COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04355728

Camillo Ricordi

cricordi@miami.edu

2020-04-21

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: patients >/= 18 years old diagnosed with covid-19 (as evaluated by pcr test confirming infection with sars-cov-2) will be eligible for inclusion if they meet all of the below criteria. inclusion criteria must all be present within a 24-hour time period at the time of enrollment: patient currently hospitalized aged ≥ 18 years willing and able to provide written informed consent, or with a legal representative who can provide informed consent peripheral capillary oxygen saturation (spo2) ≤ 94% at room air, or requiring supplemental oxygen at screening pao2/fio2 ratio < 300 mmhg bilateral infiltrates on frontal chest radiograph or bilateral ground glass opacities on a chest ct scan hypoxemia requiring an increase in the fraction of inspired oxygen (fio2) of ≥ 20% and an increase in positive end-expiratory airway pressure (peep) level of 5 cm h2o or more to maintain transcutaneous oxygen saturations in the target range of 88-95%, or requirement for escalation from oxygen therapy to invasive mechanical ventilation

pao2/fio2 ≥ 300 at the time of enrollment a previous msc infusion not related to this trial history of pulmonary hypertension (who class iii/iv) history of left atrial hypertension or decompensated left heart failure. pregnant or lactating patient unstable arrhythmia patients with previous lung transplant patients currently receiving chronic dialysis patients currently receiving extracorporeal membrane oxygenation (ecmo) presence of any active malignancy (except non-melanoma skin cancer) any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50% moderate to severe liver disease (ast and alt >5 x uln) severe chronic respiratory disease with a paco2 > 50 mm hg or the use of home oxygen baseline qt prolongation moribund patient not expected to survive > 24 hours

2

Camillo Ricordi

18

None

United States

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

24

Number of Adverse Events (AEs) and Serious Adverse Events (SAEs);Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity;Number of Adverse Events and Serious Adverse Events by Relatedness to Treatment;Number of Participants With Pre-Specified Infusion Associated Adverse Events;Number of Subjects With Serious Adverse Events by 31 Days After First Infusion;Percentage of Participants Experiencing Serious Adverse Events (SAEs) Through Study Day 90;Subjects With Adverse Events and Serious Adverse Events by Severity;Subjects With Adverse Events by Relatedness to Treatment

None

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 1334, "treatment_name": "Umbilical cord mesenchymal stem cells", "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"}]