Posts tagged with "medical trial"

AC_LatinoCovid by Allison Christensen for 360 Magazine

Antibody Cocktail May Prevent Symptomatic COVID-19 Infections

An antibody cocktail being tested at UVA Health and other sites was able to block 100% of symptomatic COVID-19 infections among people exposed to the virus, early results from the clinical trial suggest.

In addition, those who developed asymptomatic infections accumulated far less virus in their bodies than usual and saw their infections resolve within a week, according to interim data released by the cocktail’s manufacturer, Regeneron Pharmaceuticals.

“This is the first treatment shown to prevent COVID-19 after a known exposure, and offers protection for unvaccinated individuals caring for a family member with COVID-19,” said UVA Health’s William Petri Jr., MD, PhD, one of the leaders of the trial at UVA. “We expect that Regeneron will file for Emergency Use Authorization from the FDA so that this drug can be used outside of the context of a clinical trial.”

Antibodies for COVID-19

The phase 3 clinical trial aims to determine if the antibodies will prevent COVID-19 infection in people who have been exposed but not yet developed the disease. This is known as “passive immunization.”

Regeneron’s new analysis, which has not yet been published in a scientific journal, looked at outcomes in approximately 400 trial participants. Of 186 people who received the antibodies, none developed symptomatic COVID-19. Of the 223 who received a placebo, eight developed symptomatic COVID-19, the company reports.

Asymptomatic infections occurred in 15 of the antibody recipients and in 23 of the placebo recipients. Overall rates of infection, including both symptomatic and asymptomatic infections, were approximately 50% lower in the antibody group.

Among those who developed infections, placebo recipients had, on average, a peak viral load (the amount of virus in the body) that was more than 100 times greater than antibody recipients. The antibody group also recovered more quickly–all the infections resolved within seven days, while 40 percent of infections in the placebo group lasted three to four weeks, Regeneron said.

The cocktail also appears to shorten the duration of viral shedding, the time when the virus is being manufactured in the body. The viral shedding period was nine weeks among antibody recipients and 44 weeks among the placebo recipients. While people with COVID-19 are not infectious for this entire time, reducing the duration of viral shedding may shorten the period when they can spread the disease.

There were more adverse events reported among placebo recipients than among antibody recipients – 18 percent and 12 percent, respectively. Regeneron attributed this to the larger number of COVID-19 infections in the placebo group.

There was one death and one COVID-19-related hospitalization in the placebo group and none in the antibody group. Injection-site reactions were reported among 2 percent of both groups.

“We are profoundly grateful to the nurses and staff of the UVA COVID-19 clinic, led by Dr. Debbie-Anne Shirley,” Petri said. “Their day-to-day support made our participation in this trial possible.”

About the Clinical Trial

Phase 3 clinical trials, such as the one under way at UVA, examine the safety and effectiveness of new drugs and treatments in large numbers of people. Positive results in the phase 3 trial could spur the federal Food and Drug Administration to make the antibody cocktail available for post-exposure COVID-19 prevention.

The antibody cocktail is not a vaccine and is not expected to provide permanent immunity to COVID-19.

The team conducting the study at UVA is led by Petri and Shirley and includes Gregory Madden, MD; Chelsea Marie, PhD; Jennifer Sasson, MD; Jae Shin, MD; Cirle Warren, MD; Clinical Research Coordinator Igor Shumilin; assistant Rebecca Carpenter; and COVID-19 Clinic nurses Michelle Sutton, Elizabeth Brooks, Danielle Donigan, Cynthia Edwards, Jennifer Pinnata, Samantha Simmons and Rebecca Wade.

To keep up with the latest medical research news from UVA, subscribe to the Making of Medicine blog.

