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

NCT04346147 | Unknown Phase 2

• 1 other identifier: 24032020
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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

COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (1)

• time to clinical improvement

  time from inclusion to improvement by 2 points on the "seven-category ordinal scale" or high, whichever comes first

  baseline to day 14

Secondary Outcomes (2)

• Safety of treatments

  through study completion, an average of 1 month

• Tolerability of treatments

  during treatment and up to 30 days after the last treatment dose

Other Outcomes (1)

• Biomarkers and genetic markers of susceptibility to SARS-CoV-2

  baseline

Study Arms (3)

Imatinib 400 mg

EXPERIMENTAL

Imatinib 400 mg 1 tablet 24 hours

Drug: Imatinib tablets

Baricitinib 4 mg

EXPERIMENTAL

Baricitinib 4 mg 1 tablet 24 hours

Drug: Baricitinib Oral Tablet

Supportive treatment

EXPERIMENTAL

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.

Other: Supportive tratment

Interventions

Imatinib tablets DRUG

Imatinib 400 mg QD oral

Also known as: Arm A

Imatinib 400 mg

Baricitinib Oral Tablet DRUG

Baricitinib 4 mg QD oral

Also known as: Arm B

Baricitinib 4 mg

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.

Also known as: Best care

Supportive treatment

Eligibility Criteria

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

You may qualify if:

• Signed informed consent form
• ≥18 years
• Confirmed diagnosis Pneumonia Covid19 + (Pneumonia confirmed radiologically and positive test for detection of SARS-CoV-2 RNA in respiratory samples)
• ECOG functional state 0 or 1
• Less than 10 days from onset of symptoms saw.
• NO contraindication for medication
• ECG QT \< \< 440 ms males and \< 460 ms females
• Adequate liver, kidney and hematological function (or within the safety range to use these drugs):
• Absolute granulocyte count\> 1.5 x 109 / L
• Absolute platelet count\> 100 x 109 / L
• Hb\> 10 g / dL
• Cr \<1.5 mg / dL or Clearance\> 50mL / min
• Bilirubin \<3 ULN
• AST / ALT ≤ 2.5 times ULN

You may not qualify if:

• No Covid confirmation
• No pneumonia
• Previous treatment with any of the study drugs
• Concomitant serious medical condition:
• Congestive Heart failure
• Acute myocardial infarction 6 months prior
• Unstable Angina
• Cardiomyopathy
• Unstable Ventricular Arrhythmia
• Uncontrolled Hypertension
• Uncontrolled psychotic disorders
• Serious active infections
• HIV infections
• Active hepatitis
• Neoplasia in active cancer treatment

Sponsors & Collaborators

• Hospital Universitario de Fuenlabrada: lead
• Centro Nacional de Investigaciones Oncologicas CARLOS III: collaborator

Study Sites (1)

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, 28942, Spain

Location

MeSH Terms

Interventions

Imatinib Mesylate; baricitinib

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• David Bernal, Ph MD

  Hospital Universitario de Fuenlabrada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 15, 2020
• Study Start: May 7, 2020
• Primary Completion: June 2, 2021
• Study Completion: September 1, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)