HMH observational study: Tocilizumab appears to improve survival among COVID-19 patients in ICU

Officials at Hackensack Meridian Health have found that the drug tocilizumab appears to improve survival among critically ill intensive care unit patients suffering from COVID-19, the health system reported Wednesday.

The data was gleaned from an observational study of more than 3,000 hospitalized COVID-19 patients.

Among 547 ICU patients, including 134 receiving tocilizumab in the ICU, HMH officials said an exploratory analysis found a trend toward an improved survival rate: 56% who received the drug, compared with 46% who did not receive the therapy, and a propensity-adjusted hazard ratio of 0.76, HMH officials said.

The observational study also showed there was no significant difference in associated mortality for patients receiving any hydroxychloroquine during the hospital stay. Of 2,512 hospitalized patients with COVID-19, 76% received at least one dose of hydroxychloroquine and 59% received hydroxychloroquine with azithromycin.

HMH officials stressed it is important to note these findings are from an observational study. And, while randomized clinical trials will ultimately determine the efficacy of these drugs, HMH officials feel its real-world observational study offers the first useful early insights into effective treatment strategies.

If confirmed, tocilizumab would become the first medication improving survival from COVID-19.

The findings were released Wednesday on the online platform medRxiv, which allow researchers to share critical scientific information rapidly prior to publication in peer-reviewed journals. Given the potential lifesaving findings of tocilizumab, HMH researchers said they believed that sharing this information rapidly is important.

The results are based on the new data analysis platform — the HMH Universal Observational Database for COVID-19, or RECOVERY, which compiles outcomes from 13 Hackensack Meridian Health hospitals throughout New Jersey. This database enhances the understanding of this disease and helps rapidly identify effective therapies.

HMH CEO Bob Garrett said he feels the study will help hospitals throughout the world better understand the effectiveness of certain forms of treatment and the impact of certain risk factors.

“Our researchers’ observations that tocilizumab may improve survival among the most critically ill could alter the course of the pandemic if confirmed in randomized trials,” he said.

Garrett said HMH is participating in those randomized trials.

Dr. Ihor Sawczuk, HMH’s Northern Market regional president and chief research officer, said the importance of real-time data cannot be overstated.

“We are in the midst of a global pandemic, and it is critical that we have the necessary data available for our medical professionals on the front lines of the COVID-19 crisis,” he said, “In the absence of randomized clinical trials, we must learn as much as we can in real time as we battle this deadly virus. The finding that tocilizumab may be a life-saving therapy in this observational study is an important application of real-world studies. ‘’

The outcomes division of the John Theurer Cancer Center at Hackensack University Medical Center, under the leadership of Dr. Stuart Goldberg and Dr. Andrew Ip, created a database to guide the analysis of more than 3,000 patients admitted to HMH facilities for urgent care.

Using a national leader in real-world evidence analysis to assist, COTA Inc., the Hackensack Meridian JTCC team conducted propensity modeling to assess for potential effective therapeutic interventions. The data and statistical analysis were enhanced by Donald A. Berry, professor, Department of Biostatistics, the University of Texas MD Anderson Cancer Center, and his statistical team at Berry Consultants.

Researchers established an observational database through Epic — Hackensack Meridian’s electronic health records system — and collected a random sampling of COVID-19 patients who received treatment at one of 13 hospitals across the network.

Hackensack Meridian Health has been at the epicenter of the evolving COVID-19 crisis in New Jersey. To date, the network has cared for more than 10,000 patients with confirmed COVID-19 infections and has discharged more than 6,000 patients from network hospitals.

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