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

Phase 3

Completed

• Conditions: Complication
• Interventions: Drug: Control group (standard hospital treatment); Drug: Group Hydroxychloroquine and apixaban; Drug: Group Hydroxychloroquine; Drug: Group Apixaban

• Registration Number: NCT04788355
• Lead Sponsor: Universidade do Vale do Sapucai

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.

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2020-09-05
• Primary Completion: 2020-11-15
• Study Completion: 2020-12-23
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-06
• Last Update Submitted: 2021-03-06
• Study First Posted: 2021-03-09
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control Group standard treatment	Control group (standard hospital treatment)	Patients will be treated only with standard hospital treatment
Group Hydroxychloroquine	Control group (standard hospital treatment)	Patients will be treated with Hydroxychloroquine associated with standard hospital treatment
Group Hydroxychloroquine e Apixaban	Control group (standard hospital treatment)	Patients will be treated with Hydroxychloroquine associated with apixaban and standard hospital treatment
Group Hydroxychloroquine e Apixaban	Group Hydroxychloroquine and apixaban	Patients will be treated with Hydroxychloroquine associated with apixaban and standard hospital treatment
Group Apixabana	Control group (standard hospital treatment)	Patients will be treated with apixaban associated with standard hospital treatment
Group Hydroxychloroquine	Group Hydroxychloroquine	Patients will be treated with Hydroxychloroquine associated with standard hospital treatment
Group Apixabana	Group Apixaban	Patients will be treated with apixaban associated with standard hospital treatment

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Univás; 🇧🇷 Pouso Alegre, Minas Gerais, Brazil