Trial Outcomes & Findings for Coagulopathy of COVID-19: A Pragmatic Randomized Controlled Trial of Therapeutic Anticoagulation Versus Standard Care (NCT NCT04362085)

NCT ID: NCT04362085

Last Updated: 2025-01-30

Results Overview

Composite outcome of ICU admission, non-invasive positive pressure ventilation, invasive mechanical ventilation, or all-cause death up to 28 days.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

465 participants

Primary outcome timeframe

Up to 28 days

Results posted on

2025-01-30

Participant Flow

Participant milestones

Participant milestones
Measure
Therapeutic Anticoagulation
Therapeutic anticoagulation with LMWH or UFH (high dose nomogram). The choice of LMWH versus UFH will be at the clinician's discretion and dependent on local institutional supply. Therapeutic anticoagulation will be administered until discharged from hospital, 28 days or death. If the patient is admitted to the ICU or requiring ventilatory support, we recommend continuation of the allocated treatment as long as the treating physician is in agreement. Therapeutic Anticoagulation: The choice of low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) will be at the clinician's discretion. LMWH options include: Tinzaparin, Enoxaparin or Dalteparin. UFH will be administered using a weight-based nomogram with titration according to center-specific institutional protocol.
Standard Care
Administration of LMWH, UFH or fondaparinux at thromboprophylactic doses for acutely ill hospitalized medical patients, in the absence of contraindication, is considered standard care.
Overall Study
STARTED
228
237
Overall Study
COMPLETED
228
237
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Coagulopathy of COVID-19: A Pragmatic Randomized Controlled Trial of Therapeutic Anticoagulation Versus Standard Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Therapeutic Anticoagulation
n=228 Participants
Therapeutic anticoagulation with LMWH or UFH (high dose nomogram). The choice of LMWH versus UFH will be at the clinician's discretion and dependent on local institutional supply. Therapeutic anticoagulation will be administered until discharged from hospital, 28 days or death. If the patient is admitted to the ICU or requiring ventilatory support, we recommend continuation of the allocated treatment as long as the treating physician is in agreement. Therapeutic Anticoagulation: The choice of low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) will be at the clinician's discretion. LMWH options include: Tinzaparin, Enoxaparin or Dalteparin. UFH will be administered using a weight-based nomogram with titration according to center-specific institutional protocol.
Standard Care
n=237 Participants
Administration of LMWH, UFH or fondaparinux at thromboprophylactic doses for acutely ill hospitalized medical patients, in the absence of contraindication, is considered standard care.
Total
n=465 Participants
Total of all reporting groups
Age, Continuous
60.4 years
STANDARD_DEVIATION 14.1 • n=5 Participants
59.6 years
STANDARD_DEVIATION 15.5 • n=7 Participants
60.0 years
STANDARD_DEVIATION 14.8 • n=5 Participants
Sex: Female, Male
Female
105 Participants
n=5 Participants
96 Participants
n=7 Participants
201 Participants
n=5 Participants
Sex: Female, Male
Male
123 Participants
n=5 Participants
141 Participants
n=7 Participants
264 Participants
n=5 Participants
Race/Ethnicity, Customized
European
97 Participants
n=5 Participants
96 Participants
n=7 Participants
193 Participants
n=5 Participants
Race/Ethnicity, Customized
Middle Eastern, North African
65 Participants
n=5 Participants
67 Participants
n=7 Participants
132 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
27 Participants
n=5 Participants
38 Participants
n=7 Participants
65 Participants
n=5 Participants
Race/Ethnicity, Customized
Black or African American
18 Participants
n=5 Participants
23 Participants
n=7 Participants
41 Participants
n=5 Participants
Race/Ethnicity, Customized
Hispanic or Latino
14 Participants
n=5 Participants
10 Participants
n=7 Participants
24 Participants
n=5 Participants
Race/Ethnicity, Customized
American Indian, Alaska Native, First Nations, Indigenous/Aboriginal, Metis
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Missing Data
6 Participants
n=5 Participants
2 Participants
n=7 Participants
8 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Therapeutic Anticoagulation
n=228 Participants
Therapeutic anticoagulation with LMWH or UFH (high dose nomogram). The choice of LMWH versus UFH will be at the clinician's discretion and dependent on local institutional supply. Therapeutic anticoagulation will be administered until discharged from hospital, 28 days or death. If the patient is admitted to the ICU or requiring ventilatory support, we recommend continuation of the allocated treatment as long as the treating physician is in agreement. Therapeutic Anticoagulation: The choice of low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) will be at the clinician's discretion. LMWH options include: Tinzaparin, Enoxaparin or Dalteparin. UFH will be administered using a weight-based nomogram with titration according to center-specific institutional protocol.
Standard Care
n=237 Participants
Administration of LMWH, UFH or fondaparinux at thromboprophylactic doses for acutely ill hospitalized medical patients, in the absence of contraindication, is considered standard care.
Composite Outcome of ICU Admission, Non-invasive Positive Pressure Ventilation, Invasive Mechanical Ventilation, or All-cause Death up to 28 Days.
37 Participants
52 Participants

