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ACTIVE NOT RECRUITING
NCT04483960
PHASE3

Australasian COVID-19 Trial (ASCOT) ADAptive Platform Trial

Sponsor: University of Melbourne

View on ClinicalTrials.gov

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).

Official 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2200

Start Date

2020-07-28

Completion Date

2025-12-31

Last Updated

2024-05-16

Healthy Volunteers

No

Interventions

DRUG

(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.

DRUG

(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.

DRUG

(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.

DRUG

(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).

BIOLOGICAL

(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

DRUG

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.

DRUG

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.

Locations (25)

Blacktown Hospital

Blacktown, New South Wales, Australia

Campbelltown Hospital

Campbelltown, New South Wales, Australia

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

Nepean Hospital

Kingswood, New South Wales, Australia

St George Hospital

Kogarah, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

John Hunter Hospital

New Lambton Heights, New South Wales, Australia

Prince of Wales Hospital

Randwick, New South Wales, Australia

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Wagga Wagga Base Hospital

Wagga Wagga, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Wollongong Hospital

Wollongong, New South Wales, Australia

Royal Darwin Hospital

Tiwi, Northern Territory, Australia

The Prince Charles Hospital

Chermside, Queensland, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Lyell McEwin Hospital

Elizabeth Vale, South Australia, Australia

Ballarat Health Services

Ballarat Central, Victoria, Australia

Eastern Health (Box Hill Hospital)

Box Hill, Victoria, Australia

Monash Health

Clayton, Victoria, Australia

Northern Health

Epping, Victoria, Australia

Alfred Hospital

Melbourne, Victoria, Australia

Royal Melbourne Hospital

Parkville, Victoria, Australia

Western Health

St Albans, Victoria, Australia

West Gippsland Hospital

Warragul, Victoria, Australia

Royal Perth Hospital

Perth, Western Australia, Australia