Tenofovir-DF Versus Hydroxychloroquine in the Treatment of Hospitalized Patients With COVID-19 (TEDHICOV) (TEDHICOV)

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ClinicalTrials.gov Identifier: NCT04812496

Recruitment Status : Completed

First Posted : March 23, 2021

Last Update Posted : March 25, 2021

Sponsor:

Information provided by (Responsible Party):

Mario Cornejo-Giraldo, Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud

Study Description

Brief Summary:

Although several therapeutic agents have been suggested for the treatment of the disease caused by the Coronavirus of the year 2019 (COVID-19), no antiviral has yet demonstrated consistent efficacy.

This is an observational study comparing Tenofovir-DF (disoproxil fumarate) (TDF) with Hydroxychloroquine (HCQ) in the treatment of hospitalized patients with COVID-19 with evidence of pulmonary compromise and with supplemental oxygen required.

Condition or disease
Covid19 SARS-CoV Infection Tenofovir

Detailed Description:

All hospitalized patients with COVID-19 from March 2020 to May 30, 2020 at the "Hospital Nacional Carlos Alberto Seguín Escobedo (CASE)-EsSalud" (Arequipa, Peru) with a PCR-confirmed diagnosis of SARS-CoV-2 will be included.

The primary outcomes to be compared will be mortality, the need for admission to the Intensive Care Unit (ICU) and / or Mechanical Ventilation, and LOS (length of stay) in both groups.

Furthermore, demographic factors, risk factors, vital / respiratory functions, and laboratory results of both groups will be compared. The tests closest to the time of admission to the hospital will be taken into consideration.

Statistical Analysis: quantitative variables will be expressed as mean ± standard deviation, qualitative variables will be expressed as percentages (%). In the univariate analysis, the Student's t test will be used for the means and the chi2 test for nominal or ordinal variables. Kaplan-Meier survival curves will be evaluated 30 days after admission to the hospital to assess mortality. The multivariate analysis of the variables that result significant in the univariate analysis will be carried out by the Cox regression model in the evaluation of mortality; the multivariate linear regression model for the evaluation of the stay and the "log rank" model for the evaluation of admission to the Intensive Care Unit (ICU) or the need for mechanical ventilation (MV). In addition, models will be developed to estimate the effects of TDF treatment by regression adjustment for the primary outcomes of this observational study: hospital stay, need for ICU (intensive care unit) and / or MV (mechanical ventilation) and mortality. The Stata® software version 14 will be used and p <o.o5 will be considered significant.

Study Design

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Study Type :	Observational
Actual Enrollment :	100 participants
Observational Model:	Cohort
Time Perspective:	Retrospective
Official Title:	Tenofovir-DF Versus Hydroxychloroquine in the Treatment of Hospitalized Patients With COVID-19: An Observational Study (TEDHICOV)
Actual Study Start Date :	March 1, 2020
Actual Primary Completion Date :	May 30, 2020
Actual Study Completion Date :	January 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COVID-19 (Coronavirus Disease 2019)

Drug Information available for: Hydroxychloroquine Tenofovir

Genetic and Rare Diseases Information Center resources: Severe Acute Respiratory Syndrome

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

Mortality within 30 days of hospital admission [ Time Frame: 30days ]
Patients with COVID-19 who died within 30 days of hospitalization
Mechanical Ventilation [ Time Frame: 30 days ]
Patients with COVID-19 who required mechanic ventilation during hospitalization
Hospital stay [ Time Frame: 30 days ]
Length of hospitalization

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Adult patients over 18 years of age hospitalized with Pneumonia COVID-19 between March and May 2020 in the Hospital Nacional CASE-EsSalud

Criteria

Inclusion Criteria:

Hospitalized adults over 18 years of age
Positive molecular test for SARS-CoV-2
Computed tomography (TC scan) compatible with "COVID pneumonia" and / or in need of supplemental oxygen
Therapy with Tenofovir-DF (TDF) or Hydroxychloroquine (HCQ) at least 3 days
Signed informed consent

Exclusion Criteria:

Negative molecular test for SARS-CoV-2
No need for hospitalization
Negative CT scan for "COVID pneumonia" and / or no supplemental oxygen requirement for COVID-19
Had not received either HCQ or TDF, or both drugs at the same time, or had received HCQ or TDF for two days or less
No signed informed consent

Contacts and Locations

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): NCT04812496

Locations

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Peru
Hospital Nacional CASE - EsSalud
Arequipa, Peru, 04001

Sponsors and Collaborators

Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud

Investigators

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Principal Investigator:	Mario Cornejo-Giraldo, M.D.	Head of the Infectious Diseases Unit

More Information

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Responsible Party:	Mario Cornejo-Giraldo, Head of the Infectious Diseases Unit, Principal Investigator, Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud
ClinicalTrials.gov Identifier:	NCT04812496
Other Study ID Numbers:	TEDHICOV
First Posted:	March 23, 2021 Key Record Dates
Last Update Posted:	March 25, 2021
Last Verified:	March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	It is planned that all patient data included in the study will be shared after publication of the study minus those that allow the identification of the same patients
Supporting Materials:	Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
Time Frame:	The data will be shared within 30 days of the publication of the study.
Access Criteria:	The study data will be shared indefinitely for the benefit of the search for adequate therapy against COVID-19

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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 Mario Cornejo-Giraldo, Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud:


Covid-19 SARS-CoV-2 Tenofovir Hydroxychloroquine Hospitalized

Additional relevant MeSH terms:

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COVID-19 Severe Acute Respiratory Syndrome Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases	Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases

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