SECONDARY outcome

Timeframe: Up to 28 days

All-cause death

Outcome measures

Outcome measures
Measure
Therapeutic Anticoagulation
n=228 Participants
Therapeutic anticoagulation with LMWH or UFH (high dose nomogram). The choice of LMWH versus UFH will be at the clinician's discretion and dependent on local institutional supply. Therapeutic anticoagulation will be administered until discharged from hospital, 28 days or death. If the patient is admitted to the ICU or requiring ventilatory support, we recommend continuation of the allocated treatment as long as the treating physician is in agreement. Therapeutic Anticoagulation: The choice of low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) will be at the clinician's discretion. LMWH options include: Tinzaparin, Enoxaparin or Dalteparin. UFH will be administered using a weight-based nomogram with titration according to center-specific institutional protocol.
Standard Care
n=237 Participants
Administration of LMWH, UFH or fondaparinux at thromboprophylactic doses for acutely ill hospitalized medical patients, in the absence of contraindication, is considered standard care.
All-cause Death
4 Participants
18 Participants

SECONDARY outcome

Timeframe: Up to 28 days

Composite outcome of ICU admission or all-cause death

Outcome measures

Outcome measures
Measure
Therapeutic Anticoagulation
n=228 Participants
Therapeutic anticoagulation with LMWH or UFH (high dose nomogram). The choice of LMWH versus UFH will be at the clinician's discretion and dependent on local institutional supply. Therapeutic anticoagulation will be administered until discharged from hospital, 28 days or death. If the patient is admitted to the ICU or requiring ventilatory support, we recommend continuation of the allocated treatment as long as the treating physician is in agreement. Therapeutic Anticoagulation: The choice of low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) will be at the clinician's discretion. LMWH options include: Tinzaparin, Enoxaparin or Dalteparin. UFH will be administered using a weight-based nomogram with titration according to center-specific institutional protocol.
Standard Care
n=237 Participants
Administration of LMWH, UFH or fondaparinux at thromboprophylactic doses for acutely ill hospitalized medical patients, in the absence of contraindication, is considered standard care.
Composite Outcome of ICU Admission or All-cause Death
4 Participants
1 Participants

SECONDARY outcome

Timeframe: Up to 28 days

Composite outcome of mechanical ventilation or all-cause death

Outcome measures

Outcome measures
Measure
Therapeutic Anticoagulation
n=228 Participants
Therapeutic anticoagulation with LMWH or UFH (high dose nomogram). The choice of LMWH versus UFH will be at the clinician's discretion and dependent on local institutional supply. Therapeutic anticoagulation will be administered until discharged from hospital, 28 days or death. If the patient is admitted to the ICU or requiring ventilatory support, we recommend continuation of the allocated treatment as long as the treating physician is in agreement. Therapeutic Anticoagulation: The choice of low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) will be at the clinician's discretion. LMWH options include: Tinzaparin, Enoxaparin or Dalteparin. UFH will be administered using a weight-based nomogram with titration according to center-specific institutional protocol.
Standard Care
n=237 Participants
Administration of LMWH, UFH or fondaparinux at thromboprophylactic doses for acutely ill hospitalized medical patients, in the absence of contraindication, is considered standard care.
Composite Outcome of Mechanical Ventilation or All-cause Death
23 Participants
28 Participants

