Status:
COMPLETED
Chloroquine as Antiviral Treatment in Coronavirus Infection 2020
Lead Sponsor:
Wroclaw Medical University
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 composi...
Detailed Description
Until now there are no evidence-based, good-quality data from sufficiently powered clinical trials supporting the use of any antiviral medicines or immunomodulatory therapies in the management or prop...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- age \>=60 years OR age 18-59 years with one of the following conditions:
- chronic lung disease
- chronic cardiovascular disease
- diabetes
- malignancy diagnosed within 5 years prior to enrollment
- history of chronic kidney disease
- atrial fibrillation
- past haemorrhagic stroke, ischemic stroke or transient CNS ischemia
- obesity defined as BMI ≥ 30 kg / m2
- 10-year risk of fatal cardiovascular disease
- SARS-CoV-2 infection confirmed in RT-PCR (nasopharyngeal swab)
- Hospitalization not required based on clinical judgement
- Ability to participate in telemedical care
- EXCLUSION CRITERIA
- Lack of written informed consent
- Possible failure to comply with the protocol
- Chloroquine, hydroxychloroquine therapy within 30 days prior to enrollment
- Antiviral therapy within 14 days prior to enrollment
- Contraindications to chloroquine (pregnancy, breast-feeding, severe renal insufficiency, amiodarone therapy, alcohol disease, haematological disorders, epilepsia, porphyria, liver disease/cirrhosis, retinopathy, fainting/syncope, myasthenia)
- Hypersensitivity to chloroquine or drug excipients
- HIV infection
- Other relevant circumstances/conditions based on clinical judgement
- Concurrent participation in another interventional clinical trial
Exclusion
Key Trial Info
Start Date :
April 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2020
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04331600
Start Date
April 16 2020
End Date
December 17 2020
Last Update
February 11 2021
Active Locations (2)
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1
Uniwersytecki Szpital Kliniczny
Wroclaw, Ul. Borowska 213, Poland, 50-556
2
Wielospecjalistyczny Szpital Miejski
Poznan, Ul. Szwajcarska 3, Poland, 61-285