Clinical Trial to Evaluate the Efficacy of Different Treatments in Patients With COVID-19

March 5, 2024 updated by: Instituto de Investigación Hospital Universitario La Paz

Randomized Clinical Trial to Evaluate the Efficacy of Different Treatments in Patients With COVID-19

Currently COVID-19 is an international public health emergency. Most COVID-19 patients have mild or uncomplicated disease, but approximately 14% develop severe disease that requires hospitalization and oxygen therapy, and up to 5% of patients require admission to Intensive Care Units.

To date, the only treatments that have shown efficacy in a clinical trial are remdesivir and dexamethasone. The main objective is to provide reliable estimates on the effects of different treatment strategies on the outcome and mortality of patients with SARS-CoV-2 infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

356

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

First randomization

Inclusion criteria.

  • Men and women agree to participate in the study by signing the informed consent.
  • Men and women aged ≥ 60 years.
  • Men and women aged ≥18 years <60 years with ≥ 2 comorbidities of the following: hypertension, obesity, diabetes, cirrhosis, chronic neurological disease, active cancer, heart failure, ischemic heart disease, COPD.
  • Patient with a diagnosis of SARS-CoV-2 infection confirmed by PCR or rapid diagnostic test prior to randomization.
  • Patients with symptoms and signs compatible with active infection.
  • Men and women of reproductive capacity must agree to use highly effective contraceptive methods (diaphragm plus spermicide or male condom plus spermicide, oral contraceptive combined with a second method of contraceptive implant, injectable contraceptive, permanent intrauterine device, sexual abstinence or vasectomy) during your participation in the study and within 30 days of the last visit.
  • In addition, women participating in the study with reproductive capacity must have a negative pregnancy test at the time of inclusion.

Exclusion criteria.

  • Patients participating in any other clinical trial with drugs with potential antiviral action for SARS-CoV-2
  • Concomitant treatment with drugs other than the treatments included in this study with demonstrated or potential action against SARS-CoV-2 in the 24 hours prior to the administration of the study treatment.
  • Patients who are already receiving any of the study drugs.
  • Patients treated with corticosteroids at immunosuppressive doses (15 mg / day in the 7 days prior to the onset of symptoms).
  • Evidence of multi-organ failure.
  • HIV positive, confirmed by rapid test before inclusion.
  • Patients who require reservoir, mechanical ventilation or present acute respiratory distress criteria at the time of inclusion.
  • ALT or AST> 5 times the upper limit of normal during screening.
  • Creatinine clearance less than 60 ml / min during screening.
  • Pregnancy test with positive result during screening.
  • Women who are breastfeeding.
  • Patients with known hypersensitivity to any of the drugs in the treatment branches of the study, their metabolites or excipients.
  • Patients who receive medication incompatible with the study drugs after reviewing possible interactions.
  • Patients who present any contraindication or condition that is included in the section on warnings and special precautions for the use of the technical sheets of the drugs under study (Emtricitabine / Tenofovir disoproxil, and remdesivir) or any other reason that the research team has criteria is reason. not to be included in the study.
  • Subjects who are not able to understand the information sheet and are unable to sign the informed consent

Second randomization (if applicable):

Patients already included in the study and initially randomized may be re-randomized at any time if they present an O2 Sat <95% (need for oxygen therapy) and at least 1 marker of inflammation of the following: IL-6, CRP, D-Dimer , LDH, or ferritin above the upper limit of the normal range. This randomization can only be done in hospitalized patients. Patients will receive one of the following arms of treatment:

  • Baricitinib and dexamethasone
  • Dexamethasone

Exclusion criteria (rescue randomization):

  • Non-hospitalized patient
  • Being receiving cytotoxic or biological treatments (such as TNF inhibitors, anti interleukin 1, anti-interleukin 6 (tocilizumab or sarilumab), therapies against B or T cells (rituximab), interferon or Janus kinase inhibitors.
  • Have ever received convalescent plasma or intravenous immunoglobulins.
  • Suspicion of suffering from another serious bacterial, fungal or viral infection in addition to COVID-19 that in the opinion of the researcher could be a risk to receive the research products.
  • Have received a live vaccine 4 weeks before screening
  • Require mechanical ventilation or ECMO
  • Patient with a history of thromboembolic disease: deep vein thrombosis and / or pulmonary embolism within 12 weeks prior to randomization or have a history of recurrent thromboembolic disease
  • Neutropenia <1000 cells / μL
  • Lymphopenia <200 cells / μL
  • GOT or GPT> 5 times the upper limit of normal
  • MDRD <30 mL / min
  • History of hypersensitivity to baricitinib or its components.
  • Pregnant or planning pregnancy or lactating during the study
  • Are using or will be using a blood purification instrument to remove pro-inflammatory cytokines.
  • A life expectancy <48 hours from screening.
  • Contraindication to take the study medication or investigator criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Main randomization.Arm: Emtricitabine / Tenofovir disoproxil fumarate
Emtricitabine / Tenofovir disoproxil fumarate
Drug: Emtricitabine/Tenofovir Disoproxil Fumarate 200 MG-245 MG Oral Tablet [TRUVADA]
Main randomization
No Intervention: Main randomization.Arm: No treatment
No treatment
Other: Rescue randomization: Arm: Dexamethasone + Baricitinib
Rescue randomization: patients with oxygen requirements, O2 Sat <95% at any time, and at least one of the following inflammation markers: IL-6, CRP, D-dimer, LDH or ferritin above the upper limit of the normal range. Arms: Dexamethasone + Baricitinib or Dexamethasone.
Drug: Baricitinib + dexamethasone
Rescue randomization
Other: Rescue randomization: Arm: Dexamethasone
Rescue randomization: patients with oxygen requirements, O2 Sat <95% at any time, and at least one of the following inflammation markers: IL-6, CRP, D-dimer, LDH or ferritin above the upper limit of the normal range. Arms: Dexamethasone + Baricitinib or Dexamethasone.
Drug: Dexamethasone
Rescue randomization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: at 28 days
at 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2020

Primary Completion (Actual)

July 17, 2023

Study Completion (Actual)

July 17, 2023

Study Registration Dates

First Submitted

May 17, 2021

First Submitted That Met QC Criteria

May 17, 2021

First Posted (Actual)

May 18, 2021

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PanCOVID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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