Clinical trial: Daily Regimen of Tenofovir/Emtricitabine as Prevention for COVID-19 in Health Care Personnel in Colombia (NCT04519125)

Eligibility criteria:
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

        Exclusion Criteria:

          -  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.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 70 Years

Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? Contradiction