Official Title
Multicenter, Randomized, Open-label, Non-commercial, Investigator-initiated Study to Evaluate the Efficacy and Safety of Chloroquine Phosphate in Combination With Telemedicine Care in the Risk Reduction of COVID-19 Related Hospitalization or Death, in Ambulatory Patients With COVID-19 Being at Risk of Serious Complications
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 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).

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 prophylaxis of COVID-19; however there are currently being initiated studies in
Europe and U.S., and a few registered studies are ongoing in China. Currently two groups of
medicines are hypothesized to be effective therapeutic options in COVID-19: (1) classical
antiviral drugs interfering with pathogen dissemination / replication, and (2) compounds
inhibiting host inflammatory reactions, especially (and potentially selectively) in
respiratory tract / system (cytokine inhibitors and specific antibodies). Special hopes are
placed in quinoline derivatives such as chloroquine (CQ), based on some unpublished data from
China and a few experiments in vitro. CQ is an old antimalarial drug that has been used for
more than 50 years in the therapy and prevention of this parasitosis. Anti-inflammatory
features of quinolone derivatives such as CQ or hydroxychloroquine have also been used in
rheumatology (for the therapy of lupus erythematosus or rheumatoid arthritis) due to the
inhibition of the production of proinflammatory cytokines. The effectiveness (and safety) of
CQ in COVID-19 has not been investigated in sufficiently powered RCTs until now.

Completed
COVID-19

Drug: Chloroquine phosphate

Oral chloroquine phosphate for 14 days

Other: Telemedicine

Telemedical supervision for 42 days

Eligibility 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Poland
Locations

Uniwersytecki Szpital Kliniczny
Wrocław, Ul. Borowska 213, Poland

Wielospecjalistyczny Szpital Miejski
Poznań, Ul. Szwajcarska 3, Poland

Wroclaw Medical University
NCT Number
Keywords
Covid-19
MeSH Terms
COVID-19
Chloroquine
Chloroquine diphosphate