COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04315987

Not reported

Not reported

2020-03-20

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: 1. male or female, aged ≥ 18 years 2. present a confirmed or pending diagnosis of covid-19, but with tomographic and clinical signs strongly suggestive of sars-cov-2 infection (covid-19), with pulmonary impairment greater than or equal to 50% and: i. oxygen saturation <95%; ii. curb-65 rating ≥ a 4; d) participants with a score on who ordinal scale that measures illness severity over time equal to 5 (hospitalized with non-invasive ventilation or high-flow oxygen).

patients with autoimmune diseases in the past or screening; those who have serious basic diseases that affect their survival, including: malignant tumor, hematopathy, malignant fluid, active hemorrhage, severe malnutrition, etc. which have not been controlled and can not be removed due to multiple metastasis; known or self-reported hiv or syphilis infected persons; have participated in stem cell clinical research; pregnant or lactating women or those who have fertility plans in the past year; the estimated life cycle is less than 48 hours; other conditions that the researcher thinks are not suitable for participating in the experiment. shock continuous use of immunosuppressive agents or organ transplants in the past 6 months;

2

Azidus Brasil

18

100

Brazil

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

90

Change in Clinical Condition

None

Phase 2

[{"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": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]