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
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04483960




Registration number
NCT04483960
Ethics application status
Date submitted
22/07/2020
Date registered
23/07/2020
Date last updated
25/01/2021

Titles & IDs
Public title
Australasian COVID-19 Trial (ASCOT) ADAptive Platform Trial
Scientific title
A Multi-centre Randomised Adaptive Platform Clinical Trial to Assess Clinical, Virological and Immunological Outcomes in Patients With SARS-CoV-2 Infection (COVID-19)
Secondary ID [1] 0 0
ERM 62646-A
Universal Trial Number (UTN)
Trial acronym
ASCOT ADAPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 Infection (COVID-19) 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nafamostat Mesilate
Other interventions - Convalescent plasma
Treatment: Drugs - Enoxaparin
Treatment: Drugs - Dalteparin
Treatment: Drugs - Tinzaparin
Treatment: Drugs - Aspirin

No Intervention: Antiviral - Standard of care - Standard of care without nafamostat mesilate

Experimental: Antiviral - nafamostat mesilate - Nafamostat continuous IV infusion for 7 days or until day of hospital discharge at a dose of 0.2mg/kg/hour. No adjustment in dose is needed for renal impairment, including for renal dialysis. The daily dose of nafamostat should be administered in 500 mL (rate of infusion 20.8 mL/hour) of normal saline. Normal saline is recommended (due to the tendency for patients with COVID-19 towards hyponatraemia) but not mandated, and 5% dextrose would be acceptable if felt clinically appropriate.

No Intervention: Antibody - Standard of care - No convalescent plasma

Experimental: Antibody - convalescent plasma - Convalescent plasma (one unit) on day 1 and day 2

Active Comparator: Anticoagulation - standard dose thromboprophylaxis - Patients will be administered a standard thromboprophylactic dose of low molecular weight heparin, choice of agent according to availability and local practice at the participating site.

Experimental: Anticoagulation - intermediate dose thromboprophylaxis - Patients will be administered an intermediate dose of low molecular weight heparin, choice of agent according to availability and local practice at the participating site. The maximum dose of enoxaparin will be 120 mg/d, tinzaparin 125 IU/kg/day (not available within Australia), and Dalteparin 15,000 IU/d.

Experimental: Anticoagulation - standard dose thromboprophylaxis plus aspirin - Patients will be administered a standard thromboprophylactic dose of low molecular weight heparin, choice of agent according to availability and local practice at the participating site. In addition, patients will receive 100mg aspirin daily.


Treatment: Drugs: Nafamostat Mesilate
Nafamostat continuous IV infusion for 7 days or until day of hospital discharge at a dose of 0.2mg/kg/hour. No adjustment in dose is needed for renal impairment, including for renal dialysis. The daily dose of nafamostat should be administered in 500 mL (rate of infusion 20.8 mL/hour) of normal saline. Normal saline is recommended (due to the tendency for patients with COVID-19 towards hyponatraemia) but not mandated, and 5% dextrose would be acceptable if felt clinically appropriate.

Other interventions: Convalescent plasma
Convalescent plasma (one unit) on day 1 and day 2

Treatment: Drugs: Enoxaparin
Patients will be administered either a standard dose or an intermediate dose of low molecular weight heparin (depending on assigned arm), choice of agent according to availability and local practice at the participating site. The maximum dose of enoxaparin will be 120 mg/d, tinzaparin 125 IU/kg/day (not available within Australia), and Dalteparin 15,000 IU/d.

Treatment: Drugs: Dalteparin
Patients will be administered either a standard dose or an intermediate dose of low molecular weight heparin (depending on assigned arm), choice of agent according to availability and local practice at the participating site. The maximum dose of enoxaparin will be 120 mg/d, tinzaparin 125 IU/kg/day (not available within Australia), and Dalteparin 15,000 IU/d.

Treatment: Drugs: Tinzaparin
Patients will be administered either a standard dose or an intermediate dose of low molecular weight heparin (depending on assigned arm), choice of agent according to availability and local practice at the participating site. The maximum dose of enoxaparin will be 120 mg/d, tinzaparin 125 IU/kg/day (not available within Australia), and Dalteparin 15,000 IU/d.

Treatment: Drugs: Aspirin
In addition to standard dose thromboprophylaxis, patients randomised to this arm will also receive 100mg aspirin daily.

