COVID-19 (Coronavirus Disease 2019) MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Arechin
Product Name: Chlorine phosphate (Arechin)
Pharmaceutical Form: Tablet
INN or Proposed INN: CHLOROQUINE PHOSPHATE
CAS Number: 50-63-5
Other descriptive name: CHLOROQUINE PHOSPHATE
Sponsors
Wroclaw Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study will include 400 subjects meeting the following inclusion criteria: 1. Age = 60 years OR Age 18-59 with one of the following conditions: - chronic lung disease (defined as: previous diagnosis of chronic obstructive pulmonary disease, previous diagnosis of bronchial asthma, or previous diagnosis of another lung disease requiring chronic inhalation therapy) - chronic cardiovascular disease (defined as: previous diagnosis of heart failure, hypertension requiring pharmacotherapy, past myocardial infarction or any coronary revascularization) -diabetes requiring pharmacotherapy - malignancy diagnosed within 5 years prior to enrollment (excluding haematological neoplasms) after the application of radical treatment - history of chronic kidney disease (defined as eGFR according to the MDRD formula =65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: 1. No informed consent to participate in the study 2. Patient's inability to comply with the protocol in the investigator's evaluation 3. Administration of chloroquine or hydroxychloroquine in the last 30 days prior to inclusion in the study 4. Administration antiviral drugs in the last 14 days prior to inclusion in the study 5. Contraindications for the use of chloroquine phosphate: • Pregnancy or breastfeeding period • Kidney failure (eGFR<10mL/min/1.73m^2) • Cirrhosis or liver damage (AST or ALT or GGTP activity = 3xULN) • Alcoholic disease (any time) • History of Hematological diseases • History of Porphyria • History of Epilepsy diagnosed • History of myasthenia • History of Retinal diseases • Fainting or lapse into unconsciousness in the last year • Treatment with amiodarone in the last 3 months before inclusion 6. Hypersensitivity to the active substance (chloroquine phosphate) or to any of the excipients of Arechin 7. Infection with Human Immunodeficiency Virus (HIV) on the basis of medical history. 8. Abnormal laboratory tests results, medical events and any other circumstances (such as insufficient knowledge of Polish), which in the researcher's opinion may be harmful to the subject or prevent the study from being conducted in accordance with the protocol. 9. Participation in any another clinical trial in the last 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to evaluate whether the therapy with chloroquine phosphate (CQ, in combination with telemedical approach) in addition to standard care is effective and safe in reducing composite endpoint of COVID-19-related hospitalization or all cause death in 15-day observation, in ambulatory patients with SARS-SoV-2 infection (in comparison with subjects not treated with CQ but receiving standard care and supervised telemedically).;Secondary Objective: Not applicable;Primary end point(s): Hospitalisation due to COVID-19 or death for any cause in 15-day observation (up to and including the 15th study);Timepoint(s) of evaluation of this end point: Day 15 (the day after the 14-day treatment cycle) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints related to effectiveness: 1. no symptoms of COVID-19 in 15-day observation: o Fever o Tachycardia o Abnormal saturation o Cough o Dyspnea at rest o Dyspnea in small life activities o Chest compressions o Chest pain during inhalation/expiration o Headache o Sinus pain o Cold o Sore throat o General weakness o Pain or muscle weakness o Appetite deterioration o Olfactory deprivation o Flavour depreciation o Nausea or vomiting o Diarrhoea o Dizziness 2. No symptoms of COVID-19 in a 42-day or shorter observation for patients who did not have 42 days at the end of 15-day observation for the last patient on: o Fever o Tachycardia o Abnormal saturation o Cough o Dyspnea at rest o Dyspnea in small life activities o Chest compressions o Chest pain during inhalation/expiration o Headache o Sinus pain o Cold o Sore throat o General weakness o Pain or muscle weakness o Appetite deterioration o Olfactory deprivation o Flavour depreciation o Nausea or vomiting o Diarrhoea o Dizziness 3. No hospitalisation due to COVID-19 or death for any cause in a 42-day or shorter observation for patients for whom the 42-day or shorter observation has not passed at the end of the 15-day observation for the last patient included 4. No death for any cause in a 42-day or shorter observation for patients for whom 42 days have not passed at the end of a 15-day observation for the last patient included Secondary safety related endpoints: 1.Do not discontinue the drug due to side effects in 15-day observation. ;Timepoint(s) of evaluation of this end point: Days 1-1 | — |
Countries
Poland
Contacts
Public ContactClinical Trial Information Point
Wroclaw Medical University Prof. Ewa Jankowska
Outcome results
None listed