SAR COV2 virus infection, without radiological affectation. MedDRA version: 20.0 Level: LLT Classification code 10051905 Term: Coronavirus infection System Organ Class: 100000004862 MedDRA version: 20.0 Level: PT Classification code 10070255 Term: Coronavirus test positive System Organ Class: 10022891 - Investigations
Conditions
Interventions
Product Name: hydroxychloroquine
Pharmaceutical Form: Tablet
INN or Proposed INN: Hydroxychloroquine
CAS Number: 118-42-3
Concentration unit: mg milligram(s)
Concentration type: range
Concentration nu
Sponsors
Institut Català d’Oncologia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient Cohort 1) Patients diagnosed with onco-haematological disease 2) Age: over 18 years old. 3) ECOG performance status 60%) 4) Life expectancy > 3 months for the neoplastic disease. 5) Patients with laboratory confirmed Covid-19 diagnosis (PCR) 6) Patients with clinical signs compatible with Covid-19: fever, cough, dyspnea. 7) Patients should have chest radiological imaging (plaque or CT scan) with no affectation compatible with Covid-19. 8) NIT-1-2 patients 9) Mild functional alteration of organs, defined as: - Calculated creatinine clearance > 30 ml/min - Bilirubin 1.0 x 109/l, lymphocytes > 0.5 x 109/l, platelets > 75 x 109/l, hemoglobin > 8 g/100ml. -PT and PTT: normal 10) To give informed consent in accordance with current legal regulations. Professional Cohort 1) Age: over 18 years old. 2) Diagnosis Covid-19 confirmed by laboratory (PCR) 3) They must have a chest X-ray image (plate or CT) with no Covid-19 compatible affectation. 4) Adequate organic function, defined as: - Calculated creatinine clearance > 30 ml/min. - Bilirubin 1.0 x 109/l, lymphocytes > 0.5 x 109/l, platelets > 75 x 109/l, hemoglobin > 8 g/100ml. - PT and PTT: normal 5) To give informed consent in accordance with current legal regulations. 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 43
Exclusion criteria
Exclusion criteria: Patient cohort and professional cohort ? Uncontrolled intercurrent disease including infections other than CoVID19, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric or social disorder that may limit study requirements ? To be receiving any other drug or product under study ? Allergy to one or more of the medications in the trial ? Chronic concomitant immunosuppressive medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of hydroxychloroquine in the treatment of SARS-COV2 infection in oncohaematological patients without radiological alteration and SARS-COV2 positive professionals without radiological alteration.;Secondary Objective: Evaluate the toxicity profile of the treatment.;Primary end point(s): Percentage of patients (cohort A) and professionals (cohort B) who achieve control of the disease without symptoms in 14 days, assessed by chest radiography without pneumonia.;Timepoint(s) of evaluation of this end point: 14 days after treatment initiation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety endpoints.;Timepoint(s) of evaluation of this end point: Throughout the study. | — |
Countries
Spain
Contacts
Public ContactMargarita García Martín
Institut Català d’Oncologia
Outcome results
None listed