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Use of novel antithrombotic agents for COVID-19: Systematic summary of ongoing randomized controlled trials
Azita H Talasaz1,2,3, Parham Sadeghipour4, Maryam Aghakouchakzadeh1
1Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
Insights
Novel antithrombotic agents are being investigated for treating COVID-19 associated thrombosis. Ongoing trials will determine if these new drugs offer benefits beyond conventional treatments for coronavirus disease 2019.
Area of Science:
- Cardiovascular Medicine
- Infectious Diseases
- Pharmacology
Background:
- COVID-19 is linked to thrombosis due to endothelial dysfunction, coagulopathy, and inflammation.
- Conventional antithrombotic therapies have shown limited benefit in preliminary studies for COVID-19 patients.
Purpose of the Study:
- To assess ongoing randomized controlled trials (RCTs) of novel antithrombotic agents for COVID-19 management.
- To explore the potential mechanisms of action for these novel agents.
Main Methods:
- Systematic search of clinicaltrials.gov and WHO International Clinical Trials Registry Platform.
- Identification of RCTs evaluating novel antithrombotic agents in COVID-19 patients.
Main Results:
- 27 RCTs involving 10 novel antithrombotic agents were identified.
- Agents target coagulation cascade, endothelial activation, or have mixed mechanisms.
- Trial results are not yet disseminated.
Conclusions:
- Novel agents may possess anti-inflammatory and antiviral properties beneficial for COVID-19.
- Further RCT results are needed to establish their clinical role in managing COVID-19.
Background:
Coronavirus disease 2019 (COVID-19) is associated with macro- and micro-thromboses, which are triggered by endothelial cell activation, coagulopathy, and uncontrolled inflammatory response. Conventional antithrombotic agents are under assessment in dozens of randomized controlled trials (RCTs) in patients with COVID-19, with preliminary results not demonstrating benefit in several studies.
Objectives:
Given the possibility that more novel agents with antithrombotic effects may have a potential utility for management of patients with COVID-19, we assessed ongoing RCTs including these agents with their potential mechanism of action in this population.
Methods:
We searched clinicaltrials.gov and the World Health Organization International Clinical Trials Registry Platform to identify RCTs of novel antithrombotic agents in patients with COVID-19.
Results:
Based on a systematic literature search, 27 RCTs with 10 novel antithrombotic agents (including nafamostat, dociparstat, rNAPc2, and defibrotide) were identified. The results from these trials have not been disseminated yet. The studied drugs in the ongoing or completed RCTs include agents affecting the coagulation cascade, drugs affecting endothelial activation, and mixed acting agents. Their postulated antithrombotic mechanisms of action and their potential impact on patient management are summarized.
Conclusion:
Some novel antithrombotic agents have pleiotropic anti-inflammatory and antiviral effects, which may help reduce the viral load or fibrosis, and improve oxygenation. Results from ongoing RCTs will elucidate their actual role in the management of patients with COVID-19.
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