Covid-19
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients over 18 years of age with a diagnosis of SARS-CoV-2 infection, confirmed by PCR-RT Swab test
Exclusion criteria
Exclusion criteria: Exclusion criteria include pregnancy or lactation, known hypersensitivity to the extract to be administered, active cancer, human immunodeficiency virus carriers, patients undergoing solid organ or bone marrow transplantation or using immunosuppressive drugs, bacterial infection at randomization, sepsis or septic shock related to bacterial infection at randomization, inability to use medication by mouth or nasoenteral tube, known liver failure, or advanced heart failure (New York Heart Association [NYHA] class III or IV).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be the analysis of clinical symptoms (fever, cough, body pain, malaise), obtained through the information provided by the patient, daily, during the 5 days of treatment, classified as strong, moderate and mild during this time, the results being compared with the control group (Placebo). | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected a decrease in the rates of change in laboratory tests (Hemogram, TGP, TGO, Creatinine, C-Reactive Protein), which are performed before the start of treatment and on the 7th day after the start of treatment, for comparison between the two results.;A decrease in viral load is expected, to be verified through the CT index performed using the RT-PCR technique. This exam will be performed before starting treatment, and also on the 7th day after starting treatment. Comparisons of patients' CT values will be performed. | — |
Countries
Brazil