Community-acquired PneumoniaPhase 3ATTACC-CAPNCT05848713
AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia
A Phase 3 study testing Heparin in people with Community-acquired Pneumonia, run by University of Manitoba at 68 sites in 4 countries.
Trial summary
This is an international, open-label, stratified randomized controlled trial with Bayesian adaptive stopping rules to compare the effects of therapeutic-dose heparin vs. usual care pharmacological thromboprophylaxis on outcomes in patients admitted to hospital with community acquired pneumonia (CAP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired 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
- 4,000 participants
- Where
- 68 sitesin 4 countries
- Study dates
- 10 Oct 2023to 31 Mar 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Patients ≥18 years of age
- Admitted to hospital for a suspected or confirmed diagnosis of CAP defined by:
- Radiographic evidence of new or worsening infiltrate
- One or more of the following signs and/or symptoms of lower respiratory tract infection
- 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
- Requires supplemental oxygen to treat hypoxemia (or requires an increased level of supplemental oxygen if on chronic oxygen therapy)
- Hospital admission anticipated to last ≥72 hours from randomization
Who cannot join
- Suspected or confirmed active COVID-19 infection
- Hospital admission for >72 hours prior to randomization
- Patients receiving non-invasive or invasive ventilation, vasopressors, or extracorporeal life support (ECLS) within an ICU at the time of enrollment
- Requirement for chronic mechanical ventilation via tracheostomy prior to hospitalization
- Patients for whom the intent is to not use pharmacologic thromboprophylaxis
- Patients with an independent indication for therapeutic-dose anticoagulation
Show all 19Show fewer
- Patients with a contraindication to therapeutic-dose anticoagulation, including:
- Non-traumatic bleeding that requires medical evaluation or hospitalization within 30 days prior to CAP hospital admission
- History of an inherited or acquired bleeding disorder
- Cerebral aneurysm or mass lesions of the central nervous system
- Ischemic stroke within 3 months of hospital admission
- Gastrointestinal bleeding within 3 months of hospital admission
- Platelet count <50 x109/L OR INR >2.0 OR hemoglobin <80 g/L at the time of screening
- Other physician-perceived contraindications to therapeutic anticoagulation
- History of heparin induced thrombocytopenia (HIT) or other heparin allergy
- Current or recent (within 7 days of screening) use of dual anti-platelet inhibitors (For example; Aspirin + one of the following; clopidogrel, ticagrelor, prasugrel)
- Patients in whom imminent death is anticipated
- Anticipated transfer to another hospital that is not a study site within 72 hours of randomization
- Enrollment in other interventional trials related to anticoagulation or antiplatelet therapy during current hospitalization
Trial locations and contacts
68 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
68 sites in 4 countries
Brazil34 sites, 25 recruiting
- Completed
Hospital Felicio Rocho
Belo Horizonte, Minas Gerais
- Completed
NUPEC-Orizonti
Belo Horizonte, Minas Gerais
- Recruiting
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais
Claudio Dornas, MD
- Recruiting
UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu
Botucatu, São Paulo
Suzana Erico Tanni, MD
Suzana Erico Tanni, MD
- Recruiting
Hospital Universitario Sao Francisco na Providencia na Deus
Bragança Paulista, São Paulo
Gustavo Mamprin, MD
Gustavo Mamprin, MD
- Completed
Hospital Brasilia
Brasília, Federal District
- Completed
Instituto de Cardiologia e Transplantes do Distrito Federal
Brasília, Federal District
- Recruiting
Fundação Centro Médico de Campinas
Campinas, São Paulo, 13083-190
Otavio Coelho, MD
Otavio Coelho, MD
- Recruiting
IPECC
Campinas, São Paulo
Jose Francisco Kerr Saraiva, MD
Jose Francisco Kerr Saraiva, MD
- Recruiting
Hospital São Julião
Campo Grande, Mato Grosso do Sul
