Post by Nadica (She/Her) on Nov 20, 2024 3:58:09 GMT
Why are there almost no clinical trials for kids with Long COVID? - Published Nov 19, 2024
by Simon Spichak
Key points you should know:
The only ongoing pediatric trial in the U.S. is testing a drug, called larazotide, aimed at tightening the gaps between cells in the gut to prevent coronavirus spike protein from leaking into circulation.
Because of cost and age discrimination, companies often develop drugs in adults before testing new treatments in kids.
The RECOVER initiative is ramping up to start clinical trials in kids soon, but parents and kids want to see more urgency.
Involving parents and children with Long COVID throughout the clinical trial process is necessary to make trials more effective.
After an initial SARS-CoV-2 infection in January 2021, Laura’s then nine-year-old son Matthew* developed symptoms that never went away — fatigue, cognitive dysfunction, rashes, joint pain, and shortness of breath.
His school recognizes he’s at extra risk if he attends in person when there are high levels of COVID-19, flu, or other transmissible diseases. For people with Long COVID, reinfections can make symptoms worse, bring on new diagnoses, and further disable them. So far during the 2024-2025 school year, he’s attended only three and a half days.
“There’s always pretty much just pain,” Matthew, now 12, told The Sick Times.
Matthew is on a baseball team but has to pace himself to avoid crashing. A treatment could make it easier for him to participate. “I wouldn’t have to save up all my energy just to do one thing,” he said.
But as of October 16, there are only two registered drug trials for Long COVID in kids — one in the U.S. and one in Pakistan. Why?
One reason is little acknowledgment of Long COVID in children from policymakers or media outlets, according to Megan Carmilani, founder of the advocacy group Long Covid Families. “There was a lot of rhetoric and denial about the idea that COVID could affect kids so there’s just not a lot of research that has been conducted,” Carmilani said.
The tide started to shift earlier this year in February. The National Institutes of Health’s RECOVER program, which includes studies tracking Long COVID in children, published a review paper in Pediatrics estimating 5.8 million kids in the U.S. were living with Long COVID, more than the 4.9 million children living with asthma.
“Children are in the most high risk environment [for infection],” Carmilani added. Most daycares and schools have not upgraded their air filtration or implemented measures to prevent the spread of airborne infections. “Children cannot consent to infection at all, and they’re legally required to be in some of these environments where families are reporting they’re getting sicker.” Research suggests that kids represent one in every four people with Long COVID.
Carmilani tracked how often children were mentioned during the September meeting kicking off the RECOVER-Treating Long COVID initiative, which will support new clinical trials. “And in two and a half days, I think the total was 53 minutes,” Carmilani said.
The initiative is a direct response from the National Institutes of Health (NIH) to criticism that the research program was moving too slowly to find treatments.
Experts who spoke with The Sick Times brought up many different reasons why developing new drugs for children with Long COVID has moved at such a glacial pace. Many pharmaceutical companies might not see Long COVID as profitable. And running trials in children is complex and expensive, as they can have different symptoms and underlying biological processes behind those symptoms from adults.
“I want more clinical trials focused on cures and effective treatments. We want treatments that are actually getting at the underlying causes and not just sticking a band aid on symptoms,” Katherine, a parent of a 16-year old with Long COVID told The Sick Times.
*Editor’s note: Children with Long COVID and their parents who spoke to The Sick Times for this story are referred to by their first names to protect their privacy.
by Simon Spichak
Key points you should know:
The only ongoing pediatric trial in the U.S. is testing a drug, called larazotide, aimed at tightening the gaps between cells in the gut to prevent coronavirus spike protein from leaking into circulation.
Because of cost and age discrimination, companies often develop drugs in adults before testing new treatments in kids.
The RECOVER initiative is ramping up to start clinical trials in kids soon, but parents and kids want to see more urgency.
Involving parents and children with Long COVID throughout the clinical trial process is necessary to make trials more effective.
After an initial SARS-CoV-2 infection in January 2021, Laura’s then nine-year-old son Matthew* developed symptoms that never went away — fatigue, cognitive dysfunction, rashes, joint pain, and shortness of breath.
His school recognizes he’s at extra risk if he attends in person when there are high levels of COVID-19, flu, or other transmissible diseases. For people with Long COVID, reinfections can make symptoms worse, bring on new diagnoses, and further disable them. So far during the 2024-2025 school year, he’s attended only three and a half days.
“There’s always pretty much just pain,” Matthew, now 12, told The Sick Times.
Matthew is on a baseball team but has to pace himself to avoid crashing. A treatment could make it easier for him to participate. “I wouldn’t have to save up all my energy just to do one thing,” he said.
But as of October 16, there are only two registered drug trials for Long COVID in kids — one in the U.S. and one in Pakistan. Why?
One reason is little acknowledgment of Long COVID in children from policymakers or media outlets, according to Megan Carmilani, founder of the advocacy group Long Covid Families. “There was a lot of rhetoric and denial about the idea that COVID could affect kids so there’s just not a lot of research that has been conducted,” Carmilani said.
The tide started to shift earlier this year in February. The National Institutes of Health’s RECOVER program, which includes studies tracking Long COVID in children, published a review paper in Pediatrics estimating 5.8 million kids in the U.S. were living with Long COVID, more than the 4.9 million children living with asthma.
“Children are in the most high risk environment [for infection],” Carmilani added. Most daycares and schools have not upgraded their air filtration or implemented measures to prevent the spread of airborne infections. “Children cannot consent to infection at all, and they’re legally required to be in some of these environments where families are reporting they’re getting sicker.” Research suggests that kids represent one in every four people with Long COVID.
Carmilani tracked how often children were mentioned during the September meeting kicking off the RECOVER-Treating Long COVID initiative, which will support new clinical trials. “And in two and a half days, I think the total was 53 minutes,” Carmilani said.
The initiative is a direct response from the National Institutes of Health (NIH) to criticism that the research program was moving too slowly to find treatments.
Experts who spoke with The Sick Times brought up many different reasons why developing new drugs for children with Long COVID has moved at such a glacial pace. Many pharmaceutical companies might not see Long COVID as profitable. And running trials in children is complex and expensive, as they can have different symptoms and underlying biological processes behind those symptoms from adults.
“I want more clinical trials focused on cures and effective treatments. We want treatments that are actually getting at the underlying causes and not just sticking a band aid on symptoms,” Katherine, a parent of a 16-year old with Long COVID told The Sick Times.
*Editor’s note: Children with Long COVID and their parents who spoke to The Sick Times for this story are referred to by their first names to protect their privacy.