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Chloroquine as Antiviral Treatment in Coronavirus Infection 2020

Sponsor
Wroclaw Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT04331600
Collaborator
(none)
16
Enrollment
2
Locations
2
Arms
8
Actual Duration (Months)
8
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

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 Special hopes are placed in quinoline derivatives such as chloroquine (CQ), based on some unpublished data from China and a few experiments in vitro.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

Study Design

Study Type:
Interventional
Actual Enrollment :
16 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 :
Apr 16, 2020
Actual Primary Completion Date :
Dec 17, 2020
Actual Study Completion Date :
Dec 17, 2020

Arms and Interventions

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
Other: CONTROL GROUP

Standard of care + telemedical approach.

Other: Telemedicine
Telemedical supervision for 42 days

Outcome Measures

Primary Outcome Measures

  1. COVID-19-related hospitalization or all-cause death [15 days]

    Composite endpoint of COVID-19-related hospitalization or all-cause death

Secondary Outcome Measures

  1. Decrease in COVID-19 symptoms [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 [42 days]

    Based on X-ray, microbiology and laboratory results

  3. Development of coronavirus infection-related complications [42 days]

    Acute respiratory distress syndrome, bacterial infection, shock, sepsis, etc

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

INCLUSION CRITERIA

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

  2. chronic lung disease

  3. chronic cardiovascular disease

  4. diabetes

  5. malignancy diagnosed within 5 years prior to enrollment

  6. history of chronic kidney disease

  7. atrial fibrillation

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

  9. obesity defined as BMI ≥ 30 kg / m2

  10. 10-year risk of fatal cardiovascular disease

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

  12. Hospitalization not required based on clinical judgement

  13. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Uniwersytecki Szpital Kliniczny Wrocław Ul. Borowska 213 Poland 50-556
2 Wielospecjalistyczny Szpital Miejski Poznań Ul. Szwajcarska 3 Poland 61-285

Sponsors and Collaborators

  • Wroclaw Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wroclaw Medical University
ClinicalTrials.gov Identifier:
NCT04331600
Other Study ID Numbers:
  • WROCLAW CORONA STUDY 2020
First Posted:
Apr 2, 2020
Last Update Posted:
Feb 11, 2021
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
COVID-19
Chloroquine
Chloroquine diphosphate

Study Results

No Results Posted as of Feb 11, 2021