Plasma & Monoclonal Antibody Treatments / FAQs
What antibody treatments exist?
You will hear about antibodies is relation to the following treatments:
Monoclonal antibody treatments
Direct transfusion with COVID convalescent plasma (CCP)
Hyperimmune globulin (HIG)
What are monoclonal antibodies (mAbs)?
Monoclonal antibodies (mAbs) are antibodies that are made in laboratories and help the body fight specific diseases. Treatments have received EUA and have been shown to decrease hospitalizations and improve outcomes for patients in high risk categories. They serve as substitute antibodies when the body is not making its own. They mimic the immune system’s ability to fight off harmful disease-causing agents such as the virus that causes COVID-19.
Monoclonal antibody treatment is now available around the country. It is given to newly diagnosed patients who have not been hospitalized.
The immune system detects and destroys viruses such as the one that causes COVID-19, SARS-CoV-2. One way the body's immune system attacks a virus is by making large numbers of antibodies. These antibodies stick to a specific disease-causing protein or molecule called an antigen. Once attached, antibodies can force other parts of the immune system to destroy the cells containing the antigen.
The term monoclonal antibody means that a man-made antibody is cloned and targets a specific antigen. (Polyclonal antibodies are synthesized from different immune cells and the antibodies produced bind to multiple antigens.)
The companies, Regeneron and Eli Lilly received Emergency Use Authorization for their monoclonal antibody treatments. These drugs are designed to block viral attachment and entry into human cells, thus neutralizing the virus that causes COVID-19.
These and 11 other experimental monoclonal antibody treatments are undergoing human testing, with at least another 150 other antibodies in discovery research. Read more about them by clicking here.
Read more information from HHS.
Hay información disponible sobre anticuerpos monoclonales.
Información para médicos.
Who can receive monoclonal antibody treatment (as of Nov. 25, 2020)?
General Patient Eligibility Requirements for Monoclonal Treatments:
POSITIVE direct viral test for SARS-CoV-2 (Antigen or PCR, rapid or non-rapid)
Within 10 DAYS of symptom onset
12 years of age or older, weighing at least 40 kg (88 pounds) who are at HIGH RISK for progressing to severe COVID-19 requiring hospitalization
HIGH RISK DEFINED BY A MINIMUM OF ONE OF THE FOLLOWING:
65 years of age or older, or
BMI ≥ 35 (obesity), or
Diabetes Mellitus, or
Diagnosed with an Immunosuppressive Disease (a weakened immune system), or
On current immunosuppressive therapy, or
55-64 years of age AND have Cardiovascular Disease or hypertension or COPD or other Chronic Respiratory Disease, or
12 – 17 years of age AND have
BMI ≥ 85th percentile for their age and gender based on CDC growth charts (obesity), OR
sickle cell disease, OR
congenital or acquired heart disease, OR
neurodevelopmental disorders (e.g. cerebral palsy), OR
medical-related technological dependence (e.g: tracheostomy, gastrostomy, positive pressure ventilation -not related to COVID-19), OR
asthma, reactive airway or other chronic respiratory disease that requires daily medication.
The treatment is NOT authorized for patients:
who are hospitalized due to COVID-19, or
who require oxygen therapy due to COVID-19, or
who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
Where and how can I get treatment?
If I don’t qualify for treatment, what can I do?
If you do not qualify for treatment , consider joining a Clinical Trial.
To find out about mAb clinical trials, visit www.riseabovecovid.org, OR
Eli Lilly clinical trials: trials.lillytrialguide.com / blaze2study.com/ , OR
Regeneron clinical trials: https://www.regeneron.com/covid19.
Which Monoclonal Antibodies have been approved for Emergency Use?
Casirivimab and Imdevimab
Regeneron's product consists of two monoclonal antibodies that target different spike proteins. Casirivimab and Imdevimab are administered together by intravenous (IV) infusion for the treatment of mild to moderate COVID-19 in adults and pediatric patients. It is recommended that this treatment be administered as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset.
More detailed information on this treatment is available here.
Doctor Fact Sheet Patient Fact Sheet.
La información en español está disponible aquí.
Bamlanivimab and Etesevimab
Eli Lilly's product consists of two antibodies that target a spike protein. Emergency use has been authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients. The treatment is administered by intravenous (IV) infusion. It is recommended that this treatment be administered as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset. Eli Lilly's bamlanivimab is no longer given alone, but instead in combination with etesevimab. The combination has been shown to be more effective against variants.
More detailed information on this treatment is available here.
Doctor Fact Sheet Patient Fact Sheet.
La información en español está disponible aquí.
