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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04483960
Registration number
NCT04483960
Ethics application status
Date submitted
22/07/2020
Date registered
23/07/2020
Date last updated
16/05/2024
Titles & IDs
Public title
Australasian COVID-19 Trial (ASCOT) ADAptive Platform Trial
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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)
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Secondary ID [1]
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X20-0159
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Universal Trial Number (UTN)
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Trial acronym
ASCOT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 Infection (COVID-19)
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - (Arm Closed) Nafamostat Mesilate
Treatment: Drugs - (Arm Closed) Enoxaparin
Treatment: Drugs - (Arm Closed) Dalteparin
Treatment: Drugs - (Arm Closed) Tinzaparin
Other interventions - (Arm Never Opened) Hyperimmune globulin
Treatment: Drugs - Nirmatrelvir-Ritonavir
Treatment: Drugs - Remdesivir
No Intervention: (Arm Closed) Antiviral - Standard of care - Standard of care without nafamostat mesilate
Experimental: (Arm Closed) 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.
Active Comparator: (Arm Closed) 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: (Arm Closed) 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: (Arm Closed) Anticoagulation - therapeutic anticoagulation - Therapeutic anticoagulation administered with 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
No Intervention: (Arm Never Opened) Antibody - Standard of Care - No hyperimmune globulin
Experimental: (Arm Never Opened) Antibody - hyperimmune globulin - 2 doses of 30mL (3x10mL vials) of COVID-19 Hyper-Immunoglobulin (Human) given over 2 days within 48 hours of randomisation
No Intervention: Antiviral II - No antiviral agent - Participants will receive no antiviral agents intended to be active against SARS-CoV-2 for 28 days or until hospital discharge, whichever occurs first.
Experimental: Antiviral II - Nirmatrelvir-ritonavir - The dose of nirmatrelvir-ritonavir is dependent on renal function. Participants will receive 100mg BD oral/enteral Ritonavir and either 150mg BD (if eGFR 30-59 mL/min/1.73m2) or 300mg BD (eGFR >= 60 mL/min/1.73m2) oral/enteral Nirmatrelvir. Investigators are advised to consider withholding treatment if the participant's eGFR < 30 mL/min/1.73m2.
Experimental: Antiviral II - Remdisivir - The dose of intravenous remdesivir is 200 mg on day 1 followed by 100 mg daily for a further four doses (i.e., for five doses in total) or until hospital discharge, whichever occurs first. Remdesivir will be administered as an intravenous infusion via a central or peripheral venous catheter over a 30-120 minute period, as per local practice.
Experimental: Antiviral II - Nirmatrelvir-ritonavir + remdesivir - Participants will receive both nirmatrelvir-ritonavir and remdesivir using the dose and administration methods described above.
Treatment: Drugs: (Arm Closed) 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.
Treatment: Drugs: (Arm Closed) Enoxaparin
Patients will be administered either a standard dose, intermediate dose or therapeutic anticoagulation 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 1mg/kg q12h or 1.5mg/kg q24h.
Treatment: Drugs: (Arm Closed) Dalteparin
Patients will be administered either a standard dose, intermediate dose or therapeutic anticoagulation 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 Dalteparin will be 100IU/kg q12h or 200IU/kg q24h.
Treatment: Drugs: (Arm Closed) Tinzaparin
Patients will be administered either a standard dose, intermediate dose or therapeutic anticoagulation 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 Tinzaparin will be 175IU/kg q24h (not available within Australia).
Other interventions: (Arm Never Opened) Hyperimmune globulin
2 doses of 30mL (3x10mL vials) of COVID-19 Hyper-Immunoglobulin (Human) given over 2 days within 48 hours of randomisation. Three vials will have approximately 10500 AU of neutralising antibodies, equivalent to approximately 200mL of convalescent plasma
Treatment: Drugs: Nirmatrelvir-Ritonavir
The dose of nirmatrelvir-ritonavir is dependent on renal function. Participants will receive 100mg BD of Ritonavir and either 150mg BD (if eGFR 30-59 mL/min/1.73m2) or 300mg BD (eGFR = 60 mL/min/1.73m2) of Nirmatrelvir. Investigators are advised to consider withholding treatment if participant's eGFR < 30 mL/min/1.73m2.
Treatment: Drugs: Remdesivir
The dose of intravenous remdesivir is 200 mg on day 1 followed by 100 mg daily for a further four doses (i.e., for five doses in total) or until hospital discharge, whichever occurs first. Remdesivir will be administered as an intravenous infusion via a central or peripheral venous catheter over a 30-120 minute period, as per local practice.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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A hierarchical ordinal scale that is a composite of mortality during the acute hospital admission and the duration of organ failure support while admitted to an ICU up until the end of study day 21.
