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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
4/02/2021
Date data sharing statement initially provided
6/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Australasian COVID-19 Trial: An Adaptive Platform Trial (ASCOT-ADAPT). A multi-centre randomised adaptive platform clinical trial to assess clinical, virological and immunological outcomes in patients with SARS-CoV-2 infection (COVID-19)
Scientific title
Australasian COVID-19 Trial: An Adaptive Platform Trial (ASCOT-ADAPT). An International Multi-Centre Randomised Adaptive Platform Clinical Trial to Assess Different Treatment Regimens on the Clinical, Virological and Immunological Outcomes in Patients Diagnosed with SARS-CoV-2 Infection (COVID-19).
Secondary ID [1] 300905 0
none
Universal Trial Number (UTN)
U1111-1250-5165
Trial acronym
ASCOT-ADAPT
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
Treatments in ASCOT ADAPT are divided into different intervention domains. Depending on eligibility and availability of the invention at participating sites, participants are randomised to receive one intervention from each domain, and therefore, can receive a combination of treatments.

Domain A - Antiviral Interventions:
Intervention 1A
Intervention Type: Drug
Intervention Administration: Intravenous infusion
Intervention Name: Nafamostat
Intervention Description: Continuous infusion of nafamostat (0.2mg/kg/hr) for 7 days or until hospital discharge (whichever is earlier).
Intervention Adherence: direct supervision while in hospital.

Intervention 2A
Intervention Type: Other
Intervention Administration: Various
Intervention Name: Standard of care
Intervention Description: Routine usual medical care given by medical doctors to treat and control symptoms (i.e. medications for pain or oxygen therapy) of COVID-19.
Intervention Adherence: direct supervision while in hospital.

Domain B - Therapeutic Antibody Interventions:
Intervention 1B
Intervention Type: Biological
Intervention Administration: Intravenous infusion
Intervention Name: Convalescent plasma
Intervention Description: 2 units of (250-310mL) ABO compatible convalescent plasma given within 48 hours of commencement of initial infusion (minimum 12 hours between infusions).
Intervention Adherence: direct supervision while in hospital.

Intervention 2B
Intervention Type: Other
Intervention Administration: Various
Intervention Name: Standard of care
Intervention Description: Routine usual medical care without antibody therapies, given by medical doctors to treat and control symptoms (i.e. medications for pain or oxygen therapy) of COVID-19.
Intervention Adherence: direct supervision while in hospital.

Domain C - Anticoagulation Interventions:
Intervention 1C
Intervention Type: Drug
Intervention Administration: Injection
Intervention Name: Standard dose thromboprophylaxis.
Intervention Description: Standard dose of low molecular weight heparin (LMWH) daily until hospital discharge, admission to intensive care unit (ICU) or for a maximum of 28 days from randomisation. Choice of LMWH according to availability and local practice at the participating site, including Enoxaparin (dose 20mg if <50kg, 40mg if 50-120kg, 60mg if >120kg q24h), Tinzaparin (dose 75IU/kg q24h) or Dalteparin (dose 2500IU if <40kg, 5000IU if 40-120kg, 7500IU if >120kg q24h)
Intervention Adherence: direct supervision while in hospital.

Intervention 2C
Intervention Type: Drug
Intervention Administration: Injection
Intervention Name: Intermediate dose thromboprophylaxis.
Intervention Description: Intermediate dose of LMWH daily until hospital discharge, admission to ICU or for a maximum of 28 days from randomisation. Choice of LMWH according to availability and local practice at the participating site, including Enoxaparin (dose 40mg q24h if <50kg, 40mg q12h or 80mg q24h if 50-120kg, 60mg q12h or 120mg q24h if >120kg), Tinzaparin (dose 125IU/kg/day) or Dalteparin (dose 5000IU q24h if <40kg, 5000IU q12h or 10,000IU q24h if 40-120kg, 7500IU q12h or 15,000IU q24h if >120kg)
Intervention Adherence: direct supervision while in hospital.

