Covid19, SARS-CoV Infection, Tenofovir
Conditions
Keywords
Covid-19, SARS-CoV-2, Tenofovir, Hydroxychloroquine, Hospitalized
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.
Interventions
None listed
Sponsors
Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality within 30 days of hospital admission | 30days | Patients with COVID-19 who died within 30 days of hospitalization |
| Mechanical Ventilation | 30 days | Patients with COVID-19 who required mechanic ventilation during hospitalization |
| Hospital stay | 30 days | Length of hospitalization |
Countries
Peru
Outcome results
None listed