Status:
UNKNOWN
Clinical Trial to Evaluate Efficacy of 3 Types of Treatment in Patients With Pneumonia by COVID-19
Lead Sponsor:
Hospital Universitario de Fuenlabrada
Collaborating Sponsors:
Centro Nacional de Investigaciones Oncologicas CARLOS III
Conditions:
COVID-19 Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 desi...
Detailed Description
Identifying treatment options is critical to the SARS-CoV-2 outbreak response. Currently there is no vaccine and treatments used are not specifically designed for this virus; They are drugs used for o...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
May 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2021
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT04346147
Start Date
May 7 2020
End Date
September 1 2021
Last Update
August 3 2021
Active Locations (1)
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1
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain, 28942