COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-65trt53

Jose Ricardo Muniz Ferreira

josericardo@r-crio.com

2020-12-14

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

Man or woman, aged 60 years or over, with laboratory confirmation of the infection (COVID-19) by polymerase chain reaction with reverse transcription (RT-PCR), presence of at least one risk factor (co-morbidity) beyond age, adequate and healthy hematological values, hemoglobin 100 g / L, neutrophils 1.0 x 10 (9) / L, platelets 150 x 10 (9) / L, adequate livre function, ALT and AST 2.5 x ULN, bilirubin 1.5 x ULN,Adequate renal function, calculated creatinine clearance 50 mL / min, written informed consent signed by the candidate.

Patients with severe allergies, serious basic illnesses that affect survival, including blood disorders, cachexia, active bleeding, severe malnutrition, obstructive pulmonary pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis and other known viral pneumonia or bacterial pneumonia, continuous use of immunosuppressive agents or organ transplants in the last 6 months, cancer being treated or even treated (a formal opinion from the responsible doctor is required), low adherence and unable to complete the full study, increased risk of the subject or other conditions that interfere with the clinical trial and the judgment of results such as excessive stress, sensitivity or cognitive impairment.

2

R-Crio Criogenia S.A.

60

100

Brazil

Moderate disease at enrollment

3: Moderate disease at enrollment

0

Expected outcome 1: Determined by the difference in the evolution of clinicas and laboratory conditions between the experimental group and the control group (Placebo) in the treatment of volutear patients for the present clinicas study.The paramentes will be assessed through the following assessments:Titration of IgM and IgG anti-SARS-CoV-2 in patients with confirmed COVID-19 1 month after therapy with infusion with mesenchymal stem cells or placebo associated with convencional therapy;Titration of nonspecific antibodies; lymphocytes and other components of the innate immune system (natural killers; auxiliaries; suppressants; interleukin-6) at the end of the follow-up period (1 month).Computed tomography examinations of the lung should be performed at the beginning of the work; shortly after the diagnosis has been confirmed and at the end of the monitoring period (1 month)

Phase 1/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"}]