CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 176 enrolled
Drug / intervention
Intermediate dose thromboprophylaxis +1 moredrug
Likely dose
Intermediate dose thromboprophylaxis 1 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04360824
NCT04360824Phase 4Completed

COVID-19-associated Coagulopathy: Safety and Efficacy of Prophylactic Anticoagulation Therapy in Hospitalized Adults With COVID-19

University of Iowa·interventional·Posted Apr 24, 2020·Updated Mar 1, 2023

In Brief

A Phase 4 clinical trial evaluating Intermediate dose thromboprophylaxis and Standard of Care thromboprophylaxis for COVID 19 Associated Coagulopathy. Completed, enrolled 176 participants across 2 sites.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedApr 24, 2020
Enrollment StartMay 6, 2020
Primary CompletionApr 16, 2021
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 6.2 years ago

Interventions

Intermediate dose thromboprophylaxisdrug

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).

Standard of Care thromboprophylaxisdrug

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).