COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12620000982910.aspx

Mark Stein

msteintpep1@florey.edu.au

2020-09-30

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

• People aged 50 years and over who have tested positive for SARS-CoV-2 (by any NAAT/PCR based testing system recognised by public health authorities) within the preceding 12 days • Are still symptomatic or have not yet developed symptoms • Have any of the following risk factors: take medication for high blood pressure, take medication (oral or injectable) for blood glucose control, take medication for heart disease, take medication (oral or inhaled) for lung disease, currently smoke. • Are residing in the community • Have at their current place of residence (that is, at the location they are maintained in isolation) communication facilities necessary for trial functioning. These are: - Reliable mobile and/or landline phone access - reliable access to email • Capable of giving informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

• Duration of symptoms 10 days or more AND symptoms clearly getting better. • Residents in an aged care facility (hostel or nursing home) or quarantine hotel. • Not usually fully independent in activities of daily living and self-care including: washing, toileting, dressing and dental care. • Current residence outside logistical boundaries of the study as defined from time to time during recruitment. • Self reported severe liver disease and/or cirrhosis • Use of warfarin. • Known allergy to Ivermectin • Fit, seizure or stroke in the last 6 months. • Dementia of any type • Head injury requiring medical attention in the last 6 months • Concussion in the last 6 months • Current use of any of the following medications: verapamil, ciclosporin, cobicistat, ritonavir, ketoconazole, itraconazole, fusidic acid, erythromycin, clarithromycin. • Current use or use within the last 3 months of the medication: amiodarone • Psychosocial illness which in the opinion of the investigative team would make successful trial completion (including follow up data collection) unlikely, for example including: uncontrolled substance use, homelessness, poorly controlled mental state disorder. • Inability to communicate in English to the level necessary to provide verbal consent and phone call follow up data. • Current participation in another clinical drug trial for SARS-CoV-2.

2

Neuroscience Trials Australia

50

100

Australia

Mild disease at enrollment

1: Mild disease at enrollment

400

Composite Primary Outcome• The difference between the proportions of participants progressing to hospitalisation due to SARS-CoV-2 or death (for any reason); if it occurs without hospitalisation; on or before Day 14; in the two arms (ivermectin versus placebo)• For primary and secondary endpoint definitions; hospitalisation is defined as hospitalisation for at least 24 hours duration; or death should it occur within that 24 hours. Hospitalisation does not include hospital in the home and Day 1 is day of 1st treatmentThis outcome will be assessed by telephone communication and medical record review.[• Day 14; where day 1 is the first day of treatment.]

Phase 3

[{"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]