A randomized double-blind placebo-controlled trial of oral ivermectin for outpatient treatment of those at high risk for hospitalization due to COVID-19
A randomized double-blind placebo-controlled trial of oral ivermectin outpatient treatment, to prevent hospitalisation, of those at high risk for hospitalization due to SARS-CoV-2 (COVID-19)
Neuroscience Trials Australia
400 participants
Feb 15, 2021
Interventional
Conditions
Summary
A randomized double-blind placebo-controlled trial of oral ivermectin for outpatient treatment of those at high risk for hospitalization due to SARS-CoV-2.
Eligibility
Inclusion Criteria8
- 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.
Exclusion Criteria16
- 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.
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Interventions
The investigational product ivermectin will be administered at a dose of 200µg/kg on day 1. For participants who report at day 7 follow-up that their condition has not definitely improved a second dose may be dispensed. Mode of administration is oral tablet. Drug accountability will be performed by the dispensing pharmacy. Participants' will be in isolation and provide a self-report to determine if a second dose will be dispensed. The second dose will also be 200µg/kg.
Locations(1)
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ACTRN12620000982910