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)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620000982910

Acronym

TPEP-Corona-1

Enrollment

400

Registered

2020-09-30

Start date

2021-02-15

Completion date

Unknown

Last updated

2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

50 Years to No maximum

Healthy volunteers

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.

Outcome results