Intermediate-dose vs Standard Prophylactic Anticoagulation and Statin vs Placebo in ICU Patients With COVID-19
Status:
Completed
Trial end date:
2021-07-05
Target enrollment:
Participant gender:
Summary
In a 2x2 factorial design randomized controlled trial, the investigators aim to elaborate the
safety and efficacy of two pharmacological regimens on outcomes of critically-ill patients
with COVID-19. The first randomization entails open-label assignment to intermediate versus
standard dose prophylactic anticoagulation. The investigators hypothesize that intermediate
dose compared with standard prophylactic dose anticoagulation will have a superior efficacy
with respect to a composite of venous thromboembolism (VTE), requirement for extracorporeal
membrane oxygenation (ECMO), or all-cause mortality. The second randomization will be
double-blind assignment of the included patients to atorvastatin 20mg daily versus matching
placebo. The hypothesis is that statin therapy, compared with placebo, will reduce the
composite of VTE, need for ECMO, or all-cause mortality.
Phase:
Phase 3
Details
Lead Sponsor:
Rajaie Cardiovascular Medical and Research Center
Collaborators:
Brigham and Women's Hospital Firuzgar hospital affiliated to Iran University of Medical Sciences Hazrat Rasool Hospital Imam Ali Hospital Imam Khomeini Hospital Labbafinejhad Hospital Masih Daneshvari Hospital Modarres Hospital Shariati Hospital Sina Hospital, Iran Tabriz University of Medical Sciences Tehran Heart Center