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Assessment method [1]
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All patients who die before discharge from an acute hospital, irrespective of whether this occurs before or after day 21, will be coded as -1.
Survivors who receive organ failure support while admitted to an ICU within 21 days are assigned a score from 0 to 21 calculated as whole or part study days for which the patient is alive and not receiving organ failure support while admitted to an ICU up until the end of study day 21.
Survivors who never receive organ failure support while admitted to an ICU before the end of study day 21 will be coded as 22.
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Timepoint [1]
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Day 21
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Secondary outcome [1]
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Core Secondary Outcome: WHO 8-point ordinal outcome scale
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Assessment method [1]
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All participants in the platform will be assessed for this outcome.
The modified ordinal score is:
Not hospitalised
Hospitalised
Hospitalised, requiring supplemental oxygen
Hospitalised, on non-invasive ventilation or high flow oxygen devices
Hospitalised, on invasive mechanical ventilation or ECMO
Death
Note. 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.
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Timepoint [1]
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Day 14
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Secondary outcome [2]
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Core Secondary Outcome: All-cause mortality
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Assessment method [2]
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All participants in the platform will be assessed for this outcome.
All-cause mortality
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Timepoint [2]
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Day 28, 90 and 180
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Secondary outcome [3]
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Core Secondary Outcome: Days alive and free of hospital
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Assessment method [3]
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All participants in the platform will be assessed for this outcome.
Days alive and free of hospital, as it applies to the index hospital admission, by 28 days after randomisation
Note 1. 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.
Note 2. If patient is discharged prior to day 28, it will be assumed the patient has not been readmitted to hospital.
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Timepoint [3]
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Day 28
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Secondary outcome [4]
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Core Secondary Outcome: Days alive and free of supplemental oxygen, invasive or non-invasive ventilation
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Assessment method [4]
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All participants in the platform will be assessed for this outcome.
Number of days alive and free of supplemental oxygen, invasive or non-invasive ventilation by 28 days after randomisation
Note. If patient is discharged prior to day 28, it will be assumed that they have not received any supplemental oxygen, invasive or non-invasive ventilation since discharge.
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Timepoint [4]
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Day 28
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Secondary outcome [5]
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Core Secondary Outcome: Days alive and free of invasive or non-invasive ventilation or high flow oxygen
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Assessment method [5]
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All participants in the platform will be assessed for this outcome.
Days alive and free of invasive or non-invasive ventilation or high flow oxygen by 28 days after randomisation.
Note. If patient is discharged prior to day 28, it will be assumed that they have not received any invasive or non-invasive ventilation since discharge
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Timepoint [5]
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Day 28
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Secondary outcome [6]
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Core Secondary Outcome: Days alive and free of invasive mechanical ventilation
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Assessment method [6]
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All participants in the platform will be assessed for this outcome.
Days alive and free of invasive mechanical ventilation by 28 days after randomisation
Note. If patient is discharged prior to day 28, it will be assumed that they have not received any invasive ventilation since discharge.
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Timepoint [6]
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Day 28
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Secondary outcome [7]
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Core Secondary Outcome: Shortness of breath
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Assessment method [7]
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All participants in the platform will be assessed for this outcome.
A) 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?"
B) Ordinal comparison of the modified Medical Research Council (mMRC) breathlessness scale:
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
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Timepoint [7]
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Day 180
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Secondary outcome [8]
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Core Secondary Outcome: Quality of life
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Assessment method [8]
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All participants in the platform will be assessed for this outcome.
Measured by the EQ-5D-5L questionnaire
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Timepoint [8]
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Day 180
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Secondary outcome [9]
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Core Secondary Outcome: Destination at time of hospital discharge
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Assessment method [9]
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All participants in the platform will be assessed for this outcome.
Destination characterised as home, rehabilitation hospital, nursing home, or long-term care facility, or another acute hospital.
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Timepoint [9]
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Up to day 90
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Secondary outcome [10]
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Core Secondary Outcome: Admission (or re-admission) to ICU
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Assessment method [10]
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All participants in the platform will be assessed for this outcome.
Admission (or re-admission) to ICU during the index hospitalisation, censored at 90 days post-randomisation
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Timepoint [10]
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During the participant's index hospitalisation. Up to day 90.
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Secondary outcome [11]
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Core secondary outcome measures for participants admitted to ICU: ICU mortality
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Assessment method [11]
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All participants in the platform who are admitted to ICU will be assessed for this outcome.
