Study Demonstrates Lack of Efficacy of Hydroxychloroquine

Hackensack Meridian Health, New Jersey’s largest and most comprehensive health network, has utilized its large observational database of more than 3,000 hospitalized COVID-19 patients to show that the touted malaria treatment, hydroxychloroquine, does not improve survival for hospitalized patients. However, another drug, tocilizumab, appears to improve survival among critically ill intensive care unit (ICU) patients.  If confirmed, tocilizumab would become the first medication improving survival from COVID-19.

These major findings were released 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 the Hackensack Meridian Health researchers believe 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.

“I am so proud of our Hackensack Meridian Health clinical and research teams who are helping to tackle this unprecedented global challenge,” said Robert C. Garrett, FACHE, chief executive officer of Hackensack Meridian Health. “This groundbreaking study will help our hospitals, as well as 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 – and Hackensack Meridian Health is participating in those randomized trials as well.”

The outcomes division of the John Theurer Cancer Center (JTCC) 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 Hackensack Meridian Health facilities for urgent care.

“As our country and the world struggles with the adverse health effects and economic consequences of COVID-19, Hackensack Meridian Health realizes it is vital to rapidly learn all we can from the experiences of the patients in our care,” said Stuart Goldberg, M.D., a hematologist/oncologist and chief of the Division of Outcomes and Value Research at the John Theurer Cancer Center at Hackensack University Medical Center in New Jersey.

Results from the study include the following:

  • Among 2,512 hospitalized patients with COVID-19, 76% received at least one dose of hydroxychloroquine and 59% received hydroxychloroquine with azithromycin.
  • After adjusting for imbalances via propensity modeling, compared to receiving no hydroxychloroquine, there was no significant differences in associated mortality for patients receiving any hydroxychloroquine during the hospital stay.
  • Among 547 ICU patients, including 134 receiving tocilizumab in the ICU, an exploratory analysis found a trend towards an improved survival rate: 56% who received the drug compared to 46% who did not receive the therapy, and a propensity adjusted hazard ratio 0.76.

“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,” said Ihor Sawczuk, M.D., FACS, Hackensack Meridian Health regional president, Northern Market and chief research officer. “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. ‘’

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, Ph.D., professor, Department of Biostatistics, The University of Texas MD Anderson Cancer Center and his statistical team at Berry Consultants.

“Being at the epicenter with a large volume of patients and having the benefit of a single electronic health record platform like Epic, Hackensack Meridian has been able to rapidly compile real-world data experience on more than 3,000 patients to assess  the effect of therapeutic interventions being used to treat COVID-19 patients. Our study adds to the emerging data finding no benefit for hydroxychloroquine among hospitalized patients, but now we will turn our database’s attention to exploring if the medication is beneficial earlier in the pre-hospital course,’’ said Andre Goy, M.D., M.S., physician in chief Hackensack Meridian Health Oncology and chairman & chief physician officer, John Theurer Cancer Center.

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

It’s important to note these findings are from an observational study. While randomized clinical trials (RCT) will ultimately determine the efficacy of these drugs, Hackensack Meridian’s real-world observational study offers the first useful early insights into effective treatment strategies.

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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