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Death from any cause or requirement of new intensive respiratory support (invasive or non-invasive ventilation) or vasopressor/inotropic support. - 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] 0 0
28 days
Secondary outcome [1] 0 0
Time to clinical recovery - 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 [1] 0 0
28 days
Secondary outcome [2] 0 0
WHO 8-point ordinal outcome scale - The ordinal score is:
Not hospitalised, no limitations on activities
Not hospitalised, limitation on activities
Hospitalised, not requiring supplemental oxygen and no longer requiring ongoing medical care (used if hospitalization was extended for infection control purposes)
Hospitalised, not requiring supplemental oxygen but requiring ongoing medical care (COVID-19 related or other medical conditions)
Hospitalised, requiring supplemental oxygen
Hospitalised, on non-invasive ventilation or high flow oxygen devices
Hospitalised, on invasive mechanical ventilation or ECMO
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 [2] 0 0
28 days
Secondary outcome [3] 0 0
All-cause mortality - All-cause mortality
Timepoint [3] 0 0
28 days and 90 days
Secondary outcome [4] 0 0
Days alive and free of hospital - Number of days
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 [4] 0 0
28 days
Secondary outcome [5] 0 0
Days alive and free of invasive or non-invasive ventilation - Number of days
Timepoint [5] 0 0
28 days
Secondary outcome [6] 0 0
Shortness of breath - Patient reported outcome.
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?"
Ordinal comparison of the modified Medical Research Council (mMRC) breathlessness scale:
Modified Medical Research Council (mMRC) Dyspnoea Scale for grading the severity of breathlessness during daily activities:
0 - I only get breathless with strenuous exercise
- I get short of breath when hurrying on level ground or walking up a slight hill
- 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
- I stop for breath after walking about 100 metres or after a few minutes on level ground
- I am too breathless to leave the house or I am breathless when dressing or undressing
Timepoint [6] 0 0
28 days and 90 days
Secondary outcome [7] 0 0
Quality of life - Measured by the EQ-5D-5L questionnaire
Timepoint [7] 0 0
28 days and 90 days
Secondary outcome [8] 0 0
Antiviral domain-specific outcome: Viral clearance - Proportion of patients with negative SARS-CoV-2 RT-PCR from upper or lower respiratory tract samples, for those with results available.
Timepoint [8] 0 0
3 and 7 days
Secondary outcome [9] 0 0
Antiviral domain-specific 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] 0 0
3 and 7 days
Secondary outcome [10] 0 0
Antiviral domain-specific outcome: Safety (Liver enzymes) - o Elevation of Alanine Transaminase (ALT) or Aspartate Transaminase (AST) to >5x upper limit of normal
Timepoint [10] 0 0
Up to day 28 or day of discharge from hospital, whichever is earlier
Secondary outcome [11] 0 0
Antiviral domain-specific outcome: Safety (potassium) - o Elevation of serum potassium to >5.5 mmol/L
Timepoint [11] 0 0
Up to day 28 or day of discharge from hospital, whichever is earlier
Secondary outcome [12] 0 0
Antiviral domain-specific outcome: Safety (sodium) - o Decrease of serum sodium to <125 mmol/L
Timepoint [12] 0 0
Up to day 28 or day of discharge from hospital, whichever is earlier
Secondary outcome [13] 0 0
Antiviral domain-specific outcome: Safety (bleeding) - o Major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH).
Timepoint [13] 0 0
Up to day 28 or day of discharge from hospital, whichever is earlier
Secondary outcome [14] 0 0
Antiviral domain-specific outcome: Safety (thrombophlebitis) - o Thrombophlebitis/vasculitis at IV line site
Timepoint [14] 0 0
Up to day 28 or day of discharge from hospital, whichever is earlier
Secondary outcome [15] 0 0
Antiviral domain-specific outcome: serious adverse reactions - Any safety event that, in the judgment of the investigator, is both serious and either possibly, probably or definitely related to the study intervention(s).
Timepoint [15] 0 0
28 days
Secondary outcome [16] 0 0
Antibody domain-specific outcome: Serious treatment-related adverse events - Including:
Serious allergic reaction or anaphylaxis
Transfusion-related acute lung injury (TRALI)
Transfusion-associated circulatory overload (TACO)
Acute haemolytic transfusion reaction
Timepoint [16] 0 0
Within 24 hours of treatment
Secondary outcome [17] 0 0
Antibody domain-specific outcome: Haemolysis - Yes/No
Timepoint [17] 0 0
Within 72 hours of last transfusion
Secondary outcome [18] 0 0
Antibody domain-specific outcome: Confirmed arterial thrombosis - Yes/no - acute myocardial infarction, ischemic cerebrovascular event, other
Timepoint [18] 0 0
28 days
Secondary outcome [19] 0 0
Antibody domain-specific outcome: Confirmed venous thrombosis - Yes/No - deep vein thrombosis, pulmonary embolus, other
Timepoint [19] 0 0
28 days
Secondary outcome [20] 0 0
Anticoagulation domain-specific outcome: Confirmed deep venous thrombosis - Yes/No
Timepoint [20] 0 0
28 days
Secondary outcome [21] 0 0
Anticoagulation domain-specific outcome: Confirmed pulmonary embolus - Yes/No
Timepoint [21] 0 0
28 days
Secondary outcome [22] 0 0
Anticoagulation domain-specific outcome: Confirmed acute myocardial infarction - Yes/No
Timepoint [22] 0 0
28 days
Secondary outcome [23] 0 0
Anticoagulation domain-specific outcome: Confirmed ischemic cerebrovascular event - Yes/No
Timepoint [23] 0 0
28 days
Secondary outcome [24] 0 0
Anticoagulation domain-specific outcome: Major bleeding - Yes/No - As defined by International Society on Thrombosis and Haemostasis (ISTH). Site of bleeding and which of the ISTH criteria are met will be recorded.
Timepoint [24] 0 0
28 days
Secondary outcome [25] 0 0
Anticoagulation domain-specific outcome: Clinically relevant non-major bleeding - Yes/No - As defined by International Society on Thrombosis and Haemostasis (ISTH).
Timepoint [25] 0 0
28 days
Secondary outcome [26] 0 0
Anticoagulation domain-specific outcome: Heparin-induced thrombocytopenia (HIT) - Yes/No - During index hospitalisation
Timepoint [26] 0 0
28 days

Eligibility
Key inclusion criteria
Platform

1. Age = 18 years

2. Admitted to an acute-care hospital

3. Confirmed SARS-CoV-2 by nucleic acid testing in the past 14 days

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 platform 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) intervention-level exclusions:

Criteria that exclude a patient from one or more interventions are:

Nafamostat:

- Known current decompensated liver disease (Child-Pugh B or C)

- The treating clinician intends to continue or commence therapeutic anticoagulation

- 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

- Serum Potassium >5.5 mmol/L (based on most recent blood test result collected as part
of routine care within the previous 3 days)

- Serum Sodium <120 mmol/L (based on most recent blood test result collected as part of
routine care within the previous 3 days)

- Hypersensitivity to nafamostat

- Pregnancy or breastfeeding

- Currently receiving or have received nafamostat in the past 7 days

- Decompensated heart failure or renal dialysis and clinician believes an extra 500mL
fluid/day would be detrimental There are no domain-level exclusions for the antiviral
domain.

C. Domain B (Antibody) domain-level exclusions:

Patients will be excluded from this domain if they have any of the following:

- 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;

- Treating team deems enrolment in antibody intervention is not in the best interests of
the patient.

Domain B (Antibody) intervention-level exclusions:

The following are intervention exclusions:

- Known previous history of transfusion-related acute lung injury will exclude a patient
from convalescent plasma;

- Known previous history of serious allergic reaction to blood product transfusion will
exclude a patient from convalescent plasma;

- Known personal or religious objections to receiving blood products will exclude a
patient from receiving convalescent plasma;

D. Domain C (Anticoagulation) domain-level exclusions:

Patients will be excluded from this domain if they have any of the following:

- Receiving dual antiplatelet therapy

- The treating clinician intends to continue or commence therapeutic anticoagulation
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

- Severe thrombocytopenia (platelet count less than 30 x 109/L)

- History of intracranial haemorrhage in the previous 3 months

- Severe renal impairment, defined as estimated glomerular filtration rate less than
15ml/min/1.73m2

- 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

Domain C (anticoagulation) intervention-level exclusion criteria:

Criteria that exclude a patient from one or more interventions are:

- Receiving an antiplatelet agent will exclude a patient from receiving standard
thromboprophylaxis plus aspirin

