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| Column | Value |
|---|---|
| Trial registration number | NCT04836299 |
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Full text link
Last imported at : April 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : April 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : April 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
georgeavi@hotmail.com |
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Registration date
Last imported at : April 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2021-04-08 |
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Recruitment status
Last imported at : April 6, 2023, 8 p.m. Source : ClinicalTrials.gov |
Unknown |
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Study design
Last imported at : April 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : April 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : April 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : April 10, 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 |
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Study aim
Last imported at : April 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : April 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - confirmed case of covid-19 in national reference hospitals - covid sentinel hospitals. - male and female patients 18 to 75 years (inclusive) of age. - supply of signed and dated informed consent form - declared availability to comply with all study procedures and availability for the duration of the study. - in good general health with mild or moderate symptoms during the first week of disease evolution (onset of symptoms maximum 7 days before recruitment). - ability to take oral medications and be willing to adhere to the medication consumption regimen prescribed in the study. - the patient must, in the opinion of the principal investigator, be able to comply with all the requirements of the clinical trial (including home monitoring during isolation). - the patient is able and willing to comply with the requirements of this test protocol. voluntarily signed informed consent obtained prior to any proceeding related to the trial. |
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Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
known history of ivermectin allergy hypersensitivity to any component of ivermectin or the excipients of the brand to be used. covid-19 pneumonia diagnosed by the treating physician identified on a chest x-ray fever or cough present for more than 48 hours. immunoglobulin g (igg) positive against sars-cov-2 by a rapid diagnostic test 8. recent travel history to loa endemic countries (angola, cameroon, central african republic, chad, the democratic republic of the congo, ethiopia, equatorial guinea, gabon, republic of the congo, nigeria, and sudan) 9. current use of quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir, or cobicistat. use of critical drugs such as warfarin. |
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Number of arms
Last imported at : April 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : April 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Universidad Mayor de San Simón |
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Inclusion age min
Last imported at : April 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : April 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
75 |
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Countries
Last imported at : April 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Bolivia |
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Type of patients
Last imported at : April 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Mild/moderate disease at enrollment |
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Severity scale
Last imported at : April 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2: Mild/moderate disease at enrollment |
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Total sample size
Last imported at : April 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
90 |
|
primary outcome
Last imported at : April 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Clinical remission;Evolution of viral load |
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Notes
Last imported at : April 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : April 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Phase 2 |
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Arms
Last imported at : April 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |