Pragmatic clinical trial of hydroxychloroquine in the treatment of oncohematological patients and health professionals with COVID-19 infection without radiological alteration.

Phase 1

• Conditions: SAR COV2 virus infection, without radiological affectation.; MedDRA version: 20.0Level: LLTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 100000004862; MedDRA version: 20.0Level: PTClassification code 10070255Term: Coronavirus test positiveSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001765-37-ES
• Lead Sponsor: Institut Català d’Oncologia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-13
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

Patient Cohort
1) Patients diagnosed with onco-haematological disease
2) Age: over 18 years old.
3) ECOG performance status < 2 (Karnofsky>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 < 25 µmol/l (1.5 mg/dl)
- AST/ALT < 2.5 times upper limit of the centre's normality
- Alkaline phosphatase < 2.5 times upper limit of centre's normality
- Normal spinal function: Hematology: neutrophils > 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 < 25 µmol/l (1.5 mg/dl)
- AST/ALT < 2.5 times upper limit of the centre's normality
- Alkaline phosphatase < 2.5 times upper limit of centre's normality
-Normal spinal function: Hematology: neutrophils > 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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified