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

Universidade do Vale do Sapucai

Status and phase: Completed; Phase 3

Conditions: Complication

Treatments: Drug: Control group (standard hospital treatment); Drug: Group Hydroxychloroquine and apixaban; Drug: Group Apixaban; Drug: Group Hydroxychloroquine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04788355

HA and A COVID 19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 176 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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176 participants in 4 patient groups

Control Group standard treatment

Active Comparator group

Description:

Patients will be treated only with standard hospital treatment

Treatment:

Drug: Control group (standard hospital treatment)

Group Hydroxychloroquine

Experimental group

Description:

Patients will be treated with Hydroxychloroquine associated with standard hospital treatment

Treatment:

Drug: Group Hydroxychloroquine

Drug: Control group (standard hospital treatment)

Group Hydroxychloroquine e Apixaban

Experimental group

Description:

Patients will be treated with Hydroxychloroquine associated with apixaban and standard hospital treatment

Treatment:

Drug: Group Hydroxychloroquine and apixaban

Drug: Control group (standard hospital treatment)

Group Apixabana

Experimental group

Description:

Patients will be treated with apixaban associated with standard hospital treatment

Treatment:

Drug: Group Apixaban

Drug: Control group (standard hospital treatment)