Prevention of thrombosis in Covid-19 patients: only a small number of ongoing US trials investigating NOACs in the outpatient setting

The prevention of venous thromboembolism is one of many priorities in managing Covid-19 patients, but there are several complex considerations, especially when examining preventive strategies for those being managed as outpatients. General considerations include the dose of anticoagulant, anticoagulant drug/drug class choice and treatment duration, as well as when and to whom to administer anticoagulation along the disease spectrum.

According to GlobalData’s Pharma Intelligence Center Clinical Trials Database, as of 23 December, there were only two clinical trials in the US investigating the use of novel oral anticoagulants (NOACs) in Covid-19 outpatients with the goal of preventing thrombosis events. Data readouts from these trials have the potential to affect the anticoagulant landscape. If the results are notable, NOACs will have the opportunity 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 whether 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 Pfizer and BMS’ Eliquis (apixaban) and aspirin (in separate treatment arms) in Covid-19 adults who do not require hospitalisation at time of diagnosis.

According to the National Institutes of Health Covid-19 treatment guidelines, which were updated earlier this month, non-hospitalised Covid-19 patients who are being managed as outpatients should not be treated with prophylactic anticoagulants or antiplatelet therapies. As such, NOAC developers have the opportunity to fill the current void in the Covid-19 space. This sentiment was reiterated by a key opinion leader 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, as well as secondary outcome measures looking at time to disease resolution and incidence/number of days of hospitalisation.

Collectively, if these studies find that Xarelto is effective in Covid-19 settings, it could obtain a significant edge over fellow NOAC competitors, including Boehringer Ingelheim’s Pradaxa (dabigatran) and Daiichi-Sankyo’s Savaysa (edoxaban).