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Trial registered on ANZCTR


Registration number
ACTRN12620000445976
Ethics application status
Approved
Date submitted
2/04/2020
Date registered
6/04/2020
Date last updated
15/05/2020
Date data sharing statement initially provided
6/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
To compare the effectiveness of two drugs (hydroxychloroquine and lopinavir/ritonavir alone or combined in treating hospitalized patients with confirmed COVID-19 compared to standard of care

Scientific title
Australasian COVID-19 Trial (ASCOT). A multi-centre randomised clinical trial to assess clinical, virological and immunological outcomes in patients with SARS-CoV-2 infection (COVID-19) treated with lopinavir/ritonavir and/or hydroxychloroquine compared to standard of care
Secondary ID [1] 300905 0
none
Universal Trial Number (UTN)
U1111-1250-5165
Trial acronym
ASCOT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 (SARS-CoV-2) 316847 0
Condition category
Condition code
Infection 315075 315075 0 0
Other infectious diseases
Respiratory 315105 315105 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention 1
Intervention Type: Drug
Intervention Administration: Oral
Intervention Name: Lopinavir/ritonavir
Intervention Description: Lopinavir (400mg)/ritonavir (100mg) twice daily for 10 days
Intervention Adherence: direct supervision while in hospital. Once home, adherence will be monitored through daily phone calls

Intervention 2
Intervention Type: Drug
Intervention Administration: Oral
Intervention Name: Hydroxychloroquine
Intervention Description: 800mg twice a day (4x200mg administered 12 hours apart) on Day 1, followed by 400mg twice a day for 6 days
Intervention Adherence: direct supervision while in hospital. Once home, adherence will be monitored through daily phone calls

Intervention 3
Intervention Type: Drug
Intervention Administration: Oral
Intervention Name: Lopinavir / ritonavir plus hydroxychloroquine
Intervention Description: Lopinavir (400mg)/ritonavir (100mg) twice daily for 10 days plus hydroxychloroquine 800mg twice a day (4x200mg administered 12 hours apart) on Day 1, followed by 400mg twice a day for 6 days
Intervention Adherence: direct supervision while in hospital. Once home, adherence will be monitored through daily phone calls

Intervention code [1] 317227 0
Treatment: Drugs
Comparator / control treatment
The control arm will receive usual routine medical care that all patients would receive if not part of this trial.

There is no specific medical care for patients diagnosed with COVID-19. Routine ususal medical care describes the care given by medical doctors to treat and control symptoms (i.e. medications for pain or oxygen therapy).
Control group
Active

Outcomes
Primary outcome [1] 323371 0
Proportion of participants alive and not having required intensive respiratory support (invasive or non-invasive ventilation or humidified high flow nasal oxygen flow) at 15 days after enrolment.

This outcome is assessed by the number of patients who are not admitted into the intensive care unit (ICU)

Timepoint [1] 323371 0
15 days after enrolment
Secondary outcome [1] 381687 0
WHO 7-point outcome scale (clinician assessed)

Based on the following clinical improvement scale:
1. Not hospitalized, no limitations on activities;
2. Not hospitalized, limitations on activities;
3. Hospitalized, not requiring supplemental oxygen;
4. Hospitalized, requiring supplemental oxygen;
5. Hospitalized, on non-invasive ventilation or high flow oxygen devices;
6. Hospitalized, on invasive mechanical ventilation or ECMO
7. Death
Timepoint [1] 381687 0
15 days post enrolment
Secondary outcome [2] 381688 0
Mortality at 7, 15, 28, 90 days


Timepoint [2] 381688 0
7, 15, 28, 90 days post enrolment
Secondary outcome [3] 381689 0
Time to death

Assessed by reviewing hospital medical records

Timepoint [3] 381689 0
Assessed up to 90 days post-enrolment
Secondary outcome [4] 381690 0
Length of hospital stay.

Assessed by reviewing hospital medical records
Timepoint [4] 381690 0
Discharge from hospital
Secondary outcome [5] 381691 0
Receipt of invasive or non-invasive ventilation in first 28 days

Assessed by reviewing hospital medical records

Timepoint [5] 381691 0
28 days post enrolment
Secondary outcome [6] 381725 0
Length of receipt of invasive or non-invasive ventilation

Assessed by reviewing hospital medical records
Timepoint [6] 381725 0
28 days post enrolment
Secondary outcome [7] 381726 0
Length of ICU stay

Assessed by reviewing hospital medical records
Timepoint [7] 381726 0
Release from ICU or death
Secondary outcome [8] 381727 0
Presence of chest infiltrates on CXR or CT at day 3 and day 7

Assessed by reviewing hospital medical records
Timepoint [8] 381727 0
3 and 7 days post enrolment
Secondary outcome [9] 381728 0
Time to defervescence from randomisation

Assessed by reviewing hospital medical records
Timepoint [9] 381728 0
Assessed up to 90 days post-enrolment
Secondary outcome [10] 381729 0
Biomarker levels – C-reactive protein (CRP)

Assessed by serum assays
Timepoint [10] 381729 0
Days 1, 3 and 7 post enrolment
Secondary outcome [11] 381730 0
Antibiotic use – number of days of use in first 10 days

Assessed by reviewing hospital medical records
Timepoint [11] 381730 0
10 days post enrolment
Secondary outcome [12] 381746 0
Safety. Any of the following adverse events in first 10 days.
- Diarrhoea – grade 2 or greater
- Nausea – grade 2 or greater
- Vomiting – grade 2 or greater
- Pancreatitis – grade 2 or greater
- QTc prolongation (>500ms) 24 hours following initial dose of study drugs

Assessed by reviewing hospital medical records
Timepoint [12] 381746 0
10 days post enrolment
Secondary outcome [13] 381747 0
Serious ventricular arrhythmia (including ventricular fibrillation) or sudden unexpected death in hospital

Assessed by reviewing hospital medical records
Timepoint [13] 381747 0
Assessed up to 90 days post-enrolment
Secondary outcome [14] 381749 0
Viral clearance. Proportion of patients with negative SARS-CoV-2 RT-PCR at day 3 and day 7 from upper or lower respiratory tract samples.

Assessed by throat swab assay
Timepoint [14] 381749 0
3 and 7 days post enrolment
Secondary outcome [15] 381778 0
Biomarker levels – Lactate dehydrogenase (LD or LDH)

Assessed by serum assays
Timepoint [15] 381778 0
Days 1, 3 and 7 post enrolment
Secondary outcome [16] 381779 0
Biomarker levels – D-Dimer

Assessed by serum assays
Timepoint [16] 381779 0
Days 1, 3 and 7 post enrolment

Eligibility
Key inclusion criteria
1. Age 18 years and over
2. Confirmed SARS-CoV-2 by nucleic acid testing in the past 12 days
3. Able to be randomised within 12 days of symptom onset
4. Expected to be remain an inpatient for at least 48 hours from the time of randomisation
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Currently admitted to an Intensive Care Unit (ICU)
2. Currently receiving intensive respiratory support (invasive or non-invasive ventilation or humidified high flow nasal oxygen)
3. Currently taking LPV/r OR hydroxychloroquine
4. Known allergy or hypersensitivity to LPV/r OR hydroxychloroquine
5. Use of medications that are contraindicated with LPV/r OR hydroxychloroquine that cannot be replaced or stopped during the study period. https://www.covid19-druginteractions.org/.
6. Currently on other investigational agents with targeted antiviral effects
7. Known cirrhosis or ALT or AST greater than 5x upper limit of normal
8. Previous participation in the trial
9. Known pregnancy
10. Known HIV infection not on antiretroviral therapy
11. QTc greater than or equal to 470 for males, QTc greater than or equal to 480 for females
12. Treating team deems enrolment in the study is not in the best interests of the patient
13. Unable to provide consent
14. Death is deemed to be imminent and inevitable within the next 24 hours

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised in a 1:1:1:1 ratio to the standard of care or treatment arms, where the randomisation schedule will be generated by an independent statistician. Randomisation will be stratified by site and will be in permuted blocks of variable block size. The randomised sequence allocation will only be accessible to the data management group and as outlined in the data management SOP.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Data will be reported in accordance with the CONSORT guidelines for reporting of randomised trials. Proportions will be compared between treatment groups with Fisher’s exact or X2 tests, and the absolute difference in proportions reported with corresponding 95% confidence intervals. All-cause mortality will be presented in a Kaplan-Meier graph.
The primary analysis of both primary and secondary endpoints will be according to modified intention to treat principles (all participants with data available for the endpoint will be analysed according to the treatment allocation, regardless of what treatment they received). No assumptions will be made about those with missing data.
A secondary per-protocol analysis of all endpoints will be conducted. The per protocol population is defined as 1) for the control group: did not receive any LPV/r or hydroxychloroquine; 2) for the intervention group: received at least 80% of possible doses of LPV/r; 3) has available data.
We will perform the following subgroup analyses:
1. Age 65 and greater OR less than 65 years. Early experience with SARS-CoV-2 infection is that older age is associated with poorer outcomes.
2. Receipt of study drug within or after 96 hours of symptom onset. There is biological plausibility that early treatment to reduce viral replication will be more effective than later treatment when pulmonary pathology may already be evident.
3. Mild vs moderate severity at presentation. Initial severity at presentation may predict the later clinical course and there may be a differential effect of antiviral treatment. The absolute improvement in clinical outcomes may be more evident in the moderate severity group due to a higher event rate.
a. Mild severity at presentation is defined as: SaO2 equals 95% or more on room air AND not requiring supplemental oxygen AND not tachypnoeic (respiratory rate less than 24 breaths/min)
b. Moderate severity at presentation is defined as SaO2 equals 94% or less on room air OR requiring supplemental oxygen OR tachypnoeic (respiratory rate 24 or more breaths/min)
4. Baseline use of ACE inhibitors or ATIII blockers. These medications affect the renin angiotensin aldosterone system pathway, which may also be affected by SARS-CoV-2, which uses ACE2 as its cellular receptor. Use of these medications may result in differential susceptibility to SARS-CoV-2 infection, with the direction of effect uncertain.
5. Those with baseline immunosuppression vs those without. These are different patient groups with regards to underlying comorbidities and risk for severe sepsis. Patients will be considered immunosuppressed if in receipt of immunosuppressing medication considered by the site investigator to be equivalent to 20 mg or greater of prednisolone for 2 or more weeks, or with a known haematological malignancy.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 16269 0
The Canberra Hospital - Garran
Recruitment hospital [2] 16270 0
Blacktown Hospital - Blacktown
Recruitment hospital [3] 16271 0
Concord Repatriation Hospital - Concord
Recruitment hospital [4] 16272 0
John Hunter Hospital - New Lambton
Recruitment hospital [5] 16273 0
Lismore Base Hospital - Lismore
Recruitment hospital [6] 16274 0
Liverpool Hospital - Liverpool
Recruitment hospital [7] 16275 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [8] 16276 0
Nepean Hospital - Kingswood
Recruitment hospital [9] 16277 0
Orange Health Service - Orange
Recruitment hospital [10] 16278 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [11] 16279 0
Prince of Wales Hospital - Randwick
Recruitment hospital [12] 16280 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [13] 16281 0
St George Hospital - Kogarah
Recruitment hospital [14] 16282 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [15] 16283 0
The Sutherland Hospital - Caringbah
Recruitment hospital [16] 16284 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [17] 16285 0
Wollongong Hospital - Wollongong
Recruitment hospital [18] 16286 0
Westmead Hospital - Westmead
Recruitment hospital [19] 16287 0
Armidale Rural Referral Hospital - Armidale
Recruitment hospital [20] 16288 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [21] 16289 0
Caboolture Hospital - Caboolture
Recruitment hospital [22] 16290 0
Cairns Base Hospital - Cairns
Recruitment hospital [23] 16291 0
Logan Hospital - Meadowbrook
Recruitment hospital [24] 16292 0
Mackay Base Hospital - Mackay
Recruitment hospital [25] 16293 0
Mater Sydney - North Sydney
Recruitment hospital [26] 16294 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [27] 16295 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [28] 16296 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [29] 16297 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [30] 16298 0
The Prince Charles Hospital - Chermside
Recruitment hospital [31] 16299 0
The Townsville Hospital - Douglas
Recruitment hospital [32] 16300 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [33] 16301 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [34] 16302 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [35] 16303 0
Launceston General Hospital - Launceston
Recruitment hospital [36] 16304 0
Royal Hobart Hospital - Hobart
Recruitment hospital [37] 16305 0
Armadale Kelmscott Memorial Hospital - Armadale
Recruitment hospital [38] 16306 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [39] 16307 0
