Clinical Practice Guidelines From the Association for the Advancement of Blood and Biotherapies (AABB): COVID-19 Convalescent Plasma

Estcourt, Lise J; Cohn, Claudia S.; Pagano, Monica B.; Iannizzi, Claire; Kreuzberger, Nina; Skoetz, Nicole; Allen, Elizabeth S.; Bloch, Evan M.; Beaudoin, Gregory; Casadevall, Arturo; Devine, Dana V.; Foroutan, Farid; Gniadek, Thomas J.; Goel, Ruchika; Gorlin, Jed B.; Grossman, Brenda J.; Joyner, Michael J.; Metcalf, Ryan A.; Raval, Jay S.; Rice, Todd W.; Shaz, Beth H.; Vassallo, Ralph R.; Winters, Jeffrey L.; Tobian, Aaron A.R.

doi:10.7326/m22-1079

Cited by 60 publications

(74 citation statements)

References 64 publications

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“…These results, along with the recent data obtained from other trials and cohort studies may support the use of convalescent plasma in immunocompromised patients for whom therapeutic options are currently scarce. Accordingly, recent AABB guidelines suggest CCP transfusion in addition to standard of care for hospitalized patients with COVID-19 and pre-existing immunosuppression 32 .…”

Section: Discussionmentioning

confidence: 99%

COVID-19 convalescent plasma to treat hospitalised COVID-19 patients with or without underlying immunodeficiency: a randomized trial

Lacombe

Hueso

Porcher

et al. 2022

Preprint

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Background: Efficacy of COVID-19 convalescent plasma (CCP) in COVID-19 pneumonia is uncertain. Early transfusion of high antibody titre CCP may be beneficial, especially in case of underlying immunosuppression. Methods: The CORIPLASM study was a multicentric, open-label, Bayesian randomised clinical trial evaluating the efficacy of CCP in patients with moderate COVID-19 pneumonia, including patients with underlying immunosuppression. Patients hospitalised with COVID-19 for less than 9 days were assigned to receive 2 plasma units/day over 2 days (CCP) or usual care (UC) alone. Primary outcomes were the proportion of patients with a WHO-Clinical Progression Score (CPS) >= 6 on the 10-point scale on day 4 and survival without ventilation or additional immunomodulatory treatment by day 14. Main analysis was conducted on the whole population and a planned subgroup analysis was performed according to immunosuppression status. Findings: A total of 120 patients were recruited between April 16, 2020, and April 21, 2021, and assigned to CCP (n=60) or UC (n=60) with a 28 day-follow-up. The median time from symptoms onset to randomisation (days) was 7.0 [interquartile range (IQR) 5.0-9.0] and 7.0 [IQR 4.0-8.5] in CCP and UC, respectively. Thirteen (22%) patients with CCP had a WHO-CPS >= 6 at day 4 versus 8 (13%) with UC, adjusted odds ratio (aOR) 1.88 [95% confidence interval (CI), 0.71 to 5.24]. By d14, 19 (31.6%) patients with CCP and 20 (33.3%) patients with UC had ventilation, additional immunomodulatory treatment or had died. Cumulative incidence of death was 3 (5%) with CCP and 8 (13%) with UC at d14 (aHR 0.40 [95%CI 0.10 -1.53]), and 7 (12%) with CCP and 12 (20%) with UC at day 28 (aHR 0.51 [95% CI 0.20-1.32]). Subgroup analysis indicated that CCP might be associated with a lower mortality in patients with underlying immunosuppression (HR 0.37 [95% CI 0.14-0.97]). Serious adverse events were noted in 30 (50%) and 26 (43%) patients with CCP or UC, respectively. Interpretation: CCP treatment did not improve early outcomes in patients with mild-to-moderate form COVID-19 pneumonia but was associated with reduced mortality in the subgroup of immunosuppressed patients. Trial registration: clinicaltrials.gov Identifier: NCT04345991

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Section: Discussionmentioning

confidence: 99%

COVID-19 convalescent plasma to treat hospitalised COVID-19 patients with or without underlying immunodeficiency: a randomized trial

Lacombe

Hueso

Porcher

et al. 2022

Preprint

View full text Add to dashboard Cite

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“…Niches for CCP treatment of COVID-19 include outpatients who are at high risk for disease progression, hospitalized patients who do not have SARS-CoV-2 antibodies detected at admission or have preexisting immunosuppression and chronically infected patients, as recently recommended by AABB and FDA guidance [ 79 , 80 ].…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of COVID-19 Convalescent Plasma in Hospitalized Patients—An Open-Label Phase II Clinical Trial

