An observational study in Covid19, SARS-CoV Infection and Tenofovir, sponsored by Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud. Completed at 1 site in Peru. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-25.
Sponsored by Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud · Observational
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 100 is below the median of 260 across 3,135 observational studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Adult patients over 18 years of age hospitalized with Pneumonia COVID-19 between March and May 2020 in the Hospital Nacional CASE-EsSalud
Exclusion Criteria:
Mortality within 30 days of hospital admission
Patients with COVID-19 who died within 30 days of hospitalization
Time frame: 30days
Mechanical Ventilation
Patients with COVID-19 who required mechanic ventilation during hospitalization
Time frame: 30 days
Hospital stay
Length of hospitalization
Time frame: 30 days
Plan to share: Yes — 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 information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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