Clinical trial NCT04812496: Tenofovir-DF Versus Hydroxychloroquine in the Treatment of Hospitalized Patients With COVID-19 (TEDHICOV)
Official title: Tenofovir-DF Versus Hydroxychloroquine in the Treatment of Hospitalized Patients With COVID-19: An Observational Study (TEDHICOV)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
SARS-CoV Infection
Tenofovir
Keywords: Covid-19
SARS-CoV-2
Tenofovir
Hydroxychloroquine
Hospitalized
Lead sponsor: Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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

Primary outcomes:
measure: Mortality within 30 days of hospital admission
timeFrame: 30days
measure: Mechanical Ventilation
timeFrame: 30 days
measure: Hospital stay
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Arequipa
country: Peru
facility: Hospital Nacional CASE - EsSalud
Study officials:
affiliation: Head of the Infectious Diseases Unit
name: Mario Cornejo-Giraldo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: