MILWAUKEE – Two new clinical trials will begin this week testing plasma from patients who have recovered from COVID-19 on people who have been exposed to the virus, or are in the early stages of the disease.
Doctors at Johns Hopkins University in Baltimore are leading the trials, which will take place there and at 15 other sites across the country.
Already more than 16,000 Americans with COVID-19 have been infused with plasma from recovered patients under the U.S. government's expanded use program, and early reports have found no major safety issues.
A very small preliminary study released late last week found that the death rate of those infused with survivor plasma was about half that of similar patients who did not receive the plasma.
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Separate tests of the antiviral drug remdesivir have shown that it shortens the hospital stays of COVID-19 patients.
To date, doctors have no vaccine or universally accepted treatment to fight COVID-19, which has killed 350,000 people worldwide and nearly 100,000 in the U.S.
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Survivor plasma, remdesivir tackle virus in different ways
Plasma from survivors gives patients an immediate injection of virus-fighting antibodies, so that they don't have to wait for their own immune systems to kick in. The use of plasma from survivors to treat those sick with the same illness goes back more than a century and has been used to stem outbreaks of poliomyelitis, measles, mumps and influenza.
Remdesivir kills the virus by stopping it from making copies of itself.
Though very different treatments, plasma and remdesivir may prove useful in combination.
"I don't think they will conflict with one another," Arturo Casadevall, chairman of molecular microbiology and immunology at Johns Hopkins Bloomberg School of Public Health.
Last week's small plasma study occurred at only one site, The Mount Sinai Hospital in New York. Multi-site studies are considered more reliable. And although last week's study matched each COVID-19 patient who received plasma with similar patients who did not, it was not a randomized controlled trial, considered the gold standard for scientific comparison.
The two new studies, however, will be Phase 2 randomized controlled clinical trials. Patients will be chosen at random to either receive survivor plasma, or ordinary plasma donated earlier in 2019 before the virus was detected.
Phase 1 clinical trials test the safety of a new drug or treatment; Phase 2 trials measure their effectiveness in combating a specific disease.
The new studies underway this week will test plasma on two groups.
The first group includes health care workers who have either had prolonged exposure to a COVID-19 patient while not wearing a mask, or have had exposure without a mask to a patient receiving CPR or insertion of a breathing tube, procedures that generate aerosolized virus. This first trial will involve 150 patients — 75 treated with survivor plasma, 75 with ordinary plasma.
The second group consists of 300 patients, all of whom have tested positive or showed symptoms of the disease within the last 10 days.
"I'm trying to avert hospitalizations and deaths. That's really going to be what brings America back to functioning," said David Sullivan, an infectious disease doctor at the Johns Hopkins Hospital who is leading the 300-patient trial and also working on the 150-patient trial.
He said it will be easier for people to return to work if they can be confident that there is much less risk of hospitalization, should they catch the virus.
He suggested, too, that if plasma proves successful in these circumstances, members of the military, the White House, meat packers and other essential workers could receive a plasma infusion once every two months for protection.
Both of the new clinical trials will use survivor plasma known to have high antibody levels, something that is not always true at the hospitals that have been using plasma. About 30% of the people who recover from COVID-19 do not have high enough antibody levels to make their plasma suitable for treating a patient who is still sick.Typically hospitals do not measure the antibody levels.
Both studies will check in on the patients on Days 1, 7, 14, 28 and 90.
What happens if the plasma works as a treatment?
Testing patients early in the disease could prove vital if doctors have to deal with outbreaks at nursing homes or aboard Navy ships.
"If the plasma works, we could come into a nursing home where they've had one person test positive and have a swarm approach," said Shmuel Shoham, an infectious disease expert at Johns Hopkins Medicine who is collaborating with Sullivan on both trials.
"The idea is let's create a ring of protection around that person that will last."
Sullivan said if there's an outbreak on a ship, doctors could give everyone around the initial patients plasma and avoid the risks involved in bringing into port a ship full infected sailors.
Both doctors are optimistic that enough Americans who have survived COVID-19 and have suitable antibody levels in their plasma will agree to donate.
"Mark our words," Sullivan said, "Americans will donate high antibody plasma to protect other Americans and to protect our military readiness."
Plasma can be frozen and used for up to a year. Sullivan said that if the trials prove successful, the nation should build up a stockpile of high antibody plasma to prepare for future outbreaks.
Other sites involved in the two plasma clinical trials include University of California, Los Angeles, University of Alabama and the Navajo Nation.
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