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

NCT ID: NCT04812496

Last Updated: 2021-03-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2021-01-15

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.

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.

Conditions

Covid19; SARS-CoV Infection; Tenofovir

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud

OTHER

Sponsor Role: lead

Responsible Party

Mario Cornejo-Giraldo

Head of the Infectious Diseases Unit, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mario Cornejo-Giraldo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Head of the Infectious Diseases Unit

Locations

Hospital Nacional CASE - EsSalud

Arequipa, , Peru

Countries

Peru

Other Identifiers

TEDHICOV

Identifier Type: -

Identifier Source: org_study_id