COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04494386

Not reported

Not reported

2020-07-31

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: adult, male or female, age ≥18 years old diagnosis of the presence of the covid-19 agent with confirmation of covid-19 by standard reverse transcriptase polymerase chain reaction (rt-pcr) or equivalent test. patient with diagnosis of covid-related ards, classified as either: not requiring mechanical ventilation (nv) or requiring mechanical ventilation (v). according to berlin definition of acute respiratory distress syndrome (ards), patients will be categorized based on degrees of hypoxemia [arterial partial pressure of oxygen (pao2)/oxygen concentration (fio2)]: mild ards: 200 mm hg < pao2/fio2 ≤ 300 mm hg moderate ards: 100 mm hg < pao2/fio2 ≤ 200 mm hg severe ards: pao2/fio2 ≤ 100 mm hg patient who has exhibited deterioration in condition during the past 72 hours prior to the informed consent. patient receiving standard of care in-hospital therapy, including appropriate critical oxygenation, fluid, and hemodynamic support as indicated clinically. patient or responsible family member or surrogate signs informed consent. exclusion criteria hypersensitivity to study product components. history of hypersensitivity to dimethyl sulfoxide (dmso). active cancer or prior diagnosis of cancer within the past year; however, patients with basal and squamous cell cancer of skin will not be excluded. organ transplant recipient. chronic renal failure being treated by renal replacement therapy (dialysis) before development of covid-19. any other condition that, in the judgment of the investigator or sponsor, would be a contraindication to enrollment, study product administration, or follow-up. pregnancy or lactation; a negative pregnancy test between screening and day 1 (before administration of treatment) will be required of women with childbearing potential, and they will be advised of the requirement to use an effective means of contraception. a woman is considered to be of childbearing potential unless she is postmenopausal and without menses for 12 months or without a uterus and/or both ovaries.

None

3

Restem, LLC.

18

100

United States

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

17

Treatment-emergent adverse events (AE) and serious adverse events (SAE);Incidence of Dose Limiting Toxicity (DLT), suspected adverse reaction (SAR), or serious adverse event (SAE);Incidence of Dose Limiting Toxicity (DLT);Treatment-emergent adverse events (AE) and serious adverse events (SAE)

None

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 1333, "treatment_name": "Umbilical cord lining stem cells (ulsc)", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 1333, "treatment_name": "Umbilical cord lining stem cells (ulsc)", "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"}]