AABB Releases New Guidelines for Therapeutic Use of CCP

August 17, 2022

AABB has released new clinical practice guidelines for the use of COVID-19 convalescent plasma (CCP) as a treatment for patients with COVID-19. The guidelines were published this week in Annals of Internal Medicine.

The guidelines, written by a committee of experts convened by AABB, were developed after a thorough review of available data regarding CCP and reflect the most up-to-date scientific understanding of CCP’s use as a therapeutic option. The new guidelines replace AABB’s interim guidelines for CCP use, originally published in March 2021.

The new guidelines stress that CCP is “most effective when transfused with high neutralizing titers to infected patients early after symptom onset.”

The Need for Guidelines

CCP has been used as a treatment option for patients with COVID-19 since the early months of the pandemic. Following the FDA’s approval of CCP as a treatment option and the establishment of the Expanded Access Program, more than 100,000 units of CCP were distributed to U.S. hospitals every month during the fall of 2020 and winter of 2021. However, during this time, there were limited data on CCP’s efficacy and recommendations for its use were largely based on the consensus of experts.

The AABB Board of Directors recognized a need for clinical practice guidelines based on currently available scientific data. The Board commissioned a committee of experts to conduct an analysis of current data and draft clinical practice guidelines for CCP.

The committee conducted a formal systematic review and meta-analysis of the 33 randomized trials assessing CCP that have been published to date. This analysis represents data assessing more than 22,000 patients. The committee used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) method to formulate the guidelines based on their review of the available data.

Recommendations

The new guidelines comprise five central recommendations regarding CCP as a therapeutic option for patients with COVID-19:

CCP transfusion, in addition to the usual standard of care, can be considered as a potential treatment option for outpatients with COVID-19 who are at high risk for disease progression.
CCP transfusion should not be used as a treatment option for unselected hospitalized persons with moderate or severe disease. (This recommendation does not apply to immunosuppressed patients or those who lack antibodies against SARS-CoV-2.)
CCP transfusion, in addition to the usual standard of care, can be considered as a potential treatment option for hospitalized patients with COVID-19 who do not have SARS-CoV-2 antibodies detected at admission.

CCP transfusion, in addition to the usual standard of care, can be considered as a potential treatment option for hospitalized patients with COVID-19 and preexisting immunosuppression.
Prophylactic CCP transfusion is not recommended for uninfected persons with close contact exposure to a person with COVID-19.

The recommendations stress that CCP is likely to be most beneficial as a therapeutic option when administered early following the onset of symptoms. “The beneficial effects of CCP are primarily associated with its neutralizing antibodies, which target SARS-CoV-2 and assist in viral clearance,” the committee wrote in the guidelines. “Thus, persons who benefit the most from CCP are those treated early and who have not yet developed their own neutralizing antibodies.”

Expanding Scientific Knowledge

Aaron Tobian, MD, PhD, professor of pathology, medicine and epidemiology at The Johns Hopkins University School of Medicine and Bloomberg School of Public Health; director of transfusion medicine and vice chair for clinical affairs in pathology at Johns Hopkins Hospital; vice president of AABB; and member of the committee that developed the guidelines, said it was important to publish the CCP guidelines now, since randomized trial data are now available and the scientific understanding of CCP has expanded.

“AABB follows the highest standards to draft clinical practice guidelines,” Tobian said. “One of the most important steps is to understand available data. Reviewing all randomized trials of CCP allowed the committee to assess the full scope of scientific data regarding CCP and make appropriate guidelines.”

Tobian added that even as the pandemic is entering new phases, CCP remains an important therapeutic option for many patients. “As the COVID-19 pandemic continues and new variants of concern emerge, it is important to make sure all potential therapeutic options are available, especially for some of the most vulnerable patient populations,” he said.

Tobian added that these guidelines may also be useful in guiding treatment options in the future – for COVID-19 or other potential emerging infectious diseases. “Convalescent plasma is relatively easy to obtain and often one of the first therapeutics available for emerging infections,” he said. “The key principles put forth in the guidelines will be important to incorporate during the current evolving pandemic and, potentially, future epidemics.”