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

March 6, 2021 updated by: José Dias da Silva Neto, Universidade do Vale do Sapucai

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Pouso Alegre, Minas Gerais, Brazil, 37550000
        • Univás

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group standard treatment
Patients will be treated only with standard hospital treatment
Drug: Control group (standard hospital treatment)
Medications defined by the hospital involved in the study
Other Names:
  • Drug protocols recommended by WHO and the Ministry of Health that make up the standard hospital treatment
Experimental: Group Hydroxychloroquine
Patients will be treated with Hydroxychloroquine associated with standard hospital treatment
Drug: Control group (standard hospital treatment)
Medications defined by the hospital involved in the study
Other Names:
  • Drug protocols recommended by WHO and the Ministry of Health that make up the standard hospital treatment
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.
Other Names:
  • Hydroxychloroquine associated with standard treatment of the hospital involved in the study
Experimental: Group Hydroxychloroquine e Apixaban
Patients will be treated with Hydroxychloroquine associated with apixaban and standard hospital treatment
Drug: Control group (standard hospital treatment)
Medications defined by the hospital involved in the study
Other Names:
  • Drug protocols recommended by WHO and the Ministry of Health that make up the standard hospital treatment
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.
Other Names:
  • Hydroxychloroquine, Apixaban and standard treatment
Experimental: Group Apixabana
Patients will be treated with apixaban associated with standard hospital treatment
Drug: Control group (standard hospital treatment)
Medications defined by the hospital involved in the study
Other Names:
  • Drug protocols recommended by WHO and the Ministry of Health that make up the standard hospital treatment
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.
Other Names:
  • Apixaban and standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 14 evaluation days after inclusion in the study
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the presence or absence of secondary complications for patients in home isolation or hospitalized, after using the drugs.
Time Frame: 14 evaluation days after inclusion in the study
The relationship between the use of medications in the initial interventions and the presence or absence of secondary complications will be assessed both for patients in home isolation and for hospitalized patients. As for patients who are hospitalized, the following topics will be included in the table: use of oxygen therapy, mechanical ventilation, death. The parameters for answers will be yes or no.
14 evaluation days after inclusion in the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade do Vale do Sapucai

Collaborators

Pfizer
Apsen Farmaceutica S.A.
Biofarma
Dermadia
Methodos Laboratory

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

November 15, 2020

Study Completion (Actual)

December 23, 2020

Study Registration Dates

First Submitted

September 5, 2020

First Submitted That Met QC Criteria

March 6, 2021

First Posted (Actual)

March 9, 2021

Study Record Updates

Last Update Posted (Actual)

March 9, 2021

Last Update Submitted That Met QC Criteria

March 6, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HA and A COVID 19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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