| Grant number: | 20/12165-8 |
| Support Opportunities: | Research Grants - Research in Public Policies |
| Start date: | March 01, 2021 |
| End date: | July 31, 2022 |
| Field of knowledge: | Health Sciences - Medicine |
| Agreement: | CNPq - PPSUS |
| Principal Investigator: | Carlos Magno Castelo Branco Fortaleza |
| Grantee: | Carlos Magno Castelo Branco Fortaleza |
| Host Institution: | Faculdade de Medicina (FMB). Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil |
| Associated researchers: | Gustavo Constantino de Campos ; Matheus Bertanha ; Rejane Maria Tommasini Grotto |
Abstract
Coronavirus 19 (COVID-19) is a respiratory disease of viral cause that was identified in December 2019 after the first cases in China, spreading rapidly until reaching pandemic status, causing the collapse of numerous health systems and strong impact economic and social. At the end of April 2020, 3.08 million cases and more than 214 thousand deaths were already recorded. The treatment so far has not been established and there are several clinical trials testing known drugs that have antiviral activity in vitro, due to the urgency that the global situation imposes on us. Medicines with specific actions can take years to be discovered, while a vaccine also takes a long time. Recently, it has been shown that the worsening of Coronavirus infection may be related to the formation of micro clots in blood vessels and anticoagulants have been used as adjuvants in the treatment. This study is justified by conducting a pilot study that showed an in vitro antiviral action (anti-COVID-19) of a new high molecular weight heparin. A phase I / II clinical trial will be conducted. In all, 40 participants will be included in two arms. Participants allocated to Group 1 (control). Inhalation with 0.9% saline applied 4-4 hours, for 7 days. Participants allocated to Group 2 (intervention) will receive high molecular weight inhaled heparin (250ug / mL 0.9% SF), at a 4/4 hour dose, for 7 days. The outcomes of interest will be safety (absence of moderate or serious adverse events) and effectiveness (measured in a score of 7 points, with 1 absence of limitations and 7, death). The development of a new therapeutic option for COVID-19 is expected, with the possibility of use in other serious coronavirus diseases, to be subsequently tested in phase III studies. (AU)
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