Mount Sinai Actively Recruits Volunteers From Hardest Hit Communities for COVID-19 Vaccine Trial

WillieBenjamin Loadholt, right, undergoes a checkup from Kiwan Stewart, RN, at The Mount Sinai Hospital prior to receiving his second injection as a participant in the phase 3 clinical trial for Pfizer’s COVID-19 vaccine.

Participating in the Mount Sinai Health System’s clinical trial for the Pfizer COVID-19 vaccine has been deeply personal for New York City educator WillieBenjamin Loadholt. He says it has provided him with the opportunity to be proactive, to contribute to a potential solution that could put an end to the COVID-19 pandemic, which has been “devastating to the African American community.”

For months, Mr. Loadholt says, “Every time I would go on a friend’s Facebook page I would see, ‘We regret to announce the passing or the transition of this person or that person.’ A friend of mine owns a funeral home and they were doing so many funerals. This one’s mom passed away, or this one’s father or sister passed away. It was heartbreaking.”

So, in August, when a friend told him about the Pfizer COVID-19 vaccine trial at Mount Sinai, Mr. Loadholt was eager to sign up. “We want to know what’s going on,” he says. “People perish from a lack of knowledge. How can we avoid this? How can we get solutions for this?” Participating in the search for answers to the COVID-19 pandemic is “worthwhile because I am able to help myself as well as my community. We can’t get this if we don’t help each other.”

Mount Sinai is actively recruiting volunteer participants in communities of color. “We want to make sure the trial is representative of the people who were hardest hit by COVID-19,” says Debbie Lucy, Program Manager for the Mount Sinai Health System’s COVID Clinical Trials Unit. Based on a legacy of mistreatment and longstanding inequities in access to health care, Black Americans, in particular, are more hesitant than other groups to embrace the use of experimental vaccines and therapies.

Debbie Lucy

In August, Ms. Lucy and her team began handing out information about the vaccine in the communities around The Mount Sinai Hospital, between 96th and 105th Streets, east of Park Avenue. In fact, Mr. Loadholt found out about the clinical trial from a friend who lives in the area and received a knock on his door from Mount Sinai.

“We have teams of people who are out in different areas trying to educate people and get them involved. We are talking to people, handing out flyers, and making as many connections as we can,” says Ms. Lucy. “We’re going to different grocery stores, hair salons, nail salons, laundromats, restaurants—any place where we think people of color are either working or going to.”

When Ms. Lucy met a man who told her that his family did not have any masks, she says she called up a team member who immediately brought several masks to the corner of East 103rd Street where they were standing. “He was in awe that we went the extra mile to do that for him,” Ms. Lucy says. “For him it was more than the masks we gave him; it was the fact that we connected with him and met his need immediately. We stood out there and talked with him and gave him additional information about participating in the trial.”

Mount Sinai has also held community forums that educate people of color about the Pfizer vaccine trial. In September, Mr. Loadholt discussed his experience at one of these forums. Ms. Lucy says, “We believe it’s easier for people who look like you to talk with you about participating in a trial because we recognize that there’s a lot of mistrust around research among people of color. Our ultimate goal is to find a vaccine that’s going to help prevent COVID-19, but with any trial we also want to test for safety to make sure it’s not causing any negative side effects in people, and that it’s well tolerated.”

Of the more than 180 COVID-19 vaccines under development, Pfizer’s RNA vaccine is one of the furthest along in the phase 3 clinical trials taking place at Mount Sinai and other locations throughout the United States. The vaccine is based on new technology and can be produced completely in vitro, or in a laboratory.

“I am grateful to individuals like Mr. Loadholt who are participating in this vaccine study and helping us to inform others,” says Judith A. Aberg, MD, the Dr. George Baehr Professor of Clinical Medicine, and Chief of Infectious Diseases for the Mount Sinai Health System. “Involvement with communities should not be overlooked due to false assumptions that people of color are unwilling to enroll in clinical trials. Such false assumptions result in harmful health disparities. We must provide everyone with the opportunity to participate in clinical trials and receive linkage to care. Only through engagement and education can people protect themselves and their loved ones.”

