COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04611256

Martha E. Rodríguez Arellano

marthaeunicer@yahoo.com.mx

2020-11-02

Unknown

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: - aged between 18 and 65. - rt-pcr positive for sars-cov-2 (berlin protocol). - moderate to severe acute respiratory insufficiency (100 mmhg <pao2/fio2 ≤ 200 mmhg). - confirmatory diagnosis of pulmonary injury by chest teleradiography or computed axial t tomography. - being under standard therapy for covid-19. - informed consent signed by the patient or a legally acceptable representative (in the case of the legal representative, informed consent could be obtained by a phone call or email with the subsequent written confirmation).

- reserved prognosis (survival expected by the physician of fewer than three days). - being under immunosuppressive drug treatment. - severe kidney failure (estimated glomerular filtration rate < 30 ml/min) or under continuous kidney replacement therapy, hemodialysis, or peritoneal dialysis. - immunosuppressed patients (except when the cause is corticosteroid treatment). - pregnant or lactating women. - patients who plan to become pregnant during the study period or within six months after the end of the study period. - participation in another clinical trial with an experimental drug during the last 30 days. - pathologies that in medical judgment constitute a contraindication to participate in the study.

2

Hospital Reg. Lic. Adolfo Lopez Mateos

18

65

Mexico

Critical disease at enrollment

8: Critical disease at enrollment

20

Days to clinical improvement;Change form baseline in Arterial oxygen saturation;Change form baseline in Arterial oxygen saturation

None

Phase 1

[{"arm_notes": "", "treatment_id": 787, "treatment_name": "Mesenchymal stem cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]