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SARS-CoV-2 Infection (COVID-19)Phase 3ASCOTNCT04483960

Australasian COVID-19 Trial (ASCOT) ADAptive Platform Trial

A Phase 3 study testing (Arm Closed) Nafamostat Mesilate, (Arm Closed) Enoxaparin and (Arm Closed) Dalteparin in people with SARS-CoV-2 Infection (COVID-19), run by University of Melbourne at 25 sites in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
SARS-CoV-2 Infection (COVID-19)
What is being tested?
(Arm Closed) Nafamostat Mesilate, (Arm Closed) Enoxaparin and (Arm Closed) Dalteparin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,200 participants
Where
25 sitesAustralia
Study dates
28 Jul 2020to 31 Dec 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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

Who cannot join

  • Core platform exclusions (all participants must not meet the following):
  • 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
  • Patient is expected to be discharged from hospital today or tomorrow
  • More than 14 days have elapsed while admitted to hospital with symptoms of an acute illness due to proven SARS-CoV-2 infection
  • Previous participation in this trial, or another trial that is analysed within the same statistical model as this trial, within the last 90 days
  • Antiviral II Domain exclusions (patients at sites participating in the Antiviral II Domain must not meet the following):
Show all 25Show fewer
  • Severe renal impairment, defined as eGFR<30ml/min or receipt of renal replacement therapy
  • 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.
  • 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
  • The patient is known to be pregnant or breastfeeding
  • 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:
  • No venous access is available and none can be created
  • Known hypersensitivity to remdesivir or its excipients
  • Will be excluded from receiving Nirmatrelvir/ritonavir if:
  • The patient is unable to take, tolerate or absorb oral or enteral medications
  • Known hypersensitivity to any of nirmatrelvir, ritonavir or its excipients
  • 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:
  • The patient is in the Immune Suppressed Stratum
  • The patient is receiving or has received supplemental oxygen on the calendar day of eligibility assessment.
  • The patient is considered by the treating clinician to be at very high risk for progression to severe COVID-19

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

Australia25 sites

  • Ballarat Health Services

    Ballarat Central, Victoria, 3350

  • Blacktown Hospital

    Blacktown, New South Wales, 2148

  • Eastern Health (Box Hill Hospital)

    Box Hill, Victoria, 3128

  • Campbelltown Hospital

    Campbelltown, New South Wales, 2560

  • The Prince Charles Hospital

    Chermside, Queensland, 4032

  • Monash Health

    Clayton, Victoria, 3168

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Lyell McEwin Hospital

    Elizabeth Vale, South Australia, 5112

  • Northern Health

    Epping, Victoria, 3076

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4120

  • Nepean Hospital

    Kingswood, New South Wales, 2747

  • St George Hospital

    Kogarah, New South Wales, 2217

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • John Hunter Hospital

    New Lambton Heights, New South Wales, 2305

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • Western Health

    St Albans, Victoria, 3021

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Royal Darwin Hospital

    Tiwi, Northern Territory, 0810

  • Wagga Wagga Base Hospital

    Wagga Wagga, New South Wales, 2650

  • West Gippsland Hospital

    Warragul, Victoria, 3820

  • Westmead Hospital

    Westmead, New South Wales, 2145

  • Wollongong Hospital

    Wollongong, New South Wales, 2500

Other trials in Australia

About this study

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)

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).

Read the detailed description

ASCOT is an investigator-initiated, multi-centre, open-label, randomised controlled, Bayesian, adaptive platform trial. The objective of ASCOT is to identify the regimen (combination of interventions) associated with the highest chance of improving clinical outcomes in adults hospitalised with COVID-19.

Platform trials allow multiple questions to be evaluated simultaneously and sequentially within the platform, and evaluate interaction between different treatment options, to achieve the goal of determining the optimal combination of treatments for the disease as rapidly as possible. Study treatments are categorised into different treatment domains.

The adaptive nature of the trial means treatments within a domain or an entire domain can be removed or added based on accruing data analysed at frequent intervals or based on external evidence.

[Domain Closed] Intervention domain A (antiviral): Participants will be randomised to receive either i) standard of care without nafamostat; or ii) standard of care with nafamostat

[Never Opened] Intervention domain B (antibody): Participants will be randomised to receive either i) standard of care without hyperimmune globulin; or ii) standard of care with hyperimmune globulin

[Domain Closed] Intervention domain C (anticoagulation): Participants will be randomised to receive either i) standard dose thromboprophylaxis; or ii) intermediate dose thromboprophylaxis; or iii) therapeutic anticoagulation

Intervention domain Q (Antiviral II):

Participants will be randomised to receive either i) no antiviral agents; or ii) oral nirmatrelvir-ritonavir; or iii) intravenous remdesivir iiii) oral nirmatrelvir-ritonavir + Intravenous remdesivir

Being tested
(Arm Closed) Nafamostat Mesilate, (Arm Closed) Enoxaparin, (Arm Closed) Dalteparin, (Arm Closed) Tinzaparin, (Arm Never Opened) Hyperimmune globulin
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • (Arm Closed) Nafamostat MesilateDrug

    Also called Nafabelltan

    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.

  • (Arm Closed) EnoxaparinDrug

    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.

  • (Arm Closed) DalteparinDrug

    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.

  • (Arm Closed) TinzaparinDrug

    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).

  • (Arm Never Opened) Hyperimmune globulinBiological

    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

  • Nirmatrelvir-RitonavirDrug

    Also called Paxlovid

    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.

  • RemdesivirDrug

    Also called Veklury

    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.

Study groups in NCT04483960
Study groupRoleWhat they receive
(Arm Closed) Antiviral - Standard of careNo interventionStandard of care without nafamostat mesilate
(Arm Closed) Antiviral - nafamostat mesilateExperimentalNafamostat 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.
Receives: Drug: (Arm Closed) Nafamostat Mesilate
(Arm Closed) Anticoagulation - standard dose thromboprophylaxisActive comparatorPatients 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.
Receives: Drug: (Arm Closed) Enoxaparin; Drug: (Arm Closed) Dalteparin; Drug: (Arm Closed) Tinzaparin
(Arm Closed) Anticoagulation - intermediate dose thromboprophylaxisExperimentalPatients 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.
Receives: Drug: (Arm Closed) Enoxaparin; Drug: (Arm Closed) Dalteparin; Drug: (Arm Closed) Tinzaparin
(Arm Closed) Anticoagulation - therapeutic anticoagulationExperimentalTherapeutic 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
Receives: Drug: (Arm Closed) Enoxaparin; Drug: (Arm Closed) Dalteparin; Drug: (Arm Closed) Tinzaparin
(Arm Never Opened) Antibody - Standard of CareNo interventionNo hyperimmune globulin
(Arm Never Opened) Antibody - hyperimmune globulinExperimental2 doses of 30mL (3x10mL vials) of COVID-19 Hyper-Immunoglobulin (Human) given over 2 days within 48 hours of randomisation
Receives: Biological: (Arm Never Opened) Hyperimmune globulin
Antiviral II - No antiviral agentNo interventionParticipants will receive no antiviral agents intended to be active against SARS-CoV-2 for 28 days or until hospital discharge, whichever occurs first.
Antiviral II - Nirmatrelvir-ritonavirExperimentalThe 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.
Receives: Drug: Nirmatrelvir-Ritonavir
Antiviral II - RemdisivirExperimentalThe 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.
Receives: Drug: Remdesivir
Antiviral II - Nirmatrelvir-ritonavir + remdesivirExperimentalParticipants will receive both nirmatrelvir-ritonavir and remdesivir using the dose and administration methods described above.
Receives: Drug: Nirmatrelvir-Ritonavir; Drug: Remdesivir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    • 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.

    Measured: Day 21

Secondary outcomes (16)

  1. Core Secondary Outcome: WHO 8-point ordinal outcome scale

    All participants in the platform will be assessed for this outcome.

    The modified ordinal score is:

    1. Not hospitalised
    2. Hospitalised
    3. Hospitalised, requiring supplemental oxygen
    4. Hospitalised, on non-invasive ventilation or high flow oxygen devices
    5. Hospitalised, on invasive mechanical ventilation or ECMO
    6. 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.

    Measured: Day 14

  2. Core Secondary Outcome: All-cause mortality

    All participants in the platform will be assessed for this outcome.

    All-cause mortality

    Measured: Day 28, 90 and 180

  3. Core Secondary Outcome: Days alive and free of hospital

    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.

    Measured: Day 28

  4. Core Secondary Outcome: Days alive and free of supplemental oxygen, invasive or non-invasive ventilation

    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.

    Measured: Day 28

  5. Core Secondary Outcome: Days alive and free of invasive or non-invasive ventilation or high flow oxygen

    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

    Measured: Day 28

  6. Core Secondary Outcome: Days alive and free of invasive mechanical ventilation

    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.

    Measured: Day 28

  7. Core Secondary Outcome: Shortness of breath

    All participants in the platform will be assessed for this outcome.

    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

    Measured: Day 180

  8. Core Secondary Outcome: Quality of life

    All participants in the platform will be assessed for this outcome.

    Measured by the EQ-5D-5L questionnaire

    Measured: Day 180

  9. Core Secondary Outcome: Destination at time of hospital discharge

    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.

    Measured: Up to day 90

  10. Core Secondary Outcome: Admission (or re-admission) to ICU

    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

    Measured: During the participant's index hospitalisation. Up to day 90.

  11. Core secondary outcome measures for participants admitted to ICU: ICU mortality

    All participants in the platform who are admitted to ICU will be assessed for this outcome.

    ICU mortality, censored at 90 days post-randomisation

    Measured: Up to day 90

  12. Core secondary outcome measures for participants admitted to ICU: ICU length of stay

    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

    Measured: Up to day 90

  13. Core secondary outcome measures for participants admitted to ICU: Ventilator-free days

    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

    Measured: Up to day 28

  14. Core secondary outcome measures for participants admitted to ICU: Organ failure free days

    All participants in the platform who are admitted to ICU will be assessed for this outcome.

    Number of organ failure free days

    Measured: Up to day 28

  15. Antiviral II Domain Secondary Outcome: Length of hospital stay (in days)

    All participants randomised to the Antiviral II domain will be assessed for this outcome

    Number of days in hospital

    Measured: During the participant's index hospitalisation. Censored 90 days after enrolment.

  16. Antiviral II Domain Secondary Outcome: Proportion of participants with baseline respiratory symptoms in whom all acute respiratory symptoms have resolved at study day 7

    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.

    Measured: Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2020
  2. Study start28 Jul 2020
  3. Primary completion25 Jul 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
Participants enrolled into the study have the option of deciding whether to be randomised in one or more (if available) treatment domains concurrently, if they meet the eligibility criteria.
Masking
None (open label)
Enrolment
2,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04483960
Sponsor's protocol ID
X20-0159
Acronym
ASCOT
Status last verified
May 2024
First submitted
22 Jul 2020
Last updated
16 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Morpeth SC, Venkatesh B, Totterdell JA, McPhee GM, Mahar RK, Jones M, Bandara M, Barina LA, Basnet BK, Bowen AC, Burke AJ, Cochrane B, Denholm JT, Dhungana A, Dore GJ, Dotel R, Duffy E, Dummer J, Foo H, Gilbey TL, Hammond NE, Hudson BJ, Jha V, Jevaji PR, John O, Joshi R, Kang G, Kaur B, Kim S, Das SK, Lau JSY, Littleford R, Marsh JA, Marschner IC, Matthews G, Maze MJ, McArthur CJ, McFadyen JD, McMahon JH, McQuilten ZK, Molton J, Mora JM, Mudaliar V, Nguyen V, O'Sullivan MVN, Pant S, Park JE, Paterson DL, Price DJ, Raymond N, Rees MA, Robinson JO, Rogers BA, Ryu WS, Sasadeusz J, Shum O, Snelling TL, Sommerville C, Trask N, Lewin SR, Hills TE, Davis JS, Roberts JA, Tong SYC. A Randomized Trial of Nafamostat for Covid-19. NEJM Evid. 2023 Nov;2(11):EVIDoa2300132. doi: 10.1056/EVIDoa2300132. Epub 2023 Oct 18.

    PubMed 38320527

  • McQuilten ZK, Venkatesh B, Jha V, Roberts J, Morpeth SC, Totterdell JA, McPhee GM, Abraham J, Bam N, Bandara M, Bangi AK, Barina LA, Basnet BK, Bhally H, Bhusal KR, Bogati U, Bowen AC, Burke AJ, Christopher DJ, Chunilal SD, Cochrane B, Curnow JL, Das SK, Dhungana A, Di Tanna GL, Dotel R, DSouza H, Dummer J, Dutta S, Foo H, Gilbey TL, Giles ML, Goli K, Gordon A, Gyanwali P, Haksar D, Hudson BJ, Jani MK, Jevaji PR, Jhawar S, Jindal A, John MJ, John M, John FB, John O, Jones M, Joshi RD, Kamath P, Kang G, Karki AR, Karmalkar AM, Kaur B, Koganti KC, Koshy JM, Krishnamurthy MS, Lau JS, Lewin SR, Lim LL, Marschner IC, Marsh JA, Maze MJ, McGree JM, McMahon JH, Medcalf RL, Merriman EG, Misal AP, Mora JM, Mudaliar VK, Nguyen V, O'Sullivan MV, Pant S, Pant P, Paterson DL, Price DJ, Rees MA, Robinson JO, Rogers BA, Samuel S, Sasadeusz J, Sharma D, Sharma PK, Shrestha R, Shrestha SK, Shrestha P, Shukla U, Shum O, Sommerville C, Spelman T, Sullivan RP, Thatavarthi U, Tran HA, Trask N, Whitehead CL, Mahar RK, Hammond NE, McFadyen JD, Snelling TL, Davis JS, Denholm JT, Tong SYC. Anticoagulation Strategies in Non-Critically Ill Patients with Covid-19. NEJM Evid. 2023 Feb;2(2):EVIDoa2200293. doi: 10.1056/EVIDoa2200293. Epub 2022 Dec 10.

    PubMed 38320033

  • Denholm JT, Venkatesh B, Davis J, Bowen AC, Hammond NE, Jha V, McPhee G, McQuilten Z, O'Sullivan MVN, Paterson D, Price D, Rees M, Roberts J, Jones M, Totterdell J, Snelling T, Trask N, Morpeth S, Tong SY; ASCOT ADAPT investigators. ASCOT ADAPT study of COVID-19 therapeutics in hospitalised patients: an international multicentre adaptive platform trial. Trials. 2022 Dec 14;23(1):1014. doi: 10.1186/s13063-022-06929-y.

    PubMed 36514143

  • Bassi A, Arfin S, Joshi R, Bathla N, Hammond NE, Rajbhandari D, Tirupakuzhi Vijayaraghavan BK, Venkatesh B, Jha V. Challenges in operationalising clinical trials in India during the COVID-19 pandemic. Lancet Glob Health. 2022 Mar;10(3):e317-e319. doi: 10.1016/S2214-109X(21)00546-5. Epub 2021 Dec 22. No abstract available.

    PubMed 34953516

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing (Arm Closed) Nafamostat Mesilate, (Arm Closed) Enoxaparin and (Arm Closed) Dalteparin in people with SARS-CoV-2 Infection (COVID-19), run by University of Melbourne at 25 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: Day 21). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04483960, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.

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