Intervention 3C
Intervention Type: Drug
Intervention Administration: Injection and oral
Intervention Name: Standard dose thromboprophylaxis plus aspirin
Intervention Description: Standard dose of LMWH and 100mg aspirin daily until hospital discharge, admission to ICU or for a maximum of 28 days from randomisation. Choice of LMWH according to availability and local practice at the participating site, including Enoxaparin (dose 20mg if <50kg, 40mg if 50-120kg, 60mg if >120kg q24h), Tinzaparin (dose 75IU/kg q24h) or Dalteparin (dose 2500IU if <40kg, 5000IU if 40-120kg, 7500IU if >120kg q24h)
Intervention Adherence: direct supervision while in hospital.
Intervention code [1] 317227 0
Treatment: Drugs
Intervention code [2] 319059 0
Treatment: Other
Comparator / control treatment
Treatment contrasts will be:
-Superiority: Intervention is better than alternative interventions within a domain
-Effectiveness: Intervention is better than standard of care
-Futility: Intervention is insufficiently better than standard of care or insufficiently better than another reference treatment
Control group
Active

Outcomes
Primary outcome [1] 323371 0
Death from any cause or requirement of new intensive respiratory support (invasive or non-invasive ventilation) or vasopressor/inotropic support in the 28 days after randomisation. This includes any participant who receives non-invasive mechanical ventilation (either CPAP or BIPAP, apart from the below considerations) any time after enrolment even if not transferred to ICU. It does NOT include the use of humidified high-flow nasal prong oxygen.
Participants on pre-existing home BiPAP or CPAP will not be considered to have met the primary outcome unless they have either
i) required invasive mechanical ventilation (i.e. intubation), or
ii) graduated from CPAP only whilst asleep to BiPAP at any time, or
iii) graduated from BiPAP only whilst asleep to BiPAP for >12 hours/day, or
iv) died by day 28
Timepoint [1] 323371 0
28 days after randomisation
Secondary outcome [1] 381687 0
Core secondary outcome:

WHO 8-point outcome scale (clinician assessed)

Based on the following clinical improvement scale:
1) Not hospitalised, no limitations on activities;
2) Not hospitalised, limitations on activities;
3) Hospitalised, not requiring supplemental oxygen and no longer requiring ongoing medical care (used if hospitalization was extended for infection control purposes);
4) Hospitalised, not requiring supplemental oxygen but requiring ongoing medical care (COVID-19 related or other medical conditions);
5) Hospitalised, requiring supplemental oxygen;
6) Hospitalised, on non-invasive ventilation or high flow oxygen devices;
7) Hospitalised, on invasive mechanical ventilation or ECMO;
8) Death

Admission to a Hospital in the Home unit is not counted as hospitalisation for the purposes of this ordinal scale. Patients who have been admitted to hospital and transferred to a Hospital in the Home unit will be assessed as either ordinal score 1 or 2.
Timepoint [1] 381687 0
28 days after randomisation
Secondary outcome [2] 381688 0
Core secondary outcome:

All-cause mortality
Timepoint [2] 381688 0
28 and 90 days after randomisation
Secondary outcome [3] 381690 0
Core secondary outcome:

Days alive and free of hospital

Days spent in a Hospital in the Home unit will not be counted as days in hospital, as hospital means ‘acute-care hospital’ for the purposes of this endpoint.
Timepoint [3] 381690 0
By 28 days after randomisation
Secondary outcome [4] 381725 0
Core secondary outcome:

Days alive and free of invasive or non-invasive ventilation
Timepoint [4] 381725 0
By 28 days after randomisation
Secondary outcome [5] 381749 0
Antiviral domain-specific secondary outcome:

Viral clearance. Proportion of patients with negative SARS-CoV-2 RT-PCR at day 3 (post randomisation) and day 7 from upper or lower respiratory tract samples, for those with results available.
Timepoint [5] 381749 0
Day 3 and day 7 post randomisation
Secondary outcome [6] 388871 0
Antibody domain-specific secondary outcome:

Confirmed arterial thrombosis (acute myocardial infarction, ischemic cerebrovascular event, other) as assessed by patient medical records.
Timepoint [6] 388871 0
Up to day 28
Secondary outcome [7] 391446 0
Antibody domain-specific secondary outcome:

Haemolysis - defined as fever and other symptoms/signs of haemolysis confirmed by one or more of the following:
• Fall of haemoglobin
• Rise in lactic dehydrogenase
• Rise in bilirubin
• Positive direct antiglobulin test
• Positive crossmatch Haemolysis within 72 hours

Assessed using patient medical records.

Timepoint [7] 391446 0
Within 72 hours of last transfusion
Secondary outcome [8] 391447 0
Antibody domain-specific secondary outcome:

Occurrence of any of the following serious treatment-related adverse events (assessed via medical records):
1) Serious allergic reaction or anaphylaxis;
2) Transfusion-related acute lung injury (TRALI);
3) Transfusion-associated circulatory overload (TACO);
4) Acute haemolytic transfusion reaction.
Timepoint [8] 391447 0
Within 24 hours of intervention administration
Secondary outcome [9] 391448 0
Antiviral domain-specific secondary outcome:

Viral load. Changes in cycle threshold value in RT-PCR for SARS-CoV-2 from baseline to day 3 and from baseline to day 7, for those with results available from the same respiratory tract sample type.
Timepoint [9] 391448 0
Baseline and Day 3 and day 7 post randomisation
Secondary outcome [10] 391449 0
Antiviral domain-specific secondary outcome:

Safety:
Elevation of Alanine Transaminase (ALT) or Aspartate Transaminase (AST) to >5x upper limit of normal assessed via medical records
Timepoint [10] 391449 0
At any time while admitted to hospital (censored at day of discharge)
Secondary outcome [11] 391450 0
Anticoagulation domain-specific secondary outcome:
Confirmed deep venous thrombosis, assessed via medical records.

Timepoint [11] 391450 0
Up to day 28 post randomisation
Secondary outcome [12] 391451 0
Anticoagulation domain-specific secondary outcome:

Heparin-induced thrombocytopenia assessed via medical records.
Timepoint [12] 391451 0
During index hospitalisation, up to day 28 post randomisation.
Secondary outcome [13] 391452 0
Core secondary outcome:

Time to clinical recovery.

Time to clinical recovery is defined as the first day, during the 28 days after enrolment, on which a patient satisfies categories 1, 2, or 3 on the WHO eight-point ordinal outcome scale. For the purposes of this outcome measure, it will be assumed that the participant is not hospitalised on the first day following discharge.
Timepoint [13] 391452 0
up to 28 days after randomisation
Secondary outcome [14] 391453 0
Core secondary outcome:

Presence of patient-reported outcome of shortness of breath.

1. Dichotomous comparison of a subjective measure of shortness of breath such as: “Are you currently experiencing shortness of breath that you didn’t have before you got COVID, or which is worse now than before you got COVID?”

2. Ordinal comparison of the modified Medical Research Council (mMRC) breathlessness scale:
0=I only get breathless with strenuous exercise;
1=I get short of breath when hurrying on level ground or walking up a slight hill;
2=On level ground, I walk slower than people of the same age because of breathlessness, or I have to stop for breath when walking at my own pace on the level;
3=I stop for breath after walking about 100 metres or after a few minutes on level ground;
4=I am too breathless to leave the house or I am breathless when dressing or undressing
Timepoint [14] 391453 0
Day 28 and day 90 after randomisation
Secondary outcome [15] 391454 0
Core secondary outcome:

Quality of life as measured by EQ-5D-5L questionnaire
Timepoint [15] 391454 0
Day 28 and day 90 after randomisation
Secondary outcome [16] 391455 0
Antibody domain-specific secondary outcome:

Confirmed venous thrombosis (deep vein thrombosis, pulmonary embolus, other) as assessed by patient medical records.
Timepoint [16] 391455 0
Up to day 28
Secondary outcome [17] 391456 0
Antiviral domain-specific secondary outcome:

Safety:
Elevation of serum potassium to >5.5 mmol/L (assessed via medical records)
Timepoint [17] 391456 0
While admitted to hospital (censored at day of discharge).
Secondary outcome [18] 391457 0
Antiviral domain-specific secondary outcome:

Safety:
Decrease of serum sodium to <125 mmol/L (assessed via medical records)
Timepoint [18] 391457 0
While admitted to hospital (censored at day of discharge)
Secondary outcome [19] 391458 0
Antiviral domain-specific secondary outcome:

Safety:
Major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH; assessed via medical records)
Timepoint [19] 391458 0
While admitted to hospital (censored on day of discharge)
Secondary outcome [20] 391459 0
Antiviral domain-specific secondary outcome:

Safety:
Thrombophlebitis/vasculitis at IV line site (assessed via medical records).
Timepoint [20] 391459 0
While admitted to hospital (censored on day of discharge)
Secondary outcome [21] 391460 0
Anticoagulation domain-specific secondary outcome:
Confirmed pulmonary embolus assessed via medical records.
Timepoint [21] 391460 0
Up to 28 days after randomisation
Secondary outcome [22] 391461 0
Anticoagulation domain-specific secondary outcome:
Confirmed acute myocardial infarction assessed via medical records.
Timepoint [22] 391461 0
Up to 28 days after randomisation.
Secondary outcome [23] 391462 0
Anticoagulation domain-specific secondary outcome:
Confirmed ischemic cerebrovascular event assessed via medical records.
Timepoint [23] 391462 0
Up to 28 days after randomisation
Secondary outcome [24] 391463 0
Anticoagulation domain-specific secondary outcome:
Confirmed deep vein thrombosis assessed via medical records.
Timepoint [24] 391463 0
Up to 28 days after randomisation
Secondary outcome [25] 391464 0
Anticoagulation domain-specific secondary outcome:
Major bleeding (as defined by ISTH) assessed via medical records.
Timepoint [25] 391464 0
Up to 28 days after randomisation
Secondary outcome [26] 391465 0
Anticoagulation domain-specific secondary outcome:
Clinically relevant non-major bleeding (as defined by ISTH) assessed via medical records.
Timepoint [26] 391465 0
Up to 28 days after randomisation.
Secondary outcome [27] 391466 0
Anticoagulation domain-specific secondary outcome:

Heparin-induced thrombocytopenia during index hospitalisation, assessed via medical records
Timepoint [27] 391466 0
Up to 28 days after randomisation

Eligibility
Key inclusion criteria
1. Age 18 years and over
2. Admitted to an acute-care hospital
3. Confirmed SARS-CoV-2 by nucleic acid testing in the 14 days prior to randomisation
4. Able to be randomised within 14 days of symptom onset
5. At least one symptom or sign attributable to SARS-CoV-2 infection
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A. Overall exclusions:
1. Currently receiving acute intensive respiratory support (invasive or non-invasive mechanical ventilation) or vasopressor/inotropic support. Note, participants already on community based non-invasive ventilation (either CPAP or BiPAP) can still be recruited. Humidified high flow nasal oxygen will not be considered an exclusion criterion.
2. Previous participation in the trial
3. Treating team deems enrolment in the study is not in the best interests of the patient
4. Death is deemed to be imminent and inevitable within the next 24 hours
5. Either the patient or their primary treating clinician are not committed to active treatment. This criterion seeks to exclude those patients where supportive comfort measures only are being provided. Patients who are planned for active ward management with a clear aim to improve survival, even if intensive care unit level support is not being offered, should still be included.

B. Domain A (Antiviral - Nafamostat or standard care) specific exclusions:
1. Known current decompensated liver disease (Child-Pugh B or C)
2. The treating clinician intends to continue or commence therapeutic anticoagulation
3. A current or recurrent condition with a high risk of major bleeding (e.g. bleeding disorder), or a baseline coagulation profile (within the previous 3 days) that indicates a high risk of bleeding, that would be considered a contraindication to receive therapeutic anticoagulation.
4. Serum Potassium >5.5 mmol/L (based on most recent blood test result collected as part of routine care within the previous 3 days)
5. Serum Sodium <120 mmol/L (based on most recent blood test result collected as part of routine care within the previous 3 days).
6. Hypersensitivity to nafamostat
7. Pregnancy or breastfeeding
8. Currently receiving or have received nafamostat in the past 7 days
9. Decompensated heart failure or renal dialysis and clinician believes an extra 500mL fluid/day would be detrimental

C. Domain B (Antibody - convalescent plasma or standard care ) specific exclusions:
1. Participant has already received treatment with SARS-CoV-2-specific immunoglobulin therapy (convalescent plasma, hyperimmune globulin or monoclonal antibody) within 3 months prior to enrolment
2. Treating team deems enrolment in antibody intervention is not in the best interests of the patient.
3. Known previous history of transfusion-related acute lung injury will exclude a patient from convalescent plasma
4. Known previous history of serious allergic reaction to blood product transfusion will exclude a patient from convalescent plasma
5. Known personal or religious objections to receiving blood products will exclude a patient from convalescent plasma

D. Domain C (Anticoagulation - standard LMWH, intermediate LMWH, standard LMWH plus aspirin) specific exclusions:
1. Receiving dual antiplatelet therapy
2. The treating clinician intends to continue or commence therapeutic anticoagulation
3. Contraindication to receiving low molecular weight heparin or unfractionated heparin, including the known or suspected history of heparin-induced thrombocytopenia or other adverse reaction to prior heparin exposure such as hypersensitivity
4. Severe thrombocytopenia (platelet count less than 30 x 109/L)
5. History of intracranial haemorrhage in the previous 3 months
6. Severe renal impairment, defined as estimated glomerular filtration rate less than 15ml/min/1.73m2
7. A current or recurrent condition with a high risk of major bleeding (e.g. bleeding disorder), or a baseline coagulation profile (within the previous 3 days) that indicates a high risk of bleeding, that would be considered a contraindication to receive thromboprophylaxis
8. Receiving an antiplatelet agent will exclude a patient from receiving standard LMWH plus aspirin
9. Hypersensitivity to aspirin will exclude a patient from receiving standard LMWH plus aspirin

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 using response adaptive randomisation, that is the ratio of randomisation to each intervention will be proportional to the posterior probability that it is the best intervention within that domain at the most recent data examination. The initial randomisation ratios will be equal across (interventions/regimens), e.g. 1:1:1 randomisation; in other words no assumptions will be made about the relative efficacy of each intervention prior to the first examination of the accumulating data.
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.
Statistical inference will be based on the analysis of accumulated trial data using pre-specified Bayesian models at regularly scheduled analyses. The models will incorporate trial design features by accounting for potential heterogeneity by region, site, and time of enrolment (cohort). The primary model will be logistic regression on the primary outcome and incorporate model parameters which represent the effect of interventions assigned to participants from within each domain. Secondary models will investigate interaction effects between interventions across different domains as well as pre-specified sub-group effect heterogeneity. These models will be used to calculate the posterior probabilities of hypotheses of interest, including: effectiveness, futility, superiority, and inferiority of the interventions. These probabilities, in addition to informing the response adaptive randomisation, will be assessed against decision specific thresholds which will inform platform conclusions and trial adaptations such as dropping of less effective interventions. These thresholds will be selected by examining trial simulations under various scenarios.

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 hospital [70] 18005 0
Ballarat Health Services (Base Hospital) - Ballarat Central
Recruitment hospital [71] 18006 0
Northeast Health Wangaratta - Wangaratta
Recruitment hospital [72] 18007 0
Peninsula Private Hospital - Frankston - Frankston
Recruitment hospital [73] 18008 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [74] 18009 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [75] 18010 0
Canterbury Hospital - Campsie
Recruitment hospital [76] 18011 0
Wagga Wagga Base Hospital - Wagga Wagga
Recruitment hospital [77] 18012 0
The Northern Beaches Hospital - Frenchs Forest
Recruitment hospital [78] 18013 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [79] 18014 0
Griffith Base Hospital - Griffith
Recruitment hospital [80] 18015 0
Coffs Harbour Base Hospital - Coffs Harbour
Recruitment hospital [81] 18016 0
Joondalup Health Campus - Joondalup
Recruitment hospital [82] 18017 0
Gold Coast University Hospital - Southport
Recruitment hospital [83] 18018 0
Mount Isa Base Hospital - Mount Isa
Recruitment hospital [84] 18019 0
Calvary Public Hospital ACT - Bruce
Recruitment hospital [85] 18020 0
Ipswich Hospital - Ipswich
Recruitment hospital [86] 18578 0
Hornsby Ku-ring-gai Hospital - Hornsby
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
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3690 - Wodonga
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3004 - Melbourne
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3084 - Heidelberg
Recruitment postcode(s) [48] 29864 0
3220 - Geelong
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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
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3630 - Shepparton
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3152 - Wantirna
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3844 - Traralgon
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3168 - Clayton
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3175 - Dandenong
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3806 - Berwick
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3076 - Epping
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Recruitment outside Australia
Country [1] 22462 0
New Zealand
State/province [1] 22462 0
Country [2] 23100 0
India
State/province [2] 23100 0
Multiple

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
Funding source category [7] 307201 0
Charities/Societies/Foundations
Name [7] 307201 0
The Minderoo Foundation
Address [7] 307201 0
PO Box 3155, Broadway Nedlands, WA 6009
Country [7] 307201 0
Australia
Funding source category [8] 307202 0
Commercial sector/Industry
Name [8] 307202 0
BHP
Address [8] 307202 0
171 Collins Street
Melbourne Victoria 3000
Country [8] 307202 0
Australia
Funding source category [9] 307203 0
Other
Name [9] 307203 0
New Zealand Health Research Council
Address [9] 307203 0
PO Box 5541, Victoria Street West, Auckland 1142
Country [9] 307203 0
New Zealand
Funding source category [10] 307204 0
Charities/Societies/Foundations
Name [10] 307204 0
Macquarie Group Foundation
Address [10] 307204 0
Level 4, 1 Martin Place
Sydney NSW 2000
Country [10] 307204 0
Australia
Funding source category [11] 307205 0
Government body
Name [11] 307205 0
Medical Research Future Fund
Address [11] 307205 0
Department of Health
GPO Box 9848
Canberra ACT 2601
Australia
Country [11] 307205 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Parkville, VIC, 3050
Country
Australia
Secondary sponsor category [1] 305775 0
Other
Name [1] 305775 0
Middlemore Clinical Trials
Address [1] 305775 0
Middlemore Clinical Trials,
Private Bag 93311, Otahuhu 1640
Auckland, New Zealand
Country [1] 305775 0
New Zealand
Secondary sponsor category [2] 307807 0
Other
Name [2] 307807 0
The George Institute for Global Health
Address [2] 307807 0
Level 5, 1 King Street
Newtown 2042
NSW, Australia
Country [2] 307807 0
Australia
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
ASCOT ADAPT is an investigator-initiated, multi-centre, open-label, randomised controlled Bayesian adaptive platform trial that aims to identify the regimen (combination of interventions) associated with the highest chance of survival free of advanced respiratory support or vasopressor / inotropic support at 28 days after randomisation, in adults hospitalised with COVID-19 but not requiring ICU-level care.
Trial website
https://www.ascot-trial.edu.au/
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