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TerminatedPhase 4ACTRN12620000417987

Chloroquine Chemorophylaxis Countermeasure against COVID-19

Multi-Site, Randomized, Open-Label, Parallel-Group, Placebo-Controlled Study to Assess the Chemoprophylactic Efficacy of Chloroquine Against SARS-CoV-2/COVID-19 in Healthcare Workers at High-Risk of Exposure

Sponsor

Australian Defence Force Malaria and Infectious Disease Institute

Enrollment

680 participants

Start Date

Apr 3, 2020

Study Type

Interventional

Conditions

COVID-19 Infection

Summary

This study is investigating the efficacy of chloroquine phosphate as a phophylactic against SARS-CoV-2 in health care workers at high risk of exposure.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 64 Yearss

Inclusion Criteria9

  • Participants eligible for inclusion in this study must fulfill all of the following criteria:
  • Completion of the written informed consent process (signed) with video recording of the verbal consent process;
  • Male or female age 18 to 64 years inclusive, in general good health equivalent to Army Medical Employment Classification J22 or above. Civilian personnel would need to be in good general health as advised by their General Practitioner (GP);
  • Not previously diagnosed with COVID-19;
  • Participant works in/in association with a healthcare facility or other high-risk environment characterised by high level of contact with persons thought likely to be infected with respiratory viruses;
  • Possess an internet enabled smart phone capable of receiving and responding to alerts;
  • Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures;
  • Agrees not to self-medicate with chloroquine, hydroxychloroquine or other potential antivirals; and
  • Agree to stay in contact with the study site for the duration of the study and up to 2 weeks following the EOS visit (unless deployed), provide updated contact information as necessary.

Exclusion Criteria7

  • Participants fulfilling any of the following criteria are not eligible for inclusion in this study:
  • History of allergy or intolerance to chloroquine, vitamin C or any excipients.
  • Contraindication to taking chloroquine as chemoprophylaxis e.g. known epileptic, creatinine clearance < 10 mL/min, known prolonged QT syndrome, diabetes.
  • Those having previously received hydroxychloroquine for skin conditions or rheumatological diseases, chloroquine for malaria, tamoxifen, amiodarone or other drugs that may affect the retina within 30 days or 5 half-lives (whichever is longer) of study start.
  • Taking a concomitant medication (abiraterone acetate, agalsidase, amodiaquine, conivaptan, dabrafenib, dacomitinib, dapsone (systemic), enzalutamide, fusidic acid (systemic), idealisib, lanthanum, lumefantrine, mefloquine, MiFEPRIStone, Mitotane, Pimozide, QT-prolonging agents, or stiripentol) which cannot be safely stopped.
  • Participants who, in the opinion of the Investigator, do not have the ability to complete the study.
  • For other eligibility criteria considerations, the Investigator is referred to the IB (ADFMIDI IB) for detailed information regarding warnings, precautions, contraindications, AEs, and other significant data pertaining to the use of chloroquine.

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Interventions

Oral 500mg chloroquine phosphate tablets prophylactic weekly regimen against COVID-19 over 10 week trial period followed with plasma chloroquine levels.

Oral 500mg chloroquine phosphate tablets prophylactic weekly regimen against COVID-19 over 10 week trial period followed with plasma chloroquine levels.

Locations(1)

QLD, Australia

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ACTRN12620000417987

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