The University of Michigan in Ann Arbor is seeking the public’s help in COVID-19 research. Anyone can fill out a survey from the university and indicate their interest in participating in the research, creating a pool of contacts for U-M scientists.
U-M is looking for people who have already gotten the virus as well as people who have the highest risk of catching it. When participants sign up on the U-M Health Research Registry, they are asked whether they’ve had COVID-19 and indicate their interest in participation in COVID-19 research.
Researchers from U-M say will they will reach out to respondents through a confidential, secure system to share information about studies that need people like them and see whether they are eligible. Once contacted, potential participants can decide whether they want to volunteer for the study.
U-M has launched dozens of COVID-19 studies in the past six weeks that work to understand the virus, test ways to prevent or treat it, and measure the pandemic’s effects on people and society.
Some studies just involve taking a survey from home, and several are already listed here. Many need blood or saliva samples from people who have the disease or recovered from it.
The registry is designed to make it easy for sick and recovered patients to give samples that many scientists can share through U-M’s new COVID-19 Biorepository, which already contains more than 14,000 samples from hundreds of COVID-19 patients treated at Michigan Medicine, U-M’s academic medical center.
Other studies might involve taking a drug or supplement that’s already on the market or in development to see if it can prevent COVID-19 or its effects. For people who need to be hospitalized, U-M clinical trials may provide access to new drugs and devices designed to save lives.
“We can’t defeat COVID-19 without help from the community, and thousands of people who volunteer for our studies,” says Anna Lok, assistant dean for clinical research at the U-M Medical School. “The best way for us to find those volunteers is by having a database of people who are willing to help us if we need someone like them.”
Those who work in health care can also sign up for a second COVID-19 registry called the HERO Registry, available here. U-M researchers and others are tapping members of the registry to volunteer for a study that is testing the preventive power of an existing drug.
The research projects follow strict safety guidelines and could help people both locally and around the world. U-M researchers will publish their findings in medical journals so they can be shared with clinicians and health policy leaders.
Michigan Medicine teams are also offering certain critically ill patients the opportunity to try new options through the U.S. Food and Drug Administration’s Expanded Access program. Different than a clinical trial, but still with safety protections, it can give some patients access to options they would otherwise not have and record their responses.
For example, Michigan Medicine is taking part in the Convalescent Plasma Expanded Access Registry. People who have recovered from a known or likely case of COVID-19 can donate blood plasma via the American Red Cross to be given to patients in the program. More information on the program can be found here.
A full list of U-M COVID-19 research projects in planning or in progress is available here. The index should not be used to contact research teams, because not all studies are ready to recruit participants.
In related news, scientists at U-M are advancing a new antibody test to identify people who have been infected with the novel coronavirus that causes COVID-19. The test, which is being validated now, could accelerate selection of patient plasma for use in treating COVID-19 infections.
Antibody tests, also called serological tests, search blood serum for evidence that an individual has been infected with a virus. Infected peoples’ immune systems produce antibody proteins that are uniquely equipped to fight off that specific virus. If an infection occurred, the serological test will reveal these specialized antibodies when a small portion of the virus is applied to the serum.
If accurate and widely available, the tests could aid in selecting serum for patient treatments and help determine the true rate of infection and measure the spread of the virus and the disease.
Some antibody tests have already hit the market, but many are proving too inaccurate to be useful. Researchers at U-M, as well as across academia, industry, and government, are working to create and validate better tests.
Following a protocol developed at the Icahn School of Medicine at Mount Sinai, researchers from U-M are establishing test production at U-M with the goal of distributing in Michigan, other states, and developing nations.
The antibody test focuses on the spike proteins from the virus, which are on the outer surface of the virus and allow it to enter human cells but are not infectious on their own. Researchers are optimizing production of the complete spike protein and an area at the very tip of the spike called the receptor-binding domain.
That domain is the part of the spike that is recognized by human cells, allowing the virus to enter cells in the airway. It is also the portion of the spike that shows the greatest genetic variation from other coronaviruses, which could be the key to developing highly specific antibody tests.
“There are two main characteristics that are most important for these tests,” says Janet Smith, professor at the Life Sciences Institute and director of the Center for Structural Biology. “The first is sensitivity, or how many antibodies must be present before the test can detect them. But much more important is selectivity – the test’s ability to pick up only antibodies that would fight this specific coronavirus and not some other virus.”
The spike proteins produced at the Center for Structural Biology are being tested by a team of epidemiologists from the School of Public Health and the Clinical Core Lab at the Medical School. They have begun testing serum collected before the COVID-19 outbreak to ensure the tests do not detect antibodies from other viruses, as well as on serum from patients who tested positive for COVID-19 to confirm that the antibody test recognizes the new antibodies.
“This work is helping to advance the science of antibody testing at a time when it is urgently needed,” says DuBois Bowman, dean of the U-M School of Public Health. “Ensuring accurate, widely available antibody testing is an essential step in determining the cumulative impact of the virus, understanding more about immunity and ultimately gaining control over this pandemic.”
If the results of the tests demonstrate that it is both selective and sensitive enough, biotechnology companies will be able to use the protocol to mass-produce tests. This commercial, large-scale testing will be less feasible in developing countries, says Aubree Gordon, associate professor of epidemiology at the School of Public Health.
With a new grant from Open Philanthropy, the U-M team is scaling up protein production to help close this testing gap.
Gordon already works with several countries in Latin America, including Ecuador, which has been hit hard by COVID-19. While many of the countries have appropriate testing facilities, they lack capacity to mass produce the proteins and tests at necessary levels.
“Open Philanthropy is very interested in helping as many people as possible, which in this case means scientific advances that can improve health outcomes globally,” Gordon says. “And so, with their support, we’re hoping to produce proteins that can be used where other sources of tests are less available.”
The team has begun to send tests to national labs in Ecuador and Nicaragua. They hope to expand to Honduras and other Latin American countries.