Covid19NCT04829552
Prophylactic Versus Therapeutic Dose Anticoagulation In COVID-19 Infection at the Time of Admission To Critical Care Units
An observational study of Covid19, run by Corewell Health East at 1 site in United States.
Trial summary
This is a multi-center, retrospective, study to determine if therapeutic dose anticoagulation (High dose group) improves inpatient mortality in severely ill patients with COVID-19 compared to prophylactic dose anticoagulation (Low dose group). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- Type of treatment
- Injection or infusion
- How many people
- 704 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2020to 15 Apr 2020
- Phase
- Observational
- 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
Study population: Adult patients who were admitted to Beaumont Health System (Michigan, USA) ICU/SDU in the period of March 10th to April 15th, 2020.
Who may be able to join
- Age >18 years old
- positive reverse transcription-polymerase chain reaction (rRT-PCR) test for the qualitative detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens.
- Intensive care unit (ICU) patient or Step-down unit (SDU) patient on invasive mechanical ventilation, BiPAP, 100% non-rebreather mask, or high flow oxygen or supplemental oxygen of at least 4 liters per minute nasal cannula.
- peak d-dimer levels exceeding 1,000 mcg/mL at any time during admission.
Who cannot join
- Hospital length of stay less than 5 days.
- Hemorrhage before ICU/SDU admission.
- Treatment with an anticoagulant other than low molecular weight heparin or unfractionated heparin.
- Constant treatment with the same dose of anticoagulant for less than 5 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beaumont Health System (BHS)
Royal Oak, Michigan, 48073
About this study
Official title: Prophylactic Versus Therapeutic Dose Anticoagulation In COVID-19 Infection at the Time of Admission To Critical Care Units: A Multicenter Retrospective Cohort Study in the Beaumont Healthcare System
This is a multi-center, retrospective, study to determine if therapeutic dose anticoagulation (High dose group) improves inpatient mortality in severely ill patients with COVID-19 compared to prophylactic dose anticoagulation (Low dose group). The study involved 704 individuals who were admitted to Beaumont Health System (BHS) from March 10th to April 15th, 2020.
- Conditions
- Covid19
- Keywords
- anticoagulation, COVID19, thrombosis, heparin, coagulopathy
- Medical subject headings
- COVID-19, Thrombosis, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control group: low dose group. | patients treated with subcutaneous low molecular weight heparin 40 mg once daily or unfractionated heparin 5000 IU twice or three times daily for at least 5 days. | |
| Study group: high dose group. | Patients treated with subcutaneous low molecular weight heparin 1 mg/kg twice daily or 1.5 mg/kg daily or a continuous intravenous infusion of unfractionated heparin for at least 5 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inpatient all-cause mortality
Measured: During hospitalization, up to 6 months
Secondary outcomes (3)
Rates of major bleeding events
as defined by the International Society on Thrombosis and Hemostasis
Measured: During hospitalization, up to 6 months
Rates of venous thromboses
Measured: During hospitalization, up to 6 months
Intensive care unit/Step down unit length of stay
Measured: During hospitalization, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start10 Mar 2020
- Primary completion15 Apr 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 704 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faisal Musa, MD, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829552
- Sponsor's protocol ID
- 2020-219
- Status last verified
- Mar 2021
- First submitted
- 22 Mar 2021
- Last updated
- 2 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Versus Therapeutic Dose Anticoagulation In COVID-19 Infection at the Time of Admission To Critical Care Units: A Multicenter Retrospective Cohort Study in the Beaumont Healthcare System
- ClinicalTrials.gov ID
- NCT04829552
- Acronym / sponsor ID
- 2020-219
- Conditions
- Covid19
- Keywords
- anticoagulation, COVID19, thrombosis, heparin, coagulopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 704 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 2 Apr 2021 (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 a multi-center, retrospective, study to determine if therapeutic dose anticoagulation (High dose group) improves inpatient mortality in severely ill patients with COVID-19 compared to prophylactic dose anticoagulation (Low dose group). The study involved 704 individuals who were admitted to Beaumont Health System (BHS) from March 10th to April 15th, 2020.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group: low dose group. | – | –patients treated with subcutaneous low molecular weight heparin 40 mg once daily or unfractionated heparin 5000 IU twice or three times daily for at least 5 days. |
| Study group: high dose group. | – | –Patients treated with subcutaneous low molecular weight heparin 1 mg/kg twice daily or 1.5 mg/kg daily or a continuous intravenous infusion of unfractionated heparin for at least 5 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who were admitted to Beaumont Health System (Michigan, USA) ICU/SDU in the period of March 10th to April 15th, 2020.
Key inclusion criteria (4 listed)
- Age >18 years old
- positive reverse transcription-polymerase chain reaction (rRT-PCR) test for the qualitative detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens.
- Intensive care unit (ICU) patient or Step-down unit (SDU) patient on invasive mechanical ventilation, BiPAP, 100% non-rebreather mask, or high flow oxygen or supplemental oxygen of at least 4 liters per minute nasal cannula.
- peak d-dimer levels exceeding 1,000 mcg/mL at any time during admission.
Key exclusion criteria (4 listed)
- Hospital length of stay less than 5 days.
- Hemorrhage before ICU/SDU admission.
- Treatment with an anticoagulant other than low molecular weight heparin or unfractionated heparin.
- Constant treatment with the same dose of anticoagulant for less than 5 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inpatient all-cause mortality
Time frame: During hospitalization, up to 6 months
3 secondary outcomes
Rates of major bleeding events
Time frame: During hospitalization, up to 6 months
Rates of venous thromboses
Time frame: During hospitalization, up to 6 months
Intensive care unit/Step down unit length of stay
Time frame: During hospitalization, up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Corewell Health East at 1 site in United States.
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 4 inclusion and 4 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 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
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?
Inpatient all-cause mortality (time frame: During hospitalization, up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2021.