Pulmonary evaluation during inalatory enriched unfractionated heparine for SARS-CoV-2

Abstract

Coronavirus 19 (COVID-19) quickly reached pandemic status, causing the collapse of numerous health systems and a strong economic and social impact. The treatment so far is not well established. Medicines with specific actions can take years to be discovered, while vaccination has been facing problems for the immunization of the entire population. This study is justified by carrying out a pilot study that demonstrated an in vitro antiviral action (anti-COVID-19) of an enriched heparin. Objectives: To evaluate the respiratory evolution of radiological parameters and oximetry of patients treated with inhaled enriched unfractionated heparin, patented by this study team and whose main work was contemplated with resources from the PPSUS. Methods: A placebo-controlled triple-blind phase I / II clinical trial will be conducted in a single research center. 50 participants will be included who meet the inclusion criteria (hospitalization for SAR-Cov-2 with mild pneumonia and indication for oxygen non-invasive therapy). Participants will be randomized into two groups: Group 1 (control) - participants will receive standard treatment and inhalation of 10 mL of 0.9% saline solution every 4 hours (without receiving the morning dose, totaling 5 doses in 24 hours), in oxygen 5 L / min for 7 days; Group 2 (intervention) will receive unfractionated heparin enriched by nebulization in the dose of 2.5 mg in 10mL 0.9% SF every 4h (without receiving the morning dose, totaling 5 doses in 24h), in oxygen 5 L / min for 7 days. This study will objectively assess the evolution of the participants' respiratory status over seven days, considering oximetry parameters in arterial blood gases that will be collected at least every two days, the relationship between pO2 (partial arterial pressure of the gas) and FiO2 (pulmonary inspired oxygen fraction), worsening of the respiratory condition with the need for mechanical ventilation and the relationship of the findings with the pulmonary tomographic pattern. Thus, it is intended to assess whether the use of the treatment proposed in this study can be beneficial in protecting participants against the worsening of the respiratory condition of the disease. (AU)