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

• Status: Completed
• Trial end date: 2020-12-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidade do Vale do Sapucai
• Collaborators: Apsen Farmaceutica S.A.; Biofarma; Dermadia; Methodos Laboratory; Pfizer
• Treatments: Apixaban; Hydroxychloroquine

Criteria

Inclusion criteria:

• Patients with suspected or confirmed covid-19, above 18 years old

• Patients with time between symptom onset and inclusion ≤ 14 days

• Patients with time between hospital stay and inclusion ≤ 48 hours

Exclusion criteria:

• Patients tested negative for covid-19 by rt-pcr, serological or rapid test method

• Patients unable to swallow for any reason

• Patients with an extended qt interval, defined as a corrected qt (qtc) for heart rate above 450 ms for men and 470 ms for women

• Patients with liver toxicity, defined as ast / alt or increased bilirubin

• Patients with ventricular arrhythmias

• Patients with bleeding, major hematoma or blood dyscrasia;

• Patients who, at any time during the process, choose to give up participating in the study