COVID-19 Trial Tests if Common Drug Can Keep Patients Out of Hospital

At-risk people diagnosed with COVID-19 across the United States and Canada can participate in a clinical trial testing whether a common drug can keep them from getting sicker and keep them out of the hospital.­­

The trial, conducted by Washington University School of Medicine in St. Louis, is based on a discovery by the University of Virginia School of Medicine’s Alban Gaultier, PhD, and a former graduate student, Dorian A Rosen, PhD.

Gaultier and Rosen found last year that the antidepressant fluvoxamine may stop the deadly inflammation known as sepsis, in which the immune response spirals out of control. The drug’s apparent benefit for dampening dangerous inflammation prompted the Washington University researchers to begin investigating its potential benefit for COVID-19, which can also cause dangerous overreactions of the immune system.

“If this clinical trial is proven successful, fluvoxamine could become a standard treatment for patients newly diagnosed with COVID-19, especially patients at risk,” Gaultier said. “Even the best vaccines do not protect 100% of the population, and discovery of safe and affordable treatments to prevent COVID-19-associated complications is critical.”

Fluvoxamine and COVID-19

Earlier this year, the Washington University researchers launched their first clinical trial of the drug in patients with COVID-19. That trial compared fluvoxamine with a harmless placebo in 152 adult outpatients. None of the 80 participants who received fluvoxamine became seriously ill after 15 days, while six patients who received placebo did. Of those six, four were hospitalized, for periods ranging from four to 21 days. One was on a ventilator for 10 days.

Based on those initial results, Washington University is now launching a much larger trial open to residents across the United States and Canada. The trial is seeking approximately 880 at-risk participants, age 18 and older, who have tested positive for COVID-19 and are experiencing mild symptoms.

Participants will be provided with either fluvoxamine or a placebo for approximately 15 days. No face-to-face contact is required; everything necessary will be sent to the participants’ doorsteps.

Contactless Check-Ins

The researchers will track the patients by videochat, email or telephone to determine if fluvoxamine provides a benefit and helps keep participants out of the hospital. During brief daily check-ins, trial participants will report their oxygen levels, blood pressure and temperature, along with whether they are feeling shortness of breath or have had any other problems.

The study team will continue to follow the participants for approximately 90 days after they have finished taking fluvoxamine or the placebo.

The trial is open to people who have at least one risk factor for severe COVID-19, such as being 40 or older, being part of a high-risk racial/ethnic group (such as African-American, Hispanic, Native American or biracial), or having one or more medical conditions such as obesity, diabetes, high blood pressure, heart disease, a lung disease or an immune disorder such as rheumatoid arthritis.

For more information about the trial, visit this website.

Genetic Immunity Presents at First Russian-Chinese HIV Congress in Moscow

Peter Boros, Genetic Immunity’s President presented the Company’s pDNA-based platform technology and clinical trial data relating to HIV in front of an esteemed gathering of HIV experts.

As part of the presentation, Genetic Immunity announced the launch of a Phase III clinical trial for the company’s lead product candidate, a therapeutic HIV vaccine, to be conducted at the Moscow City Center for the Prevention and Control of AIDS, with the planned enrollment of up to 200 patients. Upon successful completion, Genetic Immunity plans to apply for marketing approval in the Commonwealth of Independent States (CIS) region.

“It was an honor to have been invited and to present in front of such a highly regarded group of HIV experts from Russia, China and the United States. I believe our presentation was well-received and we are all looking forward to a successful trial completion. If marketing approval is granted, our therapeutic HIV vaccine could introduce a paradigm shift in treating HIV,” stated Boros.

The DermaVir platform contains a novel plasmid DNA that encodes most HIV genes. The vaccine is administered topically using the DermaPrep medical device.

“Mr. Boros gave an excellent presentation about Genetic Immunity’s therapeutic vaccine platform with a special emphasis on the company’s HIV results to date. I look forward to completing the planned Phase III trial, and – upon a successful result – to treating patients with a very promising new vaccine product,” added Professor Alexey Mazus, Head of the Moscow City Center for the Prevention and Control of AIDS.