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

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

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Peru
  • Arequipa, Peru, 04001
    • Hospital Nacional CASE - EsSalud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud
• Investigators: Principal Investigator: Mario Cornejo-Giraldo, M.D., Head of the Infectious Diseases Unit

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): May 30, 2020
• Study Completion (Actual): January 15, 2021

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2021
• Last Update Submitted That Met QC Criteria: March 23, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Covid-19; Tenofovir; Hospitalized; Hydroxychloroquine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Severe Acute Respiratory Syndrome; COVID-19
• Other Study ID Numbers: TEDHICOV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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
• IPD Sharing Time Frame: The data will be shared within 30 days of the publication of the study.
• IPD Sharing Access Criteria: The study data will be shared indefinitely for the benefit of the search for adequate therapy against COVID-19
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No