After receiving his second of two injections in September, Mr. Loadholt says he feels fine. He does not know whether he received the real vaccine or a placebo, which is how the placebo-controlled, randomized, observer-blinded vaccine trial is designed. He will be able to find this out in two years. “If I did receive a placebo, at least I can help another person of color receive the real one,” he says.

Mount Sinai has provided Mr. Loadholt and other trial participants with either an iPhone app or their own separate device to communicate any symptoms. “The staff at Mount Sinai has been wonderful,” Mr. Loadholt adds. “I would like Mount Sinai to do what they’re doing and be a beacon in the community.”

To potential volunteers, he says, “Don’t be afraid. Try it.”

If you are interested in volunteering for a COVID-19 vaccine clinical trial, please call 212-824-7714 or email: COVIDTRIALSINFO@MOUNTSINAI.ORG. Mount Sinai offers $119 in compensation for all visits related to the clinical trial. Watch the following video to learn more

Mount Sinai Scientists Find Children with COVID-19-Related Illness Display a Unique Pattern of Immune Responses

In Mount Sinai’s study, the children were age 12 on average and otherwise healthy.

MIS-C is a rare, potentially life-threatening syndrome that occurs about five weeks after children have been infected by the SARS-CoV-2 virus, which causes COVID-19. Most of the children are actually asymptomatic for COVID-19, but when they develop MIS-C they are hospitalized with shock, excessive blood clotting, gastrointestinal symptoms, and heart dysfunction.

In a new development, researchers at the Icahn School of Medicine at Mount Sinai have identified a unique pattern of immune responses that characterize multisystem inflammatory syndrome in children (MIS-C) and could eventually serve as a biomarker, or reliable indicator that would help diagnose the disease.

The Mount Sinai scientists discovered this unique pattern of immune responses by using sophisticated single-cell technology to analyze the blood circulating through the bodies of nine MIS-C patients who were treated at Mount Sinai Kravis Children’s Hospital between late April and June 2020. The researchers found elevated levels of specific cytokines—molecules that regulate immunity and inflammation—and chemokines—signaling proteins—that distinguished the MIS-C patients. The children were age 12 on average, otherwise healthy, and almost equally divided between boys and girls.

“In order for us to really understand MIS-C, we had to describe the disease, and this is the first in-depth mapping of what the disease looks like,” says Dusan Bogunovic, PhD, Associate Professor of Microbiology, and Pediatrics, and Director of the Center for Inborn Errors of Immunity, part of The Mindich Child Health and Development Institute and Precision Immunology Institute. Dr. Bogunovic is the corresponding author of a Mount Sinai study that describes the findings in detail. The paper was posted to the pre-print server medRxiv.org last summer and is now published in Cell.

Dusan Bogunovic, PhD

Conor Gruber, an MD/PhD candidate at the Icahn School of Medicine, a member of the Bogunovic lab, and the paper’s first author, says, “We have mapped autoimmune parameters at an unprecedented level. Now we need to know if this autoimmune component causes the disease or is just a byproduct of MIS-C. We’re actively researching this.” Autoimmunity occurs when an individual’s antibodies mistakenly attack their body. Since the body’s adaptive immune response to disease usually forms after several weeks—the same amount of time it takes for children to develop MIS-C—the researchers believe this is likely where the problem lies within the immune system.

When the initial cases of MIS-C began surfacing in the spring, several weeks after the surge of adult COVID-19 cases in the New York metropolitan area, MIS-C was considered an atypical form of Kawasaki disease, an acute systemic inflammation of the blood vessels, mainly affecting very young children. Since then, the World Health Organization has classified MIS-C as a distinct syndrome. The Mount Sinai study found that “overlapping features are striking, suggesting that MIS-C may lie along a spectrum of Kawasaki disease-like pathology.”

Although further studies into the causes of MIS-C are needed, says Dr. Bogunovic, the good news is that widely accepted protocols are in place for the successful treatment of the disease. He is less certain, however, about whether a child’s predisposition to MIS-C portends a predisposition to different autoimmune disorders down the line or will interfere with the ability to successfully receive a COVID-19 vaccine.

