But COVID-19, which has already killed four million people around the world according to Johns Hopkins Medicine, required extraordinary scientific speed. Researchers conducted trials on COVID-19 vaccines with such efficiency that they were able to get emergency use authorizations from the U.S. Food and Drug Administration (FDA) in less than a year. Even more quickly, scientists were able to identify lifesaving treatments such as remdesivir and monoclonal antibodies and get them to doctors and hospitalized patients.
A Coordinated Effort to Produce Vaccines Fast
For clinical trials to succeed, volunteers are key. When it came to COVID-19 vaccine trials, more than 138,000 people in the United States jumped in to participate by mid-July of last year, according to a USA Today article from July 20, 2020. Buddy Creech, MD, director of the vaccine research program at Vanderbilt University in Nashville, Tennessee, is currently involved in a trial funded by the National Institutes of Health (NIH) for a pediatric Moderna vaccine. He’s been amazed at the response to the trial’s announcement, with more than 2,000 parents signing up their children within the first few weeks. “I think there’s been a lot of interest, particularly in individuals who may have participated in the early clinical trials,” says Dr. Creech, who helped with phase 3 studies of the Moderna and Johnson & Johnson vaccines in adults. “They had a good experience and now they’re wanting to make a vaccine available for their children in a way that’s appropriate for them.” In addition to co-leading the pediatric trial, Creech is investigating a vaccine designed to protect against a coronavirus variant that originated in South Africa. “Even though we have some successful vaccines that have made it to emergency use authorization, our job has not stopped because we continue to try to understand how to use these vaccines in special populations, and how to prepare for the next period of concern,” Creech says. RELATED: Why the Delta Variant Is a New COVID-19 Threat — and How to Stay Safe One such drug, the antiviral remdesivir (Veklury), was initially developed to fight the infectious and frequently fatal viral disease Ebola. During the 2014–15 Ebola outbreak in West Africa, Elizabeth S. Higgs, MD, was part of a team conducting clinical trials on possible medications. Volunteers in Africa who participated in these studies helped scientists gain critical data about remdesivir. “Their volunteering helped save lives,” says Dr. Higgs, who is now global health science advisor for the division of clinical research of the NIH’s National Institute for Allergy and Infectious Diseases. “Many people in Liberia [in West Africa] understand the importance of their contribution.” This success, she adds, is a source of national pride. When the NIH launched Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) — a program coordinating the efforts of the U.S. government, private industry, and institutions of higher learning — one of the first initiatives was examining drugs that already exist to see if they could be repurposed to fight COVID-19. In clinical trials, researchers found that remdesivir, administered via infusion, blocked the virus from replicating in adults and children 12 years of age and older requiring hospitalization. Based on these findings, remdesivir became the first COVID-19 treatment to be approved by the FDA. It helped that remdesivir had already been studied in the Ebola outbreak, which established the drug’s safety profile and enabled manufacturing to move forward more quickly.
New COVID-19 Trials Ahead Will Be Seeking Volunteers
As vaccinations increase in the United States, coronavirus infections have plummeted, yet finding new treatments remains a priority. Not only do certain states have dangerously low vaccination rates, but experts are concerned about a possible fall surge driven by the highly infectious delta variant. The delta variant also appears to be resistant to some existing medications for severe COVID-19. Plus, there is still no medication that can alleviate symptoms in people with milder forms of COVID-19 and help them recover faster. As NIH Director Francis S. Collins, MD, said in a statement, “While we’re doing a good job with treating hospitalized patients with severe disease, we don’t currently have an approved medication that can be self-administered to ease symptoms of people suffering from mild disease at home, and reduce the chance of their needing hospitalization.” In an effort to help this type of patient, the NIH launched ACTIV-6 studies in June to test several existing prescription and over-the-counter drugs to see if they could be repurposed to help individuals with mild or moderate COVID-19. The NIH is conducting these trials virtually, requiring no in-person check-ins unless particular circumstances warrant it. Through outreach by doctors and advertisements in newspapers and magazines and on radio, television, and social media, the NIH is still recruiting volunteers at the Rise Above COVID website and ClinicalTrials.gov. Higgs admits that finding volunteers who have mild or moderate COVID-19 at this stage in the pandemic may be challenging. Those who aren’t vaccinated who would have such symptoms also may tend to be “skeptical” about scientific trials, according to Higgs. “We might have more participate if there is a surge of the delta virus — interest and qualified candidates might grow,” she says. RELATED: Can Drugs for Other Diseases Help People With Mild or Moderate COVID-19?
What Would-Be Volunteers Need to Know
Many of the ACTIV trials compare patient reactions to drugs against responses to a placebo — an inactive treatment that looks like a real one. The patient reactions to medications versus placebo give scientists a better understanding of whether a medical intervention is safer and more effective than doing nothing. Patients aren’t told if they are being given the medication or placebo, and some patients who are desperate for treatment may be concerned about getting the latter. The University of California in Davis, which conducts many clinical trials, emphasizes that placebos are not used in clinical trials where volunteers will be harmed if they do not receive a real medical treatment. “They may or may not benefit, but science will benefit and many other people will benefit,” says Higgs. The government’s Combat COVID site offers more specifics about ongoing COVID-19 trials and opportunities to volunteer. Current studies include investigations of monoclonal antibody treatments, medications for mild and moderate COVID-19, vaccines that specifically address more contagious variants, and vaccines for kids. Higgs is encouraging everyone to get out the word that COVID-19 trials are ongoing and all of us can potentially play a role. She’d like to see people become so aware of clinical trials that, should they become sick, they’ll automatically investigate volunteer opportunities. “All of the successes that we currently enjoy in medicine are the result of volunteers who are rolling up a sleeve, getting a vaccine, trying new medications that may prevent disease, or may treat disease,” says Creech. “It’s those trailblazers that really move medicine forward.” RELATED: A Consumer’s Guide to Clinical Trials
