Coronavirus infection in unspecified location
Conditions
Interventions
A nebulized aerosol dose of sodium heparin 25,000 IU (1mL) diluted with 4 mL of 0.9% saline will be administered through a vibrating mesh nebulizer to 50 patients hospitalized with COVID-19. Another 5
B34.2
Sponsors
Galeno Desenvolvimento de Pesquisas Clínicas Ltda
Galeno Desenvolvimento de Pesquisas Clínicas Ltda
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients hospitalized with COVID-19 who do not require immediate mechanical ventilation (points 3-5 on the ordinal scale). Age from 18 to 80 years. Able to understand the nature and purpose of the study, including risks and adverse effects and with the intention of cooperating with the researcher and acting in accordance with the requirements of the entire trial, which is confirmed by signing the Term Informed Consent Form, prior to any study procedure. Women of childbearing potential should use a safe and effective method of contraception throughout the study. If the participant chooses to abstain from sex or practice any type of relationship that does not pose a risk of pregnancy, the use of contraception is not mandatory.
Exclusion criteria
Exclusion criteria: The participant is known to be hypersensitive to the studied drug (heparin) or to chemically related compounds. History of serious adverse reactions or hypersensitivity to any drug. The participant has any condition that prevents him from participating in the study due to the investigator's judgment. A participant shows a positive result for beta-HCG test and/or urine test for pregnancy; delivery or abortion in the 12 weeks prior to the scheduled vaccine administration date. Present COPD.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mortality rate in each arm of the study will be evaluated and compared;The time to hospital discharge (in days) in each arm of the study will be evaluated and compared | — |
Secondary
| Measure | Time frame |
|---|---|
| The modification of the ordinal scale (of clinical parameters) will be evaluated in 3, 7 and 14 days (or until the end of hospitalization) in each arm of the study;The number of days requiring oxygen treatment in each arm of the study will be evaluated and compared;The number of days until the absence of symptoms in each arm of the study will be evaluated and compared;Quantitative decrease in symptoms in each arm of the study will be assessed;The number of days until invasive mechanical ventilation, if any, will be evaluated and compared in each study arm | — |
Countries
Brazil
Contacts
Public ContactCarlos Sverdloff
Outcome results
None listed