A randomized double-blind placebo-controlled trial of oral ivermectin for outpatient treatment of those at high risk for hospitalization due to COVID-19

Phase 3

• Conditions: SARS-CoV-2 (COVID-19),; Infection - Other infectious diseases; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12620000982910
• Lead Sponsor: euroscience Trials Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-30
• Last Update Posted: 1 February 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

•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 Criteria

•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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified