In experimental treatments, Connecticut hospitals are using blood plasma from recovered coronavirus patients to help those who are still sick
Medical professionals are beginning trials and experimental treatments that involve taking blood plasma — which is the fluid component of blood — from recovered coronavirus patients and infusing it into the bloodstreams of severely ill patients. The plasma from the recovered patients contains antibodies, which help the human body fight pathogens such as bacteria and viruses.
While still unproven on a large scale, the theory is that a recovered COVID-19 patient’s antibodies should also help fight the disease in patients who are still sick.
“If you can take that same plasma and infuse it into a patient that’s in the ICU or really compromised, you can fight the infection with the antibodies from the [plasma],” said Dr. Justin Lundbye, chief medical officer at Waterbury Hospital. “Those antibodies will then go after the virus and kill it.”
Trinity Health was the first hospital system with Connecticut locations to begin a clinical trial using the plasma therapy, although Yale New Haven Health is applying for approval of a trial. The Yale New Haven Health, Nuvance Health and Hartford HealthCare systems are also using blood plasma in a more traditional, non-trial setting.
A number of hospitals across the state, including the Hartford HealthCare and Yale New Haven Health systems, are gearing up to provide convalescent plasma transfusions outside of the scope of a clinical trial, in a less rigorous program that the FDA refers to as “expanded access.” (In the meantime, Yale New Haven Health is also applying to conduct its own clinical trial.)
Although medical professionals around the world are now studying convalescent plasma, they have not yet proven whether it’s effective in treating COVID-19.
However, both Hussain, of Trinity Health, and Dr. Mahalia Desruisseaux of Yale New Haven Health pointed to promising results out of a small Chinese study of five critically ill COVID-19 patients. In that study, three of the patients were released from the hospital and two were stabilized after convalescent plasma treatment.
Another Chinese study showed similar results but was again very small, with only 10 patients.
Hussain also pointed to the track record of convalescent plasma in fighting other viral epidemics, from before COVID-19 came on the scene. When treated with convalescent plasma, patients had a better chance of beating Ebola, H1N1 and SARS, previous studies have found.
Trinity Health was one of the first four health systems in the U.S. to gain approval for a clinical trial of convalescent plasma. The health system has hospitals across Connecticut and Massachusetts, including St. Francis Hospital and Medical Center in Hartford and Mercy Medical Center in Springfield.
Hussain said the health system rushed to apply for a clinical trial after reading about the five-patient study in China. The study was small and didn’t have a comparison group, but Hussain said the results were attention-grabbing nonetheless.
“It’s amazing that [three patients] were able to go home,” Hussain said. “We thought, ‘We need to look into this and see what we can give our patients.’ ”
The hospital system is already using other treatments, such as hydroxychloroquine, for moderately ill patients, but there currently is no viable treatment for severely ill patients, Hussain said. So Trinity Health decided to target severely ill patients with the convalescent plasma trial.
“There isn’t really anything out there that we’re using for severe disease," Hussain said.
Dr. Latha Dulipsingh of St. Francis said on Thursday that the Trinity Health system hopes to give the first convalescent plasma transfusion by late this week. Dulipsingh said the hospital system will share results once it has enrolled 10 to 15 patients.
But Hussain said the health system will enroll as many patients as possible, in order to strengthen the study’s statistical analysis. He estimated the health system should be able to release data in about a month. The study will focus mainly on whether the treatment increases patients’ chances of survival.
“The primary outcome definitely is mortality,” Hussain said. “We want to make sure we’re able to save these patients.”
In lieu of clinical trials, some hospitals are using convalescent plasma under a protocol that the FDA dubs “expanded access." This approach, more similar to the typical in-patient treatment process, does not come with many of the requirements of a more formal clinical trial and is designed for patients who cannot participate in trials.
Under the expanded access protocol, only the most severely ill COVID-19 patients can be treated with convalescent plasma. Desruisseaux, at Yale New Haven Health, said some patients who are not yet critically ill may also be treated, if their doctors determine that they will soon become critically ill.
The Hartford HealthCare, Nuvance Health and Yale New Haven Health systems are gearing up to administer convalescent plasma under this protocol. The systems are receiving blood plasma from partner blood centers, such as the Rhode Island Blood Center and the American Red Cross.
The Yale New Haven Health system was scheduled to receive its first convalescent plasma unit on Tuesday morning, according to Tormey. Nuvance Health, which includes Danbury and Norwalk hospitals, has said it is recruiting a program that will start later this month. And Hartford HealthCare’s Dr. Ajay Kumar said the convalescent plasma program has not yet started in the hospital system, but “will begin as soon as we identify the patients.”
