AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia
NCT ID: NCT05848713
Last Updated: 2025-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
4000 participants
INTERVENTIONAL
2023-10-10
2029-03-31
Brief Summary
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Detailed Description
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Therapeutic-dose anticoagulation with heparin reduces disease progression and mortality in non-critically ill patients hospitalized with COVID-19 with an acceptable safety profile. COVID-19 shares pathogenic features, including activation of the inflammatory and coagulation cascades, with other pneumonias. Whether therapeutic-dose heparin confers similar clinical benefits in non-COVID-19 CAP is unknown.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Therapeutic-Dose Heparin
Participants randomized to the investigational arm will receive a pragmatic strategy of therapeutic-dose low molecular-weight heparin (LMWH) or unfractionated heparin (UFH) administered daily for up to 14 days or until hospital discharge, whichever occurs first. Participants should start receiving study drug as soon as possible following randomization.
Heparin
Preference is for LMWH given ease of administration and possibility of a more favorable safety profile, if no contraindication is present. Enoxaparin, dalteparin, or tinzaparin are acceptable LMWHs to be used for patients in the investigational arm and dose should be based on measured or estimated weight of the patient.
Alternatively, intravenous UFH may be used and may be preferred in the presence of significant renal compromise. Intravenous UFH is typically dosed 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, or a corresponding UFH anti-Xa level. If UFH is used, the availability of a local site policy that specifies an aPTT target in this range or a corresponding anti-Xa value is a requirement.
Usual Care
Participants randomized to the control arm will receive usual care thromboprophylactic dose anticoagulation according to local practice. To ensure adequate separation between the study groups, the dose of heparin/LMWH used in the usual care arm should not equal more than half of the approved therapeutic dose for that agent according to local VTE treatment protocols.
No interventions assigned to this group
Interventions
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Heparin
Preference is for LMWH given ease of administration and possibility of a more favorable safety profile, if no contraindication is present. Enoxaparin, dalteparin, or tinzaparin are acceptable LMWHs to be used for patients in the investigational arm and dose should be based on measured or estimated weight of the patient.
Alternatively, intravenous UFH may be used and may be preferred in the presence of significant renal compromise. Intravenous UFH is typically dosed 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, or a corresponding UFH anti-Xa level. If UFH is used, the availability of a local site policy that specifies an aPTT target in this range or a corresponding anti-Xa value is a requirement.
Eligibility Criteria
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Inclusion Criteria
2. Admitted to hospital for a suspected or confirmed diagnosis of CAP defined by:
1. Radiographic evidence of new or worsening infiltrate
2. One or more of the following signs and/or symptoms of lower respiratory tract infection
i. New or increased cough or sputum production ii. Fever of \> 37.8C or temperature \< 36C iii. WBC \> 11 x 109/L or \< 4 x 109/L c. The primary diagnosis is believed to be CAP as per the attending physician
3. Requires supplemental oxygen to treat hypoxemia (or requires an increased level of supplemental oxygen if on chronic oxygen therapy)
4. Hospital admission anticipated to last ≥72 hours from randomization
Exclusion Criteria
2. Hospital admission for \>72 hours prior to randomization
3. Patients receiving non-invasive or invasive ventilation, vasopressors, or extracorporeal life support (ECLS) within an ICU at the time of enrollment
4. Requirement for chronic mechanical ventilation via tracheostomy prior to hospitalization
5. Patients for whom the intent is to not use pharmacologic thromboprophylaxis
6. Patients with an independent indication for therapeutic-dose anticoagulation
7. Patients with a contraindication to therapeutic-dose anticoagulation, including:
1. Non-traumatic bleeding that requires medical evaluation or hospitalization within 30 days prior to CAP hospital admission
2. History of an inherited or acquired bleeding disorder
3. Cerebral aneurysm or mass lesions of the central nervous system
4. Ischemic stroke within 3 months of hospital admission
5. Gastrointestinal bleeding within 3 months of hospital admission
6. Platelet count \<50 x109/L OR INR \>2.0 OR hemoglobin \<80 g/L at the time of screening
7. Other physician-perceived contraindications to therapeutic anticoagulation
8. History of heparin induced thrombocytopenia (HIT) or other heparin allergy
9. Current or recent (within 7 days of screening) use of dual anti-platelet inhibitors (For example; Aspirin + one of the following; clopidogrel, ticagrelor, prasugrel)
10. Patients in whom imminent death is anticipated
11. Anticipated transfer to another hospital that is not a study site within 72 hours of randomization
12. Enrollment in other interventional trials related to anticoagulation or antiplatelet therapy during current hospitalization
18 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Research Manitoba
OTHER
Ozmosis Research Inc.
INDUSTRY
Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
NETWORK
Canadian Critical Care Trials Group
OTHER
AVANTI
UNKNOWN
University of Manitoba
OTHER
Responsible Party
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Principal Investigators
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Ryan Zarychanski, MD
Role: PRINCIPAL_INVESTIGATOR
University of Manitoba
Patrick Lawler, MD
Role: PRINCIPAL_INVESTIGATOR
University Health Network and McGill University
Sylvain Lother, MD
Role: PRINCIPAL_INVESTIGATOR
University of Manitoba
Alexis Turgeon, MD
Role: PRINCIPAL_INVESTIGATOR
L'Universite Laval
Locations
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University of Chicago
Chicago, Illinois, United States
Ochsner Clinic
Jefferson, Louisiana, United States
Maine Medical Centre
Portland, Maine, United States
Henry Ford University
Dearborn, Michigan, United States
Cooper University Health Care
Camden, New Jersey, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Hospital Estadual Dr. Jayme Santos Neves
Serra, Espírito Santo, Brazil
Hospital Evangelico de Vila Velha
Vila Velha, Espírito Santo, Brazil
Hospital Universitário Cassiano Antonio Moraes
Vitória, Espírito Santo, Brazil
Santa Casa de Misericordia de Itabuna
Itabuna, Estado de Bahia, Brazil
Hospital Brasilia
Brasília, Federal District, Brazil
Hospital Sao Brasilia
Brasília, Federal District, Brazil
Instituto de Cardiologia e Transplantes do Distrito Federal
Brasília, Federal District, Brazil
Hospital de Messejana Dr. Carlos Alberto Studart Gomes
Goiânia, Goiás, Brazil
Hospital Ruy Azeredo
Goiânia, Goiás, Brazil
Instituto Goiano de Oncologia e Hematologia - INGOH
Goiânia, Goiás, Brazil
Hospital Felicio Rocho
Belo Horizonte, Minas Gerais, Brazil
NUPEC-Orizonti
Belo Horizonte, Minas Gerais, Brazil
Hospital Santa Cruz
Curitiba, Paraná, Brazil
PUCPR
Curitiba, Paraná, Brazil
Hospital Bruno Born
Lajeado, Rio Grande do Sul, Brazil
Hospital Sao Vicente de Paulo
Passo Fundo, Rio Grande do Sul, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Universitario de Santa Maria
Santa Maria, Rio Grande do Sul, Brazil
Hospital Sao Jose
Criciúma, Santa Catarina, Brazil
Hospital Regional Homero Miranda Gomes
São José, Santa Catarina, Brazil
Hospital de Reabilitacao de Anomalias Craniofaciais
Bauru, São Paulo, Brazil
UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu
Botucatu, São Paulo, Brazil
Hospital Universitario Sao Francisco na Providencia na Deus
Bragança Paulista, São Paulo, Brazil
Fundação Centro Médico de Campinas
Campinas, São Paulo, Brazil
IPECC
Campinas, São Paulo, Brazil
CiTen - Centro Hospital Municipal Antonio Giglio
Osasco, São Paulo, Brazil
Hospital Regional de Presidente Prudente
Presidente Prudente, São Paulo, Brazil
Hospital Estadual de Serrana
Ribeirão Preto, São Paulo, Brazil
HCFMUSP
São Paulo, São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
Santa Casa de Misericordia de Sao Paulo
São Paulo, São Paulo, Brazil
Foothills Medical Centre
Calgary, Alberta, Canada
Grand Prairie Regional Hospital
Grande Prairie, Alberta, Canada
Nanaimo Regional General Hospital
Nanaimo, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Health Sciences Center Winnipeg
Winnipeg, Manitoba, Canada
Grace General Hospital
Winnipeg, Manitoba, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Memorial University
St. John's, Newfoundland and Labrador, Canada
Health Sciences North Research Institute
Greater Sudbury, Ontario, Canada
Hamilton Health Sciences - Juravinski
Hamilton, Ontario, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
Markham Stouffville Hospital
Markham, Ontario, Canada
Hôpital Montfort
Ottawa, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Niagara Health System - St Catharines Site
Saint Catherines, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Centre Hospitalier de Quebec - Hotel-Dieu de Levis
Lévis, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Centre Hospitalier de l'université de Montréal (CHUM)
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
CHU de Quebec-University Laval
Québec, Quebec, Canada
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
Québec, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Regina General Hospital
Regina, Saskatchewan, Canada
Countries
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Central Contacts
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Facility Contacts
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Jonathan Paul, MD
Role: primary
Derek Vondehaar, MD
Role: primary
Daniel Meyer, MD
Role: primary
Scott Kaatz, MD
Role: primary
Adam Green, MD
Role: primary
Alisha Sharma, MD
Role: primary
Marcus Matos, MD
Role: primary
Joao Moraes Junior, MD
Role: primary
Felipe Vieira, MD
Role: primary
Eduardo Kowalski, MD
Role: primary
Marina da Silva, MD
Role: primary
Mauricio Pompilio, MD
Role: primary
Adegil Silva
Role: primary
Sandra Nivea dos Reis Saraiva, MD
Role: primary
Rafael Bastos, MD
Role: primary
Mayler Santos, MD
Role: primary
Ana Carolina Procopio
Role: primary
Fernando Neuenschwander, MD
Role: primary
Marcelo Carneiro, MD
Role: primary
Jose Ribas Fortes, MD
Role: primary
Lucas Mallmann, MD
Role: primary
Alexandre Tognon, MD
Role: primary
Paulo Dalcin, MD
Role: primary
Ariovaldo Fagudes, MD
Role: primary
Felipe Pizzol, MD
Role: primary
Bruno Kroeff Bergesch, MD
Role: primary
Lucas Soler, MD
Role: primary
Suzana Erico Tanni, MD
Role: primary
Gustavo Mamprin, MD
Role: primary
Otavio Coelho, MD
Role: primary
Jose Francisco Kerr Saraiva, MD
Role: primary
Enrico Fortunato, MD
Role: primary
Luis Felipe Pires, MD
Role: primary
Marcos Borges, MD
Role: primary
Ludhmila Hajjar, MD
Role: primary
Julio Alencar, MD
Role: primary
Ricardo Chinarelli, MD
Role: primary
Tafi Madzimure, MD
Role: primary
Alistair Teale, MD
Role: primary
Ted Steiner, MD
Role: primary
Brett Houstin, MD
Role: primary
Vi Dao, MD
Role: primary
Peter Daley, MD
Role: primary
Pandma Puranam, MD
Role: primary
Bram Rochwerg, MD
Role: primary
Alison Fox-Robichaud, MD
Role: primary
Paul Lee, MD
Role: primary
Marc Carrier, MD
Role: primary
Lana Castellucci, MD
Role: primary
Jonathan Zipursky, MD
Role: primary
Jameel Abdulrehman, MD
Role: primary
Patrick Archambault, MD
Role: primary
Emily Gibson McDonald, MD, MSc
Role: primary
Emmanuelle Duceppe, MD
Role: primary
Susan Khan, MD
Role: primary
Vicky Tagalakis, MD
Role: backup
Alexis Turgeon, MD, MSc
Role: primary
Francois Lallouche, MD
Role: primary
Francois Lamontagne, MD
Role: primary
Payam Dehghani, MD
Role: primary
References
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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.
Other Identifiers
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OZM-129
Identifier Type: OTHER
Identifier Source: secondary_id
ATTACC-CAP
Identifier Type: -
Identifier Source: org_study_id
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