Enriched Heparin Anti COVID-19 Trial

Summary

Coronavirus 19 (COVID-19) is a viral respiratory disease 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 economic and social impact. By 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. 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 high molecular weight heparin. Methods: A phase I / II clinical trial will be conducted. 40 participants will be included in two arms. Participants allocated to Group 1 (control) will receive 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). Expected results: 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.

Timeline

Start

2021-06-01

Primary completion

2021-11-30

Completion

2021-12-31

Publications

• Background Phelps MK, Olson LM, Patel MAVB, Thompson MJ, Murphy CV. Nebulized Heparin for Adult Patients With Smoke Inhalation Injury: A Review of the Literature. J Pharm Technol. 2020 Aug;36(4):130-140. doi: 10.1177/8755122520925774. Epub 2020 Jun 1.
• Ramos da Silva Grillo VT, Bertanha M, da Silva Rodrigues L, de Lima MA, Mellucci Filho PL, Rahal Guaragna Machado R, Durigon EL, Dias Sertorio N, de Assis Golim M, Moroz A, Marques Braz AM, de Moraes LN, Leite MA, Bonciani Nader H, de Campos GC, Rodrigues Guzzo Carvalho C, Florenca Cardoso F, Magro AJ, Caputo Nunes H, Tommasini Grotto RM, de Cassia Alvarado R, de Moura Campos Pardini MI, Lima Sobreira M, da Costa EAPN, Naime Barbosa A, Fortaleza CMCB. Nebulized enriched heparin improves respiratory parameters in patients with COVID-19: a phase I/II randomized and triple-blind clinical trial. Sci Rep. 2024 Aug 27;14(1):19902. doi: 10.1038/s41598-024-70064-8.

Drugs

Indications