Overview

Chloroquine as Antiviral Treatment in Coronavirus Infection 2020

Status:
Completed
Trial end date:
2020-12-17
Target enrollment:
0
Participant gender:
All
Summary
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 ambulatory patients with SARS-SoV-2 infection at particular risk of serious complications due to advanced age and/or comorbid conditions (in comparison with subjects not treated with CQ but receiving standard care and supervised telemedically).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Wroclaw Medical University
Treatments:
Chloroquine
Chloroquine diphosphate
Criteria
INCLUSION CRITERIA

1. age >=60 years OR age 18-59 years with one of the following conditions:

1. chronic lung disease

2. chronic cardiovascular disease

3. diabetes

4. malignancy diagnosed within 5 years prior to enrollment

5. history of chronic kidney disease

6. atrial fibrillation

7. past haemorrhagic stroke, ischemic stroke or transient CNS ischemia

8. obesity defined as BMI ≥ 30 kg / m2

9. 10-year risk of fatal cardiovascular disease

2. SARS-CoV-2 infection confirmed in RT-PCR (nasopharyngeal swab)

3. Hospitalization not required based on clinical judgement

4. Ability to participate in telemedical care

EXCLUSION CRITERIA

1. Lack of written informed consent

2. Possible failure to comply with the protocol

3. Chloroquine, hydroxychloroquine therapy within 30 days prior to enrollment

4. Antiviral therapy within 14 days prior to enrollment

5. Contraindications to chloroquine (pregnancy, breast-feeding, severe renal
insufficiency, amiodarone therapy, alcohol disease, haematological disorders,
epilepsia, porphyria, liver disease/cirrhosis, retinopathy, fainting/syncope,
myasthenia)

6. Hypersensitivity to chloroquine or drug excipients

7. HIV infection

8. Other relevant circumstances/conditions based on clinical judgement

9. Concurrent participation in another interventional clinical trial