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

Sponsor
Hospital Universitario de Fuenlabrada
Study ID
NCT04346147
Phase
PHASE2
Status
Unknown

Conditions

  • COVID-19 Pneumonia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Imatinib tablets — DRUG
    Imatinib 400 mg QD oral
  • Baricitinib Oral Tablet — DRUG
    Baricitinib 4 mg QD oral
  • Supportive tratment — OTHER
    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.

Study Details

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

Key Dates

Start date
May 7, 2020
Status verified
Aug 2021
Primary completion
Jun 2, 2021
Completion
Sep 30, 2021

Study Design

Enrollment
168 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Imatinib 400 mg
    Imatinib 400 mg 1 tablet 24 hours
  • Experimental: Baricitinib 4 mg
    Baricitinib 4 mg 1 tablet 24 hours
  • Experimental: Supportive treatment
    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.

Primary Outcome Measure

time to clinical improvement [ Time Frame: baseline to day 14 ]

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