“Unfortunately, you cannot yet say whether the treatment works based on those publications,” says Rijnders. “These are small studies without control groups, so you cannot draw any firm conclusions from them. It seems that it is safe to give plasma with antibodies, but the books on this are not yet closed.”
In order to really get a good picture of the effect, Erasmus MC has therefore started large-scale research. With control group. The main question is whether the administration of plasma with antibodies against the new coronavirus reduces mortality in corona patients.
Some 426 corona patients will participate in the study. “These are patients who are hospitalized in a nursing ward or who recently ended up in intensive care,” says Rijnders. Because this is scientific research, patients or their representatives must give permission to participate.
Patients who enter the treatment group receive 300 milliliters of plasma with antibodies. That plasma is in addition to standard treatment. “All patients receive extra oxygen and, if necessary, ventilation and extra fluid,” says Rijnders. “Everyone is also given a course of antibiotics because we cannot exclude that corona patients also have a bacterial infection.”
The plasma comes from volunteers. Almost two weeks ago, Erasmus MC called on people to report if they have been tested positive for the virus and have been free of symptoms for at least two weeks. According to Rijnders, more than 2500 people have registered. “We make a pre-selection and then the Sanquin blood bank purchases plasma.”
Giving plasma to sick patients is not entirely without risks. “Dutch blood products are very safe,” says Rijnders. “But once we didn’t know that viruses like HIV and hepatitis existed and were transmitted through blood donations. Therefore, Sanquin tests donations for five blood-borne infections and Sanquin extensively surveys donors about behavior that may put them at risk of infection.”
Another risk is that patients develop a more severe inflammatory response. “Giving antibodies could potentially make the inflammation more severe, leading to a deterioration of the patient. The probability of this happening seems small, but we cannot yet rule it out completely. Therefore, a study of this magnitude is essential.”
A second study in the Netherlands into plasma for corona patients, including a control group, will start within a few weeks. In Leiden, Jaap Jan Zwaginga is working on a protocol for research in patients who are somewhat better off than the patients in the Rotterdam study.
The main question of the Leiden study is whether the antibodies in the plasma shorten the hospital stay. “In three weeks, we hope to give the first patients plasma,” says Zwaginga, professor of clinical transfusion medicine at the Leiden University Medical Center. He is aiming for a study with about 150 participants.
Rijnders expects the first results from Rotterdam in a few months.