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FDA permits emergency use of convalescent plasma in COVID-19 patients

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As the proportion of patients infected with COVID-19 continues to increase in the United States, the Food and Drug Administration has determined that COVID-19 convalescent plasma for use in patients with severe or life-threatening COVID-19 infections Promoting access.

While clinical trials are underway to evaluate the safety and efficacy of administering convalescent plasma to patients with COVID-19, the FDA has provided clinicians with a single-patient emergency investigational new drug application (IND) recovery Permits the use of anaphase plasma. It takes more than a year for a cure to exist and for the vaccine to be available.

This will allow FDA-approved certified physicians to use investigational drugs to treat individual patients. According to this, this does not include the use of COVID-19 convalescent plasma to prevent infection statement Published by the agency on March 24.

“Convalescent plasma containing antibodies to SARS-CoV-2 (the virus that causes COVID-19) may be effective against infection,” the FDA statement said. “The use of convalescent plasma has been studied in other outbreaks Respiratory infections, Including 2009-2010 H1N1 influenza Virus pandemics, the 2003 SARS-CoV-1 epidemic, and the 2012 MERS-CoV epidemic. Although promising, convalescent plasma has not been shown to be effective in all diseases studied. “

“I think the FDA has stepped in the development of the COVID-19 test initially, but is catching up quickly.” Peter J. PitzFrom 2002 to 2004, who served as FDA Vice-Chair, said in an interview. “My attitude is now,” If it’s safe, let’s create a path to see how these work in the real world. ” I think this also applies to treatments that reduce symptoms and shorten the duration of the disease, as well as convalescent plasma, which may replace vaccines that have not yet been developed. “

In Washington University School of Medicine, Seattle, Terry B. Gernsheimer, MD, And her colleagues are recruiting recovered COVID-19 patients to donate plasma to critically ill patients infected with the virus. “Because convalescent plasma is readily available, the idea of ​​using it makes perfect sense and you can try to give it to people,” said a professor of medicine at the School of Medicine. One hematologist, Dr. Garnsheimer, said. “It’s used in China, and a report on their experience with this should come out shortly.”

The incident series that appeared on JAMA on March 27 (Doi: 10.1001 / jama.2020.4783), A Chinese researcher led by Dr. Chenguang Shen reported findings in five severely affected COVID-19 patients Acute respiratory distress syndrome He was transfused with convalescent plasma at the Shenzhen Third People’s Hospital 10 and 22 days after admission. Patients range in age from 36 to 73 years, three are male and all are Mechanical ventilation At the time of treatment.

Shen and colleagues reported that the viral load had decreased and became negative within 12 days of transfusion. Three patients were discharged from the hospital after a 51-55 day stay, and two remained stable 37 days after transfusion. Researchers found that all patients had interferon or Lopinavir / ritonavir“It may also have contributed to the observed virus clearance” during and after the convalescent plasma treatment.

The FDA’s policy on the use of emergency INDs states that COVID-19 convalescent plasma should only be collected from individuals who are eligible to donate blood, perform the necessary tests, and only if the donation proves appropriate. Need to be collected.

Donor candidates are “screened in a way that all blood donors are screened,” Dr. Garnsheimer said. “Nothing is less secure than any unit of plasma on a shelf from a volunteer donor. Transfusion reaction What we have to worry about, [and] There are potentially unknown pathogens that we do not yet know that we have not tested. This is a normal risk found in any unit of plasma. “

She added that it appears that COVID-19 survivors are beginning to raise antibody titers around the 28th. “We are looking for individuals whose infection has been recorded and whose signs have recovered about 28 days before collection,” she said. .

The FDA advises clinicians to address a number of donor eligibility considerations, including laboratory-recorded pre-diagnosis of COVID-19. Completely resolve symptoms at least 14 days before donation. Female donors are negative for HLA antibodies or male donors, and COVID-19 is a negative result from one or more nasopharyngeal swab specimens or molecular diagnostic tests from blood.[AccesstoapartiallistoftestsavailableontheFDA[ApartiallistofavailabletestscanbeaccessedontheFDA[FDAで利用可能なテストの一部リストにアクセスできます[ApartiallistofavailabletestscanbeaccessedontheFDAwebsite. ]Authorities also advise that donors have defined SARS-CoV-2 neutralizing antibody titers if tests can be performed (optimally greater than 1: 320).

Patients who are eligible to receive COVID-19 convalescent plasma must have severe or immediate life-threatening laboratory-confirmed COVID-19 infections. Institutions have difficulty breathing, respiratory frequency of 30 or more breaths per minute, blood oxygen saturation of 93% or less, arterial oxygen partial pressure to inspired oxygen ratio of less than 300, and / or lung infiltration within 50 to 48 hours . A life-threatening disease is defined as respiratory failure, Septic shockAnd / or multiple organ failure or dysfunction. Patients must provide informed consent.

According to Gernsheimer, the potential risk of receiving COVID-19 convalescent plasma remains unknown. “What do some people think is there a viral inflammatory response that we first see in these patients getting worse?” She said. “In my understanding, this has not yet happened in China, but they are not all available, but I’m always worried about whether anything around the infection could cause inflammation. Breathe in the case of a pulmonary infection. So far I haven’t seen it. “

If you need to respond within 4-8 hours with a COVID-19 convalescent plasma authorization request, the requesting clinician can complete it Form 3296 Send by email [email protected]

If a COVID-19 convalescent plasma approval request requires a response of less than 4 hours, or if the clinician cannot fill out and submit Form 3926 due to Situation 3, call the FDA emergency operating room and speak verbally You can ask for approval. -866-300-4374.

The FDA, in collaboration with the National Institutes of Health, the Centers for Disease Control and Prevention, and other government partners, has developed a protocol used by multiple researchers to coordinate the collection and use of COVID-19 convalescent plasma. I am.

“It’s important to capture all patient data so that safety and effectiveness can be understood as quickly as possible with real-world levels as close as possible,” said the President and Center for He is a co-founder of Medicine in the Public Interest and also provides consulting services for the FDA. “I understand that healthcare professionals are overworked and overburdened now. I commend their heroic work, but that doesn’t mean that data collection is easy When I was at the FDA, I helped tackle the SARS epidemic, at which point the institution’s attitude was to “get what might work through the process, unless the cure was worse than the disease. It seems. I think that is the attitude that is taking the initiative today. “

This article was originally published MDedge.com.

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