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| Column | Value |
|---|---|
| Trial registration number | NCT04390022 |
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Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
cchaccour@unav.es |
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-05-15 |
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Recruitment status
Last imported at : Dec. 19, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.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 : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: patients diagnosed with covid-19 in the emergency room of the clínica universidad de navarra with a positive sars-cov-2 pcr. residents of the pamplona basin ("cuenca de pamplona") the patient should be aged 18 to 59 years negative pregnancy test for women of child bearing age* the patient or his/her representative, have given consent to participate in the study. the patient should, in the investigator's opinion, be able to comply with all the requirements of the clinical trial (including home follow up during isolation) women of child bearing age may participate if they use a safe contraceptive method for the entire period of the study and at least one month afterwards. a woman is considered to not have childbearing capacity if she is post-menopausal (minimum of 2 years without menstruation) or has undergone surgical sterilization (at least one month before the study) |
|
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 stromectol® covid-19 pneumonia diagnosed by the attending physician identified in a chest x-ray fever or cough present for more than 48 hours positive igg against sars-cov-2 by rapid test age under 18 or over 60 years the following co-morbidities (or any other disease that might interfere with the study in the eyes of the investigator): immunosuppression chronic obstructive pulmonary disease diabetes hypertension obesity acute or chronic renal failure history of coronary disease history of cerebrovascular disease current neoplasm recent travel history to countries that are endemic for loa loa (angola, cameroon, central african republic, chad, democratic republic of congo, ethiopia, equatorial, guinea, gabon, republic of congo, nigeria and sudan) current use of cyp 3a4 or p-gp inhibitor drugs such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat. use of critical cyp3a4 substrate drugs such as warfarin. |
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Dec. 4, 2022, 8 p.m. Source : ClinicalTrials.gov |
Clinica Universidad de Navarra, Universidad de Navarra |
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
59 |
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Spain |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
1: Mild disease at enrollment |
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Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
24 |
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primary outcome
Last imported at : Dec. 4, 2022, 8 p.m. Source : ClinicalTrials.gov |
Proportion of Patients With a Positive SARS-CoV-2 PCR |
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 2 |
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Results also available online for 2020-001474-29 at: https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001474-29/results", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Results also available online for 2020-001474-29 at: https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001474-29/results", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |