COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04399889

Not reported

Not reported

2020-05-22

Terminated

RCT

Randomized

Sequential assignment

Blind label

multi-center

Treatment

inclusion criteria: the patient or legally authorized representative (lar) must have the ability to understand and the willingness to provide a signed and dated informed consent form. age 18 years and over the patient agrees to use adequate contraception for the duration of the treatment protocol and for 6 months post treatment. positive rt- pcr testing for covid-19 nucleic acid using nasopharyngeal swabbing or any other site patient meets ards criteria and is on non-invasive or mechanical ventilation or high flow nasal cannula bilateral opacities on chest imaging consistent with pulmonary edema a need for positive pressure ventilation or high flow nasal cannula pao2/fio2 ratio ≤ 300 mmhg by arterial blood gas or spo2/fio2 imputation. infiltrates not fully explained by cardiac failure or fluid overload in the physician's best clinical judgement subjects requiring dialysis as a result of a covid-19 infection will not be excluded.

evidence of multiorgan failure involving one or more organs, excluding the lungs as defined below: presence of shock, defined as map < 65 mmhg with signs of peripheral hypoperfusion, or continuous infusion of 2 or more vasopressor or inotrope agents to maintain map ≥ 65 mmhg. serum bilirubin > 10 mg/dl platelet count < 50,000/ml subjects requiring dialysis as a result of anything other than a covid-19 infection will be excluded evidence of acquired or congenital immunodeficiency (due to immunosuppressive therapy excluding steroid use for treatment of covid-19 acute respiratory failure, hiv, previous treatment for cancer, etc.) history of metastatic cancer diagnosis or treatment in the past 1 year history of previous treatments with mscs or other cell therapies patient is co-enrolled in any other ind-sponsored clinical trials for covid-19 or ards. drugs that are administered under emergency use authorizations (eua) by the fda are permitted. evidence of pregnancy or lactation moribund patient not expected to survive >24 hours unable/unwilling to deliver lung protective ventilation patient is receiving extracorporeal membrane oxygenation (ecmo)

3

Joanne Kurtzberg, MD

18

100

United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

12

Number of Delayed Reactions;Number of Infusion Reactions;Number of Participants With Formation of New Anti-HLA Antibodies

None

Phase 1/Phase 2

[{"arm_notes": "nan", "treatment_id": 593, "treatment_name": "Human cord tissue mesenchymal stromal cells (hct-msc)", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "nan", "treatment_id": 593, "treatment_name": "Human cord tissue mesenchymal stromal cells (hct-msc)", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]