SECONDARY outcome

Timeframe: Up to 28 days

Major bleeding as defined by the ISTH Scientific and Standardization Committee (ISTH-SSC) recommendation

Outcome measures

Outcome measures
Measure
Therapeutic Anticoagulation
n=228 Participants
Therapeutic anticoagulation with LMWH or UFH (high dose nomogram). The choice of LMWH versus UFH will be at the clinician's discretion and dependent on local institutional supply. Therapeutic anticoagulation will be administered until discharged from hospital, 28 days or death. If the patient is admitted to the ICU or requiring ventilatory support, we recommend continuation of the allocated treatment as long as the treating physician is in agreement. Therapeutic Anticoagulation: The choice of low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) will be at the clinician's discretion. LMWH options include: Tinzaparin, Enoxaparin or Dalteparin. UFH will be administered using a weight-based nomogram with titration according to center-specific institutional protocol.
Standard Care
n=237 Participants
Administration of LMWH, UFH or fondaparinux at thromboprophylactic doses for acutely ill hospitalized medical patients, in the absence of contraindication, is considered standard care.
Major Bleeding
2 Participants
4 Participants

SECONDARY outcome

Timeframe: Up to 28 days

Red Blood Cell transfusion (greater than or equal to 1 unit)

Outcome measures

Outcome measures
Measure
Therapeutic Anticoagulation
n=228 Participants
Therapeutic anticoagulation with LMWH or UFH (high dose nomogram). The choice of LMWH versus UFH will be at the clinician's discretion and dependent on local institutional supply. Therapeutic anticoagulation will be administered until discharged from hospital, 28 days or death. If the patient is admitted to the ICU or requiring ventilatory support, we recommend continuation of the allocated treatment as long as the treating physician is in agreement. Therapeutic Anticoagulation: The choice of low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) will be at the clinician's discretion. LMWH options include: Tinzaparin, Enoxaparin or Dalteparin. UFH will be administered using a weight-based nomogram with titration according to center-specific institutional protocol.
Standard Care
n=237 Participants
Administration of LMWH, UFH or fondaparinux at thromboprophylactic doses for acutely ill hospitalized medical patients, in the absence of contraindication, is considered standard care.
Red Blood Cell Transfusion
3 Participants
9 Participants

SECONDARY outcome

Timeframe: Up to 28 days

Transfusion of platelets, frozen plasma, prothrombin complex concentrate, cryoprecipiate and/or fibrinogen concentrate

Outcome measures

Outcome measures
Measure
Therapeutic Anticoagulation
n=228 Participants
Therapeutic anticoagulation with LMWH or UFH (high dose nomogram). The choice of LMWH versus UFH will be at the clinician's discretion and dependent on local institutional supply. Therapeutic anticoagulation will be administered until discharged from hospital, 28 days or death. If the patient is admitted to the ICU or requiring ventilatory support, we recommend continuation of the allocated treatment as long as the treating physician is in agreement. Therapeutic Anticoagulation: The choice of low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) will be at the clinician's discretion. LMWH options include: Tinzaparin, Enoxaparin or Dalteparin. UFH will be administered using a weight-based nomogram with titration according to center-specific institutional protocol.
Standard Care
n=237 Participants
Administration of LMWH, UFH or fondaparinux at thromboprophylactic doses for acutely ill hospitalized medical patients, in the absence of contraindication, is considered standard care.
Transfusion of Platelets, Frozen Plasma, Prothrombin Complex Concentrate, Cryoprecipiate and/or Fibrinogen Concentrate
1 Participants
0 Participants

SECONDARY outcome

Timeframe: Up to 28 days

Renal replacement therapy defined as continuous renal replacement therapy or intermittent hemodialysis

Outcome measures

Outcome measures
Measure
Therapeutic Anticoagulation
n=228 Participants
Therapeutic anticoagulation with LMWH or UFH (high dose nomogram). The choice of LMWH versus UFH will be at the clinician's discretion and dependent on local institutional supply. Therapeutic anticoagulation will be administered until discharged from hospital, 28 days or death. If the patient is admitted to the ICU or requiring ventilatory support, we recommend continuation of the allocated treatment as long as the treating physician is in agreement. Therapeutic Anticoagulation: The choice of low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) will be at the clinician's discretion. LMWH options include: Tinzaparin, Enoxaparin or Dalteparin. UFH will be administered using a weight-based nomogram with titration according to center-specific institutional protocol.
Standard Care
n=237 Participants
Administration of LMWH, UFH or fondaparinux at thromboprophylactic doses for acutely ill hospitalized medical patients, in the absence of contraindication, is considered standard care.
Renal Replacement Therapy
2 Participants
5 Participants

SECONDARY outcome

Timeframe: Up to 28 days

Hospital-free days alive up to day 28

Outcome measures

Outcome measures
Measure
Therapeutic Anticoagulation
n=228 Participants
Therapeutic anticoagulation with LMWH or UFH (high dose nomogram). The choice of LMWH versus UFH will be at the clinician's discretion and dependent on local institutional supply. Therapeutic anticoagulation will be administered until discharged from hospital, 28 days or death. If the patient is admitted to the ICU or requiring ventilatory support, we recommend continuation of the allocated treatment as long as the treating physician is in agreement. Therapeutic Anticoagulation: The choice of low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) will be at the clinician's discretion. LMWH options include: Tinzaparin, Enoxaparin or Dalteparin. UFH will be administered using a weight-based nomogram with titration according to center-specific institutional protocol.
Standard Care
n=237 Participants
Administration of LMWH, UFH or fondaparinux at thromboprophylactic doses for acutely ill hospitalized medical patients, in the absence of contraindication, is considered standard care.
Hospital-free Days Alive up to Day 28
19.8 days
Standard Deviation 7.3
18.4 days
Standard Deviation 9.2

SECONDARY outcome

Timeframe: Up to 28 days

ICU-free days alive up to day 28

Outcome measures

Outcome measures
Measure
Therapeutic Anticoagulation
n=228 Participants
Therapeutic anticoagulation with LMWH or UFH (high dose nomogram). The choice of LMWH versus UFH will be at the clinician's discretion and dependent on local institutional supply. Therapeutic anticoagulation will be administered until discharged from hospital, 28 days or death. If the patient is admitted to the ICU or requiring ventilatory support, we recommend continuation of the allocated treatment as long as the treating physician is in agreement. Therapeutic Anticoagulation: The choice of low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) will be at the clinician's discretion. LMWH options include: Tinzaparin, Enoxaparin or Dalteparin. UFH will be administered using a weight-based nomogram with titration according to center-specific institutional protocol.
Standard Care
n=237 Participants
Administration of LMWH, UFH or fondaparinux at thromboprophylactic doses for acutely ill hospitalized medical patients, in the absence of contraindication, is considered standard care.
ICU-free Days Alive up to Day 28
26 days
Standard Deviation 6.1
24.2 days
Standard Deviation 8.8

SECONDARY outcome

Timeframe: Up to 28 days

Ventilator-free days alive up to day 28

Outcome measures

Outcome measures
Measure
Therapeutic Anticoagulation
n=228 Participants
Therapeutic anticoagulation with LMWH or UFH (high dose nomogram). The choice of LMWH versus UFH will be at the clinician's discretion and dependent on local institutional supply. Therapeutic anticoagulation will be administered until discharged from hospital, 28 days or death. If the patient is admitted to the ICU or requiring ventilatory support, we recommend continuation of the allocated treatment as long as the treating physician is in agreement. Therapeutic Anticoagulation: The choice of low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) will be at the clinician's discretion. LMWH options include: Tinzaparin, Enoxaparin or Dalteparin. UFH will be administered using a weight-based nomogram with titration according to center-specific institutional protocol.
Standard Care
n=237 Participants
Administration of LMWH, UFH or fondaparinux at thromboprophylactic doses for acutely ill hospitalized medical patients, in the absence of contraindication, is considered standard care.
Ventilator-free Days Alive up to Day 28
26.5 days
Standard Deviation 5.6
24.7 days
Standard Deviation 8.5