- Hypersensitivity to aspirin will exclude a patient from receiving standard
thrmoboprophylaxis 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
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,VIC,WA
Recruitment hospital [1] 0 0
Calvary Public Bruce Hospital - Bruce
Recruitment hospital [2] 0 0
The Canberra Hospital - Canberra
Recruitment hospital [3] 0 0
Armidale Hospital - Armidale
Recruitment hospital [4] 0 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [5] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [6] 0 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [7] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [8] 0 0
Canterbury Hospital - Campsie
Recruitment hospital [9] 0 0
The Sutherland Hospital - Caringbah
Recruitment hospital [10] 0 0
Coffs Harbour Health Campus - Coffs Harbour
Recruitment hospital [11] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [12] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [13] 0 0
Northern Beaches Hospital - Frenchs Forest
Recruitment hospital [14] 0 0
Griffith Base Hospital - Griffith
Recruitment hospital [15] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [16] 0 0
St George Hospital - Kogarah
Recruitment hospital [17] 0 0
Lismore Base Hospital - Lismore
Recruitment hospital [18] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [19] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [20] 0 0
Orange Health Service - Orange
Recruitment hospital [21] 0 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [22] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [23] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [24] 0 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [25] 0 0
Wagga Wagga Base Hospital - Wagga Wagga
Recruitment hospital [26] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [27] 0 0
Westmead Hospital - Westmead
Recruitment hospital [28] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [29] 0 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [30] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [31] 0 0
Caboolture Hospital - Caboolture
Recruitment hospital [32] 0 0
Cairns Hospital - Cairns
Recruitment hospital [33] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [34] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [35] 0 0
Mackay Base Hospital - Mackay
Recruitment hospital [36] 0 0
Logan Hospital - Meadowbrook
Recruitment hospital [37] 0 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [38] 0 0
Mater - South Brisbane
Recruitment hospital [39] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [40] 0 0
Townsville University Hospital - Townsville
Recruitment hospital [41] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [42] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [43] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [44] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [45] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [46] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [47] 0 0
Ballarat Health Services - Ballarat Central
Recruitment hospital [48] 0 0
St John of God Ballarat Hospital - Ballarat
Recruitment hospital [49] 0 0
Bendigo Health - Bendigo
Recruitment hospital [50] 0 0
Eastern Health (Box Hill Hospital) - Box Hill
Recruitment hospital [51] 0 0
Monash Health - Clayton
Recruitment hospital [52] 0 0
Northern Health - Epping
Recruitment hospital [53] 0 0
St. Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [54] 0 0
Frankston Hospital - Penninsula Health - Frankston
Recruitment hospital [55] 0 0
Peninsula Private Hospital - Frankston
Recruitment hospital [56] 0 0
Barwon Health - University Hospital Geelong - Geelong
Recruitment hospital [57] 0 0
Austin Health - Heidelberg
Recruitment hospital [58] 0 0
Cabrini Health - Malvern
Recruitment hospital [59] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [60] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [61] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [62] 0 0
Epworth Richmond - Richmond
Recruitment hospital [63] 0 0
Goulburn Valley Health - Shepparton
Recruitment hospital [64] 0 0
Western Health - St Albans
Recruitment hospital [65] 0 0
Latrobe Regional Hospital - Traralgon
Recruitment hospital [66] 0 0
West Gippsland Hospital - Warragul
Recruitment hospital [67] 0 0
Albury Wodonga Health - Wodonga
Recruitment hospital [68] 0 0
Rockingham General Hospital - Cooloongup
Recruitment hospital [69] 0 0
Joondalup Health Campus - Joondalup
Recruitment hospital [70] 0 0
Armadale Health Service - Mount Nasura
Recruitment hospital [71] 0 0
Fiona Stanley Hospita - Murdoch
Recruitment hospital [72] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [73] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [74] 0 0
St John of God Subiaco Hospital - Subiaco
Recruitment hospital [75] 0 0
Knox Private Hospital - Wantirna
Recruitment postcode(s) [1] 0 0
2617 - Bruce
Recruitment postcode(s) [2] 0 0
2605 - Canberra
Recruitment postcode(s) [3] 0 0
2350 - Armidale
Recruitment postcode(s) [4] 0 0
2200 - Bankstown
Recruitment postcode(s) [5] 0 0
2148 - Blacktown
Recruitment postcode(s) [6] 0 0
2560 - Campbelltown
Recruitment postcode(s) [7] 0 0
2050 - Camperdown
Recruitment postcode(s) [8] 0 0
2194 - Campsie
Recruitment postcode(s) [9] 0 0
2229 - Caringbah
Recruitment postcode(s) [10] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [11] 0 0
2139 - Concord
Recruitment postcode(s) [12] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [13] 0 0
2086 - Frenchs Forest
Recruitment postcode(s) [14] 0 0
2680 - Griffith
Recruitment postcode(s) [15] 0 0
2747 - Kingswood
Recruitment postcode(s) [16] 0 0
2217 - Kogarah
Recruitment postcode(s) [17] 0 0
2480 - Lismore
Recruitment postcode(s) [18] 0 0
2170 - Liverpool
Recruitment postcode(s) [19] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [20] 0 0
2800 - Orange
Recruitment postcode(s) [21] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [22] 0 0
2031 - Randwick
Recruitment postcode(s) [23] 0 0
2065 - St Leonards
Recruitment postcode(s) [24] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [25] 0 0
2650 - Wagga Wagga
Recruitment postcode(s) [26] 0 0
2298 - Waratah
Recruitment postcode(s) [27] 0 0
2145 - Westmead
Recruitment postcode(s) [28] 0 0
2500 - Wollongong
Recruitment postcode(s) [29] 0 0
0810 - Tiwi
Recruitment postcode(s) [30] 0 0
4575 - Birtinya
Recruitment postcode(s) [31] 0 0
4510 - Caboolture
Recruitment postcode(s) [32] 0 0
4870 - Cairns
Recruitment postcode(s) [33] 0 0
4032 - Chermside
Recruitment postcode(s) [34] 0 0
4120 - Herston
Recruitment postcode(s) [35] 0 0
4740 - Mackay
Recruitment postcode(s) [36] 0 0
4131 - Meadowbrook
Recruitment postcode(s) [37] 0 0
4020 - Redcliffe
Recruitment postcode(s) [38] 0 0
4101 - South Brisbane
Recruitment postcode(s) [39] 0 0
4215 - Southport
Recruitment postcode(s) [40] 0 0
4814 - Townsville
Recruitment postcode(s) [41] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [42] 0 0
5000 - Adelaide
Recruitment postcode(s) [43] 0 0
5042 - Bedford Park
Recruitment postcode(s) [44] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [45] 0 0
7000 - Hobart
Recruitment postcode(s) [46] 0 0
7250 - Launceston
Recruitment postcode(s) [47] 0 0
3350 - Ballarat Central
Recruitment postcode(s) [48] 0 0
3350 - Ballarat
Recruitment postcode(s) [49] 0 0
3550 - Bendigo
Recruitment postcode(s) [50] 0 0
3128 - Box Hill
Recruitment postcode(s) [51] 0 0
3168 - Clayton
Recruitment postcode(s) [52] 0 0
3076 - Epping
Recruitment postcode(s) [53] 0 0
3065 - Fitzroy
Recruitment postcode(s) [54] 0 0
3199 - Frankston
Recruitment postcode(s) [55] 0 0
3220 - Geelong
Recruitment postcode(s) [56] 0 0
3084 - Heidelberg
Recruitment postcode(s) [57] 0 0
3144 - Malvern
Recruitment postcode(s) [58] 0 0
3000 - Melbourne
Recruitment postcode(s) [59] 0 0
3004 - Melbourne
Recruitment postcode(s) [60] 0 0
3050 - Parkville
Recruitment postcode(s) [61] 0 0
3121 - Richmond
Recruitment postcode(s) [62] 0 0
3630 - Shepparton
Recruitment postcode(s) [63] 0 0
3021 - St Albans
Recruitment postcode(s) [64] 0 0
3844 - Traralgon
Recruitment postcode(s) [65] 0 0
3820 - Warragul
Recruitment postcode(s) [66] 0 0
3690 - Wodonga
Recruitment postcode(s) [67] 0 0
6168 - Cooloongup
Recruitment postcode(s) [68] 0 0
6027 - Joondalup
Recruitment postcode(s) [69] 0 0
6112 - Mount Nasura
Recruitment postcode(s) [70] 0 0
6150 - Murdoch
Recruitment postcode(s) [71] 0 0
6009 - Nedlands
Recruitment postcode(s) [72] 0 0
6000 - Perth
Recruitment postcode(s) [73] 0 0
6008 - Subiaco
Recruitment postcode(s) [74] 0 0
3152 - Wantirna

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Peter Doherty Institute for Infection and Immunity
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Australasian Society for Infectious Diseases
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Middlemore Clinical Trials
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
The George Institute
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Hunter Medical Research Institute
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
The University of Queensland
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
An International Multi-Centre Randomised Adaptive Platform Clinical Trial to Assess the
Clinical, Virological and Immunological Outcomes in Patients with SARS-CoV-2 Infection
(COVID-19).
Trial website
https://clinicaltrials.gov/show/NCT04483960
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Steven Tong, A/Prof
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Naomi Perry
Address 0 0
Country 0 0
Phone 0 0
+61 3 83442647
Fax 0 0
Email 0 0
naomi.perry@unimelb.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04483960