NCT04788355

Prevention of Complications (SARS-CoV-2): Clinical Study

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Universidade do Vale do Sapucai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Complication

Interventions

Type	Name	Description
DRUG	Control group (standard hospital treatment)	Medications defined by the hospital involved in the study
DRUG	Group Hydroxychloroquine	Patients in this group will receive hydroxychloroquine orally 200 mg every 12 hours for 7 days. In addition, patients in this group will receive standard medication for COVID-19 which is part of the hospital protocol involved in the study.
DRUG	Group Hydroxychloroquine and apixaban	Patients in this group will receive hydroxychloroquine orally 200 mg every 12 hours for 7 days + apixaban orally 2.5 mg every 12 hours, also for 14 days (prophylactic dose). In addition, patients in this group will receive standard medication, which is the protocol of the hospital involved in the study.
DRUG	Group Apixaban	Patients in this group will receive apixaban 2.5 mg orally every 12 hours, also for 14 days (prophylactic dose). In addition, patients in this group will receive standard medication, which is the protocol of the hospital involved in the study.

Timeline

• Start date: 2020-07-01
• Primary completion: 2020-11-15
• Completion: 2020-12-23
• First posted: 2021-03-09
• Last updated: 2021-03-09

Locations

1 site across 1 country: Brazil