SECONDARY outcome

Timeframe: Up to 28 days

Organ support-free days alive up to day 28

Outcome measures

Outcome measures
Measure
Therapeutic Anticoagulation
n=228 Participants
Therapeutic anticoagulation with LMWH or UFH (high dose nomogram). The choice of LMWH versus UFH will be at the clinician's discretion and dependent on local institutional supply. Therapeutic anticoagulation will be administered until discharged from hospital, 28 days or death. If the patient is admitted to the ICU or requiring ventilatory support, we recommend continuation of the allocated treatment as long as the treating physician is in agreement. Therapeutic Anticoagulation: The choice of low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) will be at the clinician's discretion. LMWH options include: Tinzaparin, Enoxaparin or Dalteparin. UFH will be administered using a weight-based nomogram with titration according to center-specific institutional protocol.
Standard Care
n=237 Participants
Administration of LMWH, UFH or fondaparinux at thromboprophylactic doses for acutely ill hospitalized medical patients, in the absence of contraindication, is considered standard care.
Organ Support-free Days Alive up to Day 28
25.8 days
Standard Deviation 6.2
24.1 days
Standard Deviation 8.8

SECONDARY outcome

Timeframe: Up to 28 days

Venous thromboembolism

Outcome measures

Outcome measures
Measure
Therapeutic Anticoagulation
n=228 Participants
Therapeutic anticoagulation with LMWH or UFH (high dose nomogram). The choice of LMWH versus UFH will be at the clinician's discretion and dependent on local institutional supply. Therapeutic anticoagulation will be administered until discharged from hospital, 28 days or death. If the patient is admitted to the ICU or requiring ventilatory support, we recommend continuation of the allocated treatment as long as the treating physician is in agreement. Therapeutic Anticoagulation: The choice of low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) will be at the clinician's discretion. LMWH options include: Tinzaparin, Enoxaparin or Dalteparin. UFH will be administered using a weight-based nomogram with titration according to center-specific institutional protocol.
Standard Care
n=237 Participants
Administration of LMWH, UFH or fondaparinux at thromboprophylactic doses for acutely ill hospitalized medical patients, in the absence of contraindication, is considered standard care.
Venous Thromboembolism
2 Participants
6 Participants

SECONDARY outcome

Timeframe: Up to 28 days

Arterial thromboembolism

Outcome measures

Outcome measures
Measure
Therapeutic Anticoagulation
n=228 Participants
Therapeutic anticoagulation with LMWH or UFH (high dose nomogram). The choice of LMWH versus UFH will be at the clinician's discretion and dependent on local institutional supply. Therapeutic anticoagulation will be administered until discharged from hospital, 28 days or death. If the patient is admitted to the ICU or requiring ventilatory support, we recommend continuation of the allocated treatment as long as the treating physician is in agreement. Therapeutic Anticoagulation: The choice of low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) will be at the clinician's discretion. LMWH options include: Tinzaparin, Enoxaparin or Dalteparin. UFH will be administered using a weight-based nomogram with titration according to center-specific institutional protocol.
Standard Care
n=237 Participants
Administration of LMWH, UFH or fondaparinux at thromboprophylactic doses for acutely ill hospitalized medical patients, in the absence of contraindication, is considered standard care.
Arterial Thromboembolism
0 Participants
1 Participants

SECONDARY outcome

Timeframe: Up to 28 days

Heparin induced thrombocytopenia

Outcome measures

Outcome measures
Measure
Therapeutic Anticoagulation
n=228 Participants
Therapeutic anticoagulation with LMWH or UFH (high dose nomogram). The choice of LMWH versus UFH will be at the clinician's discretion and dependent on local institutional supply. Therapeutic anticoagulation will be administered until discharged from hospital, 28 days or death. If the patient is admitted to the ICU or requiring ventilatory support, we recommend continuation of the allocated treatment as long as the treating physician is in agreement. Therapeutic Anticoagulation: The choice of low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) will be at the clinician's discretion. LMWH options include: Tinzaparin, Enoxaparin or Dalteparin. UFH will be administered using a weight-based nomogram with titration according to center-specific institutional protocol.
Standard Care
n=237 Participants
Administration of LMWH, UFH or fondaparinux at thromboprophylactic doses for acutely ill hospitalized medical patients, in the absence of contraindication, is considered standard care.
Heparin Induced Thrombocytopenia
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Up to day 3

Geometric mean ratio defined as ratio of geometric means of D-dimer ratios (D-dimer×ULN) of day 2 ±24 hours post-randomisation, adjusted for baseline geometric means of D-dimer ratios using analysis of covariance.

Outcome measures

Outcome measures
Measure
Therapeutic Anticoagulation
n=228 Participants
Therapeutic anticoagulation with LMWH or UFH (high dose nomogram). The choice of LMWH versus UFH will be at the clinician's discretion and dependent on local institutional supply. Therapeutic anticoagulation will be administered until discharged from hospital, 28 days or death. If the patient is admitted to the ICU or requiring ventilatory support, we recommend continuation of the allocated treatment as long as the treating physician is in agreement. Therapeutic Anticoagulation: The choice of low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) will be at the clinician's discretion. LMWH options include: Tinzaparin, Enoxaparin or Dalteparin. UFH will be administered using a weight-based nomogram with titration according to center-specific institutional protocol.
Standard Care
n=237 Participants
Administration of LMWH, UFH or fondaparinux at thromboprophylactic doses for acutely ill hospitalized medical patients, in the absence of contraindication, is considered standard care.
Changes in D-dimer
1.9 ratio
Standard Deviation 0.7
2.4 ratio
Standard Deviation 0.9

Adverse Events

Therapeutic Anticoagulation

Serious events: 228 serious events
Other events: 228 other events
Deaths: 4 deaths

Standard Care

Serious events: 237 serious events
Other events: 237 other events
Deaths: 18 deaths

Serious adverse events

Serious adverse events
Measure
Therapeutic Anticoagulation
n=228 participants at risk
Therapeutic anticoagulation with LMWH or UFH (high dose nomogram). The choice of LMWH versus UFH will be at the clinician's discretion and dependent on local institutional supply. Therapeutic anticoagulation will be administered until discharged from hospital, 28 days or death. If the patient is admitted to the ICU or requiring ventilatory support, we recommend continuation of the allocated treatment as long as the treating physician is in agreement. Therapeutic Anticoagulation: The choice of low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) will be at the clinician's discretion. LMWH options include: Tinzaparin, Enoxaparin or Dalteparin. UFH will be administered using a weight-based nomogram with titration according to center-specific institutional protocol.
Standard Care
n=237 participants at risk
Administration of LMWH, UFH or fondaparinux at thromboprophylactic doses for acutely ill hospitalized medical patients, in the absence of contraindication, is considered standard care.
General disorders
Hospitalization
100.0%
228/228 • 28 Days
100.0%
237/237 • 28 Days

Other adverse events

Other adverse events
Measure
Therapeutic Anticoagulation
n=228 participants at risk
Therapeutic anticoagulation with LMWH or UFH (high dose nomogram). The choice of LMWH versus UFH will be at the clinician's discretion and dependent on local institutional supply. Therapeutic anticoagulation will be administered until discharged from hospital, 28 days or death. If the patient is admitted to the ICU or requiring ventilatory support, we recommend continuation of the allocated treatment as long as the treating physician is in agreement. Therapeutic Anticoagulation: The choice of low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) will be at the clinician's discretion. LMWH options include: Tinzaparin, Enoxaparin or Dalteparin. UFH will be administered using a weight-based nomogram with titration according to center-specific institutional protocol.
Standard Care
n=237 participants at risk
Administration of LMWH, UFH or fondaparinux at thromboprophylactic doses for acutely ill hospitalized medical patients, in the absence of contraindication, is considered standard care.
Respiratory, thoracic and mediastinal disorders
Laboratory confirmed SARS-CoV-2 infection
100.0%
228/228 • 28 Days
100.0%
237/237 • 28 Days

Additional Information

Dr. Michelle Sholzberg

St. Michael's Hospital

Phone: 4168606060

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place