Medical professionals are beginning trials and experimental treatments that involve taking blood plasma — which is the fluid component of blood — from recovered coronavirus patients and infusing it into the bloodstreams of severely ill patients. The plasma from the recovered patients contains antibodies, which help the human body fight pathogens such as bacteria and viruses.
While still unproven on a large scale, the theory is that a recovered COVID-19 patient’s antibodies should also help fight the disease in patients who are still sick.
“If you can take that same plasma and infuse it into a patient that’s in the ICU or really compromised, you can fight the infection with the antibodies from the [plasma],” said Dr. Justin Lundbye, chief medical officer at Waterbury Hospital. “Those antibodies will then go after the virus and kill it.”
Trinity Health was the first hospital system with Connecticut locations to begin a clinical trial using the plasma therapy, although Yale New Haven Health is applying for approval of a trial. The Yale New Haven Health, Nuvance Health and Hartford HealthCare systems are also using blood plasma in a more traditional, non-trial setting.
A number of hospitals across the state, including the Hartford HealthCare and Yale New Haven Health systems, are gearing up to provide convalescent plasma transfusions outside of the scope of a clinical trial, in a less rigorous program that the FDA refers to as “expanded access.” (In the meantime, Yale New Haven Health is also applying to conduct its own clinical trial.)
Although medical professionals around the world are now studying convalescent plasma, they have not yet proven whether it’s effective in treating COVID-19.
However, both Hussain, of Trinity Health, and Dr. Mahalia Desruisseaux of Yale New Haven Health pointed to promising results out of a small Chinese study of five critically ill COVID-19 patients. In that study, three of the patients were released from the hospital and two were stabilized after convalescent plasma treatment.
Another Chinese study showed similar results but was again very small, with only 10 patients.
Hussain also pointed to the track record of convalescent plasma in fighting other viral epidemics, from before COVID-19 came on the scene. When treated with convalescent plasma, patients had a better chance of beating Ebola, H1N1 and SARS, previous studies have found.
Trinity Health was one of the first four health systems in the U.S. to gain approval for a clinical trial of convalescent plasma. The health system has hospitals across Connecticut and Massachusetts, including St. Francis Hospital and Medical Center in Hartford and Mercy Medical Center in Springfield.
Hussain said the health system rushed to apply for a clinical trial after reading about the five-patient study in China. The study was small and didn’t have a comparison group, but Hussain said the results were attention-grabbing nonetheless.
“It’s amazing that [three patients] were able to go home,” Hussain said. “We thought, ‘We need to look into this and see what we can give our patients.’ ”
The hospital system is already using other treatments, such as hydroxychloroquine, for moderately ill patients, but there currently is no viable treatment for severely ill patients, Hussain said. So Trinity Health decided to target severely ill patients with the convalescent plasma trial.
“There isn’t really anything out there that we’re using for severe disease," Hussain said.
Dr. Latha Dulipsingh of St. Francis said on Thursday that the Trinity Health system hopes to give the first convalescent plasma transfusion by late this week. Dulipsingh said the hospital system will share results once it has enrolled 10 to 15 patients.
But Hussain said the health system will enroll as many patients as possible, in order to strengthen the study’s statistical analysis. He estimated the health system should be able to release data in about a month. The study will focus mainly on whether the treatment increases patients’ chances of survival.
“The primary outcome definitely is mortality,” Hussain said. “We want to make sure we’re able to save these patients.”
In lieu of clinical trials, some hospitals are using convalescent plasma under a protocol that the FDA dubs “expanded access." This approach, more similar to the typical in-patient treatment process, does not come with many of the requirements of a more formal clinical trial and is designed for patients who cannot participate in trials.
Under the expanded access protocol, only the most severely ill COVID-19 patients can be treated with convalescent plasma. Desruisseaux, at Yale New Haven Health, said some patients who are not yet critically ill may also be treated, if their doctors determine that they will soon become critically ill.
The Hartford HealthCare, Nuvance Health and Yale New Haven Health systems are gearing up to administer convalescent plasma under this protocol. The systems are receiving blood plasma from partner blood centers, such as the Rhode Island Blood Center and the American Red Cross.
The Yale New Haven Health system was scheduled to receive its first convalescent plasma unit on Tuesday morning, according to Tormey. Nuvance Health, which includes Danbury and Norwalk hospitals, has said it is recruiting a program that will start later this month. And Hartford HealthCare’s Dr. Ajay Kumar said the convalescent plasma program has not yet started in the hospital system, but “will begin as soon as we identify the patients.”
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