Dataset Information

Nebulized enriched heparin to treat no critical patients with Sars-Cov-2: Triple-blind clinical trial.

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.

SUBMITTER: Bertanha M

PROVIDER: S-EPMC8702290 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Nebulized enriched heparin to treat no critical patients with Sars-Cov-2: Triple-blind clinical trial.

Bertanha Matheus M Rodrigues Lenize da Silva LDS Mellucci Filho Pedro Luciano PL Moroz Andrei A Pardini Maria Inês de Moura Campos MIMC Sobreira Marcone Lima ML Durigon Edison Luiz EL Machado Rafael Rahal Guaragna RRG Grotto Rejane Maria Tommasini RMT Lima Marcelo Andrade de MA Nader Helena Bonciani HB Nader Helena Bonciani HB Moraes Marli Leite de ML Barbosa Alexandre Naime AN Medolago Natália Bronzatto NB Cardoso Fábio Florença FF Magro Angelo José AJ Carvalho Cristiane Rodrigues Guzzo CRG Moraes Leonardo Nazário de LN Alvarado Rita de Cássia RC Nunes Helga Caputo HC Campos Gustavo Constantino de GC Grillo Vinicius Tadeu Ramos da Silva VTRDS Sertorio Nathalia Dias ND Fortaleza Carlos Magno Castelo Branco CMCB

Medicine 20211201 51

<h4>Background</h4>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 vac ...[more]

PMID: 34941114

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Dataset Information

Nebulized enriched heparin to treat no critical patients with Sars-Cov-2: Triple-blind clinical trial.

Background

Methods and analysis

Publications

Nebulized enriched heparin to treat no critical patients with Sars-Cov-2: Triple-blind clinical trial.

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