Health Care Providers

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

Other Issues for Providers

Evaluating Convalescent Plasma Treatment

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, is 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. Our system for doing this is right here on our website. Any health care provider can enroll their patient in this system here. Because of the need for speed, we have made this system as simple to use as possible.
      • We collect no identifiers – just age, sex, hospital and level of illness.
      • Our system is HIPAA compliant and not considered human research, rather, public health surveillance. 
      • Enrollment of each patient takes a minute or two and the daily follow up will take only a few seconds and can be completed from the provider’s cellphone.
      • We return the results to the providers who sent them in, providing graphics and tables, as found useful by the provider and institution.
      • We will summarize findings from across the country and place them for open access on our website.
      • We do require password-controlled access to ensure that the treating physician, or his or her designee, are the only people who can enter the follow-up data on a patient.

    • 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. This is 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.

Multilingual Resources 

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