Sarasota, FL (WorkersCompensation.com) – While the majority of hospitalized COVID-19 patients are moderately ill and do not initially require organ support, one of the hallmark side effects of COVID-19 is extensive inflammation as well as blood clots throughout the body, even in the smallest of vessels. Antithrombotics, which include blood thinners or anticoagulants, help prevent blood clots in patients. Researchers studying the effects of COVID-19 theorized that that blood thinners might help the effects of the disease, but were not certain which drug and at what dose would be effective. A landmark worldwide clinical trial set out to answer those questions specifically. The conclusions of the clinical trial, which are supported by the National Institutes of Health, was published earlier this month in the New England Journal of Medicine.
The worldwide study included three clinical trial platforms across five continents in more than 300 hospitals. The study patient population included 1,098 critically ill and 2,219 moderately ill patients. Moderately ill patients were enrolled at 121 sites in 9 countries. All patients, regardless of category, received the blood thinning drug heparin at either a low or full dose for a period of 14 days.
Moderately ill patient were defined as hospitalization for Covid-19 without the need for admittance to an ICU. Critically ill was defined as patients admitted for intensive level of support. While there were some variances in the definition of ICU across the globe, ICU care was defined as including the use of respiratory or cardiovascular organ support including oxygen, and noninvasive or invasive mechanical ventilation. Those patients that were admitted to ICU but did receive organ support were considered to be moderately ill.
Primary outcomes were based on organ support-free days, and were evaluated up to 21 days on a scale the combined in hospital deaths and the number of days without support for cardiovascular or respiratory organs. Secondary efficacy outcomes included survival to discharge, survival without organ support including invasive mechanical ventilation or respiratory support, length of stay, a major vascular event including stroke or embolism, and heart attack or death.
Researchers found that for moderately ill patients, a full dose of heparin was 99 percent more likely to reduce the need for organ support and the need for mechanical ventilation than the traditional lower dose of the drug. In fact, the For critically ill patients, the researchers found that using the same treatment at the same dose did not result in the same outcomes, and in fact could cause further harm.
The full results of the clinical trial are available on the New England Journal of Medicine website.
