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Daily Regimen of Tenofovir/Emtricitabine as Prevention for COVID-19 in Health Care Personnel in Colombia

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ClinicalTrials.gov Identifier: NCT04519125
Recruitment Status : Not yet recruiting
First Posted : August 19, 2020
Last Update Posted : August 19, 2020
Sponsor:
Collaborators:
Pontificia Universidad Javeriana
Hospital Universitario Nacional de Colombia
Hospital de la Samaritana, Sede Bogotá y Sede Zipaquirá
Hospital Universitario San Jorge, Pereira.
Fundación Universitaria Autónoma de Las Américas
Universidad Tecnológica de Pereira
Colsanitas
Information provided by (Responsible Party):
Sandra Liliana Valderrama, Hospital Universitario San Ignacio

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 Trial.

This is an experimental study whose aim is to evaluate the effectiveness of a drug to prevent infection with the virus that causes COVID-19 (SARS-CoV-2), in health care workers.

The drug under study is Tenofovir /Emtricitabine, a well-known antiretroviral, which is safe and is used as prophylaxis and treatment for HIV and other viral infections such as Hepatitis.

Several laboratory-based studies indicate that this drug has the potential to inhibit SARS-CoV-2 replication. In addition, one study in HIV infected persons found that those taking Tenofovir /Emtricitabine tended to have a lower occurrence of COVID-19.

In this study, we will compare the occurrence of infection with SARS-CoV-2/ COVID19 in health care workers between those assigned to an intervention group and those assigned to a control group. The intervention group will receive Tenofovir /Emtricitabine during 60 days in addition to the use of personal protective equipment (PPE), and the control group will receive a placebo during 60 days in addition to the use of personal protective equipment (PPE).

The study will recruit 950 health professionals above 18 and less than 70 years, working in the emergency room, COVID wards and intensive care units of seven hospitals in Colombia.

To make the comparison groups very similar, the participants will be assigned through a random mechanism to either the intervention (475), or the control (475) groups. In order to prevent biases in the evaluation of the results, neither the participants nor the clinical investigators, data managers, analysts and support personnel will know which intervention the participants are receiving.

To determine the occurrence of infection with the virus the study will use both molecular tests that detect the presence of viral genes in respiratory secretions, and serological tests that detect the response of the immune system to the virus. The study will evaluate also the safety of this drug determining the occurrence of adverse events.


Condition or disease Intervention/treatment Phase
Severe Acute Respiratory Syndrome Coronavirus 2 COVID-19 Drug: Tenofovir/ Emtricitabine ( 300 mg / 200 mg daily during 60 days) + Personal Protective Equipment (PPE) Other: Placebo (1 tablet daily during 60 days) + Personal Protective Equipment (PPE) Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 950 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized triple masked multicentric controlled trial to evaluate the effectiveness and safety of Tenofovir/Emtricitabine in addition to personal protective equipment in comparison to the use of personal protective equipment alone for the prevention of infection with severe acute respiratory syndrome coronavirus 2 / COVID-19 in health care personnel in Colombia.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

Participant will not be informed that is either receiving or not the product of intervention, additionally, placebo will have a similar taste of the product of intervention and packaging will be the same for both.

Investigators will be masked because there is a central randomization and only the pharmacist of the study will now in which arm is assigned the participant Data analysis will be performed with an encrypted dataset which doesn't reveal which one is the intervention or which one is placebo

Primary Purpose: Prevention
Official Title: Effectiveness of the Use of Personal Protective Equipment in Addition to Tenofovir/Emtricitabine for the Prevention of the Transmission of SARS-COV-2 to Health Care Personnel. Randomized Clinical Trial
Estimated Study Start Date : August 30, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : April 1, 2021


Arm Intervention/treatment
Experimental: Intervention
Tenofovir/ Emtricitabine ( 300 mg / 200 mg daily during 60 days) + Personal Protective Equipment (PPE)
Drug: Tenofovir/ Emtricitabine ( 300 mg / 200 mg daily during 60 days) + Personal Protective Equipment (PPE)
Tenofovir/ Emtricitabine ( 300 mg / 200 mg daily during 60 days) + Personal Protective Equipment (PPE)

Placebo Comparator: Placebo
(1 tablet daily during 60 days) + Personal Protective Equipment (PPE)
Other: Placebo (1 tablet daily during 60 days) + Personal Protective Equipment (PPE)
Placebo (1 tablet daily during 60 days) + Personal Protective Equipment (PPE)




