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COVID-19Phase 2/3ATTACCNCT04372589

Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC)

A Phase 2/3 study testing Heparin in people with COVID-19 and Pneumonia, run by University of Manitoba at 60 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Endothelial injury as a consequence of SARS-CoV-2 infection leads to a dysregulated host inflammatory response and activation of coagulation pathways. Macro- and micro-vascular thrombosis may contribute to morbidity, organ failure, and death. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19, Pneumonia
What is being tested?
Heparin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
60 sitesin 4 countries
Study dates
20 May 2020to 17 May 2021
Phase
Phase 2/3
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

  • 1. Patients ≥18 years of age providing (possibly through a substitute decision maker) informed consent who require hospitalization anticipated to last ≥72 hours, for microbiologically-confirmed COVID-19, enrolled < 72 hours of hospital admission or of COVID-19 confirmation
  • If the patient is already hospitalized and the COVID-19 diagnosis is due to an outbreak or an incidental finding, then enrollment can occur within 72 hours of a clinical syndrome attributable to COVID-19 that requires continued hospitalization (e.g. new or worsening oxygen requirements or acute kidney injury) which is further anticipated to extend the hospital admission by an additional 72 hours from randomization.

Who cannot join

  • Patients admitted to an ICU AND receiving organ support (i.e. high flow nasal oxygen, receiving non-invasive or invasive mechanical ventilation, or are requiring vasopressor/inotrope)
  • Patients for whom the intent is to not use pharmacologic thromboprophylaxis
  • Active bleeding
  • Risk factors for bleeding, including:
  • intracranial surgery or stroke within 3 months;
  • history of intracerebral arteriovenous malformation;
Show all 25Show fewer
  • cerebral aneurysm or mass lesions of the central nervous system;
  • intracranial malignancy
  • history of intracranial bleeding
  • history of bleeding diatheses (e.g., hemophilia)
  • history of gastrointestinal bleeding within previous 3 months
  • thrombolysis within the previous 7 days
  • presence of an epidural or spinal catheter
  • recent major surgery <14 days
  • uncontrolled hypertension (sBP >200 mmHg, dBP >120 mmHg)
  • other physician-perceived contraindications to anticoagulation
  • Platelet count <50 x10^9/L, INR >2.0, or baseline aPTT >50 (if available per SOC testing)
  • Hemoglobin <80 g/L (to minimize the likelihood of requiring red blood cell transfusion if potential bleeding were to occur)
  • Acute or subacute bacterial endocarditis
  • History of heparin induced thrombocytopenia (HIT) or other heparin allergy including hypersensitivity
  • Current use of dual antiplatelet therapy
  • Patients with an independent indication for therapeutic anticoagulation
  • Patients in whom imminent demise is anticipated and there is no commitment to active ongoing intervention
  • Anticipated transfer to another hospital that is not a study site within 72 hours
  • Enrollment in other trials related to anticoagulation or antiplatelet therapy

Trial locations and contacts

60 sites in 4 countries.

60 sites in 4 countries

Brazil28 sites

  • Hospital Felício Rocho

    Belo Horizonte, Minas Gerais

  • AngioCor Blumenau

    Blumenau, Santa Catarina

  • Instituto de Pesquisa Clínica de Campinas

    Campinas, São Paulo

  • Centro de Pesquisas Clínicas Humap - UFMS

    Campo Grande, Mato Grosso do Sul

  • Clinica de Campo Grande S/A

    Campo Grande, Mato Grosso do Sul

  • Unimed Campo Grande

    Campo Grande, Mato Grosso do Sul

  • Hospital das Clinicas da UFPR

    Curitiba, Paraná

  • Pontifícia Universidade Católica do Paraná

    Curitiba, Paraná

  • Instituto Goiano de Oncologia e Hematologia - INGOH

    Goiânia, Goiás

  • Santa Casa de Misericordia de Itabuna

    Itabuna, Estado de Bahia

  • Hospital Unimed do Cariri

    Juazeiro do Norte, Ceará

  • Parana Medical Research Center

    Maringá, Paraná

  • Hospital Sao Vicente de Paulo

    Passo Fundo, Rio Grande do Sul

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul

  • Instituto de Cardiologia do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul

  • Instituto de Medicina Vascular

    Porto Alegre, Rio Grande do Sul

  • Hospital Agamenon Magalhaes

    Recife, Pernanbuco

  • Hospital Universitario Pedro Ernesto

    Rio de Janeiro, Rio de Janeiro

  • Praxis Pesquisa Medica

    Santo André, São Paulo

  • Instituto de Cardiologia de Santa Catarina

    São José, Santa Catarina

  • Casa de Saúde Santa Marcelina

    São Paulo, São Paulo

  • Hospital 9 de Julho

    São Paulo

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

    São Paulo

  • Instituto de Infectologia Emilio Ribas

    São Paulo

  • Instituto do Coração do Estado de São Paulo

    São Paulo

  • Sociedade Beneficente Israelita Hospital Albert Einstein

    São Paulo

  • Instituto de Molestias Cardio Vasculares de Tatui

    Tatuí, São Paulo

  • Santa Casa de Votuporanga

    Votuporanga, São Paulo

Other trials in Brazil

Canada16 sites

  • Hamilton Health Sciences

    Hamilton, Ontario

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario

  • McGill University Health Centre

    Montreal, Quebec, H4A3J1

  • Centre Hospitalier de l'université de Montréal (CHUM)

    Montreal, Quebec

  • Jewish General Hospital

    Montreal, Quebec

  • Hôpital Montfort

    Ottawa, Ontario

  • The Ottawa Hospital

    Ottawa, Ontario

  • CHU de Quebec-University Laval

    Québec, Quebec

  • Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ)

    Québec, Quebec

  • Regina General Hospital

    Regina, Saskatchewan

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec

  • University Health Network

    Toronto, Ontario, M5G2C4

  • Victoria General Hospital

    Victoria, British Columbia

  • Health Sciences Center Winnipeg

    Winnipeg, Manitoba, R3A 1R9

  • Grace General Hospital

    Winnipeg, Manitoba

  • St. Boniface General Hospital

    Winnipeg, Manitoba

Other trials in Canada

United States13 sites

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Cooper University Health Care

    Camden, New Jersey, 08103

  • University of Chicago

    Chicago, Illinois, 60637

  • Henry Ford University

    Dearborn, Michigan, 48128

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Ochsner Clinic

    Jefferson, Louisiana, 70121

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Montefiore-Einstein Center for Heart and Vascular Care

    New York, New York, 10467

  • Maine Medical Center

    Portland, Maine, 04102

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Beaumont Hospital

    Royal Oak, Michigan, 48336

  • Saint Louis University School of Medicine/Saint Louis Veterans Affairs Medical Center

    St Louis, Missouri, 63104

Other trials in United States

Mexico3 sites

  • Hospital de Infectolog´ñia Centro Médico Nacional La Raza

    Azcapotzalco, Mexico City

  • Hospital General Regional 1 Carlos MacGregor Sánchez Navarro

    Benito Juárez, Mexico City

  • Hospital General regional 2 El Marqués

    Querétaro

Other trials in Mexico

About this study

Official title: Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC), in Collaboration With Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-4)

Endothelial injury as a consequence of SARS-CoV-2 infection leads to a dysregulated host inflammatory response and activation of coagulation pathways. Macro- and micro-vascular thrombosis may contribute to morbidity, organ failure, and death. Therapeutic anticoagulation with heparin may improve clinical outcomes in patients with COVID-19 through anti-thrombotic, anti-inflammatory, and anti-viral activities of heparins. This pragmatic, Bayesian adaptive randomized controlled trial will determine whether therapeutic anticoagulation with heparin (subcutaneous low molecular weight heparin or intravenous unfractionated heparin) versus usual care reduces the need for intubation or death in hospitalized patients with COVID-19. The trial uses an adaptive design which was chosen to overcome limitations in available data to inform a priori estimation of event rates and possible effect sizes. The adaptive design also includes response-adaptive randomization based on baseline D-dimer level, probing for differential efficacy across subgroups defined based on initial D-dimer level. This Bayesian adaptive randomized trial will stop at a conclusion 1) when the posterior probability that the proportional odds ratio is greater than 1.0 reaches 99% (definition of benefit); 2) when the posterior probability that the proportional odds ratio is greater than 1.2 is less than 10% (definition of futility) or; 3) when the posterior probability that the proportional odds ratio is less than 1.0 is greater than 90% (definition of harm). The trial will enroll a maximum of 3,000 patients, although in many simulations the trial may require fewer patients. The trial is strategically aligned with the international REMAP-CAP/COVID platform trial to accelerate evidence generation.

Read the detailed description

This is a prospective, open-label, multicentre, Bayesian adaptive randomized clinical trial to establish whether therapeutic-dose parenteral anticoagulation improves outcomes for patients hospitalized with COVID-19 (e.g., reduces intubation or mortality). Participants will be randomized either to the investigational arm (therapeutic anticoagulation with heparin for 14 days or until "recovery" [defined as hospital discharge or liberation from supplemental oxygen if initially required], whichever comes first), or to the control arm (usual care, including thromboprophylactic dose anticoagulation according to local practice).

Conditions
COVID-19, Pneumonia
Being tested
Heparin
Medical subject headings
COVID-19, Pneumonia

What participants receive

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

  • HeparinDrug

    Low molecular weight heparin (LMWH) Preferred therapeutic anticoagulant is enoxaparin. Generally regimens: 1.5 mg/kg subcutaneous once daily or 1 mg/kg subcutaneous twice daily. Alternatively, other subcutaneous LMWH used, including tinzaparin (175 anti-Xa IU/kg subcutaneous once daily) or dalteparin (200 IU/kg subcutaneous once daily or 100 IU/kg subcutaneous twice a day).

    Unfractionated heparin (UFH) Commenced, administered, and monitored according to local hospital policy, and guidelines that are used for the treatment of venous thromboembolism (i.e. not for acute coronary syndrome). Intravenous infusion of UFH is according to total body weight and pragmatically adjusted according to local institutional policy to achieve an activated partial thromboplastin time (aPTT) of 1.5-2.5x the reference value. If UFH is used, the availability of a local hospital policy that has specifies an aPTT target in this range or an anti-Xa value is a requirement.

Study groups in NCT04372589
Study groupRoleWhat they receive
Investigational armExperimentalParticipants randomized to the investigational arm will receive therapeutic anticoagulation for 14 days (or until hospital discharge or liberation from supplemental oxygen >24 hours if previously required, whichever comes first) with heparin, with preference for subcutaneous low molecular weight heparin (enoxaparin preferred, although dalteparin or tinzaparin are also acceptable, as available) if no contraindication is present; alternatively, intravenous unfractionated heparin infusion may be used.
Receives: Drug: Heparin
Control armNo interventionParticipants will receive usual care of thromboprophylactic dose anticoagulation according to local practice.

What is being measured

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

  1. Mortality and days free of organ support

    The primary endpoint in the trial is days alive and free of organ support at day 21. This endpoint is defined as the number of days that a patient is alive and free of organ support through the first 21 days after trial entry. Organ support is defined as receipt of invasive or non-invasive mechanical ventilation, high flow nasal oxygen (>30 L/min), vasopressor therapy, or ECMO support. Death at any time (including beyond 21 days) during the index hospital stay is assigned the worst possible score of -1.

    Measured: 21 days

Secondary outcomes (19)

  1. Arterial and venous thrombotic conditions

    A composite endpoint of death, deep vein thrombosis, pulmonary embolism, systemic arterial thromboembolism, myocardial infarction, or ischemic stroke collected during hospitalization or at 28 days and 90 days after enrollment (whichever is earlier).

    Measured: 28 days and 90 days

  2. Intubation and mortality

    Ordered categorical endpoint with three possible outcomes based on the worst status of each patient through day 30 following randomization: no invasive mechanical ventilation, invasive mechanical ventilation, or death.

