Health Care Providers

Is Treatment With Convalescent Plasma Right For Your Patient?

The COMPILE statistics team (members of the Division of Biostatistics at the Department of Population Health, and New York University Grossman School of Medicine) built a COVID-19 Convalescent Plasma treatment index tool to guide treatment decisions. The tool can be found here. 

Multiple studies have now shown that CCP can reduce mortality and/or improve the outcomes of patients with COVID-19. However, to date, the characteristics of patients who are most likely to benefit from CCP were not known. This gap is now filled by the Treatment Benefit Index (TBI), a decision-making tool that calculates the likelihood that a hospitalized patient with COVID-19 will benefit from CCP. The TBI was developed from data from more than 2000 participants in 8 randomized controlled trials of hospitalized patients with COVID-19 who required oxygen supplementation, but not mechanical ventilation. It uses a patient’s age, underlying clinical conditions (diabetes, heart disease, pulmonary disease) that associate with COVID-19 severity, and oxygen requirement to determine if they are likely to benefit from CCP treatment, and if so to what degree. Given that it uses information that is readily available upon admission to the hospital, the TBI provides clinicians with a powerful tool to rapidly identify patients who will benefit the most from CCP treatment.

Evaluating Convalescent Plasma Treatment

While we are committed to helping link donors who can provide convalescent plasma to providers who can use it, we are also committed to the idea that we can learn how and whether convalescent plasma works by evaluating each and every treated patient. It is tempting, in the middle of this epidemic, to just treat and hope for the best. But we owe it to our patients, now more than ever, to make sure that what we are doing is in their best interest. And if we do not have a system for evaluating the treatment, we are not doing that.

Evaluating Convalescent Plasma Treatment

• Component 1: Rapid Evaluation Program
• Treatment-Control Study
• Component 3: Clinical Trials
• Weighing the Evidence
• Antibody in Plasma

Other Issues for Providers

• Virology
• Linking Donors to Providers
• Regulatory Issues
• Endorsements
• International Use of CCP

Randomized controlled trials are the most secure way of finding out whether a new medical treatment works. But we know that while those trials are being mounted, people will be treated outside of trials. The knowledge we can gain from those treatment experiences should not be wasted.

We have therefore divided the evaluation process for learning whether and how COVID-19 convalescent plasma works into three components:

• • Component 1, the Rapid Evaluation Program, was an attempt to get a first simple look at the major outcomes of treatment – quite simply, whether the patient is getting better, worse or staying the same. The Rapid Evaluation Program was an optional extension of the Expanded Access Program (EAP) through the Mayo Clinic. As of August 23, 2020, The Mayo Clinic-led expanded access program has discontinued new physician and new patient enrollments. COVID-19 convalescent plasma remains available through emergency use authorization (EUA). For more information about the EAP to EUA transition, please see the Mayo Clinic US COVID Plasma website. 
  • Treatment-Control study, is an attempt to systematically compare the outcomes of patients enrolled in the Expanded Access Program authorized by the FDA to the outcomes in people with similar levels of illness not treated with convalescent plasma. Enrollment was being undertaken by the Mayo Clinic comparing the treated patients enrolled on their website with an appropriate control group. A team of scientists and data experts is now designing the best way to make this comparison, taking account of any and all key differences between the two populations to make our findings as valid as possible.
    
    
  • Component 3 consists of the several Randomized Controlled Trials, now being mounted in several parts of the country. These trials cover a range of treatment scenarios, from trying to prevent infection in exposed individuals to treatment in intensive care. We hope to be able to keep track of all trials being planned, which, when they are fully developed, will be registered under clinical trials.gov.

EUA Information 

• Clarifying the Emergency Use Authorization Framework for COVID-19 Convalescent Plasma: Considerations for Clinicians
• Updated Evidence to Support the Emergency Use of COVID-19 Convalescent Plasma

Multilingual Resources 

The FDA has a variety of multilingual COVID-19 resources including graphics, videos, flyers, and other helpful materials.