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

• Status: Active, not recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario de Fuenlabrada
• Collaborator: Centro Nacional de Investigaciones Oncologicas CARLOS III
• Treatments: Imatinib Mesylate; Lopinavir; Ritonavir

Criteria

Inclusion Criteria:

• 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):

1. Absolute granulocyte count> 1.5 x 109 / L

2. Absolute platelet count> 100 x 109 / L

3. Hb> 10 g / dL

4. Cr <1.5 mg / dL or Clearance> 50mL / min

5. Bilirubin <3 ULN

6. AST / ALT ≤ 2.5 times ULN

Exclusion Criteria:

• No Covid confirmation

• No pneumonia

• Previous treatment with any of the study drugs

• Concomitant serious medical condition:

1. Congestive Heart failure

2. Acute myocardial infarction 6 months prior

3. Unstable Angina

4. Cardiomyopathy

5. Unstable Ventricular Arrhythmia

6. Uncontrolled Hypertension

7. Uncontrolled psychotic disorders

8. Serious active infections

9. HIV infections

10. Active hepatitis

11. Neoplasia in active cancer treatment

• Inability to take oral medication or malabsorption syndrome saw.

• Inability to comply with study and follow-up procedures

• History of only relevant thromboembolic or hemorrhagic episodes in the last 6 months

• Contraindication to any study medication

• Pregnant women