ANZCTR - Registration

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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]

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)

Condition category

Condition code

Infection

Other infectious diseases

Respiratory

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]

Treatment: Drugs

Intervention code [2]

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]

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]

28 days after randomisation

Secondary outcome [1]

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]

28 days after randomisation

Secondary outcome [2]

Core secondary outcome:

All-cause mortality

Timepoint [2]

28 and 90 days after randomisation

Secondary outcome [3]

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]

By 28 days after randomisation

Secondary outcome [4]

Core secondary outcome:

Days alive and free of invasive or non-invasive ventilation

Timepoint [4]

By 28 days after randomisation

Secondary outcome [5]

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]

Day 3 and day 7 post randomisation

Secondary outcome [6]

Antibody domain-specific secondary outcome:

Confirmed arterial thrombosis (acute myocardial infarction, ischemic cerebrovascular event, other) as assessed by patient medical records.

Timepoint [6]

Up to day 28

Secondary outcome [7]

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]

Within 72 hours of last transfusion

Secondary outcome [8]

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]

Within 24 hours of intervention administration

Secondary outcome [9]

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]

Baseline and Day 3 and day 7 post randomisation

Secondary outcome [10]

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]

At any time while admitted to hospital (censored at day of discharge)

Secondary outcome [11]

Anticoagulation domain-specific secondary outcome:
Confirmed deep venous thrombosis, assessed via medical records.

Timepoint [11]

Up to day 28 post randomisation

Secondary outcome [12]

Anticoagulation domain-specific secondary outcome:

Heparin-induced thrombocytopenia assessed via medical records.

Timepoint [12]

During index hospitalisation, up to day 28 post randomisation.

Secondary outcome [13]

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]

up to 28 days after randomisation

Secondary outcome [14]

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]

Day 28 and day 90 after randomisation

Secondary outcome [15]

Core secondary outcome:

Quality of life as measured by EQ-5D-5L questionnaire

Timepoint [15]

Day 28 and day 90 after randomisation

Secondary outcome [16]

Antibody domain-specific secondary outcome:

Confirmed venous thrombosis (deep vein thrombosis, pulmonary embolus, other) as assessed by patient medical records.

Timepoint [16]

Up to day 28

Secondary outcome [17]

Antiviral domain-specific secondary outcome:

Safety:
Elevation of serum potassium to >5.5 mmol/L (assessed via medical records)

Timepoint [17]

While admitted to hospital (censored at day of discharge).

Secondary outcome [18]

Antiviral domain-specific secondary outcome:

Safety:
Decrease of serum sodium to <125 mmol/L (assessed via medical records)

Timepoint [18]

While admitted to hospital (censored at day of discharge)

Secondary outcome [19]

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]

While admitted to hospital (censored on day of discharge)

Secondary outcome [20]

Antiviral domain-specific secondary outcome:

Safety:
Thrombophlebitis/vasculitis at IV line site (assessed via medical records).

Timepoint [20]

While admitted to hospital (censored on day of discharge)

Secondary outcome [21]

Anticoagulation domain-specific secondary outcome:
Confirmed pulmonary embolus assessed via medical records.

Timepoint [21]

Up to 28 days after randomisation

Secondary outcome [22]

Anticoagulation domain-specific secondary outcome:
Confirmed acute myocardial infarction assessed via medical records.

Timepoint [22]

Up to 28 days after randomisation.

Secondary outcome [23]

Anticoagulation domain-specific secondary outcome:
Confirmed ischemic cerebrovascular event assessed via medical records.

Timepoint [23]

Up to 28 days after randomisation

Secondary outcome [24]

Anticoagulation domain-specific secondary outcome:
Confirmed deep vein thrombosis assessed via medical records.

Timepoint [24]

Up to 28 days after randomisation

Secondary outcome [25]

Anticoagulation domain-specific secondary outcome:
Major bleeding (as defined by ISTH) assessed via medical records.

Timepoint [25]

Up to 28 days after randomisation

Secondary outcome [26]

Anticoagulation domain-specific secondary outcome:
Clinically relevant non-major bleeding (as defined by ISTH) assessed via medical records.

Timepoint [26]

Up to 28 days after randomisation.

Secondary outcome [27]

Anticoagulation domain-specific secondary outcome:

Heparin-induced thrombocytopenia during index hospitalisation, assessed via medical records

Timepoint [27]

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?

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

10/04/2020

Actual

28/07/2020

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

2500

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Recruitment hospital [1]

The Canberra Hospital - Garran

Recruitment hospital [2]

Blacktown Hospital - Blacktown

Recruitment hospital [3]

Concord Repatriation Hospital - Concord

Recruitment hospital [4]

John Hunter Hospital - New Lambton

Recruitment hospital [5]

Lismore Base Hospital - Lismore

Recruitment hospital [6]

Liverpool Hospital - Liverpool

Recruitment hospital [7]

Calvary Mater Newcastle - Waratah

Recruitment hospital [8]

Nepean Hospital - Kingswood

Recruitment hospital [9]

Orange Health Service - Orange

Recruitment hospital [10]

Port Macquarie Base Hospital - Port Macquarie

Recruitment hospital [11]

Prince of Wales Hospital - Randwick

Recruitment hospital [12]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [13]

St George Hospital - Kogarah

Recruitment hospital [14]

St Vincent's Hospital (Darlinghurst) - Darlinghurst

Recruitment hospital [15]

The Sutherland Hospital - Caringbah

Recruitment hospital [16]

The Tweed Hospital - Tweed Heads

Recruitment hospital [17]

Wollongong Hospital - Wollongong

Recruitment hospital [18]

Westmead Hospital - Westmead

Recruitment hospital [19]

Armidale Rural Referral Hospital - Armidale

Recruitment hospital [20]

Royal Darwin Hospital - Tiwi

Recruitment hospital [21]

Caboolture Hospital - Caboolture

Recruitment hospital [22]

Cairns Base Hospital - Cairns

Recruitment hospital [23]

Logan Hospital - Meadowbrook

Recruitment hospital [24]

Mackay Base Hospital - Mackay

Recruitment hospital [25]

Mater Sydney - North Sydney

Recruitment hospital [26]

Princess Alexandra Hospital - Woolloongabba

Recruitment hospital [27]

Redcliffe Hospital - Redcliffe

Recruitment hospital [28]

Royal Brisbane & Womens Hospital - Herston

Recruitment hospital [29]

Sunshine Coast University Hospital - Birtinya

Recruitment hospital [30]

The Prince Charles Hospital - Chermside

Recruitment hospital [31]

The Townsville Hospital - Douglas

Recruitment hospital [32]

Flinders Medical Centre - Bedford Park

Recruitment hospital [33]

Lyell McEwin Hospital - Elizabeth Vale

Recruitment hospital [34]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [35]

Launceston General Hospital - Launceston

Recruitment hospital [36]

Royal Hobart Hospital - Hobart

Recruitment hospital [37]

Armadale Kelmscott Memorial Hospital - Armadale

Recruitment hospital [38]

Fiona Stanley Hospital - Murdoch

Recruitment hospital [39]

Rockingham General Hospital - Cooloongup

Recruitment hospital [40]

Sir Charles Gairdner Hospital - Nedlands

Recruitment hospital [41]

St John of God Hospital, Midland - Midland

Recruitment hospital [42]

St John of God Hospital, Subiaco - Subiaco

Recruitment hospital [43]

Royal Perth Hospital - Perth

Recruitment hospital [44]

Albury Wodonga Health - Albury campus - Albury

Recruitment hospital [45]

Albury Wodonga Health - Wodonga campus - Wodonga

Recruitment hospital [46]

The Alfred - Melbourne

Recruitment hospital [47]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [48]

Barwon Health - Geelong Hospital campus - Geelong

Recruitment hospital [49]

Bendigo Health Care Group - Bendigo Hospital - Bendigo

Recruitment hospital [50]

Cabrini Hospital - Malvern - Malvern

Recruitment hospital [51]

Box Hill Hospital - Box Hill

Recruitment hospital [52]

Epworth Freemasons (Clarendon Street) - East Melbourne

Recruitment hospital [53]

Goulburn Valley Health - Shepparton campus - Shepparton

Recruitment hospital [54]

Knox Private Hospital - Wantirna

Recruitment hospital [55]

Latrobe Regional Hospital - Traralgon

Recruitment hospital [56]

Royal Melbourne Hospital - Royal Park campus - Parkville

Recruitment hospital [57]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [58]

Dandenong Hospital - Dandenong

Recruitment hospital [59]

Casey Hospital - Berwick

Recruitment hospital [60]

The Northern Hospital - Epping

Recruitment hospital [61]

Broadmeadows Health Service - Broadmeadows

Recruitment hospital [62]

Bundoora Extended Care Centre - Bundoora

Recruitment hospital [63]

Frankston Hospital - Frankston

Recruitment hospital [64]

Peter MacCallum Cancer Centre - Melbourne

Recruitment hospital [65]

St John of God Hospital, Ballarat - Ballarat

Recruitment hospital [66]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment hospital [67]

Footscray Hospital - Footscray

Recruitment hospital [68]

Sunshine Hospital - St Albans

Recruitment hospital [69]

West Gippsland Healthcare Group - Warragul

Recruitment hospital [70]

Ballarat Health Services (Base Hospital) - Ballarat Central

Recruitment hospital [71]

Northeast Health Wangaratta - Wangaratta

Recruitment hospital [72]

Peninsula Private Hospital - Frankston - Frankston

Recruitment hospital [73]

Campbelltown Hospital - Campbelltown

Recruitment hospital [74]

Bankstown-Lidcombe Hospital - Bankstown

Recruitment hospital [75]

Canterbury Hospital - Campsie

Recruitment hospital [76]

Wagga Wagga Base Hospital - Wagga Wagga

Recruitment hospital [77]

The Northern Beaches Hospital - Frenchs Forest

Recruitment hospital [78]

Royal North Shore Hospital - St Leonards

Recruitment hospital [79]

Griffith Base Hospital - Griffith

Recruitment hospital [80]

Coffs Harbour Base Hospital - Coffs Harbour

Recruitment hospital [81]

Joondalup Health Campus - Joondalup

Recruitment hospital [82]

Gold Coast University Hospital - Southport

Recruitment hospital [83]

Mount Isa Base Hospital - Mount Isa

Recruitment hospital [84]

Calvary Public Hospital ACT - Bruce

Recruitment hospital [85]

Ipswich Hospital - Ipswich

Recruitment hospital [86]

Hornsby Ku-ring-gai Hospital - Hornsby

Recruitment postcode(s) [1]

2605 - Garran

Recruitment postcode(s) [2]

2148 - Blacktown

Recruitment postcode(s) [3]

2139 - Concord

Recruitment postcode(s) [4]

2305 - New Lambton

Recruitment postcode(s) [5]

2480 - Lismore

Recruitment postcode(s) [6]

2170 - Liverpool

Recruitment postcode(s) [7]

2298 - Waratah

Recruitment postcode(s) [8]

2747 - Kingswood

Recruitment postcode(s) [9]

2800 - Orange

Recruitment postcode(s) [10]

2444 - Port Macquarie

Recruitment postcode(s) [11]

2031 - Randwick

Recruitment postcode(s) [12]

2050 - Camperdown

Recruitment postcode(s) [13]

2217 - Kogarah

Recruitment postcode(s) [14]

2010 - Darlinghurst

Recruitment postcode(s) [15]

2229 - Caringbah

Recruitment postcode(s) [16]

2485 - Tweed Heads

Recruitment postcode(s) [17]

2500 - Wollongong

Recruitment postcode(s) [18]

2145 - Westmead

Recruitment postcode(s) [19]

2350 - Armidale

Recruitment postcode(s) [20]

0810 - Tiwi

Recruitment postcode(s) [21]

4510 - Caboolture

Recruitment postcode(s) [22]

4870 - Cairns

Recruitment postcode(s) [23]

4131 - Meadowbrook

Recruitment postcode(s) [24]

4740 - Mackay

Recruitment postcode(s) [25]

2060 - North Sydney

Recruitment postcode(s) [26]

4102 - Woolloongabba

Recruitment postcode(s) [27]

4020 - Redcliffe

Recruitment postcode(s) [28]

4029 - Herston

Recruitment postcode(s) [29]

4575 - Birtinya

Recruitment postcode(s) [30]

4032 - Chermside

Recruitment postcode(s) [31]

4814 - Douglas

Recruitment postcode(s) [32]

5042 - Bedford Park

Recruitment postcode(s) [33]

5112 - Elizabeth Vale

Recruitment postcode(s) [34]

5000 - Adelaide

Recruitment postcode(s) [35]

7250 - Launceston

Recruitment postcode(s) [36]

7000 - Hobart

Recruitment postcode(s) [37]

6112 - Armadale

Recruitment postcode(s) [38]

6150 - Murdoch

Recruitment postcode(s) [39]

6168 - Cooloongup

Recruitment postcode(s) [40]

6009 - Nedlands

Recruitment postcode(s) [41]

6056 - Midland

Recruitment postcode(s) [42]

6008 - Subiaco

Recruitment postcode(s) [43]

6000 - Perth

Recruitment postcode(s) [44]

2640 - Albury

Recruitment postcode(s) [45]

3690 - Wodonga

Recruitment postcode(s) [46]

3004 - Melbourne

Recruitment postcode(s) [47]

3084 - Heidelberg

Recruitment postcode(s) [48]

3220 - Geelong

Recruitment postcode(s) [49]

3550 - Bendigo

Recruitment postcode(s) [50]

3144 - Malvern

Recruitment postcode(s) [51]

3128 - Box Hill

Recruitment postcode(s) [52]

3002 - East Melbourne

Recruitment postcode(s) [53]

3630 - Shepparton

Recruitment postcode(s) [54]

3152 - Wantirna

Recruitment postcode(s) [55]

3844 - Traralgon

Recruitment postcode(s) [56]

3052 - Parkville

Recruitment postcode(s) [57]

3168 - Clayton

Recruitment postcode(s) [58]

3175 - Dandenong

Recruitment postcode(s) [59]

3806 - Berwick

Recruitment postcode(s) [60]

3076 - Epping

Recruitment postcode(s) [61]

3047 - Broadmeadows

Recruitment postcode(s) [62]

3083 - Bundoora

Recruitment postcode(s) [63]

3199 - Frankston

Recruitment postcode(s) [64]

3350 - Ballarat

Recruitment postcode(s) [65]

3065 - Fitzroy

Recruitment postcode(s) [66]

3011 - Footscray

Recruitment postcode(s) [67]

3021 - St Albans

Recruitment postcode(s) [68]

3820 - Warragul

Recruitment postcode(s) [69]

3350 - Ballarat Central

Recruitment postcode(s) [70]

3677 - Wangaratta

Recruitment postcode(s) [71]

3199 - Frankston

Recruitment postcode(s) [72]

2560 - Campbelltown

Recruitment postcode(s) [73]

2200 - Bankstown

Recruitment postcode(s) [74]

2194 - Campsie

Recruitment postcode(s) [75]

2650 - Wagga Wagga

Recruitment postcode(s) [76]

2086 - Frenchs Forest

Recruitment postcode(s) [77]

2065 - St Leonards

Recruitment postcode(s) [78]

2680 - Griffith

Recruitment postcode(s) [79]

2450 - Coffs Harbour

Recruitment postcode(s) [80]

6027 - Joondalup

Recruitment postcode(s) [81]

4215 - Southport

Recruitment postcode(s) [82]

4825 - Mount Isa

Recruitment postcode(s) [83]

2617 - Bruce

Recruitment postcode(s) [84]

4305 - Ipswich

Recruitment postcode(s) [85]

2077 - Hornsby

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Country [2]

India

State/province [2]

Multiple

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Melbourne

Address [1]

Parkville, VIC 3010

Country [1]

Australia

Funding source category [2]

University

Name [2]

University of Queensland

Address [2]

Centre for Clinical Research
Building 71/918, Royal Brisbane Women's Campus
Herston, QLD 4029

Country [2]

Australia

Funding source category [3]

Other

Name [3]

Hunter Medical Research Institute: a partnership between the University of Newcastle, Hunter New England Local Health District

Address [3]

Lot 1, Kookaburra Cct
New Lambton Heights NSW 2305

Country [3]

Australia

Funding source category [4]

Charities/Societies/Foundations

Name [4]

The Pratt Foundation

Address [4]

Level 11, 2 Southbank Bvd
Southbank VIC 3006

Country [4]

Australia

Funding source category [5]

Charities/Societies/Foundations

Name [5]

Royal Brisbane Women's Hospital Foundation

Address [5]

Block 20, Royal Brisbane Women's Hospital
Butterfield St, Herston, QLD 4029

Country [5]

Australia

Funding source category [6]

Charities/Societies/Foundations

Name [6]

Hospital Research Foundation

Address [6]

60 Woodville Rd,
Woodville SA 5011

Country [6]

Australia

Funding source category [7]

Charities/Societies/Foundations

Name [7]

The Minderoo Foundation

Address [7]

PO Box 3155, Broadway Nedlands, WA 6009

Country [7]

Australia

Funding source category [8]

Commercial sector/Industry

Name [8]

BHP

Address [8]

171 Collins Street
Melbourne Victoria 3000

Country [8]

Australia

Funding source category [9]

Other

Name [9]

New Zealand Health Research Council

Address [9]

PO Box 5541, Victoria Street West, Auckland 1142

Country [9]

New Zealand

Funding source category [10]

Charities/Societies/Foundations

Name [10]

Macquarie Group Foundation

Address [10]

Level 4, 1 Martin Place
Sydney NSW 2000

Country [10]

Australia

Funding source category [11]

Government body

Name [11]

Medical Research Future Fund

Address [11]

Department of Health
GPO Box 9848
Canberra ACT 2601
Australia

Country [11]

Australia

Primary sponsor type

University

Name

University of Melbourne

Address

Parkville, VIC, 3050

Country

Australia

Secondary sponsor category [1]

Other

Name [1]

Middlemore Clinical Trials

Address [1]

Middlemore Clinical Trials,
Private Bag 93311, Otahuhu 1640
Auckland, New Zealand

Country [1]

New Zealand

Secondary sponsor category [2]

Other

Name [2]

The George Institute for Global Health

Address [2]

Level 5, 1 King Street
Newtown 2042
NSW, Australia

Country [2]

Australia

Other collaborator category [1]

Other Collaborative groups

Name [1]

The Australasian Society for Infectious Diseases Clinical Research Network (ASID CRN)

Address [1]

Suite 302, Level 3, 478 George Street
Sydney NSW 2000
Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne Health Human Research Ethics Committee

Ethics committee address [1]

Royal Melbourne Hospital Office for Research
CITY CAMPUS
Level 2
South West
300 Grattan Street
Parkville Victoria 3050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/03/2020

Approval date [1]

03/04/2020

Ethics approval number [1]

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

A/Prof Steven Tong

Address

The Peter Doherty Institute for Infection and Immunity
792 Elizabeth Street
Melbourne, Victoria 3000

Country

Australia

Phone

+61 03 9342 9406

Fax

steven.tong@unimelb.edu.au

Contact person for public queries

Name

A/Prof Steven Tong

Address

The Peter Doherty Institute for Infection and Immunity
792 Elizabeth Street
Melbourne, Victoria 3000

Country

Australia

Phone

+61 03 9342 9406

Fax

ascot-team@unimelb.edu.au

Contact person for scientific queries

Name

A/Prof Steven Tong

Address

The Peter Doherty Institute for Infection and Immunity
792 Elizabeth Street
Melbourne, Victoria 3000

Country

Australia

Phone

+61 03 9342 9406

Fax

steven.tong@unimelb.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Trial Review