COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12620000417987.aspx

Scott Hahn

ADFMIDI.C4@defence.gov.au

2020-03-30

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Prevention

Participants eligible for inclusion in this study must fulfill all of the following criteria: 1. Completion of the written informed consent process (signed) with video recording of the verbal consent process, 2. 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), 3. Not previously diagnosed with COVID-19, 4. 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, 5. Possess an internet enabled smart phone capable of receiving and responding to alerts, 6. Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures, 7. Agrees not to self-medicate with chloroquine, hydroxychloroquine or other potential antivirals, and 8. 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.

Participants fulfilling any of the following criteria are not eligible for inclusion in this study: 1. History of allergy or intolerance to chloroquine, vitamin C or any excipients. 2. Contraindication to taking chloroquine as chemoprophylaxis e.g. known epileptic, creatinine clearance < 10 mL/min, known prolonged QT syndrome, diabetes. 3. 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. 4. 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. 5. 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.

3

Australian Defence Force Malaria and Infectious Disease Institute

18

64

Australia

Health workers

N/A

680

Number of sick days (SDS) during the study period: The number of sick days will be obtained from participants medical records as defined as the number of days deemed 'not fit for duty/work' by their reviewing medical professional; and will be compared between participants randomised to chloroquine and vitamin C.[12 weeks post-commencement of the IMP. Study to commence Apr 2020.]

Phase 4

[{"arm_notes": "", "treatment_id": 279, "treatment_name": "Chloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1369, "treatment_name": "Vitamin c", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]