NCT04360824|CompletedPhase 4ResultsFDA Drug
Covid-19 Associated Coagulopathy
COVID-19-associated Coagulopathy: Safety and Efficacy of Prophylactic Anticoagulation Therapy in Hospitalized Adults With COVID-19
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Sponsor study identifier
interventional
176
1 country
2
Study Start
May 6, 2020
Actual (reported)Primary Completion
April 16, 2021
Actual (reported)Study Completion
April 16, 2021
Actual (reported)This prospective, randomized, open-label, multi-center interventional study is designed to compare the safety and efficacy of two LMWH dosing protocols in patients admitted to the University of Iowa Hospitals with COVID-19 who meet the modified ISTH Overt DIC criteria score ≥3. Patients will be randomized to standard prophylactic dose LMWH (standard of care arm) or intermediate-dose LMWH (intervention arm).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 16, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 13, 2020
Actual (reported)April 24, 2020
Actual (reported)May 6, 2020
Actual (reported)April 16, 2021
Actual (reported)April 16, 2021
Actual (reported)March 1, 2023
Actual (reported)Mortality
All-cause mortality
30 Days post intervention
Number of Participants With Acute Kidney Injury
30 days post intervention
Number of Participants With Arterial Thrombosis
30 Days post intervention
Number of Participants With Venous Thrombosis
30 Days post intervention
Number of Participants With Major Bleeding
30 Days post intervention
Number of Participants With Minor Bleeding
30 Days post intervention
1\) Patients randomized to the standard of care arm will receive standard prophylactic dose enoxaparin (40 mg subcutaneously daily if BMI \<30kg/m2 and 30 mg subcutaneously twice daily or 40 mg subcutaneously twice daily if BMI ≥ 30kg/m2).
2\) Patients randomized to the intervention arm will receive intermediate-dose enoxaparin (1 mg/kg Subcutaneously daily if BMI\<30 kg/m2 or 0.5 mg/kg Subcutaneously twice daily if BMI ≥ 30kg/m2).
2\) Patients randomized to the intervention arm will receive intermediate-dose enoxaparin (1 mg/kg Subcutaneously daily if BMI\<30kg/m2 or 0.5 mg/kg Subcutaneously twice daily if BMI ≥ 30kg/m2).
Patients randomized to the standard of care arm will receive standard prophylactic dose enoxaparin (40 mg subcutaneously daily if BMI \<30kg/m2 and 30 mg subcutaneously twice daily or 40 mg subcutaneously twice daily if BMI ≥ 30 kg/m2).
University of Iowa
Iowa City, Iowa, 52242, United States
Gundersen Health System
La Crosse, Wisconsin, 54601, United States
Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020 Apr;18(4):844-847. doi: 10.1111/jth.14768. Epub 2020 Mar 13.
The trial design was based on data available in early 2020 that suggested a mortality of up to 40% in hospitalized patients with severe COVID-19. Another limitation is that the results cannot be extrapolated to all patients hospitalized with COVID-19, because more than 85% of screened patients did not meet eligibility criteria. Lastly, this study was not designed to examine outcomes beyond 30 days.
176 participants (actual enrollment reported by the registry).
First Submitted
April 13, 2020
First Posted
April 24, 2020
University Hospital of Ioannina COVID-19 (Coronavirus Disease 2019) Registry
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Lentz SR. Thrombosis in the setting of obesity or inflammatory bowel disease. Hematology Am Soc Hematol Educ Program. 2016 Dec 2;2016(1):180-187. doi: 10.1182/asheducation-2016.1.180.
Eustes AS, Palani Kumar MK, Peterson JA, Mast AE, Lentz SR, Dayal S. Elevated tissue factor pathway inhibitor delays thrombin generation in COVID-19 but is not associated with clinical outcomes. Blood Vessel Thromb Hemost. 2025 Apr 29;2(3):100071. doi: 10.1016/j.bvth.2025.100071. eCollection 2025 Aug.
Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.
Flumignan RL, Tinoco JDS, Pascoal PI, Areias LL, Cossi MS, Fernandes MI, Costa IK, Souza L, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Prophylactic anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD013739. doi: 10.1002/14651858.CD013739.
Study Start
May 6, 2020
Actual (reported)Primary Completion
April 16, 2021
Actual (reported)Study Completion
April 16, 2021
Actual (reported)Last Updated
March 1, 2023
Results First Posted
March 1, 2023
Record last verified: 2023-01
No individual participant data will be shared
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Source: ClinicalTrials.gov.
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