow
    nasal cannula (heated, humidified, oxygen delivered via reinforced
    nasal cannula at flow rates > 20 L/min with fraction of delivered
    oxygen ≥ 0.5), noninvasive positive pressure ventilation, or clinical
    diagnosis of respiratory failure (i.e. clinical need for one of the
    preceding therapies, but preceding therapies not able to be
    administered in setting of resource limitation).
  8. Shock (defined by systolic blood pressure < 90 mmHg, or diastolic
    blood pressure 60 mmHg or requiring pressors)
  9. Multi-organ dysfunction/failure
  10. PaO2/FiO2 (P/F ratio) ≤ 200.
    Note for Inclusion Criterion #7:
    • PaO2 will be obtained from ABG.
    • FiO2 may be obtained from the setting on MV, CPAP, BIPAP, HFNO, or HFOV. If the
    patient is on RA, NC, FM, or NRB, Appendix Section 10.3 will be used for estimating
    FiO2 from oxygen delivery.
    5.2 Exclusion Criteria
    Any individual who meets any of the following criteria will be excluded from participation in this
    study:
  11. Active malignancy requiring treatment within the last five years.
  12. Any uncontrolled chronic respiratory disease, such as asthma or COPD.
  13. Use of extracorporeal membrane oxygenation (ECMO) during the current hospitalization.
  14. ALT or AST > 5 x Upper Limit of Normal (ULN).
  15. Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min.
  16. Overt Disseminated Intravascular Coagulopathy (DIC) as evidenced by a total score of ≥
    5 on the following DIC score from International Society of Thrombosis & Hemostasis:
    • INR ≤ 1.3 (0 Points); 1.3- 1.7 (1 Point); > 1.7 (2 Points)
    • Fibrinogen > 100 mg/dL (0 Points); < 100 mg/dL (1 Point)
    • D-dimer < 400 ng/dL (0 Points); 400-4000 ng/mL (2 Points); >4,000 ng/ml (3 Points)
    • Platelets > 100,000/uL (0 Points); 50,000-100,000/uL (1 Point); < 50,000/uL (2 Points)
  17. Pneumonia that is primarily attributable to a non-COVID-19 related process, including
    tuberculosis, mycoplasma, aspiration pneumonia or pneumonia that is exclusively bacterial,
    or originating from a diagnosed alternative virus (e.g., influenza).
  18. DNR order, as in

Get in touch with our study team