Coronavirus disease
Conditions
Interventions
This project will recruit 10 individuals of both sexes, with age between 18 and 80 years old, who have been diagnosed with COVID-19 infection confirmed by RT-PCR and with severe respiratory failure. A
Drug
Sponsors
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: COVID-19 diagnosis confirmed by RT-PCR. Age between 18 and 80 years. Severe form of SARS-CoV-2 infection. ECOG prior to infection < ou igual a 2.
Exclusion criteria
Exclusion criteria: Age less than 18 years or more than 80 years. Known hypersensitivity and / or previous eculizumab therapy; septic shock and / or multiple organ failure syndrome; hstory of infection by human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C (HCV) (with the exception of chronic infections treated or cured for HBV and HCV, which will be accepted); neoplasms in activity or under treatment, except for basal cell carcinomas; any major surgery, extensive radiation therapy, delayed toxicity chemotherapy, biological therapy, or immunotherapy within 6 weeks prior to clinical trial screening; any investigational medication other than the study drugs in the 6 weeks before the first dose of the study drug; history of chronic liver disease (Child-Pugh B or C); hystory of chronic kidney disease (glomerular filtration rate <30 mL / min / 1.73 m²); any contraindication to the use of penicillin for bacterial meningitis's prophylaxis during the use of eculizumab; any contraindications to the use of contraceptive methods in childbearing age women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival of patients who started treatment, assessed using Kaplan-meier curves and comparison with the historical survival of other patients affected by the severe form of COVID-19 in other studies. | — |
Secondary
| Measure | Time frame |
|---|---|
| Length of stay in the ICU, measured in days, assessed from the first day of intervention; evaluation using Kaplan-meier curves and chi square test.;Time under mechanical ventilation support, measured in days, assessed from the first day of intervention; evaluation using Kaplan-Meier curves and chi square test.;nflammatory parameters (measurement of LDH, CRP, lactate, ferritin), measured before each application of the intervention medication and weekly up to 4 weeks after the last application of the medication. Continuous numeric variables will be evaluated using the GraphPad Prism version 8 program.;Complement activity (CH50 dosage) measured before each intervention drug application and 4 weeks after the last drug application. Continuous numerical variables will be evaluated using the GraphPad Prism version 8 program. | — |
Countries
Brazil
Contacts
Public ContactBruno;Rodrigo Pires;Calado
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo;Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Outcome results
None listed