tetano
Editor, Senior Moderator
Medicine (Baltimore)
. 2021 Dec 23;100(51):e28288.
doi: 10.1097/MD.0000000000028288.
Nebulized enriched heparin to treat no critical patients with Sars-Cov-2: Triple-blind clinical trial
Matheus Bertanha[SUP] 1 2 [/SUP], Lenize da Silva Rodrigues[SUP] 1 [/SUP], Pedro Luciano Mellucci Filho[SUP] 1 [/SUP], Andrei Moroz[SUP] 3 [/SUP], Maria Inês de Moura Campos Pardini[SUP] 2 4 [/SUP], Marcone Lima Sobreira[SUP] 1 [/SUP], Edison Luiz Durigon[SUP] 5 6 [/SUP], Rafael Rahal Guaragna Machado[SUP] 5 [/SUP], Rejane Maria Tommasini Grotto[SUP] 2 7 [/SUP], Marcelo Andrade de Lima[SUP] 8 [/SUP], Helena Bonciani Nader[SUP] 9 [/SUP], Marli Leite de Moraes[SUP] 10 [/SUP], Alexandre Naime Barbosa[SUP] 11 [/SUP], Natália Bronzatto Medolago[SUP] 12 [/SUP], Fábio Florença Cardoso[SUP] 13 [/SUP], Angelo José Magro[SUP] 13 [/SUP], Cristiane Rodrigues Guzzo Carvalho[SUP] 5 [/SUP], Leonardo Nazário de Moraes[SUP] 2 7 [/SUP], Rita de Cássia Alvarado[SUP] 2 [/SUP], Helga Caputo Nunes[SUP] 14 [/SUP], Gustavo Constantino de Campos[SUP] 15 [/SUP], Vinicius Tadeu Ramos da Silva Grillo[SUP] 1 [/SUP], Nathalia Dias Sertorio[SUP] 1 [/SUP], Carlos Magno Castelo Branco Fortaleza[SUP] 11 [/SUP]
Affiliations
Abstract
Background: Coronavirus disease 2019 (COVID-19) is a viral respiratory disease that spreads rapidly, reaching pandemic status, causing the collapse of numerous health systems, and a strong economic and social impact. The treatment so far has not been well established and there are several clinical trials testing known drugs that have antiviral activity, due to the urgency that the global situation imposes. Drugs with specific mechanisms of action can take years to be discovered, while vaccines may also take a long time to be widely distributed while new virus variants emerge. Thus, drug repositioning has been shown to be a good strategy for defining new therapeutic approaches. Studies of the effect of enriched heparin in the replication of severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) in vitro assays justify the advance for clinical tests.
Methods and analysis: A phase I/II triple-blind parallel clinical trial will be conducted. Fifty participants with radiological diagnosis of grade IIA pneumonia will be selected, which will be allocated in 2 arms. Participants allocated in Group 1 (placebo) will receive nebulized 0.9% saline. Participants allocated in Group 2 (intervention) will receive nebulized enriched heparin (2.5 mg/mL 0.9% saline). Both groups will receive the respective solutions on a 4/4 hour basis, for 7 days. The main outcomes of interest will be safety (absence of serious adverse events) and efficacy (measured by the viral load).Protocols will be filled on a daily basis, ranging from day 0 (diagnosis) until day 8.
. 2021 Dec 23;100(51):e28288.
doi: 10.1097/MD.0000000000028288.
Nebulized enriched heparin to treat no critical patients with Sars-Cov-2: Triple-blind clinical trial
Matheus Bertanha[SUP] 1 2 [/SUP], Lenize da Silva Rodrigues[SUP] 1 [/SUP], Pedro Luciano Mellucci Filho[SUP] 1 [/SUP], Andrei Moroz[SUP] 3 [/SUP], Maria Inês de Moura Campos Pardini[SUP] 2 4 [/SUP], Marcone Lima Sobreira[SUP] 1 [/SUP], Edison Luiz Durigon[SUP] 5 6 [/SUP], Rafael Rahal Guaragna Machado[SUP] 5 [/SUP], Rejane Maria Tommasini Grotto[SUP] 2 7 [/SUP], Marcelo Andrade de Lima[SUP] 8 [/SUP], Helena Bonciani Nader[SUP] 9 [/SUP], Marli Leite de Moraes[SUP] 10 [/SUP], Alexandre Naime Barbosa[SUP] 11 [/SUP], Natália Bronzatto Medolago[SUP] 12 [/SUP], Fábio Florença Cardoso[SUP] 13 [/SUP], Angelo José Magro[SUP] 13 [/SUP], Cristiane Rodrigues Guzzo Carvalho[SUP] 5 [/SUP], Leonardo Nazário de Moraes[SUP] 2 7 [/SUP], Rita de Cássia Alvarado[SUP] 2 [/SUP], Helga Caputo Nunes[SUP] 14 [/SUP], Gustavo Constantino de Campos[SUP] 15 [/SUP], Vinicius Tadeu Ramos da Silva Grillo[SUP] 1 [/SUP], Nathalia Dias Sertorio[SUP] 1 [/SUP], Carlos Magno Castelo Branco Fortaleza[SUP] 11 [/SUP]
Affiliations
- PMID: 34941114
- DOI: 10.1097/MD.0000000000028288
Abstract
Background: Coronavirus disease 2019 (COVID-19) is a viral respiratory disease that spreads rapidly, reaching pandemic status, causing the collapse of numerous health systems, and a strong economic and social impact. The treatment so far has not been well established and there are several clinical trials testing known drugs that have antiviral activity, due to the urgency that the global situation imposes. Drugs with specific mechanisms of action can take years to be discovered, while vaccines may also take a long time to be widely distributed while new virus variants emerge. Thus, drug repositioning has been shown to be a good strategy for defining new therapeutic approaches. Studies of the effect of enriched heparin in the replication of severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) in vitro assays justify the advance for clinical tests.
Methods and analysis: A phase I/II triple-blind parallel clinical trial will be conducted. Fifty participants with radiological diagnosis of grade IIA pneumonia will be selected, which will be allocated in 2 arms. Participants allocated in Group 1 (placebo) will receive nebulized 0.9% saline. Participants allocated in Group 2 (intervention) will receive nebulized enriched heparin (2.5 mg/mL 0.9% saline). Both groups will receive the respective solutions on a 4/4 hour basis, for 7 days. The main outcomes of interest will be safety (absence of serious adverse events) and efficacy (measured by the viral load).Protocols will be filled on a daily basis, ranging from day 0 (diagnosis) until day 8.