    Measured: 30 days

  3. All-cause mortality

    Measured: 28 days and 90 days

  4. Intubation

    Invasive mechanical ventilation.

    Measured: 30 days

  5. Hospital-free days

    Days alive outside of the hospital through 28 days following randomization.

    Measured: 28 days

  6. Ventilator-free days

    Days alive not on a ventilator assessed at 28 days following randomization.

    Measured: 28 days

  7. Myocardial infarction

    Measured: 28 days and 90 days

  8. Ischaemic stroke

    Measured: 28 days and 90 days

  9. Venous thromboembolism

    Symptomatic proximal venous thromboembolism (DVT or PE).

    Measured: 28 days and 90 days

  10. Vasopressor-free days

    Days alive not on a vasopressor assessed at 28 days following randomization.

    Measured: 28 days

  11. Renal replacement free days

    Days alive not on renal replacement assessed at 28 days following randomization.

    Measured: 28 days

  12. Hospital re-admission

    Hospital re-admission within 28 days.

    Measured: 28 days

  13. Acute kidney injury

    As defined by KDIGO criteria.

    Measured: Duration of study

  14. Systemic arterial thrombosis or embolism

    Measured: 28 days and 90 days

  15. ECMO support

    Use of extracorporeal membrane oxygenation (ECMO) support.

    Measured: Duration of study

  16. Mechanical circuit thrombosis

    Dialysis or ECMO.

    Measured: Duration of study

  17. WHO ordinal scale

    Peak scale over 28 days, scale at 14 days, and proportion with improvement by at least 2 categories compared to enrollment, at 28 days.

    Measured: 28 days

  18. Major bleeding

    As defined by the International Society on Thrombosis and Haemostasis (ISTH).

    Measured: Intervention period (maximum 14 days)

  19. Heparin-induced thrombocytopenia (HIT)

    Laboratory-confirmed.

    Measured: Intervention period (maximum 14 days)

Timeline

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

  1. First posted4 May 2020
  2. Study start20 May 2020
  3. Primary completion17 May 2021
  4. Study completion17 May 2021

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Pragmatic, Bayesian adaptive randomized controlled trial
Masking
None (open label)
Enrolment
1,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04372589
Sponsor's protocol ID
ATTACC
Other IDs
OZM-113
Acronym
ATTACC
Status last verified
Jan 2021
First submitted
24 Apr 2020
Last updated
27 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Wahid L, Froess JD, Ortel TL, Zarychanski R, Berger JS, Cushman M, Angus DC, Renard V, Farahani P, Webb S, Heath A, Godoy LC, Farkouh ME, Hochman JS, Neal MD, Lawler PR. On-Treatment Change in d-Dimer Is Associated With Differential Outcomes Among Therapeutic Dose Heparin-Treated Noncritically Ill Patients Hospitalized for COVID-19. Arterioscler Thromb Vasc Biol. 2025 Jan;45(1):162-164. doi: 10.1161/ATVBAHA.124.321108. Epub 2024 Dec 5.

    PubMed 39633573

  • Goligher EC, Lawler PR, Jensen TP, Talisa V, Berry LR, Lorenzi E, McVerry BJ, Chang CH, Leifer E, Bradbury C, Berger J, Hunt BJ, Castellucci LA, Kornblith LZ, Gordon AC, McArthur C, Webb S, Hochman J, Neal MD, Zarychanski R, Berry S, Angus DC; REMAP-CAP, ATTACC, and ACTIV-4a Investigators. Heterogeneous Treatment Effects of Therapeutic-Dose Heparin in Patients Hospitalized for COVID-19. JAMA. 2023 Apr 4;329(13):1066-1077. doi: 10.1001/jama.2023.3651.

