Pneumonia due to SARS Cov2 (COVID-19)
Conditions
Interventions
Trade Name: Dolquine
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Dolquine
CAS Number: 747-36-4
Other descriptive name: HYDROXYCHLOROQUINE SULFATE
Concentration unit: mg milligram(s)
Concen
Sponsors
Hospital Universitario de Fuenlabrada
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 1.5 x 109 / L 2. Absolute platelet count> 100 x 109 / L 3. Hb> 10 g / dL 4. Cr 50mL / min 5. Bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 85
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare and evaluate the efficacy of 3 treatment regimens (Hydroxychloroquine in combination with baricitinib, imatinib or lopinavir / ritonavir) in SARS-CoV-2 patients with severe pneumonia requiring admission, considering primary efficacy as time to clinical improvement.;Secondary Objective: To assess the safety (serious adverse effects, premature discontinuation of treatment), tolerability and secondary efficacy parameters of the 3 treatment guidelines, understood as: absence of progression to respiratory failure, absence of increased O2 requirements; need for mechanical ventilation; reduction of analytical parameters associated with poor prognosis; radiological progression of the disease on day + 7 of starting treatment; average hospital stay, intensification treatments, such as steroid boluses and tocilizumab, ICU admission,% mortality at the end of follow-up. In addition, in those patients who consent and participate in an additional sub-study, possible biomarkers and genetic markers of susceptibility to SARS-CoV-2 will be evaluated using high-performance techniques with serum DNA from the participants.;Primary end point(s): 8.1 Demographics Age Sex Tobacco Alcohol Significant comorbidity - HTA - Cardiovascular disease - DM - COPD - Cancer - Chronic liver disease - I kidney - Known immunosuppression 8.2 Laboratory parameters COVID BIOMARKERS - PCR - Procalcitonin - LDH - Dimero D -Ferritin - IL6 BIOCHEMICAL PARAMETERS - Enzymatic creatinine - ALT - AST - Bilirubin - GGT - F Alkaline - Albumine - Venous lactate - Ultrasensitive Troponin I - Creatin Kinasa (CK) HEMATOLOGICAL PARAMETERS - White Series - Leukocytes (in absolute value) - Neutrophils (in absolute value) - Lymphocytes (in absolute value) - Neutrophil / lymphocyte ratio - Platelet / lymphocyte ratio - Red Series - erythrocytes - Hb - Platelets - Coagulation - Fibrinogen - Coagulation Study MICROBIOLOGICAL PARAMETERS - SARS-Cov2 PCR in nasopharyngeal exudate 8.3 Radiodiagnosis - | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Security variable. The intensity of an AA will be classified according to version 5.0 of the NCI CTCAE. https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_5x7.pdf;Timepoint(s) of evaluation of this end point: Baseline, 7 days during treatment, day 14, day 35+/-5 and day 70+/- | — |
Countries
Spain
Contacts
Public ContactComisión de Investigación
Hospital Universitario de Fuenlabrada
Outcome results
None listed