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Anticoagulation in Patients Suffering From COVID-19 Disease The ANTI-CO Trial

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ClinicalTrials.gov Identifier: NCT04445935
Recruitment Status : Recruiting
First Posted : June 24, 2020
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Marcus Daniel Lance, Hamad Medical Corporation

Brief Summary:

Patients with COVID-19 associated ARDS and mechanical ventilation have a high mortality. Part of the disease is an activation of the coagulation system which seems to contribute to clotformation in the pulmonary bloodstream. Recently we implemented an algorithm applying higher doses of heparins (LMWH). However, this approach could not inhibit clotformation enough. Bivalirudin could prevent clotformation better and support dissolving existing clots.

Therefore, we want to compare 50 patients with the standard treatment with 50 patients under bivalirudin treatment which we normally apply in patients with a HIT-syndrome.

Our primary outcome measure is oxygenation reflected as P/F ratio.


Condition or disease Intervention/treatment Phase
Anticoagulation in COVID-19 ARDS Drug: Bivalirudin Injection Drug: Standard treatment Phase 4

Detailed Description:

The pandemic of COVID-19, a newly upcoming viral disease caused by SARS-CoV-2, puts the whole worlds health system under pressure.

Patients suffering from this disease mainly develop respiratory symptoms, which can lead to severe acute respiratory distress syndrome (ARDS) necessitating ICU admission in 10-20% of the cases admitted to hospital. In addition to these symptoms, patients show lymphopenia, cardiac symptoms and altered coagulation profiles. Although those patients are treated in the ICU the mortality there is more than 20% due to multiorgan failure.

One of the recent insights in this disease is its effect on the coagulation system. Meanwhile we know that the coagulation system gets activated. Furthermore, it seems that clot formation takes place in the pulmonary micro-vasculature which could contribute to the widely observed gas-exchange impairment. Therefore, many centers apply empiric anticoagulation for their COVID-patients. At the moment, we at HMC, also apply an empirical anticoagulation protocol as our standard approach. However, this is a symptomatic treatment without good proof.

Bivalirudin is a well-known agent which is used in HMC for cases in which anticoagulation is needed, but a contraindication for heparin exists (i.e. HIT syndrome). This drug has an interesting pharmacologic profile. It acts independent of antithrombin (AT), the physiological compound which enhances heparin effects under normal circumstances. This lack of dependence on AT, makes Bivalirudin an attractive choice in light of the contradictory reports on the levels of AT during COVID infection. If AT levels are decreased during the infection, heparin (as well as LMWH) cannot work efficiently, which would render our treatment less effective. Luckily, bivalirudin acts without the support of AT, so we could bypass this problem. In addition, bivalirudin has some fibrinolytic activities. It inhibits clot-bound thrombin which as a result destabilizes the clot rendering it more susceptible to thrombolysis. This property partially supports the dissolving of clots and could support re-opening the pulmonary microcirculation.

Objectives:

To prove the positive effect of anticoagulation with bivalirudin intravenously on gas-exchange in patients with COVID-19 and respiratory failure on invasive mechanical ventilation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a randomized controlled trial.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: This study will be blinded to the above mentioned group. The PI is not involved in active treatment. Patients are sedated and ventilated when treatment starts and finally the outcome assessors will not be knowing the patients treatment.
Primary Purpose: Supportive Care
Official Title: Anticoagulation in Patients Suffering From COVID-19 Disease-The Anti-Co Trial
Estimated Study Start Date : June 28, 2020
Estimated Primary Completion Date : September 28, 2020
Estimated Study Completion Date : March 28, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Bivalirudin

Arm Intervention/treatment
Active Comparator: Standard treatment

In this arm the patients will be treated according to our standard anticoagulation protocol.

The patients will not be treated with Bivalirudin (the investigational drug).

Drug: Standard treatment
This group will receive standard anticoagulation with LMWH/UFH

Experimental: Bivalirudin arm
The patients will be anticoagulated according to the institutional HIT-protocol which uses Bivalirudin as anticoagulant.
Drug: Bivalirudin Injection
The patients will receive iv Bivalirudin according to the institutional HIT protocol.
Other Name: anticoagulation




Primary Outcome Measures :
  1. P/F ratio [ Time Frame: three days of intervention ]
    the P/F ratio is a surrogate parameter for oxygenation in ARDS.


Secondary Outcome Measures :
  1. Kidney function [ Time Frame: three days of intervention ]
    The kidney function frequently is deteriorated in COVID-19 patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patient (≥ 18 years of age)
  • Positive COVID-test
  • Under mechanical ventilation
  • D-Dimers>1.2 mg/L

Exclusion Criteria:

  • Pregnancy
  • Allergy to the drug (bivalirudin)
  • Inherited coagulation abnormalities
  • No informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04445935


Contacts
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Contact: Marcus Lance, MD, PhD 00974 ext 33530292 mlance@hamad.qa
Contact: Stefan Roehrig, MD, MBA 00974 ext 66030924 srohrig@hamad.qa

Locations
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Qatar
Hamad Medical Corporation Recruiting
Doha, Qatar
Contact: Nadir Kharma, MD    00974 ext 55118621    nkharma@hamad.qa   
Sponsors and Collaborators
Hamad Medical Corporation
Investigators
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Principal Investigator: Marcus Lance, MD, PhD HMC
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Marcus Daniel Lance, Professor Dr. Marcus Lance, Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT04445935    
Other Study ID Numbers: MRC-05-082
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: this will depend on IRB advice

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dr. Marcus Daniel Lance, Hamad Medical Corporation:
COVID-19
ARDS
Anticoagulation
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms
Bivalirudin
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants