COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04728698

Mike Royal, MD

mroyal@sorrentotherapeutics.com

2021-01-28

Withdrawn

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: - provides informed consent - has laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay in any specimen - 3. is hospitalized with covid-19-induced ard or ards (any severity) with a pao2/fio2 ≤300. the pao2/fio2 may be estimated from pulse oximetry or determined by arterial blood gas - requires oxygen supplementation at screening - is willing to follow contraception requirements

- current standard of care treatments for covid-19 appear to be working and the subject is clinically improving - a previous msc infusion unrelated to this trial - have any of the following medical conditions: - cardio-pulmonary resuscitation within 14 days of randomization - uncontrolled or untreated symptomatic arrhythmias. exception: subjects with controlled, asymptomatic atrial fibrillation during screening may enroll - myocardial infarction within the last 6 weeks - congestive heart failure (nyha grade 3 or 4) - pulmonary hypertension (who class iii/iv) - currently receiving extracorporeal life support or membrane oxygenation (ecls/ecmo) - alanine aminotransferase (alt) ≥ 5x upper limit of normal (uln) - relevant renal impairment (egfr < 50 ml/min) - any significant medical condition, laboratory abnormality or psychiatric illness that in the investigator's opinion would interfere or prevent the subject from safely participating in the study - pregnant or breast feeding or planning for either during the study - suspected uncontrolled active bacterial, fungal, viral, or other infection (aside from infection with covid-19) - history of a splenectomy, lung transplant or lung lobectomy; - concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable). - expected survival or time to withdrawal of life-sustaining treatments expected to be < 7 days. - do not intubate order; - home mechanical ventilation (noninvasive ventilation or via tracheotomy) except for continuous positive airway pressure or bi-level positive airway pressure (cpap/bipap) used solely for sleep-disordered breathing

2

Sorrento Therapeutics, Inc.

18

100

United States

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

0

Mortality at Day 28

None

Phase 2

[{"arm_notes": "", "treatment_id": 63, "treatment_name": "Allogeneic culture-expanded adipose-derived mesenchymal stem cells (mscs)", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]