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

NCT ID: NCT04788355

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2020-12-23

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.

Conditions

Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control Group standard treatment

Patients will be treated only with standard hospital treatment

Group Type: ACTIVE_COMPARATOR

Control group (standard hospital treatment)

Intervention Type: DRUG

Medications defined by the hospital involved in the study

Group Hydroxychloroquine

Patients will be treated with Hydroxychloroquine associated with standard hospital treatment

Group Type: EXPERIMENTAL

Control group (standard hospital treatment)

Intervention Type: DRUG

Medications defined by the hospital involved in the study

Group Hydroxychloroquine

Intervention Type: DRUG

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.

Group Hydroxychloroquine e Apixaban

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

Group Type: EXPERIMENTAL

Control group (standard hospital treatment)

Intervention Type: DRUG

Medications defined by the hospital involved in the study

Group Hydroxychloroquine and apixaban

Intervention Type: DRUG

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.

Group Apixabana

Patients will be treated with apixaban associated with standard hospital treatment

Group Type: EXPERIMENTAL

Control group (standard hospital treatment)

Intervention Type: DRUG

Medications defined by the hospital involved in the study

Group Apixaban

Intervention Type: DRUG

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.

Interventions

Control group (standard hospital treatment)

Medications defined by the hospital involved in the study

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Drug protocols recommended by WHO and the Ministry of Health that make up the standard hospital treatment; Hydroxychloroquine associated with standard treatment of the hospital involved in the study; Hydroxychloroquine, Apixaban and standard treatment; Apixaban and standard treatment

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Apsen Farmaceutica S.A.

INDUSTRY

Sponsor Role: collaborator

Dermadia

UNKNOWN

Sponsor Role: collaborator

Methodos Laboratory

UNKNOWN

Sponsor Role: collaborator

Biofarma

INDUSTRY

Sponsor Role: collaborator

Universidade do Vale do Sapucai

OTHER

Sponsor Role: lead

Responsible Party

José Dias da Silva Neto

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Univás

Pouso Alegre, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

HA and A COVID 19

Identifier Type: -

Identifier Source: org_study_id