Clinical trial NCT04788355: Prevention of Complications (SARS-CoV-2): Clinical Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Complication
Keywords: Complications
Novel coronavirus 2019
SARS-CoV-2
Chloroquine
Anticoagulants
Lead sponsor: Universidade do Vale do Sapucai
Sponsor class: OTHER
Collaborators: name: Pfizer
name: Apsen Farmaceutica S.A.
name: Dermadia
name: Methodos Laboratory
name: Biofarma
First posted: 2021-03-09
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Clinical study that will evaluate the action of drugs combined or not to reduce complications of patients with covid 19
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 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
timeFrame: 14 evaluation days after inclusion in the study
Secondary outcomes:
measure: Assessment of the presence or absence of secondary complications for patients in home isolation or hospitalized, after using the drugs.
timeFrame: 14 evaluation days after inclusion in the study
Other outcomes:
Locations:
city: Pouso Alegre
country: Brazil
facility: Univás
state: Minas Gerais
Study officials:
References: