INTRODUCTION
Convalescent plasma for the treatment of emerging infectious disease has shown to reduce mortality during the 1918 influenza, 2003 SARS, and 2009 influenza H1N1 pandemics. The overall cumulative COVID-19 hospitalization rate is 130 per 100,000, with up to 50% mortality in critically ill patients. In response to the COVID-19 pandemic, the US Food and Drug Administration (FDA) collaborated with the Mayo Clinic to develop a national Expanded Access Program (EAP) for COVID convalescent plasma (CCP). In the early days of the COVID-19 pandemic, when CCP was scarce, the MedStar Health system leveraged a large number of recovered patients enrolled in a donor protocol to ensure adequate CCP and meet the demand across the hospital network, including our community hospitals.
AIM
To work as a hospital system to enroll donors and obtain convalescent plasma across a hospital network of eight hospitals in the Maryland and Washington DC area, including our smaller community hospitals to ensure all patients with COVID -19 infection had access to this resource. Additionally, we worked to treat patients uniformly and track metrics to measure outcomes.
METHODS
Due to the unavailability of CCP at the beginning of the pandemic, a working group from MedStar Washington Hospital Center, the largest hospital in the healthcare system, designed a protocol to systematically screen and send eligible donors to our local blood collection centers.
As each donor can donate two to three units of plasma, we were able to distribute CCP units obtained to all hospitals across our hospital network, which included our smaller community hospitals.
The donor screening protocol was utilized from April 9, 2020, until June 1, 2020, when the CCP became more available from our local blood collector. Dedicated nurse practitioners screened all potential donors that called a dedicated donor line. At the beginning of the pandemic, we worked with our COVID clinic to screen potential donors for PCR negativity and obtain blood types; when deemed eligible, we sent them to AABB accredited local donation centers. All CCP units obtained were returned to our hospital network to be directed by the working group to in-system hospitals. Regular system-wide calls were utilized to monitor COVID admission rates and project demand in our health system.
For the treatment arm, we included patients over 18 years old with laboratory-confirmed SARS-CoV-2 enrolled between April 13, 2020, to June 1, 2020. As a healthcare system, we attempted to treat patients early in their disease course, especially within 14 days of symptoms. When resources were scarce, we aimed to treat patients that appeared to have tangentially worsening symptoms as judged by continued/increasing oxygen requirements and worsening inflammatory markers.
RESULTS
We screened 159 potential donors, and 143 (89.9%) were sent to our local blood collectors to provide between 2 and 4 units of CCP per donation. We started our screening protocol five days before our first CCP transfusion and were able to meet the demand for convalescent plasma until the American Red Cross (ARC) could provide enough CCP for our needs, end of May 2020.
A total of 324 patients were enrolled in the Mayo Expanded Access Program, and 116 patients were excluded: 4 (3%) were transferred to outside hospitals, 27 (23%) died before CCP transfusion (when resources were scarce), 5 (4%) had more than 14 days of symptoms onset, 64 (55%) were discharged before CCP infusion, and 36 patients were waiting for plasma transfusion. 172 patients received convalescent plasma, including 12 patients (6.9%) that received two units of CCP. 114 (66%) discharged. The adjusted 28 day-mortality rate was 23%.
CONCLUSION
The MedStar Health System was able to leverage many potential donors to match the demand for CCP early in the pandemic and provide this scarce resource to the maximum number of patients treated in our network. By designing a donor protocol to obtain the ideal amount of CCP units, we were able to meet demand across a hospital system and treat patients at community hospitals in the network who may not have otherwise had access to this resource.
No relevant conflicts of interest to declare.
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