Status:
UNKNOWN
Daily Regimen of Tenofovir/Emtricitabine as Prevention for COVID-19 in Health Care Personnel in Colombia
Lead Sponsor:
Hospital Universitario San Ignacio
Collaborating Sponsors:
Pontificia Universidad Javeriana
Hospital Universitario Nacional de Colombia
Conditions:
Severe Acute Respiratory Syndrome Coronavirus 2
COVID-19
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
Effectiveness of the use of Tenofovir/Emtricitabine in addition to personal protective equipment for the prevention of the transmission of SARS-COV-2 to health care personnel. A Randomized Clinical Tr...
Detailed Description
Background and Rationale The global impact of SARS-CoV-2/COVID-19 is unprecedented, and it is the greatest pandemic of a respiratory virus since the 1918 Influenza. With high infectiousness, important...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
August 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2021
Estimated Enrollment :
950 Patients enrolled
Trial Details
Trial ID
NCT04519125
Start Date
August 30 2020
End Date
April 1 2021
Last Update
August 19 2020
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