Infectious Disease

Early convalescence plasma cannot prevent the progression of COVID-19 in high risk outpatients

August 18, 2021

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Callaway does not report any relevant financial information. Please refer to the study for all relevant financial information from the other authors.

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COVID-19 convalescent plasma given within 7 days of the onset of symptoms did not appear to prevent disease progression in high-risk outpatients with COVID-19, according to study results published in the New England Journal of Medicine.

“Giving convalescent plasma from patients who have recovered from infection has been a strategy for treating newly infected patients for over 100 years, but this strategy has rarely been rigorously tested.” Clifton W. Callaway, MD, PhD, Professor and vice chairman of emergency medicine and Ronald D. Stewart chairman of emergency medicine research at the University of Pittsburgh, Healio said. “Especially for newly emerging infections for which there is no known therapeutic agent, convalescent plasma could be the first available treatment.”

COVID-19 convalescent plasma given within 7 days of the onset of symptoms did not appear to prevent disease progression in high-risk outpatients with COVID-19.

Data derived from Korley FK et al. N Engl J Med. 2021; doi: 10.1056 / NEJMoa2103784.

This strategy was used at the start of the COVID-19 pandemic when many patients were receiving convalescent plasma, Callaway added.

Clifton W. Callaway, MD, PhD (Image credit: UPMC)

Clifton W. Callaway (Source: UPMC)

“We used this situation to test whether COVID-19 convalescent plasma actually reduced the progression of the disease,” he said. “We started our experiment to test whether the plasma was effective at an early stage of the disease when we thought it would have the best chance of having an effect. We have selected patients at risk for serious illness, including those with risk factors and / or older age groups, so that we have enough events to investigate. “

The randomized, multicenter, single-blind study enrolled 511 patients (mean age 54 years) with COVID-19 symptoms in 48 hospital emergency rooms in 21 states. All patients presented to the emergency room within 7 days of onset of symptoms (median duration of symptoms 4 days) and were in stable condition for outpatient treatment. Study participants received either one unit of convalescent plasma with high-titre antibodies against the severe acute respiratory syndrome COVID-19 (n = 257; 52.5% women; 66.9% white) or placebo (n = 254; 54.7% women; 65%) white). The mean titer of the neutralizing COVID-19 antibodies was 1: 641 in the donor’s convalescent plasma samples.

Common risk factors for severe COVID-19 in patients in the convalescent plasma group and placebo group were age 50 or older (60.3% vs. 61%), BMI of 30 kg / m2 or more (59.1% for both ), High blood pressure (40.9.). % vs. 43.7%), current or previous tobacco consumption (31.5% vs. 28%), diabetes (29.6% vs. 26%) and chronic obstructive pulmonary disease or asthma (21.8% vs. 26%) 8th%).

The primary endpoint was disease progression within 15 days of randomization. The secondary endpoints were worst disease severity on an eight-point ordinal scale, hospital-free days within 30 days of randomization and death from any cause.

The results showed that disease progression occurred in 30% of patients in the convalescent plasma group compared to 31.9% in the placebo group, a risk difference of 1.9 percentage points (95% CI, 6 to 9.8; Posterior probability of superiority of convalescent plasma, 0.68.)).

Five patients who received convalescent plasma died compared with one in the placebo group. The researchers observed similar results between the convalescence plasma and placebo groups in terms of severity of worst illness and average number of days off hospital (28.3 vs. 28.6; mean percentage point difference 0.3; 95% – KI 0.4 to 1.1).

“Time to worsening, severity of worst illness, mortality, and hospital-free days did not differ between the convalescent plasma and placebo groups, and we did not see a subgroup with different responses to treatment,” Callaway said. “That was all surprising because we had expected that passive immunization with convalescent plasma would change the course of the disease somewhat. These data may suggest that post-infection disease severity is related to the host’s response to the infection – how much inflammation there is in the lungs – than to how antibodies clear the virus, as most patients do over time make their own antibodies. “

Future research will include an assessment of COVID-19 antibody levels after infusion between collected plasma samples from patients in the current study, Callaway added.

“We will investigate whether the convalescent plasma altered the endogenous antibody response, whether the baseline antibody levels altered the treatment response, and whether the transfused plasma actually increased the recipient’s humoral immunity,” said Callaway. “With the same plasma samples, we can also examine the inflammatory reactions to the infection and whether the transfusion has changed this at all.”

For more informations:

Clifton W. Callaway, MD, PhD, available at the University of Pittsburgh, 400A Iroquois, 3600 Forbes Ave., Pittsburgh, PA 15260; Email: callawaycw@upmc.edu.

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