“All of these postulates need careful, methodical, and well-controlled experimental dissection,” the study authors wrote. “Until then, MIS-C remains scientifically puzzling, but therapeutically manageable.”

Mount Sinai Lab Creates Shared Database to Help Scientists Find Drugs That Can Be Used to Treat COVID-19

Avi Ma’ayan, PhD

As the public turns its attention to vaccine development in the hope of ending the COVID-19 pandemic, equally important work is taking place in the area of drug repurposing—identifying drugs already approved for other diseases that may also be effective for COVID-19. Repurposed drugs offer a safe and relatively quick and inexpensive treatment route.

At the Icahn School of Medicine at Mount Sinai, a team of researchers led by Avi Ma’ayan, PhD, Director of the Mount Sinai Center for Bioinformatics and Professor of Pharmacological Sciences, is investigating drugs with the most potential. To that end, they created the COVID-19 Drug and Gene Set Library, a crowdsourced database and website that consolidates information from multiple labs around the world that performed in vitro COVID-19 drug screens. These in vitro tests are performed in a petri dish, which is the first stage in drug discovery, before the drugs are tested in animal models and then in human clinical trials. The website is available to all scientists who want to compare drug screen “hits,” and has drawn 2,000 viewers since it was launched in April.

“Drugs are just as important as vaccines and offer a solution for dealing with this pandemic,” says Dr. Ma’ayan. “The hope is that we’ll find a drug, or a combination of drugs, that people can take after they’re infected with the virus to block the virus from spreading and enable them to mount an effective immune response.” After all, he adds, not everyone may be eligible to receive a vaccine, based on their health profile, and even with a vaccine there will be people who get COVID-19 and need treatment.

Venn diagram shows some overlap in a set of drugs relevant to COVID-19 research

In September, the journal Patterns, a Cell Press publication, published an article that described the Ma’ayan Laboratory’s work on the project. The article described the lab’s machine learning approach, which explored approximately 200 “positive hit” drugs that were identified as inhibiting the SARS-CoV-2 virus, which causes COVID-19, from infecting human cells in vitro. Based on the shared biological and chemical properties of these drugs, the machine-learning model prioritized these drugs further and predicted additional compounds with similar properties.

“When you start synthesizing data from multiple studies, you look for consistency and seek to identify interesting mechanisms,” he says. “We want to understand the mechanism of action of those drugs. Why do they work? What are the pathways they affect? What are the targets of those drugs so we can better understand the lifecycle of the virus?” Currently, the laboratory led by Benjamin tenOever, PhD, Director of the Virus Engineering Center for Therapeutics and Research at the Icahn School of Medicine at Mount Sinai, is conducting experiments to further explore some of these questions in collaboration with Dr. Ma’ayan.

According to Dr. Ma’ayan, the COVID-19 Drug and Gene Set Library organizes information in a way that can be clearly summarized and reused at a crucial time in COVID-19 research, when time is of the essence. The library allows the scientific community to work together toward a cure and avoid promoting drugs that are not fully validated, which happened last spring with hydroxychloroquine.

“The website that we built is supposed to be unbiased,” he says, “and it looks at evidence in a way that offers consistency across the studies, where the right answer comes up in a more distributed, democratic way.”

When considering promising drugs Dr. Ma’ayan points to the example of HIV, a virus for which there is no vaccine, but many combinations of drugs that effectively keep the viral load very low and prevent new infections. These drug “cocktails” have helped improve the lives of many people around the world. “There are fewer people dying from HIV because of these drugs,” he says. “It’s not guaranteed we’ll have a vaccine for COVID-19 that’s 100 percent effective or even 50 percent effective, and there are people who aren’t going to be able to receive the vaccine. If people get sick from COVID-19 and you have drugs that can treat them, you could turn it into a disease that more people can recover from.”

COVID-19: How to Safely Commute to the Office

As New York City adjusts to the post-COVID-19 world, more people are going back to the office. If you are one of them, you may be wondering how to do so safely; after all, while New York has done comparatively well at controlling the spread of the virus, the pandemic is far from over.

