Two trials show complexity of managing thromboembolism in Covid-19 patients

GlobalData Healthcare 24th December 2020 (Last Updated December 24th, 2020 12:03)

Two trials show complexity of managing thromboembolism in Covid-19 patients
A Phase II ongoing trial sponsored by the Bill and Melinda Gates Foundation, is evaluating Xarelto in COVID-19 patients with mild disease who are at increased risk of disease progression. Credit: Victor Josan/Shutterstock.

Prevention of venous thromboembolism is one of many priorities in managing Covid-19 patients, but there is a number of complex considerations, especially when examining preventive strategies for those managed as outpatients.

General considerations include the dose of anticoagulant, anticoagulant drug/drug class choice, treatment duration, and to whom and when to administer anticoagulation along the disease spectrum. According to GlobalData’s Pharma Intelligence Center clinical trials database on 23 December, there are only two clinical trials in the US that are investigating the use of novel oral anticoagulants (NOACs) in Covid-19 outpatients towards preventing thrombosis events.

Data readouts from these trials have the potential to affect the anticoagulant landscape in the shadow of Covid-19, and if results are telling, provide opportunities for NOAC(s) to be integrated into Covid-19 outpatient management strategies.

The two ongoing US trials identified in GlobalData’s database have indicated that NOACs, specifically factor Xa inhibitors, are being investigated in Covid-19 studies. These include Johnson & Johnson’s PREVENT-HD Phase III trial evaluating if Xarelto (rivaroxaban) reduces the risk of thrombotic events, all-cause hospitalisation and all-cause mortality in outpatients with acute Covid-19 infection, and the University of Pittsburg’s Phase III study evaluating Eliquis (apixaban) and aspirin (separate treatment arms) in Covid-19 adults not requiring hospitalisation at time of diagnosis.

Currently, according to NIH Covid-19 treatment guidelines updated earlier this month, non-hospitalised Covid-19 patients managed as outpatients should not be treated with prophylactic anticoagulant or antiplatelet therapies. As such, NOAC developers have the opportunity to fill the current void in the Covid space, a sentiment reiterated by a KOL interviewed by GlobalData.

In addition to the studies mentioned above, a Phase II ongoing trial sponsored by the Bill and Melinda Gates Foundation is evaluating Xarelto in Covid-19 patients with mild disease who are at increased risk of disease progression. The study is unlike the previous two studies mentioned in that it will specifically involve primary outcome measures looking at adverse events and the proportion of Covid-19 patients with disease progression and secondary outcome measures looking at time to disease resolution and incidence/number of days of hospitalisation.

Collectively, if the studies prove fruitful in Covid-19 settings, it is possible that Xarelto will obtain a significant edge over fellow NOAC competitors, including Pradaxa (dabigatran) and Savaysa (edoxaban).