Covid19TEDHICOVNCT04812496
Tenofovir-DF Versus Hydroxychloroquine in the Treatment of Hospitalized Patients With COVID-19 (TEDHICOV)
An observational study of Covid19 and SARS-CoV Infection, run by Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud at 1 site in Peru.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, SARS-CoV Infection, Tenofovir
- How many people
- 100 participants
- Where
- 1 sitePeru
- Study dates
- 1 Mar 2020to 15 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tenofovir-DF Versus Hydroxychloroquine in the Treatment of Hospitalized Patients With COVID-19: An Observational Study (TEDHICOV)
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.
Read the 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
- Keywords
- Covid-19, SARS-CoV-2, Tenofovir, Hydroxychloroquine, Hospitalized
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality within 30 days of hospital admission
Patients with COVID-19 who died within 30 days of hospitalization
Measured: 30days
Mechanical Ventilation
Patients with COVID-19 who required mechanic ventilation during hospitalization
Measured: 30 days
Hospital stay
Length of hospitalization
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start1 Mar 2020
- Primary completion30 May 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Cornejo-Giraldo, Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud
- Investigators
- Mario Cornejo-Giraldo, M.D., Principal investigator, Head of the Infectious Diseases Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812496
- Sponsor's protocol ID
- TEDHICOV
- Acronym
- TEDHICOV
- Status last verified
- Mar 2021
- First submitted
- 19 Mar 2021
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tenofovir-DF Versus Hydroxychloroquine in the Treatment of Hospitalized Patients With COVID-19: An Observational Study (TEDHICOV)
- ClinicalTrials.gov ID
- NCT04812496
- Acronym / sponsor ID
- TEDHICOV / TEDHICOV
- Conditions
- Covid19, SARS-CoV Infection, Tenofovir
- Keywords
- Covid-19, SARS-CoV-2, Tenofovir, Hydroxychloroquine, Hospitalized
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospital Nacional Carlos Alberto Seguin Escobedo - EsSaludUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality within 30 days of hospital admission
Time frame: 30days
Patients with COVID-19 who died within 30 days of hospitalization
Mechanical Ventilation
Time frame: 30 days
Patients with COVID-19 who required mechanic ventilation during hospitalization
Hospital stay
Time frame: 30 days
Length of hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Cornejo-Giraldo, M.D. principal investigator
Head of the Infectious Diseases Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and SARS-CoV Infection, run by Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality within 30 days of hospital admission (time frame: 30days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2021.