The first thing to remember, says Dana S. Mazo, MD, MSc, Assistant Professor of Medicine (Infectious Disease) at the Icahn School of Medicine at Mount Sinai and physician lead for Infection Prevention at Mount Sinai Queens, is that the skills we need to safely go back to the office are the same ones we’ve been practicing since New York was the pandemic’s epicenter in March.

In this Q & A, Dr. Mazo provides salient advice for those returning to the office in addition to the basic tools of social distancing, wearing a face covering, avoiding face touching, and hand washing.

I commute using a cab/car service. How can I ride safely?

First, everyone in the vehicle should wear a mask for the entire ride. To improve the air flow, keep the windows open if possible and, if you need to turn on the air conditioning, don’t recirculate the air as that will only spread germs.

The virus can also be spread by touching a contaminated surface and then touching your face—especially the mouth, nose or eyes. To prevent this from happening, you should sanitize your hands and/or use antiseptic wipes on frequently touched surfaces especially before handling your own belongings or face.

If you are the passenger, be sure to use hand sanitizer soon after you first get in the car when you will have just touched the door handles, seat belt and possibly window controls. Then, try not to touch anything during the trip—especially your face—and use hand sanitizer, if you do. If possible, use a contactless payment option. When you leave, and again have to touch seat belts and door handles, don’t forget to again use hand sanitizer as soon as possible and definitely before touching your belongings or face.

If you are the driver, or you share your car, be sure to sanitize the steering wheel, dashboard, gear shift, and any other frequently touched surfaces. As an extra step to help keep passengers and our city safe, use a wipe to clean between passengers, pay special attention to highly touched surfaces such as interior door handles and seat belts. Make sure to sanitize your hands after touching anything the passenger may have touched. And, if you use valet parking, remember to sanitize everything the valet may have touched before you start for home.

Finally, if you are sharing a car with someone outside your household “bubble,” you will need to be especially cautious since you will have to sit close to that person in an enclosed space for presumably more than 10-15 minutes. Even if you are both wearing face coverings, there is still some risk; although much less than if one of you were not masked. Are you willing to be at risk from everyone that person has had contact with? Remember, it’s not just the car mate, it’s also everyone they interact with. If you don’t want to take on that risk, sharing a car becomes more complicated.

Should I take special precautions when using public transportation?

While you may be nervous about public transportation, just keep using the same public health tools you have been practicing. The most important step is to wear a face covering and to walk away from someone who is not wearing one.

These days, subways and trains are less crowded than they used to be, so social distancing is less difficult than it would have been at the start of the year. Stand apart from others on the subway or train platform or at the bus stop.

Try to avoid touching the handrails on stairs or escalators, the turnstiles, the gate—or anything else, for that matter. Opt for contactless payment whenever possible. While onboard, don’t touch anything if you don’t have to—sanitize your hands immediately if you need to push a button, pull a cord, or touch a pole—and try to keep at least six feet of space between you and anyone else. When you are settled in your seat, you can sanitize your hands just in case. Remember to hit the hand sanitizer again once you’re back on the sidewalk, and, when you get to your building, sanitize again if you must push or pull a door open.

How do I deal with my anxiety about going back to the office?

Anxiety is normal. We are in the middle of an international crisis; this is not business as usual. Remember, you have been practicing social distancing, mask wearing, and hand sanitizing for months now. These skills will now be applied to a new situation: commuting and the office environment. The key is to plan ahead and stay vigilant. To protect yourself and your loved ones from COVID-19, you must assume everyone around you may be an asymptomatic carrier of the virus.

And, if you feel sick, stay home. If you start to feel sick on your way to work, go back home. If you start to feel sick when you’re at the office, pack up your stuff and go home. Given the dangerousness and high communicability of COVID-19, this is not the time to tough it out.

Mount Sinai Leaders Explore COVID-19 Vaccines, Treatments, and the Path Ahead in Aspen Ideas: Health Panel Discussion

Does convalescent plasma therapy work? Is a successful vaccine for COVID-19 on the way? Will it be suitable for senior citizens and available to minority communities that were hardest hit by the pandemic? These pressing topics are explored in a recent Aspen Ideas: Health panel discussion that was led by Kenneth L. Davis, MD, President and Chief Executive Officer of the Mount Sinai Health System. Mount Sinai’s renowned vaccinologist Florian Krammer, PhD, and infectious disease specialist, Judith A. Aberg, MD, weigh in with informative answers to some of the nation’s most important health care questions.

