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

NCT04788355 | Completed Phase 3

• 1 other identifier: HA and A COVID 19
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Complication

Keywords

Complications; Novel coronavirus 2019; SARS-CoV-2; Chloroquine; Anticoagulants

Outcome Measures

Primary Outcomes (1)

• Patients in home isolation will be followed for (telemedicine) 14 days. The Beck scale will assess anxiety. Questions will be asked to patients about their health conditions. The answers will be tabulated in a spreadsheet composed of the following result

  The Beck scale will assess anxiety. Questions asked by telemedicine: cough, dyspnea, fatigue, malaise, myalgia, runny nose, odynophagia, anosmia, ageusia, headache, anorexia, abdominal pain, conjunctival congestion, diarrhea, nausea, vomiting, palpitation, bleeding, atypical symptoms. The parameters for such telemedicine evaluations were: yes or no.

  14 evaluation days after inclusion in the study

Secondary Outcomes (1)

• Assessment of the presence or absence of secondary complications for patients in home isolation or hospitalized, after using the drugs.

  14 evaluation days after inclusion in the study

Study Arms (4)

Control Group standard treatment

ACTIVE COMPARATOR

Patients will be treated only with standard hospital treatment

Drug: Control group (standard hospital treatment)

Group Hydroxychloroquine

EXPERIMENTAL

Patients will be treated with Hydroxychloroquine associated with standard hospital treatment

Drug: Control group (standard hospital treatment); Drug: Group Hydroxychloroquine

Group Hydroxychloroquine e Apixaban

EXPERIMENTAL

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

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

Group Apixabana

EXPERIMENTAL

Patients will be treated with apixaban associated with standard hospital treatment

Drug: Control group (standard hospital treatment); Drug: Group Apixaban

Interventions

Control group (standard hospital treatment) DRUG

Medications defined by the hospital involved in the study

Also known as: Drug protocols recommended by WHO and the Ministry of Health that make up the standard hospital treatment

Control Group standard treatment; Group Apixabana; Group Hydroxychloroquine; Group Hydroxychloroquine e Apixaban

Group Hydroxychloroquine 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.

Also known as: Hydroxychloroquine associated with standard treatment of the hospital involved in the study

Group Hydroxychloroquine

Group Hydroxychloroquine and apixaban 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.

Also known as: Hydroxychloroquine, Apixaban and standard treatment

Group Hydroxychloroquine e Apixaban

Group Apixaban 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.

Also known as: Apixaban and standard treatment

Group Apixabana

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade do Vale do Sapucai: lead
• Pfizer: collaborator
• Apsen Farmaceutica S.A.: collaborator
• Dermadia: collaborator
• Methodos Laboratory: collaborator
• Biofarma: collaborator

Study Sites (1)

Univás

Pouso Alegre, Minas Gerais, 37550000, Brazil

Location

MeSH Terms

Interventions

Control Groups; apixaban; Hydroxychloroquine

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and outcome assessors will not know which groups the patients belong to
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Clinical study that will evaluate the action of drugs combined or not to reduce complications of patients with covid 19

Study Record Dates

• First Submitted: September 5, 2020
• First Posted: March 9, 2021
• Study Start: July 1, 2020
• Primary Completion: November 15, 2020
• Study Completion: December 23, 2020
• Last Updated: March 9, 2021

Record last verified: 2021-03

Locations

BR (1)