PROVIDENCE — Hasbro Children’s Hospital is now offering monoclonal antibody treatments to pediatric patients 11 and younger that have tested positive with COVID-19.
Officials at the US Food and Drug Administration recently an emergency use authorization for monoclonal antibody treatments for pediatric patients age 12 and older, but Lifespan Corporation, which owns Hasbro Children’s, is participating in a new open research study offering the treatment to even younger patients.
While children 12 and older are eligible to receive a COVID-19 vaccine, younger children are not yet eligible. As the Delta variant continues to infect Rhode Islanders, including unvaccinated children, this treatment could help some of them fight off the virus, according to health experts.
Monoclonal antibody treatment is safe and effective for treating adults with COVID-19. The study focuses on dosing for pediatric patients and understanding the efficacy of the medication, according to the Rhode Island study lead.
“Everything we do in pediatrics is based on weight. We don’t give standard doses like we do in the adult medicine world. So in order for us to understand how to use this medicine in terms of the lowest possible dose that’s the most effective and with the least side effects, we have to study it,” said Dr. Michael Koster, director of the division of pediatric infectious diseases at Hasbro Children’s Hospital. “And that’s what this study is all about.”
Here’s what parents need to know about the study in Rhode Island.
What are the eligibility requirements?
- Younger than 12 years old
- A positive COVID-19 test within 72 hours and onset of symptoms within seven days.
- Outpatients only
- Children with “mild to moderate” symptoms that do not require oxygen or hospitalizations.
What indicates a “high risk” for developing severe COVID-19?
- A BMI higher than the 85th percentile for their age and gender based on growth charts by the Centers for Disease Control and Prevention.
- Immunosuppressive disease or immunosuppressive treatment
- Cardiovascular disease, including congenital heart disease and hypertension
- Chronic lung diseases (chronic obstructive pulmonary disease, asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension)
- Sickle cell disease or thalassemia
- Neuro-developmental disorders like cerebral palsy or other conditions that confer medical complexity, like metabolic syndromes and severe congenital anomalies
- A medical-related technological dependence unrelated to COVID (tracheostomy, gastrostomy, positive pressure ventilation)
- Diabetes (types 1 and 2)
- Chronic kidney disease
- Chronic liver disease
How do monoclonal antibodies work?
According to the state health department, “Antibodies are proteins that people’s bodies make to fight viruses, such as the virus that causes COVID-19. Antibodies made in a laboratory act a lot like natural antibodies to limit the amount of virus in your body.”
Are antibody treatments new?
No. Health care providers have been using antibodies to treat viral infections like HIV and Ebola. For COVID-19, there are several monoclonal antibody therapies that have been authorized by the federal government.
How has the administration of monoclonal antibodies changed over the pandemic?
According to Koster, monoclonal antibodies were initially used in studies, in hospitalized patients, and in ambulatory patients. Now they are being used as a prevention tool.
This month, the New England Journal of Medicine published a study that showed how monoclonal antibodies casirivimab and imdevimab have been shown to “markedly reduce the risk of hospitalization or death among high-risk” patients with COVID-19. Koster, who also teaches pediatrics at The Warren Alpert Medical School of Brown University, said the study included children 12 and older and found a significant reduction in the development of COVID-19.
How is the treatment administered?
Typically, monoclonal antibodies are administered by intravenous, or IV, infusion. The infusion takes about 20 minutes.
Where can I bring my child to receive monoclonal antibody treatments in Rhode Island?
Infusions are performed at the Tomorrow Fund Clinic at Hasbro Children’s Hospital. The treatment can only be provided to patients where providers have immediate access to medications to treat any reactions and where emergency medical systems are available, in case they are needed.
When should you start treatment?
The earlier the child starts treatment after symptoms start, the more effective it is. According to the state health department, many people with COVID-19 start feeling better as early as the next day after completing a simple infusion.
Will my insurance cover the treatment?
Since this is a study within Hasbro Children’s, it is fully covered. Parents may also receive compensation for their participation and their time, according to Koster.
What if the FDA authorizes for children under 12 to get the COVID-19 vaccine and they’ve already had this treatment? Can they get the vaccine?
It’s unclear how effective COVID-19 vaccines are in adults who received monoclonal antibody treatment or if the treatment could interfere with the body’s immune system. However, contracting COVID-19 again within three months after you were initially infected is unlikely. Health officials advise waiting three months before the child receives the vaccine after receiving treatment. It’s also advised to speak to your child’s pediatrician.
What about if my child (12 or older) has already been vaccinated? Can they receive monoclonal antibody treatment?
Yes. And being vaccinated should not effect treatment, according to health officials. But also consult with your child’s pediatrician.