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| Column | Value |
|---|---|
| Trial registration number | NCT04788355 |
|
Full text link
Last imported at : March 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : March 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : March 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : March 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2021-03-09 |
|
Recruitment status
Last imported at : March 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : March 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : March 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : March 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Crossover |
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Masking
Last imported at : March 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : March 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : March 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
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
Last imported at : March 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
- 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 |
|
Number of arms
Last imported at : March 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
4 |
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Funding
Last imported at : March 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Universidade do Vale do Sapucai |
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Inclusion age min
Last imported at : March 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : March 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : March 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Brazil |
|
Type of patients
Last imported at : March 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Mild/moderate disease at enrollment |
|
Severity scale
Last imported at : March 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2: Mild/moderate disease at enrollment |
|
Total sample size
Last imported at : March 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
176 |
|
primary outcome
Last imported at : March 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
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 |
|
Notes
Last imported at : March 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : March 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : March 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1532, "treatment_name": "Apixaban+hydroxychloroquine", "treatment_type": "Coagulation modifiers+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 110, "treatment_name": "Apixaban", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |