LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
We are experiencing 4 week turn-around time in review of submissions and resubmissions. We recommend commencing this process concurrently with your ethics submission and allowing at least 8 weeks for registration to be completed from date of first submission. We currently do not have the capacity to expedite reviews.
Note also there are delays to review of updates. We appreciate your patience.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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)
Query!
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).
Query!
Secondary ID [1]
300905
0
none
Query!
Universal Trial Number (UTN)
U1111-1250-5165
Query!
Trial acronym
ASCOT-ADAPT
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
COVID-19 (SARS-CoV-2)
316847
0
Query!
Condition category
Condition code
Infection
315075
315075
0
0
Query!
Other infectious diseases
Query!
Respiratory
315105
315105
0
0
Query!
Other respiratory disorders / diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
317227
0
Treatment: Drugs
Query!
Intervention code [2]
319059
0
Treatment: Other
Query!
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
Query!
Control group
Active
Query!
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
Query!
Timepoint [1]
323371
0
28 days after randomisation
Query!
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.
Query!
Timepoint [1]
381687
0
28 days after randomisation
Query!
Secondary outcome [2]
381688
0
Core secondary outcome:
All-cause mortality
Query!
Timepoint [2]
381688
0
28 and 90 days after randomisation
Query!
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.
Query!
Timepoint [3]
381690
0
By 28 days after randomisation
Query!
Secondary outcome [4]
381725
0
Core secondary outcome:
Days alive and free of invasive or non-invasive ventilation
Query!
Timepoint [4]
381725
0
By 28 days after randomisation
Query!
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.
Query!
Timepoint [5]
381749
0
Day 3 and day 7 post randomisation
Query!
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.
Query!
Timepoint [6]
388871
0
Up to day 28
Query!
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.
Query!
Timepoint [7]
391446
0
Within 72 hours of last transfusion
Query!
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.
Query!
Timepoint [8]
391447
0
Within 24 hours of intervention administration
Query!
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.
Query!
Timepoint [9]
391448
0
Baseline and Day 3 and day 7 post randomisation
Query!
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
Query!
Timepoint [10]
391449
0
At any time while admitted to hospital (censored at day of discharge)
Query!
Secondary outcome [11]
391450
0
Anticoagulation domain-specific secondary outcome:
Confirmed deep venous thrombosis, assessed via medical records.
Query!
Timepoint [11]
391450
0
Up to day 28 post randomisation
Query!
Secondary outcome [12]
391451
0
Anticoagulation domain-specific secondary outcome:
Heparin-induced thrombocytopenia assessed via medical records.
Query!
Timepoint [12]
391451
0
During index hospitalisation, up to day 28 post randomisation.
Query!
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.
Query!
Timepoint [13]
391452
0
up to 28 days after randomisation
Query!
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
Query!
Timepoint [14]
391453
0
Day 28 and day 90 after randomisation
Query!
Secondary outcome [15]
391454
0
Core secondary outcome:
Quality of life as measured by EQ-5D-5L questionnaire
Query!
Timepoint [15]
391454
0
Day 28 and day 90 after randomisation
Query!
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.
Query!
Timepoint [16]
391455
0
Up to day 28
Query!
Secondary outcome [17]
391456
0
Antiviral domain-specific secondary outcome:
Safety:
Elevation of serum potassium to >5.5 mmol/L (assessed via medical records)
Query!
Timepoint [17]
391456
0
While admitted to hospital (censored at day of discharge).
Query!
Secondary outcome [18]
391457
0
Antiviral domain-specific secondary outcome:
Safety:
Decrease of serum sodium to <125 mmol/L (assessed via medical records)
Query!
Timepoint [18]
391457
0
While admitted to hospital (censored at day of discharge)
Query!
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)
Query!
Timepoint [19]
391458
0
While admitted to hospital (censored on day of discharge)
Query!
Secondary outcome [20]
391459
0
Antiviral domain-specific secondary outcome:
Safety:
Thrombophlebitis/vasculitis at IV line site (assessed via medical records).
Query!
Timepoint [20]
391459
0
While admitted to hospital (censored on day of discharge)
Query!
Secondary outcome [21]
391460
0
Anticoagulation domain-specific secondary outcome:
Confirmed pulmonary embolus assessed via medical records.
Query!
Timepoint [21]
391460
0
Up to 28 days after randomisation
Query!
Secondary outcome [22]
391461
0
Anticoagulation domain-specific secondary outcome:
Confirmed acute myocardial infarction assessed via medical records.
Query!
Timepoint [22]
391461
0
Up to 28 days after randomisation.
Query!
Secondary outcome [23]
391462
0
Anticoagulation domain-specific secondary outcome:
Confirmed ischemic cerebrovascular event assessed via medical records.
Query!
Timepoint [23]
391462
0
Up to 28 days after randomisation
Query!
Secondary outcome [24]
391463
0
Anticoagulation domain-specific secondary outcome:
Confirmed deep vein thrombosis assessed via medical records.
Query!
Timepoint [24]
391463
0
Up to 28 days after randomisation
Query!
Secondary outcome [25]
391464
0
Anticoagulation domain-specific secondary outcome:
Major bleeding (as defined by ISTH) assessed via medical records.
Query!
Timepoint [25]
391464
0
Up to 28 days after randomisation
Query!
Secondary outcome [26]
391465
0
Anticoagulation domain-specific secondary outcome:
Clinically relevant non-major bleeding (as defined by ISTH) assessed via medical records.
Query!
Timepoint [26]
391465
0
Up to 28 days after randomisation.
Query!
Secondary outcome [27]
391466
0
Anticoagulation domain-specific secondary outcome:
Heparin-induced thrombocytopenia during index hospitalisation, assessed via medical records
Query!
Timepoint [27]
391466
0
Up to 28 days after randomisation
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Gender
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Query!
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.
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Factorial
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint(s)
Efficacy
Query!
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.
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
10/04/2020
Query!
Actual
28/07/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
2500
Query!
Accrual to date
33
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Query!
Recruitment hospital [1]
16269
0
The Canberra Hospital - Garran
Query!
Recruitment hospital [2]
16270
0
Blacktown Hospital - Blacktown
Query!
Recruitment hospital [3]
16271
0
Concord Repatriation Hospital - Concord
Query!
Recruitment hospital [4]
16272
0
John Hunter Hospital - New Lambton
Query!
Recruitment hospital [5]
16273
0
Lismore Base Hospital - Lismore
Query!
Recruitment hospital [6]
16274
0
Liverpool Hospital - Liverpool
Query!
Recruitment hospital [7]
16275
0
Calvary Mater Newcastle - Waratah
Query!
Recruitment hospital [8]
16276
0
Nepean Hospital - Kingswood
Query!
Recruitment hospital [9]
16277
0
Orange Health Service - Orange
Query!
Recruitment hospital [10]
16278
0
Port Macquarie Base Hospital - Port Macquarie
Query!
Recruitment hospital [11]
16279
0
Prince of Wales Hospital - Randwick
Query!
Recruitment hospital [12]
16280
0
Royal Prince Alfred Hospital - Camperdown
Query!
Recruitment hospital [13]
16281
0
St George Hospital - Kogarah
Query!
Recruitment hospital [14]
16282
0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Query!
Recruitment hospital [15]
16283
0
The Sutherland Hospital - Caringbah
Query!
Recruitment hospital [16]
16284
0
The Tweed Hospital - Tweed Heads
Query!
Recruitment hospital [17]
16285
0
Wollongong Hospital - Wollongong
Query!
Recruitment hospital [18]
16286
0
Westmead Hospital - Westmead
Query!
Recruitment hospital [19]
16287
0
Armidale Rural Referral Hospital - Armidale
Query!
Recruitment hospital [20]
16288
0
Royal Darwin Hospital - Tiwi
Query!
Recruitment hospital [21]
16289
0
Caboolture Hospital - Caboolture
Query!
Recruitment hospital [22]
16290
0
Cairns Base Hospital - Cairns
Query!
Recruitment hospital [23]
16291
0
Logan Hospital - Meadowbrook
Query!
Recruitment hospital [24]
16292
0
Mackay Base Hospital - Mackay
Query!
Recruitment hospital [25]
16293
0
Mater Sydney - North Sydney
Query!
Recruitment hospital [26]
16294
0
Princess Alexandra Hospital - Woolloongabba
Query!
Recruitment hospital [27]
16295
0
Redcliffe Hospital - Redcliffe
Query!
Recruitment hospital [28]
16296
0
Royal Brisbane & Womens Hospital - Herston
Query!
Recruitment hospital [29]
16297
0
Sunshine Coast University Hospital - Birtinya
Query!
Recruitment hospital [30]
16298
0
The Prince Charles Hospital - Chermside
Query!
Recruitment hospital [31]
16299
0
The Townsville Hospital - Douglas
Query!
Recruitment hospital [32]
16300
0
Flinders Medical Centre - Bedford Park
Query!
Recruitment hospital [33]
16301
0
Lyell McEwin Hospital - Elizabeth Vale
Query!
Recruitment hospital [34]
16302
0
The Royal Adelaide Hospital - Adelaide
Query!
Recruitment hospital [35]
16303
0
Launceston General Hospital - Launceston
Query!
Recruitment hospital [36]
16304
0
Royal Hobart Hospital - Hobart
Query!
Recruitment hospital [37]
16305
0
Armadale Kelmscott Memorial Hospital - Armadale
Query!
Recruitment hospital [38]
16306
0
Fiona Stanley Hospital - Murdoch
Query!
Recruitment hospital [39]
16307
0
Rockingham General Hospital - Cooloongup
Query!
Recruitment hospital [40]
16308
0
Sir Charles Gairdner Hospital - Nedlands
Query!
Recruitment hospital [41]
16309
0
St John of God Hospital, Midland - Midland
Query!
Recruitment hospital [42]
16310
0
St John of God Hospital, Subiaco - Subiaco
Query!
Recruitment hospital [43]
16311
0
Royal Perth Hospital - Perth
Query!
Recruitment hospital [44]
16312
0
Albury Wodonga Health - Albury campus - Albury
Query!
Recruitment hospital [45]
16313
0
Albury Wodonga Health - Wodonga campus - Wodonga
Query!
Recruitment hospital [46]
16314
0
The Alfred - Melbourne
Query!
Recruitment hospital [47]
16318
0
Austin Health - Austin Hospital - Heidelberg
Query!
Recruitment hospital [48]
16319
0
Barwon Health - Geelong Hospital campus - Geelong
Query!
Recruitment hospital [49]
16320
0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Query!
Recruitment hospital [50]
16321
0
Cabrini Hospital - Malvern - Malvern
Query!
Recruitment hospital [51]
16322
0
Box Hill Hospital - Box Hill
Query!
Recruitment hospital [52]
16323
0
Epworth Freemasons (Clarendon Street) - East Melbourne
Query!
Recruitment hospital [53]
16324
0
Goulburn Valley Health - Shepparton campus - Shepparton
Query!
Recruitment hospital [54]
16325
0
Knox Private Hospital - Wantirna
Query!
Recruitment hospital [55]
16326
0
Latrobe Regional Hospital - Traralgon
Query!
Recruitment hospital [56]
16327
0
Royal Melbourne Hospital - Royal Park campus - Parkville
Query!
Recruitment hospital [57]
16328
0
Monash Medical Centre - Clayton campus - Clayton
Query!
Recruitment hospital [58]
16329
0
Dandenong Hospital - Dandenong
Query!
Recruitment hospital [59]
16330
0
Casey Hospital - Berwick
Query!
Recruitment hospital [60]
16331
0
The Northern Hospital - Epping
Query!
Recruitment hospital [61]
16332
0
Broadmeadows Health Service - Broadmeadows
Query!
Recruitment hospital [62]
16333
0
Bundoora Extended Care Centre - Bundoora
Query!
Recruitment hospital [63]
16334
0
Frankston Hospital - Frankston
Query!
Recruitment hospital [64]
16335
0
Peter MacCallum Cancer Centre - Melbourne
Query!
Recruitment hospital [65]
16336
0
St John of God Hospital, Ballarat - Ballarat
Query!
Recruitment hospital [66]
16337
0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Query!
Recruitment hospital [67]
16338
0
Footscray Hospital - Footscray
Query!
Recruitment hospital [68]
16339
0
Sunshine Hospital - St Albans
Query!
Recruitment hospital [69]
16340
0
West Gippsland Healthcare Group - Warragul
Query!
Recruitment hospital [70]
18005
0
Ballarat Health Services (Base Hospital) - Ballarat Central
Query!
Recruitment hospital [71]
18006
0
Northeast Health Wangaratta - Wangaratta
Query!
Recruitment hospital [72]
18007
0
Peninsula Private Hospital - Frankston - Frankston
Query!
Recruitment hospital [73]
18008
0
Campbelltown Hospital - Campbelltown
Query!
Recruitment hospital [74]
18009
0
Bankstown-Lidcombe Hospital - Bankstown
Query!
Recruitment hospital [75]
18010
0
Canterbury Hospital - Campsie
Query!
Recruitment hospital [76]
18011
0
Wagga Wagga Base Hospital - Wagga Wagga
Query!
Recruitment hospital [77]
18012
0
The Northern Beaches Hospital - Frenchs Forest
Query!
Recruitment hospital [78]
18013
0
Royal North Shore Hospital - St Leonards
Query!
Recruitment hospital [79]
18014
0
Griffith Base Hospital - Griffith
Query!
Recruitment hospital [80]
18015
0
Coffs Harbour Base Hospital - Coffs Harbour
Query!
Recruitment hospital [81]
18016
0
Joondalup Health Campus - Joondalup
Query!
Recruitment hospital [82]
18017
0
Gold Coast University Hospital - Southport
Query!
Recruitment hospital [83]
18018
0
Mount Isa Base Hospital - Mount Isa
Query!
Recruitment hospital [84]
18019
0
Calvary Public Hospital ACT - Bruce
Query!
Recruitment hospital [85]
18020
0
Ipswich Hospital - Ipswich
Query!
Recruitment hospital [86]
18578
0
Hornsby Ku-ring-gai Hospital - Hornsby
Query!
Recruitment postcode(s) [1]
29814
0
2605 - Garran
Query!
Recruitment postcode(s) [2]
29815
0
2148 - Blacktown
Query!
Recruitment postcode(s) [3]
29816
0
2139 - Concord
Query!
Recruitment postcode(s) [4]
29817
0
2305 - New Lambton
Query!
Recruitment postcode(s) [5]
29818
0
2480 - Lismore
Query!
Recruitment postcode(s) [6]
29819
0
2170 - Liverpool
Query!
Recruitment postcode(s) [7]
29820
0
2298 - Waratah
Query!
Recruitment postcode(s) [8]
29821
0
2747 - Kingswood
Query!
Recruitment postcode(s) [9]
29822
0
2800 - Orange
Query!
Recruitment postcode(s) [10]
29823
0
2444 - Port Macquarie
Query!
Recruitment postcode(s) [11]
29824
0
2031 - Randwick
Query!
Recruitment postcode(s) [12]
29825
0
2050 - Camperdown
Query!
Recruitment postcode(s) [13]
29826
0
2217 - Kogarah
Query!
Recruitment postcode(s) [14]
29827
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [15]
29828
0
2229 - Caringbah
Query!
Recruitment postcode(s) [16]
29829
0
2485 - Tweed Heads
Query!
Recruitment postcode(s) [17]
29830
0
2500 - Wollongong
Query!
Recruitment postcode(s) [18]
29831
0
2145 - Westmead
Query!
Recruitment postcode(s) [19]
29832
0
2350 - Armidale
Query!
Recruitment postcode(s) [20]
29833
0
0810 - Tiwi
Query!
Recruitment postcode(s) [21]
29834
0
4510 - Caboolture
Query!
Recruitment postcode(s) [22]
29835
0
4870 - Cairns
Query!
Recruitment postcode(s) [23]
29836
0
4131 - Meadowbrook
Query!
Recruitment postcode(s) [24]
29837
0
4740 - Mackay
Query!
Recruitment postcode(s) [25]
29838
0
2060 - North Sydney
Query!
Recruitment postcode(s) [26]
29839
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [27]
29840
0
4020 - Redcliffe
Query!
Recruitment postcode(s) [28]
29841
0
4029 - Herston
Query!
Recruitment postcode(s) [29]
29842
0
4575 - Birtinya
Query!
Recruitment postcode(s) [30]
29843
0
4032 - Chermside
Query!
Recruitment postcode(s) [31]
29844
0
4814 - Douglas
Query!
Recruitment postcode(s) [32]
29845
0
5042 - Bedford Park
Query!
Recruitment postcode(s) [33]
29846
0
5112 - Elizabeth Vale
Query!
Recruitment postcode(s) [34]
29847
0
5000 - Adelaide
Query!
Recruitment postcode(s) [35]
29848
0
7250 - Launceston
Query!
Recruitment postcode(s) [36]
29849
0
7000 - Hobart
Query!
Recruitment postcode(s) [37]
29850
0
6112 - Armadale
Query!
Recruitment postcode(s) [38]
29851
0
6150 - Murdoch
Query!
Recruitment postcode(s) [39]
29852
0
6168 - Cooloongup
Query!
Recruitment postcode(s) [40]
29853
0
6009 - Nedlands
Query!
Recruitment postcode(s) [41]
29854
0
6056 - Midland
Query!
Recruitment postcode(s) [42]
29855
0
6008 - Subiaco
Query!
Recruitment postcode(s) [43]
29856
0
6000 - Perth
Query!
Recruitment postcode(s) [44]
29857
0
2640 - Albury
Query!
Recruitment postcode(s) [45]
29858
0
3690 - Wodonga
Query!
Recruitment postcode(s) [46]
29859
0
3004 - Melbourne
Query!
Recruitment postcode(s) [47]
29863
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [48]
29864
0
3220 - Geelong
Query!
Recruitment postcode(s) [49]
29865
0
3550 - Bendigo
Query!
Recruitment postcode(s) [50]
29866
0
3144 - Malvern
Query!
Recruitment postcode(s) [51]
29867
0
3128 - Box Hill
Query!
Recruitment postcode(s) [52]
29868
0
3002 - East Melbourne
Query!
Recruitment postcode(s) [53]
29869
0
3630 - Shepparton
Query!
Recruitment postcode(s) [54]
29870
0
3152 - Wantirna
Query!
Recruitment postcode(s) [55]
29871
0
3844 - Traralgon
Query!
Recruitment postcode(s) [56]
29872
0
3052 - Parkville
Query!
Recruitment postcode(s) [57]
29873
0
3168 - Clayton
Query!
Recruitment postcode(s) [58]
29874
0
3175 - Dandenong
Query!
Recruitment postcode(s) [59]
29875
0
3806 - Berwick
Query!
Recruitment postcode(s) [60]
29876
0
3076 - Epping
Query!
Recruitment postcode(s) [61]
29877
0
3047 - Broadmeadows
Query!
Recruitment postcode(s) [62]
29878
0
3083 - Bundoora
Query!
Recruitment postcode(s) [63]
29879
0
3199 - Frankston
Query!
Recruitment postcode(s) [64]
29880
0
3350 - Ballarat
Query!
Recruitment postcode(s) [65]
29881
0
3065 - Fitzroy
Query!
Recruitment postcode(s) [66]
29882
0
3011 - Footscray
Query!
Recruitment postcode(s) [67]
29883
0
3021 - St Albans
Query!
Recruitment postcode(s) [68]
29884
0
3820 - Warragul
Query!
Recruitment postcode(s) [69]
31974
0
3350 - Ballarat Central
Query!
Recruitment postcode(s) [70]
31975
0
3677 - Wangaratta
Query!
Recruitment postcode(s) [71]
31976
0
3199 - Frankston
Query!
Recruitment postcode(s) [72]
31977
0
2560 - Campbelltown
Query!
Recruitment postcode(s) [73]
31978
0
2200 - Bankstown
Query!
Recruitment postcode(s) [74]
31979
0
2194 - Campsie
Query!
Recruitment postcode(s) [75]
31980
0
2650 - Wagga Wagga
Query!
Recruitment postcode(s) [76]
31981
0
2086 - Frenchs Forest
Query!
Recruitment postcode(s) [77]
31982
0
2065 - St Leonards
Query!
Recruitment postcode(s) [78]
31983
0
2680 - Griffith
Query!
Recruitment postcode(s) [79]
31984
0
2450 - Coffs Harbour
Query!
Recruitment postcode(s) [80]
31985
0
6027 - Joondalup
Query!
Recruitment postcode(s) [81]
31986
0
4215 - Southport
Query!
Recruitment postcode(s) [82]
31987
0
4825 - Mount Isa
Query!
Recruitment postcode(s) [83]
31988
0
2617 - Bruce
Query!
Recruitment postcode(s) [84]
31989
0
4305 - Ipswich
Query!
Recruitment postcode(s) [85]
32952
0
2077 - Hornsby
Query!
Recruitment outside Australia
Country [1]
22462
0
New Zealand
Query!
State/province [1]
22462
0
Query!
Country [2]
23100
0
India
Query!
State/province [2]
23100
0
Multiple
Query!
Funding & Sponsors
Funding source category [1]
305377
0
University
Query!
Name [1]
305377
0
University of Melbourne
Query!
Address [1]
305377
0
Parkville, VIC 3010
Query!
Country [1]
305377
0
Australia
Query!
Funding source category [2]
305393
0
University
Query!
Name [2]
305393
0
University of Queensland
Query!
Address [2]
305393
0
Centre for Clinical Research
Building 71/918, Royal Brisbane Women's Campus
Herston, QLD 4029
Query!
Country [2]
305393
0
Australia
Query!
Funding source category [3]
305394
0
Other
Query!
Name [3]
305394
0
Hunter Medical Research Institute: a partnership between the University of Newcastle, Hunter New England Local Health District
Query!
Address [3]
305394
0
Lot 1, Kookaburra Cct
New Lambton Heights NSW 2305
Query!
Country [3]
305394
0
Australia
Query!
Funding source category [4]
305395
0
Charities/Societies/Foundations
Query!
Name [4]
305395
0
The Pratt Foundation
Query!
Address [4]
305395
0
Level 11, 2 Southbank Bvd
Southbank VIC 3006
Query!
Country [4]
305395
0
Australia
Query!
Funding source category [5]
305396
0
Charities/Societies/Foundations
Query!
Name [5]
305396
0
Royal Brisbane Women's Hospital Foundation
Query!
Address [5]
305396
0
Block 20, Royal Brisbane Women's Hospital
Butterfield St, Herston, QLD 4029
Query!
Country [5]
305396
0
Australia
Query!
Funding source category [6]
305397
0
Charities/Societies/Foundations
Query!
Name [6]
305397
0
Hospital Research Foundation
Query!
Address [6]
305397
0
60 Woodville Rd,
Woodville SA 5011
Query!
Country [6]
305397
0
Australia
Query!
Funding source category [7]
307201
0
Charities/Societies/Foundations
Query!
Name [7]
307201
0
The Minderoo Foundation
Query!
Address [7]
307201
0
PO Box 3155, Broadway Nedlands, WA 6009
Query!
Country [7]
307201
0
Australia
Query!
Funding source category [8]
307202
0
Commercial sector/Industry
Query!
Name [8]
307202
0
BHP
Query!
Address [8]
307202
0
171 Collins Street
Melbourne Victoria 3000
Query!
Country [8]
307202
0
Australia
Query!
Funding source category [9]
307203
0
Other
Query!
Name [9]
307203
0
New Zealand Health Research Council
Query!
Address [9]
307203
0
PO Box 5541, Victoria Street West, Auckland 1142
Query!
Country [9]
307203
0
New Zealand
Query!
Funding source category [10]
307204
0
Charities/Societies/Foundations
Query!
Name [10]
307204
0
Macquarie Group Foundation
Query!
Address [10]
307204
0
Level 4, 1 Martin Place
Sydney NSW 2000
Query!
Country [10]
307204
0
Australia
Query!
Funding source category [11]
307205
0
Government body
Query!
Name [11]
307205
0
Medical Research Future Fund
Query!
Address [11]
307205
0
Department of Health
GPO Box 9848
Canberra ACT 2601
Australia
Query!
Country [11]
307205
0
Australia
Query!
Primary sponsor type
University
Query!
Name
University of Melbourne
Query!
Address
Parkville, VIC, 3050
Query!
Country
Australia
Query!
Secondary sponsor category [1]
305775
0
Other
Query!
Name [1]
305775
0
Middlemore Clinical Trials
Query!
Address [1]
305775
0
Middlemore Clinical Trials,
Private Bag 93311, Otahuhu 1640
Auckland, New Zealand
Query!
Country [1]
305775
0
New Zealand
Query!
Secondary sponsor category [2]
307807
0
Other
Query!
Name [2]
307807
0
The George Institute for Global Health
Query!
Address [2]
307807
0
Level 5, 1 King Street
Newtown 2042
NSW, Australia
Query!
Country [2]
307807
0
Australia
Query!
Other collaborator category [1]
281261
0
Other Collaborative groups
Query!
Name [1]
281261
0
The Australasian Society for Infectious Diseases Clinical Research Network (ASID CRN)
Query!
Address [1]
281261
0
Suite 302, Level 3, 478 George Street
Sydney NSW 2000
Australia
Query!
Country [1]
281261
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
305686
0
Melbourne Health Human Research Ethics Committee
Query!
Ethics committee address [1]
305686
0
Royal Melbourne Hospital Office for Research
CITY CAMPUS
Level 2
South West
300 Grattan Street
Parkville Victoria 3050
Query!
Ethics committee country [1]
305686
0
Australia
Query!
Date submitted for ethics approval [1]
305686
0
20/03/2020
Query!
Approval date [1]
305686
0
03/04/2020
Query!
Ethics approval number [1]
305686
0
HREC/62646/MH-2020
Query!
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.
Query!
Trial website
https://www.ascot-trial.edu.au/
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
101226
0
A/Prof Steven Tong
Query!
Address
101226
0
The Peter Doherty Institute for Infection and Immunity
792 Elizabeth Street
Melbourne, Victoria 3000
Query!
Country
101226
0
Australia
Query!
Phone
101226
0
+61 03 9342 9406
Query!
Fax
101226
0
Query!
Email
101226
0
steven.tong@unimelb.edu.au
Query!
Contact person for public queries
Name
101227
0
A/Prof Steven Tong
Query!
Address
101227
0
The Peter Doherty Institute for Infection and Immunity
792 Elizabeth Street
Melbourne, Victoria 3000
Query!
Country
101227
0
Australia
Query!
Phone
101227
0
+61 03 9342 9406
Query!
Fax
101227
0
Query!
Email
101227
0
ascot-team@unimelb.edu.au
Query!
Contact person for scientific queries
Name
101228
0
A/Prof Steven Tong
Query!
Address
101228
0
The Peter Doherty Institute for Infection and Immunity
792 Elizabeth Street
Melbourne, Victoria 3000
Query!
Country
101228
0
Australia
Query!
Phone
101228
0
+61 03 9342 9406
Query!
Fax
101228
0
Query!
Email
101228
0
steven.tong@unimelb.edu.au
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
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.
Query!
What supporting documents are/will be available?
No other documents available
Query!
Summary results
No Results
Download to PDF