Maurício Pompílio Pompílio, MD
- Recruiting
Santa Casa de Campo Grande
Campo Grande, Mato Grosso do Sul
Eduardo Calvoso, MD
- Recruiting
Hospital do Rocio
Campo Largo, Paraná, 83606-177
CESAR DUSILEK, MD
- Recruiting
Hospital Sao Jose
Criciúma, Santa Catarina
Felipe Pizzol, MD
Felipe Pizzol, MD
- Recruiting
Hospital Santa Cruz
Curitiba, Paraná
Marcelo Carneiro, MD
Marcelo Carneiro, MD
- Completed
PUCPR
Curitiba, Paraná
- Recruiting
Hospital de Messejana Dr. Carlos Alberto Studart Gomes
Goiânia, Goiás
Sandra Nivea dos Reis Saraiva, MD
Sandra Falcao, MD
- Recruiting
Hospital Ruy Azeredo
Goiânia, Goiás
Rafael Bastos, MD
Rafael Bastos, MD
- Recruiting
Instituto Goiano de Oncologia e Hematologia - INGOH
Goiânia, Goiás
Mayler Santos, MD
Mayler Santos, MD
- Completed
Santa Casa de Misericordia de Itabuna
Itabuna, Estado de Bahia
- Recruiting
Hospital Bruno Born
Lajeado, Rio Grande do Sul
Lucas Mallmann, MD
Lucas Mallmann, MD
- Recruiting
CiTen - Centro Hospital Municipal Antonio Giglio
Osasco, São Paulo
Enrico Fortunato, MD
Enrico Fortunato, MD
- Recruiting
Hospital Sao Vicente de Paulo
Passo Fundo, Rio Grande do Sul
Alexandre Tognon, MD
Alexandre Tognon
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
Paulo Dalcin, MD
Paulo Dalcin, MD
- Recruiting
Hospital Regional de Presidente Prudente
Presidente Prudente, São Paulo
Luis Felipe Pires, MD
Luis Felipe Pires, MD
- Not yet recruiting
Hospital Estadual de Serrana
Ribeirão Preto, São Paulo
Marcos Borges, MD
Marcos Borges, MD
- Recruiting
Hospital Clementino Fraga Filho - UFRJ
Rio de Janeiro, Rio de Janeiro
Fernanda Mello
- Completed
Hospital Universitario de Santa Maria
Santa Maria, Rio Grande do Sul
- Completed
Hospital Regional Homero Miranda Gomes
São José, South Carolina
- Recruiting
Hospital Nipo-Brasileiro
São Paulo, São Paulo, 02189-010
Jose Victor Krasner Schubsky, MD
- Recruiting
HCFMUSP
São Paulo, São Paulo, 05403-010
Ludhmila Hajjar, MD
Ludhmila Hajjar, MD
- Completed
Santa Casa de Misericordia de Sao Paulo
São Paulo, São Paulo
- Recruiting
Hospital Estadual Dr. Jayme Santos Neves
Serra, Espírito Santo, 29166-828
Marcus Matos, MD
Marcus Matos, MD
- Recruiting
Hospital das Clínicas da Universidade Federal do Triângulo Mineiro
Uberaba, Minas Gerais
- Recruiting
Hospital Evangelico de Vila Velha
Vila Velha, Espírito Santo
Joao Moraes Junior, MD
Joao Moraes Junior, MD
Canada27 sites, 27 recruiting
- Recruiting
Foothills Medical Centre - Alberta Health Services
Calgary, Alberta, T2N 2T9
Deepa Suryanarayan, MD, 4039448167, dsuryana@ucalgary.ca
Deepa Suryanarayan, MD
- Not yet recruiting
Grand Prairie Regional Hospital
Grande Prairie, Alberta, T8V 4B1
Tafi Madzimure, MD
Tafi Madzimure, MD
- Recruiting
Health Sciences North Research Institute
Greater Sudbury, Ontario, P3E 2H3
Pandma Puranam, MD
Pandma Puranam, MD
- Recruiting
Health Sciences North ResearchInstitute (HSNRI)
Greater Sudbury, Ontario
Pandma Puranam, MD
- Recruiting
Hamilton Health Sciences - Juravinski
Hamilton, Ontario
Bram Rochwerg, MD
Bram Rochwerg, MD
- Recruiting
Hamilton Health Sciences
Hamilton, Ontario
Alison Fox-Robichaud, MD
Alison Fox-Robichaud, MD
- Recruiting
Markham Stouffville Hospital
Markham, Ontario, L3P 7P3
Paul Lee, MD
Paul Lee, MD
- Recruiting
McGill University Health Centre
Montreal, Quebec, H4A3J1
Emily Gibson McDonald, MD, MSc
- Recruiting
Centre Hospitalier de l'université de Montréal (CHUM)
Montreal, Quebec
Emmanuelle Duceppe, MD
- Recruiting
Jewish General Hospital
Montreal, Quebec
Susan Khan, MD
Vicky Tagalakis, MD
- Recruiting
Nanaimo Regional General Hospital
Nanaimo, British Columbia
Alistair Teale, MD
Alistair Teale, MD
- Recruiting
Hôpital Montfort
Ottawa, Ontario
Marc Carrier, MD
- Recruiting
The Ottawa Hospital
Ottawa, Ontario
Lana Castellucci, MD
- Not yet recruiting
Penticton Regional Hospital
Penticton, British Columbia
Teresa Rodriguez, MD
- Recruiting
CHU de Quebec-University Laval
Québec, Quebec
Alexis Turgeon, MD, MSc
- Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
Québec, Quebec
Francois Lallouche, MD
- Recruiting
Regina General Hospital
Regina, Saskatchewan, S4P 0W5
Payam Dehghani, MD
Payam Dehghani, MD
- Recruiting
Niagara Health System - St Catharines Site
Saint Catherines, Ontario, L2S 0A9
Aidan Findlater, MD, Aidan.Findlater@niagarahealth.on.ca
Aidan Findlater, MD
- Not yet recruiting
University of Saskatchewan
Saskatoon, Saskatchewan
Geroffrey Shumailak, MD
- Recruiting
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec
Francois Lamontagne, MD
Francois Lamontagne, MD
- Recruiting
Memorial University
St. John's, Newfoundland and Labrador, A1C 5S7
Peter Daley, MD
Peter Daley, MD
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Jonathan Zipursky, MD
Jonathan Zipursky, MD
- Not yet recruiting
St. Michael's Hospital
Toronto, Ontario
Michael Colacci, MD
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Ted Steiner, MD
Ted Steiner, MD
- Recruiting
Health Sciences Center Winnipeg
Winnipeg, Manitoba, R3A 1R9
Brett Houstin, MD
- Recruiting
Grace General Hospital
Winnipeg, Manitoba
Sylvain Lother, MD, sylvain.lother@umanitoba.ca
Sylvain Lother, MD
- Recruiting
St. Boniface General Hospital
Winnipeg, Manitoba
Vi Dao, MD
Terry Wuerz, MD
United States6 sites, 5 recruiting
- Recruiting
Cooper University Health Care
Camden, New Jersey, 08103
Adam Green, MD
Adam Green, MD
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Jonathan Paul, MD
- Completed
Henry Ford Health System
Dearborn, Michigan, 48128
- Recruiting
Ochsner Clinic
Jefferson, Louisiana, 70121
Derek Vondehaar, MD
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Alisha Sharma, MD
Alisha Sharma, MD
- Recruiting
Maine Medical Centre
Portland, Maine, 04102
Daniel Meyer, MD
Daniel Meyer, MD
Mexico1 site, 1 recruiting
- Recruiting
Hospital General Regional 1. Carlos MacGregor Sánchez Navarro
Mexico City, Mexico City
About this study
This is an international, open-label, stratified randomized controlled trial with Bayesian adaptive stopping rules to compare the effects of therapeutic-dose heparin vs. usual care pharmacological thromboprophylaxis on outcomes in patients admitted to hospital with community acquired pneumonia (CAP).
Read the detailed description
The global incidence of hospitalization due to CAP is high and associated with substantive morbidity and mortality. Thrombotic complications - including venous, arterial, and possibly microvascular - occur commonly in hospitalized patients across many etiologies of CAP. Poor outcomes may be mediated by both inflammatory and thrombotic processes leading to respiratory, cardiac, and other end organ dysfunction. There are currently no established therapies that modify the potentially maladaptive immunothrombosis pathway in CAP.
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
- Community-acquired Pneumonia
- Being tested
- Heparin
- Keywords
- Pneumonia, Heparin, Anticoagulation, Community acquired pneumonia, Unfractionated Heparin, Low Molecular Weight Heparin, Dalteparin, Enoxaparin, Tinzaparin
- Medical subject headings
- Community-Acquired Pneumonia, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeparinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic-Dose Heparin | Experimental | 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. Receives: Drug: Heparin |
| Usual Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ordinal endpoint reflecting survival
Survival to hospital discharge without ICU-level organ support. Organ support is defined as receipt of high flow nasal oxygen, invasive or non-invasive mechanical ventilation, vasopressor/inotropic therapy, or extracorporeal life support (ECLS) within an ICU. This outcome reflects disease progression to ICU-level organ failure or the worst possible outcome (death). It was chosen because of its importance to patients, clinicians, and other stakeholders. Given the limited number of ICU beds, reducing the burden of critical illness has important health system capacity implications.
Measured: 30 days
Secondary outcomes (8)
Bleeding events
Number of participants with major bleeds as defined by the ISTH definition.
Measured: 14 days
HIT events
Number of participants with laboratory confirmed heparin induced thrombocytopenia (HIT)
Measured: 14 days
Thrombotic events
Number of participants with deep vein thrombosis, pulmonary embolism, systemic arterial thromboembolism, myocardial infarction, or ischemic stroke
Measured: 30 days and 90 days
Invasive mechanical ventilation
Ordered categorical endpoint with three possible outcomes based on the worst status of each patient through day 30 following randomization
Measured: 30 days
All cause mortality
Measured: 30 days, 90 days, and 180 days
Hospital-free days
Days alive outside hospital
Measured: 30 days, 90 days, and 180 days
Health related quality of life
Using the EQ-5D-5L instrument
Measured: 30 days, 90 days, and 180 days
Health related quality of life
Using the Clinical Frailty Scale instrument
Measured: 30 days, 90 days, and 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start10 Oct 2023
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Model description
- Adaptive stratified randomized clinical trial with Bayesian stopping rules
- Masking
- None (open label)
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Research Manitoba, Ozmosis Research Inc., Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network, Canadian Critical Care Trials Group, AVANTI, Aurora Clinical Research
- Responsible party
- Sponsor
- Investigators
- Ryan Zarychanski, MD, Principal investigator, University of ManitobaPatrick Lawler, MD, Principal investigator, University Health Network and McGill UniversitySylvain Lother, MD, Principal investigator, University of ManitobaAlexis Turgeon, MD, Principal investigator, L'Universite Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848713
- Sponsor's protocol ID
- ATTACC-CAP
- Other IDs
- OZM-129
- Acronym
- ATTACC-CAP
- Status last verified
- Sep 2026
- First submitted
- 17 Apr 2023
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia
- ClinicalTrials.gov ID
- NCT05848713
- Acronym / sponsor ID
- ATTACC-CAP / ATTACC-CAP
- Conditions
- Community-acquired Pneumonia
- Keywords
- Pneumonia, Heparin, Anticoagulation, Community acquired pneumonia, Unfractionated Heparin, Low Molecular Weight Heparin, Dalteparin, Enoxaparin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Research Manitoba, Ozmosis Research Inc., Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network, Canadian Critical Care Trials Group, AVANTI, Aurora Clinical Research
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an international, open-label, stratified randomized controlled trial with Bayesian adaptive stopping rules to compare the effects of therapeutic-dose heparin vs. usual care pharmacological thromboprophylaxis on outcomes in patients admitted to hospital with community acquired pneumonia (CAP).
Detailed description
The global incidence of hospitalization due to CAP is high and associated with substantive morbidity and mortality. Thrombotic complications - including venous, arterial, and possibly microvascular - occur commonly in hospitalized patients across many etiologies of CAP. Poor outcomes may be mediated by both inflammatory and thrombotic processes leading to respiratory, cardiac, and other end organ dysfunction. There are currently no established therapies that modify the potentially maladaptive immunothrombosis pathway in CAP.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Adaptive stratified randomized clinical trial with Bayesian stopping rules
| Arm | Type | Receives |
|---|---|---|
| Therapeutic-Dose Heparin | Experimental | Drug: HeparinParticipants 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. |
| Usual Care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients ≥18 years of age
- Admitted to hospital for a suspected or confirmed diagnosis of CAP defined by:
- Requires supplemental oxygen to treat hypoxemia (or requires an increased level of supplemental oxygen if on chronic oxygen therapy)
- Hospital admission anticipated to last ≥72 hours from randomization
Key exclusion criteria (19 listed)
- Suspected or confirmed active COVID-19 infection
- Hospital admission for >72 hours prior to randomization
- Patients receiving non-invasive or invasive ventilation, vasopressors, or extracorporeal life support (ECLS) within an ICU at the time of enrollment
- Requirement for chronic mechanical ventilation via tracheostomy prior to hospitalization
- Patients for whom the intent is to not use pharmacologic thromboprophylaxis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeparinPreference 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. | Drug | Therapeutic-Dose Heparin |
Primary outcome
Ordinal endpoint reflecting survival
Time frame: 30 days
Survival to hospital discharge without ICU-level organ support. Organ support is defined as receipt of high flow nasal oxygen, invasive or non-invasive mechanical ventilation, vasopressor/inotropic therapy, or extracorporeal life support (ECLS) within an ICU. This outcome reflects disease progression to ICU-level organ failure or the worst possible outcome (death). It was chosen because of its importance to patients, clinicians, and other stakeholders. Given the limited number of ICU beds, reducing the burden of critical illness has important health system capacity implications.
8 secondary outcomes
Bleeding events
Time frame: 14 days
HIT events
Time frame: 14 days
Thrombotic events
Time frame: 30 days and 90 days
Invasive mechanical ventilation
Time frame: 30 days
All cause mortality
Time frame: 30 days, 90 days, and 180 days
Hospital-free days
Time frame: 30 days, 90 days, and 180 days
Health related quality of life
Time frame: 30 days, 90 days, and 180 days
Health related quality of life
Time frame: 30 days, 90 days, and 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 34351721ATTACC 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ryan Zarychanski, MD principal investigator
University of Manitoba
Patrick Lawler, MD principal investigator
University Health Network and McGill University
Sylvain Lother, MD principal investigator
University of Manitoba
68 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Heparin in people with Community-acquired Pneumonia, run by University of Manitoba at 68 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 7 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chantale Pineau (2042353223, attacc.cap@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ordinal endpoint reflecting survival (time frame: 30 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 NCT05848713, which also lists 1 linked publication.
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 30 Sep 2026.