What Should We Know About Blood Products and CONVALESCENT PLASMA Therapy During the Coronavirus Outbreak?

COVID-19, caused by the novel coronavirus (SARS-CoV-2), has drawn particular attention to convalescent (recovered-patient) plasma therapy. Most people who develop COVID-19 acquire immunity to this virus: their bodies can recognize it, and IgG antibodies ready to attack it immediately if it reinfects them are present in plasma, the liquid component of blood outside the cells. People who become infected but cannot develop immunity to the virus die. This information led to the question: "Could plasma from people who have recovered from COVID-19 and developed immunity to coronavirus be used to treat people with active disease?" However, plasma therapy for infectious diseases dates back to the 1880s.

Important Development: On 23 August, the FDA Granted "Authorization" for Convalescent Plasma Therapy!

As part of its ongoing efforts to combat the disease, the US Food and Drug Administration (FDA) issued an "emergency use authorization" for investigational convalescent plasma to treat hospitalized patients with COVID-19. This is not final approval. However, based on available scientific evidence, the FDA concluded, as stated in its decision document, that this product might be effective in treating COVID-19 and that its known and potential benefits outweighed its known and potential risks in COVID-19 treatment.

FDA official Dr. Stephen M. Hahn claims that 35 of every 100 people treated with plasma will be saved. Interestingly, this authorization was based on Mayo Clinic’s observational data. Normally, treatment approval requires comprehensive randomized clinical trials, in which patients are allocated at random. Here, we face FDA authorization without strong evidence.

The data suggest that the earlier convalescent plasma is used—for example, within 3 days of diagnosis—the more helpful it might be. This mechanism also makes sense: the virus plays an active role early in the disease, when neutralization by convalescent plasma antibodies seems more likely. Severe disease develops after an excessive or abnormal immune response to the virus, and, naturally, binding the virus with convalescent plasma at that stage has less influence on disease outcomes. 

History

Convalescent plasma therapy dates back to 1880. In the absence of disease-specific treatment, it returned to attention out of desperation, particularly for Ebola. It promises rapid, passive immunization but also poses many problems. In 1890, physiologists Von Behring and Kitasato used blood plasma (serum) to treat diphtheria. It was initially produced from immunized animals, but whole blood or serum from immune donors was soon identified as a possible source of specific human antibodies. There are several examples of convalescent plasma being used until the 1970s to prevent or treat bacterial infectious diseases such as scarlet fever and whooping cough. Most studies to date reported few cases and therefore may provide only low-quality evidence that cannot represent the population. However, the COVID-19 pandemic has raised hopes for large-scale clinical trials of convalescent plasma therapy.

FDA "Authorization," Not Approval

On 24 March 2020, the US Food and Drug Administration (FDA) updated its rules for experimental treatments during the ongoing COVID-19 outbreak. Under these rules, when a patient’s life was seriously or immediately threatened by COVID-19, the disease caused by the novel coronavirus, "plasma from recovered patients" could be used only in critically ill patients as an experimental intervention. However, it was emphasized that this was only case-by-case, exceptional "authorization," and that, as a COVID-19 treatment, it had not yet been approved. Although the FDA authorized its use in limited circumstances, it believes convalescent plasma may contribute to research into highly effective treatments (for details of this authorization, see here).

Becoming a COVID-19 Convalescent Plasma Donor

If you have had COVID-19 and recovered, your plasma may contain antibodies ready to attack the virus. Your donated plasma could be used in a scientific study to establish conclusively whether this treatment works.

Why Is Convalescent Plasma Being Investigated for COVID-19 Treatment?

There is currently no COVID-19 treatment approved by the FDA or by any other institution leading the development of new treatments worldwide. Convalescent plasma is being investigated for COVID-19 because preliminary findings from earlier studies suggest it might help people recover from COVID-19. Further research is needed to determine whether convalescent plasma can shorten the illness or prevent COVID-19-related death.

Is Convalescent Plasma Safe and Effective Against COVID-19?

It is not yet known whether convalescent plasma will be an effective treatment against COVID-19. Plasma transfusions are generally safe and well tolerated by most patients, but can sometimes cause allergic reactions and other adverse effects. Because there is no approved treatment, the FDA permits convalescent plasma to be tried for COVID-19 only in certain critically ill patients, with authorization obtained for each patient.

I Recently Recovered From COVID-19. Can I Donate Plasma?

Yes. However, COVID-19 convalescent plasma can be collected only from people who have recovered and are eligible to donate blood. Their previous COVID-19 diagnosis must have been documented by a laboratory test, and they must meet other laboratory criteria. Before donating convalescent plasma, individuals must have fully recovered from COVID-19, with complete resolution of symptoms for at least 14 days. You must also be aged 18-60.

Where Should I Apply If I Want to Donate Convalescent Plasma?

You can contact blood centers with an apheresis unit or the Turkish Red Crescent (Kızılay). Apheresis to collect plasma takes an average of 60-80 minutes. Approximately 200-600 ml of plasma is collected using apheresis equipment. Afterward, the donor is monitored for 15 minutes and, with their consent, may be given an appointment for another plasma donation.

What Happens to the Collected Plasma?

After plasma collection, the Turkish Red Crescent assigns barcodes. The barcoded products are stored in a separate cabinet at minus 18-25 degrees or lower and may subsequently be transfused into patients with severe or critical COVID-19.

Can I Catch Coronavirus by Donating Blood?

No. Blood donation is safe. New, sterile needles are always used and discarded afterward.

Is Blood Tested Before It Goes to Recipients?

All donated blood is tested for blood type, hepatitis, HIV, syphilis and other transfusion-transmitted diseases, even if the donor has given blood many times before.

Can I Donate Plasma to Be Tested for Coronavirus?

No. Plasma donation is accepted only from people with a previous test-confirmed COVID-19 infection who have fully recovered. Blood donation centers do not perform coronavirus tests.

Can I Catch Coronavirus If I Receive Blood?

So far, we have discussed plasma donation for COVID-19 treatment. However, other patients continue to need, for conditions other than COVID-19, blood and blood products. There is no evidence that coronaviruses are transmitted through blood transfusion. Predonation screening and questionnaires completed by prospective donors are also designed to prevent donations from people with symptoms of respiratory illness. Moreover, a volunteer with a history of COVID-19 cannot donate blood for ordinary purposes. This should not be confused with convalescent plasma donation, which involves a special type of donor.

Why Is COVID-19 Not Transmitted Through Blood Transfusions?

Viruses need host cells to invade and replicate. Once inside, they use cellular machinery to copy their genetic instructions and create new virus particles called virions, then leave the host cell to repeat the cycle. Viruses rely on binding sites on host cells—proteins that allow attachment and invasion. For the COVID-19 virus, these sites occur in the respiratory tract, particularly the lungs, and in the digestive system. There is no evidence that this novel coronavirus is carried by blood cells such as leukocytes (white blood cells). Leukocytes are also removed by filtration when ordinary blood products are prepared, making them safe.

If Coronavirus Is Not in Blood and Is Not Transmitted Through Blood, How Can a Blood Test Detect It?

Coronavirus blood tests do not screen for the virus itself or its particles. They detect antibodies (IgM and IgG) produced by the immune system against the virus. * - ALL OUR CORONAVIRUS ARTICLES *