In COVID-19 clinical trials, Long Islanders help to move medicine forward

Long Island researchers and residents are doing their part to help grow understanding of long-term effects of the coronavirus, and the success rate of vaccines, with hundreds volunteering for clinical trials in the region.

The trials have played a major role in developing treatments that led to a decline in virus-related deaths, health experts said.

Trials conducted in Nassau and Suffolk counties include evaluating the safety of two vaccines yet to be approved in the United States, studying the effectiveness of mixing and matching vaccines in a single patient, and weighing the use of various drugs to beat COVID-19.

"Clinical trials are the only way to move medicine forward," said Dr. Sharon Nachman, chief of pediatric infectious diseases at Stony Brook Medicine. "Without trials, science does not advance."

There have been hundreds of clinical trials related to COVID-19 treatments worldwide, according to Clinicaltrials.gov, a site by the U.S. National Library of Medicine. Millions of dollars are spent on trials, where thousands of health care professionals and researchers are involved in treatment, research and record-keeping. Money to support such trials often comes from drug companies or government and charitable grants.

Clinical trials go through phases, starting with an early one that tests the safety of treatments. Later trials test their effectiveness.

Trials being conducted across the country include a study of the safety and effectiveness of COVID-19 vaccines in children under 12. Only the Pfizer-BioNTech vaccine is approved for use in children 12 years of age and older. No vaccine is approved for children under 12.

Stony Brook Medicine earlier this month said it has joined a nationwide trial combining phases II and III to test the safety of the Pfizer vaccine between six months and 12 years of age. The trial seeks 4,500 participants, but the hospital has not disclosed how many children are joining in the region.

Combined trial phases may allow research questions to be answered more quickly with fewer patients, according to the National Cancer Institute. Phase III trials are randomized, where some get the test treatment, while others get a placebo, which is a substance with no therapeutic effect.

Stony Brook also has joined a national study that includes more than 20 university campuses nationwide to see how effective the Moderna vaccine is against spreading the virus. About 400 students from the region are expected to participate.

The trial, named Prevent Covid U, is being conducted by the Seattle-based COVID-19 Prevention Network, which plans to enroll more than 12,000 people between the ages of 18 and 26.

NYU Langone Hospital–Long Island in Mineola is participating in that trial as well. The hospital also is about to start recruiting for a trial that tests the impact of delivering a COVID-19 booster that is different from the vaccine a person originally received, said Dr. Martin Backer, associate director of the vaccine center at NYU Langone–Long Island.

"As more vaccines become available, it would be helpful to know if someone has to find the same vaccine as before" or whether a vaccine from another manufacturer can be used to administer a booster shot, Backer said. "I think it would be safe and effective to get a different one. But we don’t want to think. We need to know.

"It is also possible that using a different vaccine could lead to better support for your immune system," he added.

Volunteer wants to give others hope

NYU Langone is participating in testing the safety and effectiveness of the AstraZeneca vaccine, approved in the European Union but not yet in the United States. Backer said the hospital has signed up about 1,000 participants for that trial, about 150 of them from Long Island.

Joseph Lopez, 51, of Rockville Centre, joined the AstraZeneca trial because he wanted to be of help in the virus fight.

"I know a lot of people who were afraid to go outside, so I wanted to give them hope," he said. "I didn’t want friends, or even strangers, hiding for the rest of their lives. I wanted to help as much as I could."

Lopez, who was vaccinated in November 2020 as part of the trial, said he has had no side effects.

Meanwhile, Stony Brook participated in a clinical trial that examined the efficacy of a COVID-19 vaccine manufactured by Novavax, a biotech company based in Maryland.

Stony Brook signed up 376 subjects for the study, mostly in the first two months of 2021, said Dr. Benjamin Luft, the study's principal investigator, also a professor of medicine.

Earlier this week, Novavax said the study of nearly 30,000 people showed its vaccine had a 90% success rate against contracting the virus and was 100% effective at preventing a more severe COVID-19 case.

"This vaccine was also highly effective against the broader array of variants," Luft said. "It was more than 90% effective. It’s extremely gratifying to participate in this."

Luft added "this vaccine is also easy to transfer and distribute, so when you get a result like this, you’re in heaven."

Exploring a range of treatments

Long Island health systems played a big role in clinical trials that tested COVID-19 treatments, although most of those trials have slowed due to the large drop-off in the number of patients, experts said.

Islandwide, there were 40 new cases on Sunday, compared with about 1,700 daily cases in early April. The region reported more than 3,000 daily cases at the height of the pandemic in April 2020.

New Hyde Park-based Northwell Health and its science arm, The Feinstein Institutes for Medical Research, have enrolled 1,700 patients in 15 treatment trials, said Dr. Christina Brennan, vice president of clinical research.

The trials range from treatments that prevent blood clots to whether Pepcid, a heartburn medicine, helped hospitalized patients with COVID-19 when administered intravenously.

Feinstein also participated in a large, national trial on the effectiveness of remdesivir in fighting COVID-19.

Based on the trial, remdesivir became the first Food and Drug Administration-approved treatment for COVID-19 and has been shown to shorten the recovery time in hospitalized adults. Since its approval, other treatment options, such as monoclonal antibody combinations, have received emergency-use authorization from the FDA to treat mild-to-moderate patients.

Catholic Health, based in Rockville Centre, participated in two treatment clinical trials, including the remdesivir trial, said Dr. Jason Golbin, its chief medical officer.

The second trial, led by the Mayo Clinic, focused on the use of convalescent plasma donated by recovered COVID-19 patients.

Mount Sinai South Nassau in Oceanside took part in a National Institutes of Health trial earlier this year in which hospitalized COVID-19 patients were given hyperimmune immunoglobulin intravenously, said Dr. Aaron E. Glatt, chairman of medicine and chief of infectious diseases.

The immunoglobulin — a type of antibody — is taken from recovered COVID-19 patients. The theory: "In other illnesses, passively providing immunoglobulin assists a patient’s immune system to fight the virus. Hopefully, this would work for COVID-19 illness as well. Study results are pending.

"Does it work?," Glatt said. "It makes sense and has parallels in other viral illnesses. However, we’ve had other treatments that, in theory, made sense — but in the end, failed."