Rockingham General Hospital - Cooloongup
Recruitment hospital [40] 16308 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [41] 16309 0
St John of God Hospital, Midland - Midland
Recruitment hospital [42] 16310 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [43] 16311 0
Royal Perth Hospital - Perth
Recruitment hospital [44] 16312 0
Albury Wodonga Health - Albury campus - Albury
Recruitment hospital [45] 16313 0
Albury Wodonga Health - Wodonga campus - Wodonga
Recruitment hospital [46] 16314 0
The Alfred - Melbourne
Recruitment hospital [47] 16318 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [48] 16319 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [49] 16320 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment hospital [50] 16321 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [51] 16322 0
Box Hill Hospital - Box Hill
Recruitment hospital [52] 16323 0
Epworth Freemasons (Clarendon Street) - East Melbourne
Recruitment hospital [53] 16324 0
Goulburn Valley Health - Shepparton campus - Shepparton
Recruitment hospital [54] 16325 0
Knox Private Hospital - Wantirna
Recruitment hospital [55] 16326 0
Latrobe Regional Hospital - Traralgon
Recruitment hospital [56] 16327 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment hospital [57] 16328 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [58] 16329 0
Dandenong Hospital - Dandenong
Recruitment hospital [59] 16330 0
Casey Hospital - Berwick
Recruitment hospital [60] 16331 0
The Northern Hospital - Epping
Recruitment hospital [61] 16332 0
Broadmeadows Health Service - Broadmeadows
Recruitment hospital [62] 16333 0
Bundoora Extended Care Centre - Bundoora
Recruitment hospital [63] 16334 0
Frankston Hospital - Frankston
Recruitment hospital [64] 16335 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [65] 16336 0
St John of God Hospital, Ballarat - Ballarat
Recruitment hospital [66] 16337 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [67] 16338 0
Footscray Hospital - Footscray
Recruitment hospital [68] 16339 0
Sunshine Hospital - St Albans
Recruitment hospital [69] 16340 0
West Gippsland Healthcare Group - Warragul
Recruitment postcode(s) [1] 29814 0
2605 - Garran
Recruitment postcode(s) [2] 29815 0
2148 - Blacktown
Recruitment postcode(s) [3] 29816 0
2139 - Concord
Recruitment postcode(s) [4] 29817 0
2305 - New Lambton
Recruitment postcode(s) [5] 29818 0
2480 - Lismore
Recruitment postcode(s) [6] 29819 0
2170 - Liverpool
Recruitment postcode(s) [7] 29820 0
2298 - Waratah
Recruitment postcode(s) [8] 29821 0
2747 - Kingswood
Recruitment postcode(s) [9] 29822 0
2800 - Orange
Recruitment postcode(s) [10] 29823 0
2444 - Port Macquarie
Recruitment postcode(s) [11] 29824 0
2031 - Randwick
Recruitment postcode(s) [12] 29825 0
2050 - Camperdown
Recruitment postcode(s) [13] 29826 0
2217 - Kogarah
Recruitment postcode(s) [14] 29827 0
2010 - Darlinghurst
Recruitment postcode(s) [15] 29828 0
2229 - Caringbah
Recruitment postcode(s) [16] 29829 0
2485 - Tweed Heads
Recruitment postcode(s) [17] 29830 0
2500 - Wollongong
Recruitment postcode(s) [18] 29831 0
2145 - Westmead
Recruitment postcode(s) [19] 29832 0
2350 - Armidale
Recruitment postcode(s) [20] 29833 0
0810 - Tiwi
Recruitment postcode(s) [21] 29834 0
4510 - Caboolture
Recruitment postcode(s) [22] 29835 0
4870 - Cairns
Recruitment postcode(s) [23] 29836 0
4131 - Meadowbrook
Recruitment postcode(s) [24] 29837 0
4740 - Mackay
Recruitment postcode(s) [25] 29838 0
2060 - North Sydney
Recruitment postcode(s) [26] 29839 0
4102 - Woolloongabba
Recruitment postcode(s) [27] 29840 0
4020 - Redcliffe
Recruitment postcode(s) [28] 29841 0
4029 - Herston
Recruitment postcode(s) [29] 29842 0
4575 - Birtinya
Recruitment postcode(s) [30] 29843 0
4032 - Chermside
Recruitment postcode(s) [31] 29844 0
4814 - Douglas
Recruitment postcode(s) [32] 29845 0
5042 - Bedford Park
Recruitment postcode(s) [33] 29846 0
5112 - Elizabeth Vale
Recruitment postcode(s) [34] 29847 0
5000 - Adelaide
Recruitment postcode(s) [35] 29848 0
7250 - Launceston
Recruitment postcode(s) [36] 29849 0
7000 - Hobart
Recruitment postcode(s) [37] 29850 0
6112 - Armadale
Recruitment postcode(s) [38] 29851 0
6150 - Murdoch
Recruitment postcode(s) [39] 29852 0
6168 - Cooloongup
Recruitment postcode(s) [40] 29853 0
6009 - Nedlands
Recruitment postcode(s) [41] 29854 0
6056 - Midland
Recruitment postcode(s) [42] 29855 0
6008 - Subiaco
Recruitment postcode(s) [43] 29856 0
6000 - Perth
Recruitment postcode(s) [44] 29857 0
2640 - Albury
Recruitment postcode(s) [45] 29858 0
3690 - Wodonga
Recruitment postcode(s) [46] 29859 0
3004 - Melbourne
Recruitment postcode(s) [47] 29863 0
3084 - Heidelberg
Recruitment postcode(s) [48] 29864 0
3220 - Geelong
Recruitment postcode(s) [49] 29865 0
3550 - Bendigo
Recruitment postcode(s) [50] 29866 0
3144 - Malvern
Recruitment postcode(s) [51] 29867 0
3128 - Box Hill
Recruitment postcode(s) [52] 29868 0
3002 - East Melbourne
Recruitment postcode(s) [53] 29869 0
3630 - Shepparton
Recruitment postcode(s) [54] 29870 0
3152 - Wantirna
Recruitment postcode(s) [55] 29871 0
3844 - Traralgon
Recruitment postcode(s) [56] 29872 0
3052 - Parkville
Recruitment postcode(s) [57] 29873 0
3168 - Clayton
Recruitment postcode(s) [58] 29874 0
3175 - Dandenong
Recruitment postcode(s) [59] 29875 0
3806 - Berwick
Recruitment postcode(s) [60] 29876 0
3076 - Epping
Recruitment postcode(s) [61] 29877 0
3047 - Broadmeadows
Recruitment postcode(s) [62] 29878 0
3083 - Bundoora
Recruitment postcode(s) [63] 29879 0
3199 - Frankston
Recruitment postcode(s) [64] 29880 0
3350 - Ballarat
Recruitment postcode(s) [65] 29881 0
3065 - Fitzroy
Recruitment postcode(s) [66] 29882 0
3011 - Footscray
Recruitment postcode(s) [67] 29883 0
3021 - St Albans
Recruitment postcode(s) [68] 29884 0
3820 - Warragul
Recruitment outside Australia
Country [1] 22462 0
New Zealand
State/province [1] 22462 0