ICU mortality, censored at 90 days post-randomisation
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Timepoint [11]
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Up to day 90
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Secondary outcome [12]
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Core secondary outcome measures for participants admitted to ICU: ICU length of stay
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Assessment method [12]
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All participants in the platform who are admitted to ICU will be assessed for this outcome.
ICU length of stay, censored at 90 days post-randomisation
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Timepoint [12]
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Up to day 90
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Secondary outcome [13]
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Core secondary outcome measures for participants admitted to ICU: Ventilator-free days
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Assessment method [13]
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All participants in the platform who are admitted to ICU will be assessed for this outcome.
Number of ventilator-free days, censored at 28 days post-randomisation
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Timepoint [13]
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Up to day 28
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Secondary outcome [14]
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Core secondary outcome measures for participants admitted to ICU: Organ failure free days
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Assessment method [14]
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All participants in the platform who are admitted to ICU will be assessed for this outcome.
Number of organ failure free days
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Timepoint [14]
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Up to day 28
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Secondary outcome [15]
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Antiviral II Domain Secondary Outcome: Length of hospital stay (in days)
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Assessment method [15]
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All participants randomised to the Antiviral II domain will be assessed for this outcome
Number of days in hospital
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Timepoint [15]
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During the participant's index hospitalisation. Censored 90 days after enrolment.
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Secondary outcome [16]
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Antiviral II Domain Secondary Outcome: Proportion of participants with baseline respiratory symptoms in whom all acute respiratory symptoms have resolved at study day 7
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Assessment method [16]
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All participants randomised to the Antiviral II domain will be assessed for this outcome
Proportion of participants with baseline respiratory symptoms in whom all acute respiratory symptoms have resolved at study day 7 after randomisation.
Note 1. Respiratory symptoms are defined as one or more of: cough, sore throat, runny nose sneezing, shortness of breath or chest pain. "Acute" means the symptom in question is not usually present in that individual, or during the current COVID episode was substantially worse or more frequent than usual.
Note 2. Resolution of all acute respiratory symptoms means return to baseline state - not necessarily the absence of all respiratory symptoms. Note 3. Ongoing non-respiratory symptoms (such as fatigue, anorexia, delirium, diarrhea) are not counted as part of this endpoint.
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Timepoint [16]
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Day 7
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Eligibility
Key inclusion criteria
A.Core Platform (all participants must meet the following):
1. Adult (as defined by local jurisdiction) patient admitted to hospital with acute illness
and suspected or proven SARS-CoV-2 infection.
B. Antiviral II Domain (all participants in the Antiviral II domain must meet the
following):
1. SARS-CoV-2 infection has been confirmed by positive rapid antigen test OR polymerase
chain reaction test within the last 7 days
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
A. Core platform exclusions (all participants must not meet the following):
1. Death is deemed to be imminent and inevitable during the next 24 hours AND one or more
of the patient, substitute decision maker or attending physician are not committed to
full active treatment
2. Patient is expected to be discharged from hospital today or tomorrow
3. More than 14 days have elapsed while admitted to hospital with symptoms of an acute
illness due to proven SARS-CoV-2 infection
4. Previous participation in this trial, or another trial that is analysed within the
same statistical model as this trial, within the last 90 days
B. Antiviral II Domain exclusions (patients at sites participating in the Antiviral II
Domain must not meet the following):
1. Severe renal impairment, defined as eGFR<30ml/min or receipt of renal replacement
therapy
2. Severe hepatic impairment, defined as proven or suspected cirrhosis with Child Pugh
class of C, OR acute hepatitis, defined as AST or ALT>5 times the upper limit of
normal in the testing laboratory.
3. The patient has received, at the time of eligibility assessment, >24h of an antiviral
agent intended to have activity against SARS-CoV-2, within the past 7 days
4. The patient is known to be pregnant or breastfeeding
5. The treating clinician believes that participation in the domain would not be in the
best interests of the patient
B.1. Antiviral II Domain Non-Immune Suppressed Stratum-specific Exclusion Criteria (all
non-immune suppressed patients at sites participating in the Antiviral II Domain must not
meet the following):
1. Onset of COVID-related symptoms was more than 7 days (i.e., 168 hours) ago
B2. Antiviral II domain Intervention-specific Exclusion Criteria (All patients at sites
participating in the Antiviral II Domain will be excluded from the below interventions if
they meet the following):
Will be excluded from receiving Remdesivir if:
1. No venous access is available and none can be created
2. Known hypersensitivity to remdesivir or its excipients
Will be excluded from receiving Nirmatrelvir/ritonavir if:
1. The patient is unable to take, tolerate or absorb oral or enteral medications
2. Known hypersensitivity to any of nirmatrelvir, ritonavir or its excipients
3. Receipt of a concomitant drug with a high-risk interaction with nirmatrelvir-ritonavir
which cannot be ceased or substituted.
Will be excluded from receiving no antiviral agent if:
1. The patient is in the Immune Suppressed Stratum
2. The patient is receiving or has received supplemental oxygen on the calendar day of
eligibility assessment.
3. The patient is considered by the treating clinician to be at very high risk for
progression to severe COVID-19
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Factorial
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/07/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2025
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Actual
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Sample size
Target
2200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Blacktown Hospital - Blacktown
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Recruitment hospital [2]
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Campbelltown Hospital - Campbelltown
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Recruitment hospital [3]
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St Vincent's Hospital Sydney - Darlinghurst
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Recruitment hospital [4]
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Nepean Hospital - Kingswood
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Recruitment hospital [5]
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St George Hospital - Kogarah
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Recruitment hospital [6]
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Liverpool Hospital - Liverpool
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Recruitment hospital [7]
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John Hunter Hospital - New Lambton Heights
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Recruitment hospital [8]
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Prince of Wales Hospital - Randwick
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Recruitment hospital [9]
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [10]
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Wagga Wagga Base Hospital - Wagga Wagga
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Recruitment hospital [11]
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Westmead Hospital - Westmead
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Recruitment hospital [12]
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Wollongong Hospital - Wollongong
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Recruitment hospital [13]
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Royal Darwin Hospital - Tiwi
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Recruitment hospital [14]
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The Prince Charles Hospital - Chermside
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Recruitment hospital [15]
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Royal Brisbane and Women's Hospital - Herston
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Recruitment hospital [16]
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Lyell McEwin Hospital - Elizabeth Vale
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Recruitment hospital [17]
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Ballarat Health Services - Ballarat Central
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Recruitment hospital [18]
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Eastern Health (Box Hill Hospital) - Box Hill
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Recruitment hospital [19]
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Monash Health - Clayton
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Recruitment hospital [20]
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Northern Health - Epping
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Recruitment hospital [21]
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Alfred Hospital - Melbourne
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Recruitment hospital [22]
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Royal Melbourne Hospital - Parkville
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Recruitment hospital [23]
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Western Health - St Albans
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Recruitment hospital [24]
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West Gippsland Hospital - Warragul
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Recruitment hospital [25]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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2560 - Campbelltown
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Recruitment postcode(s) [3]
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2010 - Darlinghurst
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Recruitment postcode(s) [4]
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2747 - Kingswood
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Recruitment postcode(s) [5]
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2217 - Kogarah
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Recruitment postcode(s) [6]
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2170 - Liverpool
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Recruitment postcode(s) [7]
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2305 - New Lambton Heights
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Recruitment postcode(s) [8]
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2031 - Randwick
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Recruitment postcode(s) [9]
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2065 - St Leonards
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Recruitment postcode(s) [10]
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2650 - Wagga Wagga
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Recruitment postcode(s) [11]
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2145 - Westmead
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Recruitment postcode(s) [12]
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2500 - Wollongong
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Recruitment postcode(s) [13]
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0810 - Tiwi
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Recruitment postcode(s) [14]
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4032 - Chermside
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Recruitment postcode(s) [15]
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4120 - Herston
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Recruitment postcode(s) [16]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [17]
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3350 - Ballarat Central
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Recruitment postcode(s) [18]
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3128 - Box Hill
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Recruitment postcode(s) [19]
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3168 - Clayton
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Recruitment postcode(s) [20]
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3076 - Epping
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Recruitment postcode(s) [21]
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3004 - Melbourne
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Recruitment postcode(s) [22]
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3050 - Parkville
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Recruitment postcode(s) [23]
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3021 - St Albans
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Recruitment postcode(s) [24]
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3820 - Warragul
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Recruitment postcode(s) [25]
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6000 - Perth
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Melbourne
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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The Peter Doherty Institute for Infection and Immunity
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Address [1]
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0
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Australasian Society for Infectious Diseases
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Address [2]
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0
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Country [2]
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0
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Other collaborator category [3]
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Other
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Name [3]
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Hunter Medical Research Institute
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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Aotearoa Clinical Trials
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Address [4]
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Country [4]
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Other collaborator category [5]
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Other
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Name [5]
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Australian and New Zealand Intensive Care Research Centre
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Address [5]
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Country [5]
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Ethics approval
Ethics application status
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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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04483960
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Steven Tong, Prof
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Address
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Melbourne Health
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04483960
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