You can read more about the different treatments at:
Is there someone I can call to ask more questions?
Providers or patients in need of assistance locating an infusion site or connecting with a clinical trial, can call the ASPR Monoclonal Antibody Therapy Call Center. English: 877-332-6585 Spanish: 877-366-0310.
Does antibody therapy protect against viral variants?
Certain circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies. Due to the overall increase in variants resistant to bamlanivimab alone, starting March 24, 2021, bamlanivimab will be paired with etesevimab for infusion treatment, which has been shown to be more effective. Casirivimab and Imdevimab are also being used. Updated EUAs are available from the FDA. Facilities that received bamlanivimab doses should request etesevimab doses for co-infusion from the US government.
COVID variants are evident in the USA and are tracked through genetic sequencing (state variant rates). Although sequencing information is helpful on a population level, individual patient results are not told to the provider, submitting laboratory or patient. Whole genome sequencing is not currently approved for use as a diagnostic test to make individual patient treatment decisions. In addition, the lengthy turnaround time for this type of testing means it is unsuitable for treatment decisions involving mAbs, which should be given as soon as possible once a patient has developed symptoms and tests positive. Antibody treatments, given early, remain the only option for newly diagnosed , non-hospitalized, COVID-19 patients. Looking to the future, the US governments announced in April a new 1.5 billion dollar initiative to increase the country’s ability to genetically sequence tests.
How are monoclonal antibody treatments given to a patient?
Monoclonal antibody treatment is given by infusion. Since many infusion centers often treat other patients with compromised immune systems, great care must be taken by centers to ensure that patients who have COVID-19 do not come into contact with other immunocompromised patients, such as those with cancer. Infusions may be administered only in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as allergic reactions, and the ability to activate the emergency medical system, as necessary. These requirements limit the number of locations able to provide mAbs to COVID patients.
If a hospital cannot meet these requirements, they will not offer this treatment. If a hospital receives a shipment of mAb and cannot safely distribute it, these doses will be given to another institution that can use them.
Can monoclonal antibodies be used to prevent COVID-19?
No. These drugs are not authorized to be used to prevent COVID-19.
If I receive a monoclonal antibody treatment, do I still need to mask and practice social distancing?
Yes! Every day and every way. Please don't put someone else's health at risk for your own comfort.
Where can I find out more about the history of and science behind monoclonal antibodies?
For some great info, visit here and here. There’s also some great discussion at this link.
What is COVID convalescent plasma (CCP) treatment?
CCP is plasma taken from a person who has recovered from COVID-19. When you have the disease, your body creates antibodies to fight off the illness. These antibodies are in your blood plasma. When antibody-rich plasma from one person is put into another person, it can kick start their immune response and help them to recover.
Talk to your doctor about treatment with CCP. CCP is available to people who are hospitalized with COVID-19, and the latest research shows the treatment to be most effective when given as early as possible.
On September 1, 2020 the FDA issued an Emergency Use Authorization (EUA) for the use of COVID convalescent plasma as a treatment for patients hospitalized with COVID-19. Information for physicians interested in obtaining plasma for their patients is available, here. Additional information for patients and families is available, here. Your physician should work with their affiliated blood collection center or hospital to obtain plasma.
You may also gain access to convalescent plasma by enrolling in a clinical trial that will continue to track the safety and effectiveness of CCP treatments. Patients are being recruited to participate in these studies at many different medical facilities. To receive plasma treatment, you must either enter a controlled medical trial or receive permission through an Emergency Use Authorization. Trials and more information are listed here.
For more information about antibodies and plasma see our other FAQ listings.
Aprender sobre las opciones de tratamiento de covid.
What is hyperimmune globulin (HIG)?
Hyperimmune globulin (HIG) is a concentrated product manufactured from thousands of units of convalescent plasma from thousands of donors. An unprecedented partnership of industry leaders are working together to quickly and safely develop, test and produce this plasma derived treatment, which concentrates antibodies in plasma into a medicine. Equitable distribution and wide access to HIG are a priority. At this time, access to HIG is only possible through limited clinical trials. Learn more about HIG here.
Are other treatment options available for COVID-19?
Other treatments are being used to treat COVID, and even more are being studied. At this time the treatments below are being used to treat COVID in a hospital setting or under the caAprender sobre las opciones de tratamiento de covid.re of a physician. In addition the FDA has issued an Emergency Use Authorization for the use of the gammaCore Sapphire CV vagus nerve stimulation device for acute use at home or in a healthcare setting to treat adult COVID patients who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief. More information is available, here.
Additional information about treatments is available, here.
