A multicenter, open, randomized, non-commercial study to evaluate the efficacy and safety of chloroquine phosphate in the outpatient treatment of COVID-19 in combination with telemedicine care for patients with SARS-CoV-2 infection with the risk of developing complications to reduce the risk of COVID-19-related hospitalization and death.

Phase 1

• Conditions: COVID-19 (Coronavirus Disease 2019); MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001469-35-PL
• Lead Sponsor: Wroclaw Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-08
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

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 <60 ml/min / 1.73m2)
- atrial fibrillation (any type found in the past or now)
- haemorrhagic stroke, ischemic stroke or transient cerebral ischemia
- obesity defined as BMI = 30 kg / m2
- 10-year risk of fatal CVD in populations at high CVD risk based on the following risk factors: age, gender, smoking status, systolic blood pressure, total cholesterol - SCORE (Systematic COronary Risk Evaluation) = 10%
2. SARS-CoV-2 infection (positive PR-PCR test for SARS-CoV-2)
3. Indication for treatment at home isolation or public isolation
centre
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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

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.

Study & Design

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