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Trial registered on ANZCTR


Registration number
ACTRN12620000982910
Ethics application status
Approved
Date submitted
14/09/2020
Date registered
30/09/2020
Date last updated
27/01/2021
Date data sharing statement initially provided
30/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized double-blind placebo-controlled trial of oral ivermectin for outpatient treatment of those at high risk for hospitalization due to COVID-19
Scientific title
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)
Secondary ID [1] 302202 0
None
Universal Trial Number (UTN)
Trial acronym
TPEP-Corona-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 (COVID-19), 318891 0
Condition category
Condition code
Infection 316875 316875 0 0
Other infectious diseases
Respiratory 317081 317081 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 318495 0
Treatment: Drugs
Comparator / control treatment
Participants will be randomised 1:1 ivermection to placebo.
Placebo is an oral tablet.
Control group
Placebo

Outcomes
Primary outcome [1] 324980 0
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 treatment

This outcome will be assessed by telephone communication and medical record review.
Timepoint [1] 324980 0
• Day 14, where day 1 is the first day of treatment.
Secondary outcome [1] 386431 0
Composite secondary 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 in the two arms (ivermectin versus placebo)

Outcome will be assessed by telephone communication and medical record review.
Timepoint [1] 386431 0
On or before Day 7, Day 21, Day 28, where day 1 is the first day of treatment.
Secondary outcome [2] 386432 0
Composite secondary outcome
• The difference between the proportions of participants progressing to hospitalisation or death (for any reason) in the two arms (ivermectin versus placebo)

Outcome will be assessed by telephone communication and medical record review.
Timepoint [2] 386432 0
On or before: Day 7, Day 14, Day 21 or Day 28, where day 1 is the first day of treatment.
Secondary outcome [3] 386433 0
• The difference between the proportions of participants presentation to hospital with any of the following: clinical signs of respiratory distress (> 20 ) and/or oximetry desaturation (<=94%), clinical or radiological signs of pneumonia, in the two arms (ivermectin versus placebo)

Outcome will be assessed by telephone communication and medical record review.
Timepoint [3] 386433 0
On or before: Day 7, Day 14, Day 21 or Day 28, where day 1 is the first day of treatment.
Secondary outcome [4] 386434 0
Composite secondary outcome
• The difference between the proportions of participants progressing to admission to intensive care due to SARS-CoV-2 or death (for any reason), in the two arms (ivermectin versus placebo)

Outcome will be assessed by telephone communication and medical record review.
Timepoint [4] 386434 0
On or before: Day 7, Day 14, Day 21 or Day 28, where day 1 is the first day of treatment.
Secondary outcome [5] 386435 0
• The difference between the proportions of participants progressing to requirement for intubation because of SARS-CoV-2 or death, in the two arms (ivermectin versus placebo)

Outcome will be assessed by telephone communication and medical record review
Timepoint [5] 386435 0
*On or before: Day 7, Day 14, Day 21 or Day 28, where day 1 is the first day of treatment.
Secondary outcome [6] 386443 0
• The difference between the duration of hospitalization for those hospitalized in the two arms (ivermectin versus placebo)

Outcome will be assessed by telephone communication and medical record review
Timepoint [6] 386443 0
Before and after excluding those who died while still in hospital.
at Days 7, 14, 21, 28 and months 2,3,4,5 and 6, where day 1 is the first day of treatment
Secondary outcome [7] 386444 0
• The difference between the proportion of participants progressing to death (for any reason) in the two arms (ivermectin versus placebo)

Outcome will be assessed by telephone communication and medical record review
Timepoint [7] 386444 0
at Days 7, 14, 21, 28 and months 2,3,4,5 and 6, where day 1 is the first day of treatment
Secondary outcome [8] 386445 0
• The difference in the duration of outpatient symptoms amongst those who were not hospitalized and had not died in the two arms (ivermectin versus placebo)

Outcome will be assessed by telephone communication and medical record review. All symptoms will be collected.
Timepoint [8] 386445 0
at: Days 7, 14, 21 and 28, where day 1 is the first day of treatment.

Eligibility
Key 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.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/02/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 306623 0
Charities/Societies/Foundations
Name [1] 306623 0
The Leona M and Harry B Helmsley Charitable Trust (The United States of America).
Country [1] 306623 0
United States of America
Primary sponsor type
Other Collaborative groups
Name
Neuroscience Trials Australia
Address
30 Royal Parade
Parkville
Victoria 3052
Country
Australia
Secondary sponsor category [1] 307175 0
None
Name [1] 307175 0
Address [1] 307175 0
Country [1] 307175 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306808 0
Melbourne Health HREC
Ethics committee address [1] 306808 0
Ethics committee country [1] 306808 0
Australia
Date submitted for ethics approval [1] 306808 0
07/08/2020
Approval date [1] 306808 0
29/09/2020
Ethics approval number [1] 306808 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105082 0
Dr Mark Stein
Address 105082 0
Department of Diabetes and Endocrinology
Royal Melbourne Hospital
300 Grattan Street (corner of Royal Parade)
Victoria, 3050
Country 105082 0
Australia
Phone 105082 0
+61 3 9035 7269
Fax 105082 0
Email 105082 0
msteintpep1@florey.edu.au
Contact person for public queries
Name 105083 0
Michele Sallaberger
Address 105083 0
Neuroscience Trials Australia
30 Royal Parade
Parkville, Victoria, 3052
Country 105083 0
Australia
Phone 105083 0
+61 3 9035 7269
Fax 105083 0
Email 105083 0
TPEPCorona@florey.edu.au
Contact person for scientific queries
Name 105084 0
Mark Stein
Address 105084 0
Department of Diabetes and Endocrinology
Royal Melbourne Hospital
300 Grattan Street (corner of Royal Parade)
Victoria, 3050
Country 105084 0
Australia
Phone 105084 0
+61 3 9035 7269
Fax 105084 0
Email 105084 0
msteintpep1@florey.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.