Funding & Sponsors
Funding source category [1] 305377 0
University
Name [1] 305377 0
University of Melbourne
Address [1] 305377 0
Parkville, VIC 3010
Country [1] 305377 0
Australia
Funding source category [2] 305393 0
University
Name [2] 305393 0
University of Queensland
Address [2] 305393 0
Centre for Clinical Research
Building 71/918, Royal Brisbane Women's Campus
Herston, QLD 4029
Country [2] 305393 0
Australia
Funding source category [3] 305394 0
Other
Name [3] 305394 0
Hunter Medical Research Institute: a partnership between the University of Newcastle, Hunter New England Local Health District
Address [3] 305394 0
Lot 1, Kookaburra Cct
New Lambton Heights NSW 2305
Country [3] 305394 0
Australia
Funding source category [4] 305395 0
Charities/Societies/Foundations
Name [4] 305395 0
The Pratt Foundation
Address [4] 305395 0
Level 11, 2 Southbank Bvd
Southbank VIC 3006
Country [4] 305395 0
Australia
Funding source category [5] 305396 0
Charities/Societies/Foundations
Name [5] 305396 0
Royal Brisbane Women's Hospital Foundation
Address [5] 305396 0
Block 20, Royal Brisbane Women's Hospital
Butterfield St, Herston, QLD 4029
Country [5] 305396 0
Australia
Funding source category [6] 305397 0
Charities/Societies/Foundations
Name [6] 305397 0
Hospital Research Foundation
Address [6] 305397 0
60 Woodville Rd,
Woodville SA 5011
Country [6] 305397 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Parkville, VIC, 3050
Country
Australia
Secondary sponsor category [1] 305775 0
None
Name [1] 305775 0
Address [1] 305775 0
Country [1] 305775 0
Other collaborator category [1] 281261 0
Other Collaborative groups
Name [1] 281261 0
The Australasian Society for Infectious Diseases Clinical Research Network (ASID CRN)
Address [1] 281261 0
Suite 302, Level 3, 478 George Street
Sydney NSW 2000
Australia
Country [1] 281261 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305686 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 305686 0
Royal Melbourne Hospital Office for Research
CITY CAMPUS
Level 2
South West
300 Grattan Street
Parkville Victoria 3050
Ethics committee country [1] 305686 0
Australia
Date submitted for ethics approval [1] 305686 0
20/03/2020
Approval date [1] 305686 0
03/04/2020
Ethics approval number [1] 305686 0
HREC/62646/MH-2020