    PubMed 36942550

  • REMAP-CAP Investigators; ACTIV-4a Investigators; ATTACC Investigators; Goligher EC, Bradbury CA, McVerry BJ, Lawler PR, Berger JS, Gong MN, Carrier M, Reynolds HR, Kumar A, Turgeon AF, Kornblith LZ, Kahn SR, Marshall JC, Kim KS, Houston BL, Derde LPG, Cushman M, Tritschler T, Angus DC, Godoy LC, McQuilten Z, Kirwan BA, Farkouh ME, Brooks MM, Lewis RJ, Berry LR, Lorenzi E, Gordon AC, Ahuja T, Al-Beidh F, Annane D, Arabi YM, Aryal D, Baumann Kreuziger L, Beane A, Bhimani Z, Bihari S, Billett HH, Bond L, Bonten M, Brunkhorst F, Buxton M, Buzgau A, Castellucci LA, Chekuri S, Chen JT, Cheng AC, Chkhikvadze T, Coiffard B, Contreras A, Costantini TW, de Brouwer S, Detry MA, Duggal A, Dzavik V, Effron MB, Eng HF, Escobedo J, Estcourt LJ, Everett BM, Fergusson DA, Fitzgerald M, Fowler RA, Froess JD, Fu Z, Galanaud JP, Galen BT, Gandotra S, Girard TD, Goodman AL, Goossens H, Green C, Greenstein YY, Gross PL, Haniffa R, Hegde SM, Hendrickson CM, Higgins AM, Hindenburg AA, Hope AA, Horowitz JM, Horvat CM, Huang DT, Hudock K, Hunt BJ, Husain M, Hyzy RC, Jacobson JR, Jayakumar D, Keller NM, Khan A, Kim Y, Kindzelski A, King AJ, Knudson MM, Kornblith AE, Kutcher ME, Laffan MA, Lamontagne F, Le Gal G, Leeper CM, Leifer ES, Lim G, Gallego Lima F, Linstrum K, Litton E, Lopez-Sendon J, Lother SA, Marten N, Saud Marinez A, Martinez M, Mateos Garcia E, Mavromichalis S, McAuley DF, McDonald EG, McGlothlin A, McGuinness SP, Middeldorp S, Montgomery SK, Mouncey PR, Murthy S, Nair GB, Nair R, Nichol AD, Nicolau JC, Nunez-Garcia B, Park JJ, Park PK, Parke RL, Parker JC, Parnia S, Paul JD, Pompilio M, Quigley JG, Rosenson RS, Rost NS, Rowan K, Santos FO, Santos M, Santos MO, Satterwhite L, Saunders CT, Schreiber J, Schutgens REG, Seymour CW, Siegal DM, Silva DG Jr, Singhal AB, Slutsky AS, Solvason D, Stanworth SJ, Turner AM, van Bentum-Puijk W, van de Veerdonk FL, van Diepen S, Vazquez-Grande G, Wahid L, Wareham V, Widmer RJ, Wilson JG, Yuriditsky E, Zhong Y, Berry SM, McArthur CJ, Neal MD, Hochman JS, Webb SA, Zarychanski R. Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19. N Engl J Med. 2021 Aug 26;385(9):777-789. doi: 10.1056/NEJMoa2103417. Epub 2021 Aug 4.

    PubMed 34351722

  • ATTACC Investigators; ACTIV-4a Investigators; REMAP-CAP Investigators; Lawler PR, Goligher EC, Berger JS, Neal MD, McVerry BJ, Nicolau JC, Gong MN, Carrier M, Rosenson RS, Reynolds HR, Turgeon AF, Escobedo J, Huang DT, Bradbury CA, Houston BL, Kornblith LZ, Kumar A, Kahn SR, Cushman M, McQuilten Z, Slutsky AS, Kim KS, Gordon AC, Kirwan BA, Brooks MM, Higgins AM, Lewis RJ, Lorenzi E, Berry SM, Berry LR, Aday AW, Al-Beidh F, Annane D, Arabi YM, Aryal D, Baumann Kreuziger L, Beane A, Bhimani Z, Bihari S, Billett HH, Bond L, Bonten M, Brunkhorst F, Buxton M, Buzgau A, Castellucci LA, Chekuri S, Chen JT, Cheng AC, Chkhikvadze T, Coiffard B, Costantini TW, de Brouwer S, Derde LPG, Detry MA, Duggal A, Dzavik V, Effron MB, Estcourt LJ, Everett BM, Fergusson DA, Fitzgerald M, Fowler RA, Galanaud JP, Galen BT, Gandotra S, Garcia-Madrona S, Girard TD, Godoy LC, Goodman AL, Goossens H, Green C, Greenstein YY, Gross PL, Hamburg NM, Haniffa R, Hanna G, Hanna N, Hegde SM, Hendrickson CM, Hite RD, Hindenburg AA, Hope AA, Horowitz JM, Horvat CM, Hudock K, Hunt BJ, Husain M, Hyzy RC, Iyer VN, Jacobson JR, Jayakumar D, Keller NM, Khan A, Kim Y, Kindzelski AL, King AJ, Knudson MM, Kornblith AE, Krishnan V, Kutcher ME, Laffan MA, Lamontagne F, Le Gal G, Leeper CM, Leifer ES, Lim G, Lima FG, Linstrum K, Litton E, Lopez-Sendon J, Lopez-Sendon Moreno JL, Lother SA, Malhotra S, Marcos M, Saud Marinez A, Marshall JC, Marten N, Matthay MA, McAuley DF, McDonald EG, McGlothlin A, McGuinness SP, Middeldorp S, Montgomery SK, Moore SC, Morillo Guerrero R, Mouncey PR, Murthy S, Nair GB, Nair R, Nichol AD, Nunez-Garcia B, Pandey A, Park PK, Parke RL, Parker JC, Parnia S, Paul JD, Perez Gonzalez YS, Pompilio M, Prekker ME, Quigley JG, Rost NS, Rowan K, Santos FO, Santos M, Olombrada Santos M, Satterwhite L, Saunders CT, Schutgens REG, Seymour CW, Siegal DM, Silva DG Jr, Shankar-Hari M, Sheehan JP, Singhal AB, Solvason D, Stanworth SJ, Tritschler T, Turner AM, van Bentum-Puijk W, van de Veerdonk FL, van Diepen S, Vazquez-Grande G, Wahid L, Wareham V, Wells BJ, Widmer RJ, Wilson JG, Yuriditsky E, Zampieri FG, Angus DC, McArthur CJ, Webb SA, Farkouh ME, Hochman JS, Zarychanski R. Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid-19. N Engl J Med. 2021 Aug 26;385(9):790-802. doi: 10.1056/NEJMoa2105911. Epub 2021 Aug 4.

    PubMed 34351721

  • Flumignan RL, Tinoco JDS, Pascoal PI, Areias LL, Cossi MS, Fernandes MI, Costa IK, Souza L, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Prophylactic anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD013739. doi: 10.1002/14651858.CD013739.

    PubMed 33502773

  • Houston BL, Lawler PR, Goligher EC, Farkouh ME, Bradbury C, Carrier M, Dzavik V, Fergusson DA, Fowler RA, Galanaud JP, Gross PL, McDonald EG, Husain M, Kahn SR, Kumar A, Marshall J, Murthy S, Slutsky AS, Turgeon AF, Berry SM, Rosenson RS, Escobedo J, Nicolau JC, Bond L, Kirwan BA, de Brouwer S, Zarychanski R. Anti-Thrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC): Study design and methodology for an international, adaptive Bayesian randomized controlled trial. Clin Trials. 2020 Oct;17(5):491-500. doi: 10.1177/1740774520943846. Epub 2020 Aug 20.

    PubMed 32815416

  • Levi M, Thachil J, Iba T, Levy JH. Coagulation abnormalities and thrombosis in patients with COVID-19. Lancet Haematol. 2020 Jun;7(6):e438-e440. doi: 10.1016/S2352-3026(20)30145-9. Epub 2020 May 11. No abstract available.

    PubMed 32407672

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Heparin in people with COVID-19 and Pneumonia, run by University of Manitoba at 60 sites in 4 countries.

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 2 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: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in Brazil, Canada, United States, Mexico. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Mortality and days free of organ support (time frame: 21 days). 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 NCT04372589, which also lists 7 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 27 Jul 2021.

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