“Many vaccine trials fail,” says Dr. Krammer, “but if you go with diverse approaches to creating a vaccine, it is very likely that one or even more of these will succeed.” With regard to convalescent plasma therapy, Dr. Aberg says, timing is everything. Administer the treatment early on before patients develop their own antibodies. Mount Sinai, she adds, is educating at-risk communities about the need for COVID-19 vaccines. When vaccines are ready to be administered Mount Sinai will be there.

To learn more about the most promising vaccines under development, why the infection rate in New York City is relatively low at this time, and whether we should be concerned about mutations to the SARS-CoV-2 virus, go to Aspen Idea’s Perspectives in Health.

How Do I Prepare My Child to Go Back to School?

As children head back to school—whether in person or virtually—parents may have some concerns about how they will adapt to a new, potentially stressful academic year. Aliza Pressman, PhD, Co-Founding Director and Director of Clinical Programming for the Mount Sinai Parenting Center, answers some of your questions.

How can I address my children’s anxiety about going back to school in person?

Start by making sure that you are calm and not imposing your own anxiety onto the conversation. Your children will pick up on your energy and you want to be focused on their concerns. Also, remember that your anxiety—and your child’s anxiety—is very reasonable at this challenging time. If your child is anxious, don’t try to get rid of that anxiety. Instead, validate their feelings. Tell them that what they are feeling makes sense. Children have been out of school for a long time and for months have been hearing about the importance of staying away from people. Now they’re going to head back into a building full of people. Of course they are nervous.

Once you’ve validated your child’s emotions, explain that you would not send them back to school if you did not think they would be safe. Go over the precautions that the school is taking to protect teachers and students and, for younger children, remind them about what COVID-19 is and what individual measures they can take to keep themselves safe while at school.

Will my child’s learning be affected by having their teachers wear masks?

This is a natural concern. Our facial expressions are part of how we communicate and masks obscure half the face. One way to prepare your child is to practice communicating and reading people’s emotions when they are wearing a mask. Make a game of it. Have everyone at home wear a mask and guess what each person is trying to say by just using body language. Once your kids go back to school, you can reinforce the lessons they are receiving in the classroom; for instance, have them read to you. You’ll probably pick up cues from your children about what they need, and you can adjust accordingly. Remember, kids are incredibly adaptable, more so than adults.

How can I help my child connect with their friends while attending school remotely?

If your child is attending school remotely, they will probably miss spending time with their friends, and interactive screen time is a great way for them to safely connect. Since screen time may be your child’s only opportunity to socialize, you might even want to allow more screen time than you permitted before the pandemic. Just make sure it doesn’t interrupt family mealtime, homework, or replace outdoor activity.

Also, remember that some kids don’t enjoy online interaction. Some children enjoy a more passive interaction like being in the same virtual room as a friend while doing an art project. This allows children to chat with each other without the pressure of an ongoing conversation. As kids get older, they will be able to tell you how they want to connect with their friends. It may be through a video game, taking an exercise class together, or watching a movie together. Or, they may just want to talk on the phone or text.

How do I talk to my child about what is happening in the world?

Before you talk with your child about current events, make sure that you have come to terms with your own state of mind. You don’t want to enter the conversation with the weight of your own feelings. When you are ready to talk, determine what you want to discuss before beginning the conversation. Whether it is COVID-19, social unrest, or something else, begin by asking what they know and what they’re thinking about regarding the topic. You want to be your child’s first resource with any questions and concerns. Be prepared to explain your opinions.

When should I seek professional help?

If you or your child cannot manage to sleep or eat or are feeling out of control, consider seeking the guidance of a mental health professional. It is completely reasonable to feel overwhelmed; this is an enormously stressful time. And, remember, if your child sees that you are willing to seek help, they will know that it is okay for them to do the same.

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