Administration of convalescent plasma full of antibody to hospitalized adult patients with COVID-19 who did not require mechanical ventilation was associated with a lower risk of death than transfusion of plasma with lower antibody density, according to a study published today in the New England Journal of Medicine.
Led by researchers at the Mayo Clinic in Rochester, Minnesota, the cohort study used a U.S.-wide record of COVID-19 adult patients from 680 hospitals and determined levels, or titers, of immunoglobulin G anti-SARS-CoV-2 (IgG) antibodies in plasma administered to recovered COVID-19 patients and transmitted to study participants through Jul 4, 2020 .The blood collection centers, researchers and study partners were blinded to the antibody concentrations at the time of transmission.
Among the 3,082 patients included in the analysis, all of whom had at least one risk factor for adverse coronavirus outcomes, 830 died (26.9%). One hundred and fifteen of 515 patients (22.3%) who received high-titer plasma died within 30 days of the patient, compared with 549 of 2,006 patients (27.4%) who were given moderate plasma titer, and 166 of 561 (29.6%) provided low titer plasma.
Of the 3,082 patients, 2,014 did not require mechanical ventilation before plasma transfusion. In this subgroup, 50 of 352 (14.2%) recipients of high-titer plasma died within 30 days, as did 251 of 1,297 patients (19.4%) who received mid-titer plasma, and 81 of 365 patients (22.2%) were given low -titer plasma.
This means that patients who did not receive mechanical ventilation provided by high-titer plasma within 30 days of remission had a 34% lower risk of death than those who received low-titer plasma (relative risk) [RR], 0.66).
No benefit in patients on mechanical ventilation
In contrast, convalescent plasma administered to the 1,068 COVID-19 patients receiving mechanical ventilation did not appear to alter the risk of death (RR, 1.02). In this subgroup, 64 of 158 patients (40.5%) in the high-titer group died within 30 days, against 277 of 666 patients (41.6%) in the middle-titer group, and 80 of 183 (43.7%) in the low level. -titer group.
The average time between COVID-19 diagnosis and plasma transfusion was 10.0 days for patients who received mechanical ventilation prior to transfusion – nearly twice the number of patients who did not require mechanical ventilation. The unchanged mortality rate within 30 days of relapse was lower in patients who received their referral within 3 days of diagnosis (point estimate, 22.2%) than in those who received the referral. some later in the course of the disease (point estimate, 29.5%).
The main variables associated with risk of death within 30 days, depending on importance, age, were signs of severe coronavirus infection (e.g., requiring aggressive mechanical ventilation, admission to an intensive care unit [ICU]), and antibody density.
Of all participants, 61% were male, 23% black, 37% Hispanic, and 69% younger than 70 years.
“These data show that convalescent plasma benefit was more pronounced in patients who received plasma transfusion containing higher levels of anti-SARS-CoV-2 IgG antibodies early in the course of the disease,” so -the authors closed.
Convalescent plasma has been used for over one hundred years to treat various types of viral respiratory diseases. Among the pandemic, plasma COVID-19 patients were given plasma on the assumption that the antibodies that counteract SARS-CoV-2, the virus that causes COVID-19, help them reduce serious disease. However, it is being investigated whether high levels of antibody are associated with a lower risk of death than low levels of antibody.
On August 23, 2020, the U.S. Food and Drug Administration approved emergency use for the use of convalescent plasma in hospitalized coronavirus patients with signs of exacerbated disease.
But the National Institutes of Health steering panel said, “There is not enough data for the COVID-19 Treatment Control Panel (the Panel) to recommend its use either for or against.” Previous Blood Banks of America) recommend limiting the use of convalescent plasma to clinical trials, noting that critically ill patients are unlikely to benefit and if plasma is used, it should be done alongside within 3 days of diagnosis to achieve optimal results.
Plasma preservation for high-risk patients
A report today in the same journal reflecting a Jan 6 convalescent plasma study found that early transmission of high-titer convalescent plasma into slightly ill older adults reduced COVID progression. -19.
In the statement, Louis Katz, MD, of the Mississippi Valley Regional Blood Center in Davenport, Iowa, noted that previous experiments on convalescent plasma in COVID-19 patients have produced mixed results. Observational studies, which cannot cause causation, have been more promising than randomized trials, considering the gold standard of the studies, regarding the efficacy of convalescent plasma in COVID-19 patients, he said.
Given these results and sometimes scarce plasma, Katz said convalescent plasma should be used in only slightly older COVID-19 patients, younger patients at high risk for severe disease, and some immunocompromised patients. Everything should be treated with high-titer plasma within 3 days of the onset of the symptom, he said.
“Uncontrolled convalescent plasma uncontrolled use should be discouraged in patients but those with early disease who are prone to progress to more serious illness, even though clinicians recognize the difficulty.” and could be ‘just standing there’ by a patient’s bedside. in the ICU, “Katz said.
“Restrictions on treatments for COVID-19 that are effective for limited patient numbers are a powerful argument for consistent adherence to recommended non-pharmacological interventions and rapid use and uptake of effective vaccines,” he said.