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Clinical Trial to Evaluate Efficacy of 3 Types of Treatment in Patients With Pneumonia by COVID-19

NCT04346147 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2021-08-03

No results posted yet for this study

Summary

In absence of vaccine and medications specifically designed to treat SARS-CoV-2 disease, identifying treatment options is critical at this time to control the disease outbreak.

For this, we have designed a phase II trial of efficacy and safety with 3 branches of different combinations of treatment to identify which is the best early treatment option for patients with pneumonia due to SARS-CoV-2 (Covid-19) Identifying treatment options as early as possible is critical to the SARS-CoV-2 outbreak response. Currently, there is no approved vaccine for the disease and the treatments being used are not specifically designed for the SARS-CoV-2 virus, but are different groups of drugs used for other pathologies with mechanisms of action that justify their use because they inhibit entry of the virus into virus cells or proteases.

The study aims to compare Imatinib 400mg, Baricitinib 4mg or supportive treatment, administered for 7 days in the setting of SARS-CoV-2 pneumonia treatment.

Patients who meet inclusion criteria and do not have any exclusion criteria will be randomized to receive open treatment 1:1:1

Conditions

Interventions

DRUG

Imatinib tablets

Imatinib 400 mg QD oral

DRUG

Baricitinib Oral Tablet

Baricitinib 4 mg QD oral

OTHER

Supportive tratment

Any therapeutic intervention aimed at the control of clinical deterioration is contemplated without initiating or having previously initiated any drug with potential beneficial effect previously described in vitro or in pre-clinical / clinical models against SARS-CoV-2 prior to patient recruitment.

Sponsors & Collaborators

  • Centro Nacional de Investigaciones Oncologicas CARLOS III

    collaborator OTHER

  • Hospital Universitario de Fuenlabrada

    lead OTHER

Principal Investigators

  • David Bernal, Ph MD · Hospital Universitario de Fuenlabrada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-07
Primary Completion
2021-06-02
Completion
2021-09-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04346147 on ClinicalTrials.gov