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| Column | Value |
|---|---|
| Trial registration number | NCT04519125 |
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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 |
slvalderrama@husi.org.co |
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-08-19 |
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Recruitment status
Last imported at : Oct. 3, 2022, 7 a.m. Source : ClinicalTrials.gov |
Unknown |
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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 : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
inclusion criteria: - medical doctor, nurse ,respiratory therapist or nurse assistant who work in the emergency room, general covid ward or intensive care unit - age : between 18-70 years - rt-pcr and serology tests for sars-cov-2 negative at baseline evaluation - direct care of patients in the emergency room, general covid wards or intensive care unit - informed consent signed |
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Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
- two or more of the following : body temperature higher than 38 celsius, cough of recent onset (in the previous 10 days), dyspnea, odinophagia, malaise, fatigue, acute diarrheal disease. - history of covid-19 confirmed by rt-pcr or igg antibodies - family member with suspected or confirmed covid 19 - cohabitating with a suspected or confirmed case of covid-19 - hepatitis b anti-surface antigen antibodies lower than 10mu/ml at baseline evaluation - acute or chronic hepatitis b - confirmed diagnosis of hiv infection either by clinical history or elisa inmunassay at baseline evaluation - use of tdf/ftc in the last three months for other clinical conditions - alt or ast higher than 2 times the upper reference limit - serum hemoglobin <11g/dl or neutropenia<1.000cell/mm3 - renal dysfunction defined as egfr lower than 60ml/min (using the ckdepi formula) or history of chronic kidney disease known hypersensitivity to tdf/ftc serum phosphorus level <2.5mg/dl - diagnosed osteopenia or osteoporosis - history of pathological fractures - pregnancy, lactation or pregnancy desire during the period of the study - being a participant in another clinical trial of prevention for covid-19 - use of any of the following drugs: cidofovir, celecoxib, diclofenac, ibuprofen, metadon, naproxen, nimesulide, piroxicam, amiodarone, quinine, amikacin, cephalexin, clarithromycin, gentamicin, piperacillin / tazobazorcin, flucomycin, flucomycin, sulfadiazine, vancomycin , ganciclovir, ledipasvir / sofosbuvir, sofosbuvir / velpatasvir, furosemide, hydralazine, sacubitril, verapamil, interferon, hydroxyurea, dolutegravir / lamivudine abacavir, didanosine, lamivudine, atazanavir / cobicistat, atazanavir / ritonavir, darunavir / ritonavir, darunavir / cobicistat, indinavir, interferon, hydroxyurea, cyclosporine, mycophenolate, sirolimus, tacrolimus, acetazolamide orlistat, probenecid, pyridostigmine, sevelamer, zoledronic acid. |
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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 : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Hospital Universitario San Ignacio |
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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 |
70 |
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Health workers |
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
950 |
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primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
SARS-CoV-2 infection |
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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/Phase 3 |
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1496, "treatment_name": "Emtricitabine+tenofovir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |