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

NCT04519125 | Unknown Phase 2

• 2 other identifiers: 2020 /14377389
• Study Type: interventional
• Target: 950
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2; COVID-19

Keywords

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Prevention and control; Chemoprevention; Severe acute respiratory syndrome coronavirus 2; Health Personnel; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• SARS-CoV-2 infection

  * 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

  At any time during follow up 75 days ( 60 days of intervention + final follow-up 15 days post-intervention)

Secondary Outcomes (4)

• Serious and non-serious adverse events

  At any time during follow up 75 days ( 60 days of intervention + final follow-up 15 days post-intervention)

• Discontinuation of using TDF/FTC for any reason

  At any time during follow up 75 days ( 60 days of intervention + final follow-up 15 days post-intervention)

• Adherence to TDF/FTC

  At any time during the 60 days of intervention

• Severity of SARS-CoV-2 infection

  At any time during follow up 75 days ( 60 days of intervention + final follow-up 15 days post-intervention)

Study Arms (2)

Intervention

EXPERIMENTAL

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)

Placebo

PLACEBO COMPARATOR

(1 tablet daily during 60 days) + Personal Protective Equipment (PPE)

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

Interventions

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)

Intervention

Placebo (1 tablet daily during 60 days) + Personal Protective Equipment (PPE) OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario San Ignacio: lead
• Pontificia Universidad Javeriana: collaborator
• Hospital Universitario Nacional de Colombia: collaborator
• Hospital de la Samaritana, Sede Bogotá y Sede Zipaquirá: collaborator
• Hospital Universitario San Jorge, Pereira.: collaborator
• Fundación Universitaria Autónoma de Las Américas: collaborator
• Universidad Tecnológica de Pereira: collaborator
• Colsanitas: collaborator

Related Publications (13)

• Daihai H, Daozhou G, Zhuang Z, Peihua C, Yijun L, Lin Y. The attack rate of the COVID-19 in a year. :3-5.

  BACKGROUND

• 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

  BACKGROUND

• 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).

  BACKGROUND

• Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection: Recommendations for a Public Health Approach. 2nd edition. Geneva: World Health Organization; 2016. Available from http://www.ncbi.nlm.nih.gov/books/NBK374294/

  PMID: 27466667 BACKGROUND

• Krakower DS, Mayer KH. Pre-exposure prophylaxis to prevent HIV infection: current status, future opportunities and challenges. Drugs. 2015 Feb;75(3):243-51. doi: 10.1007/s40265-015-0355-4.

  PMID: 25673022 BACKGROUND

• 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.

  BACKGROUND

• European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017 Aug;67(2):370-398. doi: 10.1016/j.jhep.2017.03.021. Epub 2017 Apr 18.

  PMID: 28427875 BACKGROUND

• Del Amo J, Polo R, Moreno S, Diaz A, Martinez E, Arribas JR, Jarrin I, Hernan MA; The Spanish HIV/COVID-19 Collaboration. Incidence and Severity of COVID-19 in HIV-Positive Persons Receiving Antiretroviral Therapy : A Cohort Study. Ann Intern Med. 2020 Oct 6;173(7):536-541. doi: 10.7326/M20-3689. Epub 2020 Jun 26.

  PMID: 32589451 BACKGROUND

• 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

  BACKGROUND

• Elfiky AA. Anti-HCV, nucleotide inhibitors, repurposing against COVID-19. Life Sci. 2020 May 1;248:117477. doi: 10.1016/j.lfs.2020.117477. Epub 2020 Feb 28.

  PMID: 32119961 BACKGROUND

• Parang K, El-Sayed NS, Kazeminy AJ, Tiwari RK. Comparative Antiviral Activity of Remdesivir and Anti-HIV Nucleoside Analogs Against Human Coronavirus 229E (HCoV-229E). Molecules. 2020 May 17;25(10):2343. doi: 10.3390/molecules25102343.

  PMID: 32429580 BACKGROUND

• 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.

  BACKGROUND

• Elfiky AA. SARS-CoV-2 RNA dependent RNA polymerase (RdRp) targeting: an in silico perspective. J Biomol Struct Dyn. 2021 Jun;39(9):3204-3212. doi: 10.1080/07391102.2020.1761882. Epub 2020 May 6.

  PMID: 32338164 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Tenofovir; Emtricitabine; Personal Protective Equipment

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Protective Devices; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Sandra Valderrama- Beltrán, MD. Msc.

CONTACT

+57-310-33222; slvalderrama@husi.org.co

Juliana Maria Cuervo Rojas, MD. MSc. PhD.

CONTACT

+571 3148634125; cuervoj@javeriana.edu.co

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Msc

Model Details: 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.

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 19, 2020
• Study Start: August 30, 2020
• Primary Completion: December 31, 2020
• Study Completion: April 1, 2021
• Last Updated: August 19, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share