COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-2tfxtnz

Lydia Ferreira

lydiamferreira@gmail.com

2022-02-21

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

SARS-CoV-2 (COVID-19) infection proven by reverse transcription polimerase chain reaction (RT-PCR). Age range: 18 to 80 years. Need for Mechanical Ventilation. Presentation of the critical form of COVID-19 including de following criteria: Patient with worsening of respiratory symptoms resulting in orotracheal intubation for a maximum of 96 hours, Chest radiography or tomography: Bilateral opacities - not fully explained by pleural effusions, lobar or pulmonary collapse or nodules, Origin of edema: Respiratory failure not fully explained by heart failure or volume overload, Oxygenation: partial pressure of oxygen (PaO2) divided by the fraction of inspired oxygen (FiO2) inferior to 300mmHg with positive end-expiratory pressure (PEEP) inferior to 5cm H2O. Signed informed consent by family member and / or guardian.

Pregnancy or lactation. Participation in another interventional clinical study capable of altering the patient's response to the application of vascular stromal fraction. Patients with viral infections by other etiologic agents that are not SARS-CoV-2. Other diseases affecting the respiratory tract with negative testing for COVID-19. Body mass index (BMI) under 20 and over 40 kg / m2. Presence of active malignancy (except non-melanoma skin cancer). Venous thromboembolism receiving anticoagulation currently or in the last 3 months. Patient receiving extracorporeal life support (ECMO). Patient with thrombocytopenia. Number of platelets inferior to 100,000 plaq / µL. Patients with severe chronic liver disease (Child-Pugh 12 or above). Patients in palliative care.

2

Escola Paulista de Medicina /Universidade Federal de São Paulo (EPM/Unifesp)

18

80

Brazil

Critical disease at enrollment

8: Critical disease at enrollment

0

Eventos adversos associados à infusão endovenosa de fração vascular estromal dentro de 6 horas após a infusão;Mortalidade até 24 horas após a infusão de fração vascular estromal;Incidence of adverse effects between 6 hours and 7 days after stromal vascular fraction infusion

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

[{"arm_notes": "", "treatment_id": 2386, "treatment_name": "Stromal vascular fraction", "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"}]