PATIENT CONSENT FORM FOR COVID-19 TREATMENT PURPOSE OF INFORMED CONSENT
As your physician has discussed with you, you have been diagnosed with COVID-19 (or SARS-CoV-2). At the present time, there are few Food and Drug Administration (FDA) approved, or clinically proven therapies for treatment of COVID-19. As new clinical data emerges, local treatment guidelines have been developed and will be updated as new information becomes available. CDC guidelines reflect what is known about therapies that may work against the SARS-CoV-2 virus, have been used to treat other coronaviruses, or may theoretically target the underlying causes of virus- related severe lung conditions that make breathing difficult.
The FDA has granted Emergency Use Authorization (EUA) to permit investigational therapies in patients with confirmed or suspected COVID-19. Investigational therapies are not approved for any indication. They are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. If checked below and signed, you consent to the use under this authorization.
In order for you to be treated with the therapy by the Pharmacy Team, you must sign this form to show that you agree to the use of investigational or off label treatments, that you have been informed of the benefits and risks of taking such therapies as well as the benefits and risks of declining or refusing such use. The pharmacy team will annotate the monoclonal therapy available below for your encounter and the particular therapy chosen is based upon availability. You will be provided a patient informational handout regards the specific monoclonal antibody infusion before the therapy begins. You have the right to refuse to take this treatment(s) for any reason.
Bebtelovimab is an investigational medicine which are monoclonal antibodies used for the treatment of COVID-19 in non-hospitalized adults and adolescents 12 years of age and older with mild to moderate symptoms who weigh 88 pounds (40 kg) or more, and who are at high risk for developing severe COVID-19 symptoms or the need for hospitalization. The FDA has issued an Emergency Use Authorization (EUA) to permit the use of this unapproved medication. Clinical trials are ongoing to study its safety and efficacy.
It is possible that the medications listed above may help to control your symptoms, slow or stop the growth of the virus, shorten the duration or lessen the severity of the illness in you. Possible benefits primarily include improvement in lung function (ability to breathe without assistance) and normalization of blood pressure. However, there is the possibility that these medications may be of NO direct medical benefit to you. Your condition may get worse.
POSSIBLE RISKS AND KNOWN SIDE EFFECTS
It is possible that the medication prescribed may not improve your symptoms and not shorten the duration nor severity of the illness. It is possible that the medication will unexpectedly interfere with your ability to improve, hasten damage to the lungs or other organs, and shorten your life
Possible side effects of Bebtelovimab are:
• Allergic reactions. Allergic reactions can happen during and after infusion with bebtelovimab. Tell your healthcare provider right away if you get any of the following signs and symptoms of allergic reactions: fever; difficulty breathing; low oxygen level in your blood; chills; tiredness; fast or slow heart rate; chest discomfort or pain; weakness; confusion; nausea; headache; shortness of breath; low or high blood pressure; wheezing; swelling of your lips, face, or throat; rash including hives; itching; muscle aches; dizziness; feeling faint; and sweating.
The side effects of getting any medicine through a vein may include brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site.
These are not all the possible side effects of bebtelovimab. Not many people have been given bebtelovimab.
Serious and unexpected side effects may happen. Bebtelovimab are still being studied, so it is possible that all of the risks are not known at this time.
It is possible that bebtelovimab could interfere with your body’s own ability to fight off a future infection of SARS-CoV-2. Similarly, bebtelovimab may reduce your body’s immune response to a vaccine for SARSCoV-2. Specific studies have not been conducted to address these possible risks. Talk to your healthcare provider if you have any questions.
CERTIFICATION AND SIGNATURES
I have read this informed consent form and all of my questions have been answered to my satisfaction by my physician/pharmacy team. I understand that I have the right to refuse to take this medication(s) for any reason. If I choose not to take this medication(s), this decision will not otherwise affect my status as a patient. I voluntarily consent to take the monoclonal antibody medication by infusionas discussed with my physician, and pharmacy team members as described in this consent form.
The FDA has granted Emergency Use Authorization (EUA) to permit investigational therapies in patients with confirmed or suspected COVID-19. Investigational therapies are not approved for any indication. They are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1),
unless the authorization is terminated or revoked sooner. If checked below and signed, you consent to the use under this authorization.
I have read and had explained to me the benefits versus risk of the above therapy. I am capable of making an informed decision and voluntarily grant consent, without coercion or duress to accept therapy.