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Chloroquine as Antiviral Treatment in Coronavirus Infection 2020

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ClinicalTrials.gov Identifier: NCT04331600
Recruitment Status : Recruiting
First Posted : April 2, 2020
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
Wroclaw Medical University

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).

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Chloroquine phosphate Other: Telemedicine Phase 4

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 Special hopes are placed in quinoline derivatives such as chloroquine (CQ), based on some unpublished data from China and a few experiments in vitro.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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 16, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Experimental: CHLOROQUINE
Standard of care + chloroquine phosphate + telemedical approach.
Drug: Chloroquine phosphate
Oral chloroquine phosphate for 14 days

Other: Telemedicine
Telemedical supervision for 42 days

CONTROL GROUP
Standard of care + telemedical approach.
Other: Telemedicine
Telemedical supervision for 42 days




Primary Outcome Measures :
  1. COVID-19-related hospitalization or all-cause death [ Time Frame: 15 days ]
    Composite endpoint of COVID-19-related hospitalization or all-cause death


Secondary Outcome Measures :
  1. Decrease in COVID-19 symptoms [ Time Frame: 15 days and 42 days ]
    Decrease in self-reported symptoms of novel coronavirus infection. Non-dichotomous symptoms (e.g. syncope is dichotomous - yes or no) such as dyspnoea will be self-evaluated by patients using the 0-3 scale with the severity increasing with the punctation (0-no symptoms, 1-mild symptoms, 2-moderate symptoms, 3-severe symptoms).

  2. Development of pneumonia [ Time Frame: 42 days ]
    Based on X-ray, microbiology and laboratory results

  3. Development of coronavirus infection-related complications [ Time Frame: 42 days ]
    Acute respiratory distress syndrome, bacterial infection, shock, sepsis, etc



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04331600


Contacts
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Contact: Marta Duda-Sikula, MBA 48 71 784 00 34 marta.duda-sikula@umed.wroc.pl

Locations
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Poland
Uniwersytecki Szpital Kliniczny Recruiting
Wrocław, Ul. Borowska 213, Poland, 50-556
Wielospecjalistyczny Szpital Miejski Recruiting
Poznań, Ul. Szwajcarska 3, Poland, 61-285
Sponsors and Collaborators
Wroclaw Medical University
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Responsible Party: Wroclaw Medical University
ClinicalTrials.gov Identifier: NCT04331600    
Other Study ID Numbers: WROCLAW CORONA STUDY 2020
First Posted: April 2, 2020    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Wroclaw Medical University:
COVID-19
Additional relevant MeSH terms:
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Chloroquine
Chloroquine diphosphate
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics