Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04743011
Status:
COMPLETED
Last Update Posted:
2021-09-29
First Post:
2021-02-03
Brief Title:
Enriched Heparin Anti COVID-19 Trial
Sponsor:
UPECLIN HC FM Botucatu Unesp
Organization:
UPECLIN HC FM Botucatu Unesp
Study Overview
Official Title:
Nebulized Enriched Heparin to Treat no Critical Patients With Sars-Cov-2 - Triple Blind Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EnHanCed
Brief 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 308 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 09 saline applied 44 hours for 7 days Participants allocated to Group 2 intervention will receive high molecular weight inhaled heparin 250ug mL 09 SF at a 44 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
Detailed Description:
In view of the enormous health financial and social crisis resulting of the pandemic caused by SARS-Cov-2 it is justified to urgently conduct tests with possible antiviral drugs The high molecular weight heparin HMWH heparin enriched by ultrafiltration process proposed by this study has a potential inhibition activity over viral replication demonstrated by preliminary in vitro tests carried out in a model established in partnership with the Laboratory of Clinical and Molecular Virology LVCM of the Institute of Biomedical Sciences of the University of São Paulo ICB-USP
Along with the findings in the literature such as the study carried out by Phelps MK et al 2020 among others the use of inhaled heparin presents adequate levels of safety to be used in a clinical trial Taking into account that the dose of high molecular weight heparin enriched by this study team with antiviral activity in vitro is much lower than the doses currently presented in published clinical trials using inhaled UFH we have the safety premise to carry out this study The intentions of this study differ from what has been presented in the world literature so far as it does not aim to induce anticoagulation nor to effectively inhibit the formation of pulmonary fibrin but rather to act as an inhibitor of viral replication
Also as characteristics of the product to be tested this heparin HMWH is presented in a buffered solution free of low-sulfated low-weight molecules which is obtained in a sterile environment through ultrafiltration of the unfractionated solution of porcine origin available in Brazil Hemofol - Cristália using Centriprep-10kDa centrifuge filter Millipore used as recommended by the manufacturer
The high molecular weight heparin HMWH - enriched heparin - had two process patents filed one under the description HIGH MOLECULAR WEIGHT DEFINITION HEPARINE DEVELOPMENT PROCESS BR 102014027804-4 A2 - granted by the Instituto Nacional de Propriedade Industrial INPI and another with the description COMPOSITION OF HIGH MOLECULAR WEIGHT NON-FRACTIONAL HEPARINE FOR ANTIVIRAL ACTION BR 102020 011964-8 - deposited at INPI
Along with the findings in the literature such as the study carried out by Phelps MK et al 2020 among others the use of inhaled heparin presents adequate levels of safety to be used in a clinical trial Taking into account that the dose of high molecular weight heparin enriched by this study team with antiviral activity in vitro is much lower than the doses currently presented in published clinical trials using inhaled UFH we have the safety premise to carry out this study The intentions of this study differ from what has been presented in the world literature so far as it does not aim to induce anticoagulation nor to effectively inhibit the formation of pulmonary fibrin but rather to act as an inhibitor of viral replication
Also as characteristics of the product to be tested this heparin HMWH is presented in a buffered solution free of low-sulfated low-weight molecules which is obtained in a sterile environment through ultrafiltration of the unfractionated solution of porcine origin available in Brazil Hemofol - Cristália using Centriprep-10kDa centrifuge filter Millipore used as recommended by the manufacturer
The high molecular weight heparin HMWH - enriched heparin - had two process patents filed one under the description HIGH MOLECULAR WEIGHT DEFINITION HEPARINE DEVELOPMENT PROCESS BR 102014027804-4 A2 - granted by the Instituto Nacional de Propriedade Industrial INPI and another with the description COMPOSITION OF HIGH MOLECULAR WEIGHT NON-FRACTIONAL HEPARINE FOR ANTIVIRAL ACTION BR 102020 011964-8 - deposited at INPI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None