In an effort to help patients with serious or immediately life-threatening illness associated with coronavirus disease 2019 (COVID-19), the Food and Drug Administration (FDA) is facilitating access to COVID-19 convalescent plasma through the process of single patient emergency Investigational New Drug Applications (IND).
Convalescent plasma, which is collected from patients who have recovered from COVID-19, contains antibodies to SARS-CoV-2, the virus that causes the disease. This type of therapy has been investigated before during other respiratory infection outbreaks such as the 2009-2010 H1N1 influenza virus pandemic and the 2003 SARS-CoV-1 epidemic, however, the Agency noted it has not been shown to be effective in every disease studied.
Under a single patient emergency IND, COVID-19 convalescent plasma must only be collected from recovered individuals if they are eligible to donate blood; required testing must be performed and the donation must be found suitable. According to the FDA, the following should be considered when evaluating donor eligibility:
- Prior laboratory-documented diagnosis of COVID-19
- Complete resolution of symptoms at least 14 days before donation
- Female donors negative for HLA antibodies or male donors
- Negative for COVID-19 based on 1 or more tests
- Defined SARS-CoV-2 neutralizing antibody titers (optimally >1:320), if testing can be conducted
In addition, the container with the COVID-19 convalescent plasma must be labeled with the statement: “Caution: New Drug—Limited by Federal (or US) law to investigational use.”
Patients who are eligible to receive the convalescent plasma include those with lab confirmed COVID-19 who have severe or immediately life-threatening disease (ie, severe dyspnea, respiratory failure, septic shock and/or multiple organ dysfunction or failure); informed consent must be provided for eligibility.
More information on how to obtain authorization from the FDA can be found here.