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

NCT04812496 | Completed

• 1 other identifier: TEDHICOV
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; SARS-CoV Infection; Tenofovir

Keywords

Covid-19; SARS-CoV-2; Tenofovir; Hydroxychloroquine; Hospitalized

Outcome Measures

Primary Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud: lead

Study Sites (1)

Hospital Nacional CASE - EsSalud

Arequipa, 04001, Peru

Location

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mario Cornejo-Giraldo, M.D.

  Head of the Infectious Diseases Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Infectious Diseases Unit, Principal Investigator

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 23, 2021
• Study Start: March 1, 2020
• Primary Completion: May 30, 2020
• Study Completion: January 15, 2021
• Last Updated: March 25, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be shared within 30 days of the publication of the study.
• Access Criteria: The study data will be shared indefinitely for the benefit of the search for adequate therapy against COVID-19

Locations

PE (1)