Clinical trial phase II to evaluate the efficacy of 3 types of treatment in patients with pneumonia by COVID-19
- Conditions
- Pneumonia due to SARS Cov2 (COVID-19)Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-001321-31-ES
- Lead Sponsor
- Hospital Universitario de Fuenlabrada
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 165
i. Signed informed consent form
ii. =18 years
iii. Confirmed diagnosis Pneumonia Covid19 +
iv. ECOG functional state 0 or 1
v. Less than 7 days from onset of symptoms
saw. NO contraindication for medication
vii. ECG QT <0.4
viii. 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 85
i. No Covid confirmation
ii. No pneumonia
iii. Previous treatment with any of the study drugs
iv. Concomitant serious medical condition
1. ICC
2. IAM 6 months prior
3. Unstable Angina
4. Cardiomyopathy
5. Unstable Ventricular Arrhythmia
6. uncontrolled HTA
7. Uncontrolled psychotic disorders
8. Serious active infections
9. HIV
10. Active hepatitis
11. Neoplasia in active cancer treatment
v. Inability to take oral medication or malabsorption syndrome
saw.
vi. Inability to comply with study and follow-up procedures
vii. History of only relevant thromboembolic or hemorrhagic episodes in the last 6 months
viii. Contraindication to any study medication
ix. Pregnant women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method