Summary
Brief summary
The study aims to assess clinical, virological and immunological outcomes in patients with SARS-CoV-2 infection (COVID-19) treated with lopinavir/ritonavir and/or hydroxychloroquine compared to standard of care
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101226 0
A/Prof Steven Tong
Address 101226 0
The Peter Doherty Institute for Infection and Immunity
792 Elizabeth Street
Melbourne, Victoria 3000
Country 101226 0
Australia
Phone 101226 0
+61 03 9342 9406
Fax 101226 0
Email 101226 0
steven.tong@unimelb.edu.au
Contact person for public queries
Name 101227 0
A/Prof Steven Tong
Address 101227 0
The Peter Doherty Institute for Infection and Immunity
792 Elizabeth Street
Melbourne, Victoria 3000
Country 101227 0
Australia
Phone 101227 0
+61 03 9342 9406
Fax 101227 0
Email 101227 0
ascot-team@unimelb.edu.au
Contact person for scientific queries
Name 101228 0
A/Prof Steven Tong
Address 101228 0
The Peter Doherty Institute for Infection and Immunity
792 Elizabeth Street
Melbourne, Victoria 3000
Country 101228 0
Australia
Phone 101228 0
+61 03 9342 9406
Fax 101228 0
Email 101228 0
steven.tong@unimelb.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
The trial steering committee will be the custodians of the final trial dataset. No-one outside the trial steering committee will be given access to the data without the permission of the trial steering committee. No identifying data will be given to any third parties at any stage.
What supporting documents are/will be available?
No other documents available
Summary results
No Results