COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04466098

David Ingbar, MD

ingba001@umn.edu

2020-07-10

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: - age 18-80 years - meets 'berlin criteria' for diagnosis of moderate to severe ards for a minimum of 4 hours - less than 48 hours on a ventilator after meeting criteria for diagnosis of ards - sars-cov-2 (proven by rt-pcr assay) with radiographic infiltrates - pao2/fio2 < 250 - positive end-expiratory airway pressure (peep) >5 cm h20 - elevated c-reactive protein (above laboratory upper limit of normal) - meets organ function requirements, including left ventricular ejection fraction (lvef) >35% ( as defined below) - off other investigational agents directed against inflammatory cytokines 48 hours prior to enrollment; agents directed against the replication of sars-cov-2 [e.g., remdesivir] are permitted - voluntary informed consent in person or virtually by the patient or patient surrogate considering the face to face limitations during the covid-19 pandemic and, given the nature of the study population, which frequently requires mechanical ventilation with sedation, surrogate consent will likely occur in a substantial proportion of the study population (this will remain a valid consent until the patient is fully alert, and aware, and can provide a second consent to continue participation in the study). - adequate organ function is defined as: - renal: calculated estimated glomerular filtration rate >30 ml/min/1.73 m2 (on chemistry panel) - hepatic: bilirubin <3x upper limit of normal (uln) and ast, alt and alkaline phosphatase <5x uln - cardiac: absence of uncontrolled arrhythmia and lvef >35%

- ventilator support of fio2 >0·8 or peep >20 cm h2o and ongoing use of more than two vasopressors for 2 or more hours with any agent at doses shown below in the supine position. - norepinephrine >12 μg/min or 0.2 μg/kg per min - phenylephrine >150 μg/min or 3 μg/kg per min - epinephrine >10 ug/min or 0.2 μg/kg per min - vasopressin >0.04 units/min - concurrent use of other investigational agents specifically for treatment of ards or inflammatory cytokines. (note: agents established to be efficacious and/or those used outside of formal trials are permitted as supportive data emerge) - known ineligibility for use of a ventilator for a minimum of 7 days, as judged by the institution's triage team - known allergy to msc components: fetal calf serum, human albumin or dmso - active invasive malignant disease requiring chemotherapy/radiation - other concurrent life-threatening disease (life expectancy <6 months) or eligible for hospice care - known history of hiv infection on active treatment - females who are pregnant or breastfeeding - current mean arterial pressure (map) <60 mmhg while on 2 or more vasopressors at above doses for more than 2 hours - history of any significant cardiac (myocardial infarction within 12 months of screening visit or unstable angina), chronic ongoing hepatic, or renal disease (grade 3 or higher); diagnosis of congestive heart failure with hypoxemia primarily due to decompensated heart failure; diagnosis of severe chronic obstructive pulmonary disease (copd) or interstitial lung disease requiring supplemental oxygen at home - concurrent diagnosis of diffuse alveolar hemorrhage - requiring continuous dialysis (unable to stop dialysis during study agent infusion)

2

Masonic Cancer Center, University of Minnesota

18

80

United States

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

9

Incidence of grade 3-5 infusional toxicities and predefined hemodynamic or respiratory adverse events related to the infusion of MSC

None

Phase 2

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