Intermediate-dose vs Standard Prophylactic Anticoagulation and Statin vs Placebo in ICU Patients With COVID-19

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.

Conditions

• Covid19

Interventions

DRUG

intermediate dose Enoxaparin/ unfractionated heparin

Intermediate dose anticoagulation according to creatinine clearance and weight

DRUG

standard prophylactic dose Enoxaparin/ unfractionated heparin

Standard prophylaxis anticoagulation according to creatinine clearance and weight

DRUG

Atorvastatin 20mg

Statin

DRUG

Matched placebo

Matched placebo to atorvastatin 20 mg

Sponsors & Collaborators

• Brigham and Women's Hospital

  collaborator OTHER

• Tehran Heart Center

  collaborator OTHER

• Masih Daneshvari Hospital

  collaborator OTHER

• Hazrat Rasool Hospital

  collaborator OTHER

• Modarres Hospital

  collaborator OTHER

• Firuzgar hospital affiliated to Iran University of Medical Sciences

  collaborator OTHER

• Imam Khomeini Hospital

  collaborator OTHER

• Sina Hospital, Iran

  collaborator OTHER

• Tabriz University of Medical Sciences

  collaborator OTHER

• Shariati Hospital

  collaborator OTHER

• Imam Ali Hospital

  collaborator UNKNOWN

• Labbafinejhad Hospital

  collaborator OTHER

• Rajaie Cardiovascular Medical and Research Center

  lead OTHER

Principal Investigators

• Parham Sadeghipour, MD · Rajaie Cardiovascular Medical and Research Center

• Behnood Bikdeli, MD, MS · Brigham and Women's Hospital, Harvard Medical School

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-30

Primary Completion

2021-04-04

Completion

2021-07-05

Countries

• Iran

Study Locations