Pneumonia by the SARS-CoV-2 virus
Conditions
Interventions
PHASE A: Treatment of 5 patients with Nomacopan subcutaneously for at least 7 days, until completing 14 days. When the fifth patient completes treatment or withdraws from the study, a drug safety moni
Drug
E02.319
Sponsors
Hospital Eduardo de Menezes
Universidade Federal de Minas Gerais
Akari pharmaceutis
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Be between 18 and 80 years old; weight between 50 and 100 kg; maximum of 10 days of symptoms; admission to the intensive care unit or COVID-19 unit with suspected COVID-19 pneumonia and 93% less oxygen saturation in room air, but not receiving mechanical ventilation; diagnosis of COVID-19 infection based on a viral polymerase chain reaction test, rapid test or based on symptoms associated with a consistent lung tomography; be able to provide a free consent form or have the free consent form provided by a legally designated representative.
Exclusion criteria
Exclusion criteria: Patients who received treatment with inhibitors of complement system factors (such as eculizumab) or treatments with therapy with biological immunomodulators (example tocilizumab, etanercept, infliximab) in the 4 weeks prior to the admission in the study; patients involved in other clinical studies; patients with active tissue or systemic bacterial or fungal infection; pregnant or breastfed patients; patients with more than ten days of symptoms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantify the number of days for respiratory recovery, defined as oxygen saturation greater than 93% measured by pulse oximeter, without oxygen supplementation for at least 24 hours. If the patient achieves this goal, but is kept in the hospital for other reasons (for example, non-respiratory organ dysfunction), the goal will be considered fulfilled. ;With regard to secondary outcomes, it is expected to measure the number of days without a ventilator until hospital discharge; hospitalization time; presence of recovery or death, which will be verified by telephone; what is the frequency, severity and ratio of adverse effects related to treatment; what is the frequency of adverse events that justify premature discontinuation of treatment or study; what are the changes in clinical and laboratory parameters (biochemical, hematological and urinary) between admission to the study and post-treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Regarding exploratory outcomes, it is expected to analyze the serum transcriptome of patients before and after treatment; quantify cytokines and inflammatory and anti-inflammatory markers in serum; quantify the C5a complement in serum; quantify the complement CH50 in serum before and 3 days after the start of treatment; measure cytokines associated with viral bleaching. | — |
Countries
Brazil
Contacts
Public ContactMauro Teixeira
UNIVERSIDADE FEDERAL DE MINAS GERAIS
Outcome results
None listed