Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04788355
Status:
COMPLETED
Last Update Posted:
2021-03-09
First Post:
2020-09-05
Brief Title:
Prevention of Complications SARS-CoV-2 Clinical Study
Sponsor:
Universidade do Vale do Sapucai
Organization:
Universidade do Vale do Sapucai
Study Overview
Official Title:
Hydroxychloroquine and Apixaban Analysis of Physiological Parameters for the Prevention of Complications in Patients With Infection With the New Coronavirus Covid-19 A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
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:
None
Brief Summary:
Viral diseases have always posed a threat to public health Recently the SARS-Cov2 virus spread in an epidemic that began in China and soon spread globally making its study extremely relevant in order to seek mechanisms to combat it Therefore this study seeks to evaluate the benefit of using Hydroxychloroquine with or without Apixaban in the early treatment of patients with suspected COVID-19 Prospective randomized double-blind controlled study performed at Hospital das Clínicas Samuel Libânio Universidade do Vale do Sapucaí UNIVÁS Pouso Alegre Minas Gerais Brasil Patients treated in the emergency department who are reported as suspected cases of COVID-19 patients will be included according to current guidelines Will be randomized into 4 groups Hydroxychloroquine Hydroxychloroquine Apixabana only Apixabana and Control group all receiving standard treatment recommended Included patients will be monitored during hospitalization or remotely assisted in home treatment Clinical laboratory electrocardiographic and image evaluation criteria will be considered to assess the evolution in 7 and 14 days after inclusion Results will be subjected to appropriate statistical analysis with sample calculation An early therapeutic approach is proposed in suspected and confirmed patients with COVID-19 with the hope of reducing hospitalizations and severe forms of the disease
Detailed Description:
The early administration of HCQ or in association with apixaban could prevent worsening of suspected COVID-19 as well as preventing hospitalizations and the need for intensive treatment In patients with mild to moderate disease the use of hydroxychloroquine or hydroxychloroquine with apixaban or apixaban alone could be able to reduce disease progression on an ordinal scale of outcome including use of mechanical ventilation and death and decrease the likelihood of hospitalization or worsening of clinical conditions
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