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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
| Apsen Farmaceutica S.A. | INDUSTRY |
| Dermadia | UNKNOWN |
| Methodos Laboratory |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group standard treatment | Active Comparator | Patients will be treated only with standard hospital treatment |
|
| Group Hydroxychloroquine | Experimental | Patients will be treated with Hydroxychloroquine associated with standard hospital treatment |
|
| Group Hydroxychloroquine e Apixaban | Experimental | Patients will be treated with Hydroxychloroquine associated with apixaban and standard hospital treatment |
|
| Group Apixabana | Experimental | Patients will be treated with apixaban associated with standard hospital treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control group (standard hospital treatment) | Drug | Medications defined by the hospital involved in the study |
|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the presence or absence of secondary complications for patients in home isolation or hospitalized, after using the drugs. | 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. |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univás | Pouso Alegre | Minas Gerais | 37550000 | Brazil |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| C522181 | apixaban |
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Biofarma | INDUSTRY |
Clinical study that will evaluate the action of drugs combined or not to reduce complications of patients with covid 19
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Patients and outcome assessors will not know which groups the patients belong to
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| 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. |
|
|
| 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. |
|
|
| 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. |
|
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| 14 evaluation days after inclusion in the study |
| D008722 | Methods |
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |