Regulatory Issues

Regulatory Issues In Use Of Convalescent Plasma

Date of posting: June 24, 2020

There are currently three options for use of convalescent plasma available in the US: IND, EAP, and clinical trials. 

Investigational New Drug (IND) 

On March 24th, the FDA issued a single-patient experimental IND (eIND) for case-by-case use of convalescent plasma in very sick patients with COVID-19. The FDA IND site provides guidance and FAQ for use of convalescent plasma via IND.

Expanded Access Program (EAP) 

On April 3rd, the FDA teamed up with Mayo Clinic to create the Expanded Access Program (EAP). The EAP permits the use of convalescent plasma in patients without having to fill out forms on a case-by-case basis. The EAP also acts as a registry of patients receiving treatment. As of June 16, 2020, 8,422 physicians have infused 31,541 patients with convalescent plasma under the EAP. Protocols, enrollment information, and more can be found on the US COVID Plasma/Mayo Clinic website. The criteria for enrollment in the EAP were that the patient was either severely ill or capable of becoming severely ill.

CCPP19 investigators are now developing a Treatment-Control Study in connection to the EAP to match patients with COVID-19 treated with convalescent plasma to untreated patients on risk characteristics, in an attempt to better understand the impact on mortality and improvement of respiratory status of convalescent plasma.

Clinical Trials 

The FDA has approved number of clinical trials investigating convalescent plasma. Trials cover a range of circumstances from providing convalescent plasma to uninfected people at high risk all the way to patients in intensive care units. An updated list of clinical trials occurring in the US can be found on our Clinical Trials page. We try to obtain template consent forms and protocols from each trial for those interested in starting a new trial . We also include contact information for investigators willing to collaborate as well as potential trial participants. The FDA requires investigators who plan to do randomized or other trials to submit requests for investigational use under the traditional IND pathway (21 CFR 312).

 

Antibody Detection

The FDA has licensed a number of antibody tests. Many scientists at universities and research institutions are developing additional tests which may be used in research, but not in clinical practice until licensed by the FDA. Current scientific opinion favors plasma donors with high antibody titers to the SARS-coronavirus-2 spike protein and/or its receptor binding domain, which may correspond with viral neutralization.

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