Status:
COMPLETED
Intermediate-dose vs Standard Prophylactic Anticoagulation and Statin vs Placebo in ICU Patients With COVID-19
Lead Sponsor:
Rajaie Cardiovascular Medical and Research Center
Collaborating Sponsors:
Brigham and Women's Hospital
Tehran Heart Center
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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. ...
Detailed Description
Coronavirus disease-2019 (COVID-19) -- a viral illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) -- has important manifestations outside the pulmonary parenchyma, incl...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Anticoagulation Hypothesis
- Adult patients (≥18 years), with polymerase chain reaction (PCR)-confirmed COVID-19 admitted to ICU within 7 days of initial hospitalization , who do not have another firm indication for anticoagulation (such as mechanical valve, high-risk atrial fibrillation (AF), VTE, or left ventricle (LV) thrombus),who are not enrolled in another blinded randomized trial, and are willing to participate in the study and provide informed consent .
- Estimated survival of at least 24 hours at the discretion of enrolling physician
- Exclusion Criteria for Anticoagulation Hypothesis
- Weight \<40 Kilogram (kg)
- Overt bleeding at the day of enrollment
- Known major bleeding within 30 days (according to the Bleeding Academic Research Consortium (BARC) definition, Appendix A)
- Platelet count \<50,000/Fl
- Pregnancy (as confirmed by Beta human chorionic gonadotropin (HCG) testing among female patients \<50 years)
- Patients on Extracorporeal Membrane Oxygenation (ECMO)
- History of heparin induced thrombocytopenia or immune thrombocytopenia
- Ischemic stroke within the past 2 weeks
- Craniotomy/major neurosurgery within the past 3 months
- Major head or spinal trauma in the past 30 days
- Known brain metastases or vascular malformations (aneurysm)
- Presence of an epidural, spinal or pericardial catheter
- Major surgery other than neurosurgery within 14 days prior to enrollment
- Coexistence of severe obesity (weight \>120 kg or BMI\>35 kg/m2 along with severe renal insufficiency defined as creatinine clearance (CrCl) \<30 mL/sec)
- Allergic reaction to study medications
- Lack or withdrawal of informed consent
- Inclusion Criteria for the Statin Randomization
- Patients enrolled for the anticoagulation randomization
- Willingness to participation in the study and providing informed consent
- Exclusions Criteria for the Statin Randomization
- Baseline liver function tests\> 3 times upper normal limits (ULN) or creatine kinase (CK) \>500 U/L
- Active liver disease (LFT\>3 ULN plus histologic finding including cirrhosis or inflammation or necrosis)
- Routine use of statins prior to the index hospitalization
- Previous documented statin intolerance
Exclusion
Key Trial Info
Start Date :
July 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 5 2021
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04486508
Start Date
July 30 2020
End Date
July 5 2021
Last Update
August 17 2021
Active Locations (1)
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1
Masih Daneshvari Hospital
Tehran, Iran, 199691110