Primary Outcome Measures :
  1. SARS-CoV-2 infection [ Time Frame: At any time during follow up 75 days ( 60 days of intervention + final follow-up 15 days post-intervention) ]
    • Positivity of RT-PCR in nasopharyngeal samples in any of the measurements during follow up, or in symptomatic participants at any time.
    • Positive IgG antibodies against SARS- CoV-2 in any of the measurements during follow up


Secondary Outcome Measures :
  1. Serious and non-serious adverse events [ Time Frame: At any time during follow up 75 days ( 60 days of intervention + final follow-up 15 days post-intervention) ]
    Reported Serios and non serious adverse events during follow up

  2. Discontinuation of using TDF/FTC for any reason [ Time Frame: At any time during follow up 75 days ( 60 days of intervention + final follow-up 15 days post-intervention) ]
    To discontinue the intervention during follow up

  3. Adherence to TDF/FTC [ Time Frame: At any time during the 60 days of intervention ]
    number of tablets taken/total number of dispensed tablets

  4. Severity of SARS-CoV-2 infection [ Time Frame: At any time during follow up 75 days ( 60 days of intervention + final follow-up 15 days post-intervention) ]

    Severity of SARS-CoV-2 infections according to the following categories:

    Asymptomatic infection Mild symptomatic SARS-CoV-2 infection with no need for hospitalization Moderate symptomatic SARS-CoV-2 infection that requires hospitalization, but no ICU Severe SARS-CoV-2 infection: dyspnea with other SARS-CoV-2 symptoms requiring ICU hospitalization




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04519125


Contacts
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Contact: Sandra Valderrama- Beltrán, MD. Msc. +57-310-33222 slvalderrama@husi.org.co
Contact: Juliana Maria Cuervo Rojas, MD. MSc. PhD. +571 3148634125 cuervoj@javeriana.edu.co

Sponsors and Collaborators
Hospital Universitario San Ignacio
Pontificia Universidad Javeriana
Hospital Universitario Nacional de Colombia
Hospital de la Samaritana, Sede Bogotá y Sede Zipaquirá
Hospital Universitario San Jorge, Pereira.
Fundación Universitaria Autónoma de Las Américas
Universidad Tecnológica de Pereira
Colsanitas
  Study Documents (Full-Text)

Documents provided by Sandra Liliana Valderrama, Hospital Universitario San Ignacio:
Publications:
Daihai H, Daozhou G, Zhuang Z, Peihua C, Yijun L, Lin Y. The attack rate of the COVID-19 in a year. :3-5.
Ferguson N, Laydon D, Nedjati Gilani G, Imai N, Ainslie K, Baguelin M, et al. Report 9: Impact of non-pharmaceutical interventions (NPIs) to reduce COVID19 mortality and healthcare demand
Centers for Diasease Control and Prevention. Interim U.S. Guidance for Risk Assessment and Public Health Management of Healthcare Personnel with Potential Exposure in a Healthcare Setting to Patients with Coronavirus Disease (COVID-19).
WHO. THE USE OF ANTIRETROVIRAL DRUGS FOR TREATING AND PREVENTING HIV INFECTION. 2016;480.
AIDSinfo. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. Dep Heal Hum Serv [Internet].2018;298.
Lampertico P, Agarwal K, Berg T, Buti M, Janssen HLA, Papatheodoridis G, et al. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017;67(2):370-98.
Ju J, Kumar S, Li X, Jockusch S, Russo JJ. Nucleotide Analogues as Inhibitors of Viral Polymerases. bioRxiv [Internet]. 2020;1:2020.01.30.927574. Available from: https://doi.org/10.1101/2020.03.18.997585%0Ahttps://www.biorxiv.org/content/biorxiv/early/2020/01/31/2020.01.30.927574.full.pdf
Jockusch S, Tao C, Li X, Anderson TK, Chien M, Kumar S, et al. Triphosphates of the two components in DESCOVY and TRUVADA are inhibitors of the SARS-CoV-2 polymerase. bioRxiv. 2020;1-8.

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Responsible Party: Sandra Liliana Valderrama, MD, Msc, Hospital Universitario San Ignacio
ClinicalTrials.gov Identifier: NCT04519125    
Other Study ID Numbers: 2020 /143
77389 ( Other Grant/Funding Number: Ministerio de Ciencia y Tecnológia Republica de Colombia )
First Posted: August 19, 2020    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sandra Liliana Valderrama, Hospital Universitario San Ignacio:
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Prevention and control
Chemoprevention
Severe acute respiratory syndrome coronavirus 2
Health Personnel
Randomized Controlled Trial
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Tenofovir
Emtricitabine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents