Trial · NCT04362085
Coagulopathy of COVID-19: A Pragmatic Randomized Controlled Trial of Therapeutic Anticoagulation Versus Standard Care
NCT04362085, Phase 3, Completed, Unity Health Toronto; results first posted 2025-01-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Coagulopathy of COVID-19: A Pragmatic Randomized Controlled Trial of Therapeutic Anticoagulation Versus Standard Care. Trials, record NCT04362085. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04362085
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Coagulopathy of COVID-19: A Pragmatic Randomized Controlled Trial of Therapeutic Anticoagulation Versus Standard Care
- NCT number
- NCT04362085
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 465 participants, actual
- Lead sponsor
- Unity Health Toronto
- Conditions
- COVID-19
- Interventions
- Therapeutic Anticoagulation
- First posted
- 2020-04-24
- Last updated
- 2025-01-30
- Results first posted
- 2025-01-30
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite Outcome of ICU Admission, Non-invasive Positive Pressure Ventilation, Invasive Mechanical Ventilation, or All-cause Death up to 28 Days. | Up to 28 days | Composite outcome of ICU admission, non-invasive positive pressure ventilation, invasive mechanical ventilation, or all-cause death up to 28 days. |
| Secondary | All-cause Death | Up to 28 days | All-cause death |
| Secondary | Composite Outcome of ICU Admission or All-cause Death | Up to 28 days | Composite outcome of ICU admission or all-cause death |
| Secondary | Composite Outcome of Mechanical Ventilation or All-cause Death | Up to 28 days | Composite outcome of mechanical ventilation or all-cause death |
| Secondary | Major Bleeding | Up to 28 days | Major bleeding as defined by the ISTH Scientific and Standardization Committee (ISTH-SSC) recommendation |
| Secondary | Red Blood Cell Transfusion | Up to 28 days | Red Blood Cell transfusion (greater than or equal to 1 unit) |
| Secondary | Transfusion of Platelets, Frozen Plasma, Prothrombin Complex Concentrate, Cryoprecipiate and/or Fibrinogen Concentrate | Up to 28 days | Transfusion of platelets, frozen plasma, prothrombin complex concentrate, cryoprecipiate and/or fibrinogen concentrate |
| Secondary | Renal Replacement Therapy | Up to 28 days | Renal replacement therapy defined as continuous renal replacement therapy or intermittent hemodialysis |
| Secondary | Hospital-free Days Alive up to Day 28 | Up to 28 days | Hospital-free days alive up to day 28 |
| Secondary | ICU-free Days Alive up to Day 28 | Up to 28 days | ICU-free days alive up to day 28 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Composite Outcome of ICU Admission, Non-invasive Positive Pressure Ventilation, Invasive Mechanical Ventilation, or All-cause Death up to 28 Days. | Up to 28 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | All-cause Death | Up to 28 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Composite Outcome of ICU Admission or All-cause Death | Up to 28 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Composite Outcome of Mechanical Ventilation or All-cause Death | Up to 28 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Major Bleeding | Up to 28 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Red Blood Cell Transfusion | Up to 28 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Transfusion of Platelets, Frozen Plasma, Prothrombin Complex Concentrate, Cryoprecipiate and/or Fibrinogen Concentrate | Up to 28 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Renal Replacement Therapy | Up to 28 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Hospital-free Days Alive up to Day 28 | Up to 28 days | days | MEAN | |
| SECONDARY | ICU-free Days Alive up to Day 28 | Up to 28 days | days | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Composite Outcome of ICU Admission, Non-invasive Positive Pressure Ventilation, Invasive Mechanical Ventilation, or All-cause Death up to 28 Days. | Therapeutic Anticoagulation | 37 | Participants | ||
| Composite Outcome of ICU Admission, Non-invasive Positive Pressure Ventilation, Invasive Mechanical Ventilation, or All-cause Death up to 28 Days. | Standard Care | 52 | Participants | ||
| All-cause Death | Therapeutic Anticoagulation | 4 | Participants | ||
| All-cause Death | Standard Care | 18 | Participants | ||
| Composite Outcome of ICU Admission or All-cause Death | Therapeutic Anticoagulation | 4 | Participants | ||
| Composite Outcome of ICU Admission or All-cause Death | Standard Care | 1 | Participants | ||
| Composite Outcome of Mechanical Ventilation or All-cause Death | Therapeutic Anticoagulation | 23 | Participants | ||
| Composite Outcome of Mechanical Ventilation or All-cause Death | Standard Care | 28 | Participants | ||
| Major Bleeding | Therapeutic Anticoagulation | 2 | Participants | ||
| Major Bleeding | Standard Care | 4 | Participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Therapeutic Anticoagulation | 228 | |
| Overall Study | STARTED | Standard Care | 237 | |
| Overall Study | COMPLETED | Therapeutic Anticoagulation | 228 | |
| Overall Study | COMPLETED | Standard Care | 237 | |
| Overall Study | NOT COMPLETED | Therapeutic Anticoagulation | 0 | |
| Overall Study | NOT COMPLETED | Standard Care | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Laboratory confirmed SARS-CoV-2 infection | Respiratory, thoracic and mediastinal disorders | Therapeutic Anticoagulation | 228 | 228 | |
| other | Laboratory confirmed SARS-CoV-2 infection | Respiratory, thoracic and mediastinal disorders | Standard Care | 237 | 237 | |
| serious | Hospitalization | General disorders | Therapeutic Anticoagulation | 228 | 228 | |
| serious | Hospitalization | General disorders | Standard Care | 237 | 237 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Therapeutic Anticoagulation | 4 | 228 |
| Total, all-cause mortality | Standard Care | 18 | 237 |
| Total, other adverse events | Therapeutic Anticoagulation | 228 | 228 |
| Total, other adverse events | Standard Care | 237 | 237 |
| Total, serious adverse events | Therapeutic Anticoagulation | 228 | 228 |
| Total, serious adverse events | Standard Care | 237 | 237 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons13
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Therapeutic Anticoagulation vs Standard Care: All-cause Death | Trial comparisons |
| Therapeutic Anticoagulation vs Standard Care: Composite Outcome of ICU Admission or All-cause Death | Trial comparisons |
| Therapeutic Anticoagulation vs Standard Care: Composite Outcome of Mechanical Ventilation or All-cause Death | Trial comparisons |
| Therapeutic Anticoagulation vs Standard Care: Major Bleeding | Trial comparisons |
| Therapeutic Anticoagulation vs Standard Care: Arterial Thromboembolism | Trial comparisons |
| Therapeutic Anticoagulation vs Standard Care: Heparin Induced Thrombocytopenia | Trial comparisons |
| Therapeutic Anticoagulation vs Standard Care: Renal Replacement Therapy | Trial comparisons |
| Therapeutic Anticoagulation vs Standard Care: Composite Outcome of ICU Admission, Non-invasive Positive Pressure Ventilation, Invasive Mechanical Ventilation, or All-cause Death up to 28 Days. | Trial comparisons |
| Therapeutic Anticoagulation vs Standard Care: Red Blood Cell Transfusion | Trial comparisons |
| Therapeutic Anticoagulation vs Standard Care: Transfusion of Platelets, Frozen Plasma, Prothrombin Complex Concentrate, Cryoprecipiate and/or Fibrinogen Concentrate | Trial comparisons |
1 to 10 of 13
See all 13 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04362085
GET https://conductscience.org/api/trials/v1/NCT04362085/results?page=2