Severe Acute Respiratory Syndrome
Conditions
Interventions
Experimental group: 18 patients with COVID-19 with positive reverse transcription polymerase chain reaction (RT-PCR) result for SARS-CoV-2 with acute respiratory syndrome resulting in intubation that
A11.872.590.500
E04.936.225.687.
A10.165.114
A11.872
Sponsors
Escola Paulista de Medicina /Universidade Federal de São Paulo (EPM/Unifesp)
Associação Beneficente de Coleta de Sangue - COLSAN
Associação Paulista para o Desenvolvimento da Medicina (SPDM)
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Negative reverse transcriptase polymerase chain reaction (RT-PCR) exam for SARS-CoV-2 ;Mortality between 24 hours and 28 days after intervention;WHO progression scale at 7 and 14 days ;Clinical, laboratory and imaging tests: Vital data: measurement of axillary temperature; heart rate, respiratory rate and pulse oximetry (minimum, maximum and average.Use of vasoactive drugs. Mechanical ventilation parameters (PEEP, FiO2, PaO2 / FiO2 ratio). Arterial blood gases (assessing the presence of hypercarbia or acidosis), blood glucose, urea, total bilirubin and fractions, D-dimer, ferritin, transaminases (TGO and TGP), creatinine, CK, complete blood count, coagulogram (TAP and TTPa), inflammatory markers (C-reactive protein), serum troponin, lactate dehydrogenase and chest X-ray. Chest Computed Tomography | — |
Countries
Brazil
Contacts
Public ContactLydia Ferreira
Escola Paulista de Medicina /Universidade Federal de São Paulo (EPM/Unifesp)
Outcome results
None listed