Rastvorceva

Useini

Stevanović

et al. 2022

Life

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Background: COVID-19 convalescent plasma (CCP) is an important antiviral option for selected patients with COVID-19. Materials and Methods: In this open-label, phase 2, clinical trial conducted from 30 April 2020 till 10 May 2021 in the Republic of North Macedonia, we evaluated the efficacy and safety of CCP in hospitalized patients. Treatment was with a single unit of CCP having an anti-RBD IgG concentration higher than 5 AU/mL. Results: There were 189 patients that completed the study, of which 65 (34.4%) had WHO 8-point clinical progression scale score of 3 (requiring hospital care but not oxygen support), 65 (34.4%) had a score of 4 (hospitalized and requiring supplemental oxygen by mask or nasal prongs), and 59 (31.2%) had a score of 5 (hospitalized and requiring supplemental oxygen by non-invasive ventilation or high-flow oxygen). Mean age was 57 years (range 22–94), 78.5% were males, 80.4% had elevated body mass index, and 70.9% had comorbidity. Following CCP transfusion, we observed clinical improvement with increase rates in oxygenation-free days of 32.3% and 58.5% at 24 h and seven days after CCP transfusion, a decline in WHO scores, and reduced progression to severe disease (only one patient was admitted to ICU after CCP transfusion). Mortality in the entire cohort was 11.6% (22/189). We recorded 0% mortality in WHO score 3 (0/65) and in patients that received CCP transfusion in the first seven days of disease, 4.6% mortality in WHO score 4 (3/65), and 30.5% mortality in WHO score 5 (18/59). Mortality correlated with WHO score (Chi-square 19.3, p < 0.001) and with stay in the ICU (Chi-square 55.526, p ≤ 0.001). No severe adverse events were reported. Conclusions: This study showed that early administration of CCP to patients with moderate disease was a safe and potentially effective treatment for hospitalized COVID-19 patients. The trial was registered at clinicaltrials.gov (NCT04397523).

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“…Also, patients with advanced B-cell defects or other immunocompromised conditions lacking efficient antibody producing ability may benefit from passive immunisation [46][47][48][49][50]. Furthermore, the Association for the Advancement of Blood and Biotherapies recently published a clinical practice guideline for the appropriate use of CCP that suggests CCP transfusion in addition to the usual standard of care for selected patient groups, based on low-to-moderate-certainty pieces of evidence [51].…”

Section: Main Findings and Limitationsmentioning

confidence: 99%

Use of convalescent plasma therapy in hospitalised adult patients with non-critical COVID-19: a focus on the elderly from Hungary

et al. 2022

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Convalescent plasma therapy might be a feasible option for treatment of novel infections. During the early phases of the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic, several promising results were published with convalescent plasma therapy, followed by more disappointing findings of randomised controlled trials. In our single-centre, open-label, prospective, cohort study, we assessed the findings of 180 patients treated with convalescent plasma during the first four waves of the pandemic in Hungary. The primary outcome was all-cause mortality; secondary outcomes were clinical improvement and need for intensive care unit admission by day 28. Subgroup analysis comparing elderly and non-elderly (less than 65 years of age) was performed. Twenty (11.4%) patients died by day 28, at significantly higher rates in the elderly subgroup (3 vs. 17, p < 0.01). One hundred twenty-eight (72.7%) patients showed clinical improvement, and 15 (8.5%) were transferred to the intensive care unit until day 28. Non-elderly patients showed clinical improvement by day 28 in significantly higher rates (improvement 74 vs. 54, no improvement 15 vs. 11, worsening or death 4 vs. 18 patients, p < 0.01). In conclusion, we found similar clinical outcome results as randomised controlled trials, and the impact of risk factors for unfavourable clinical outcomes among patients in the elderly population.

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Clinical Practice Guidelines From the Association for the Advancement of Blood and Biotherapies (AABB): COVID-19 Convalescent Plasma

Abstract: The Association for the Advancement of Blood and Biotherapies developed clinical practice guidelines for the appropriate use of COVID-19 convalescent plasma. This article describes the evidence and rationale for recommendations for inpatient and outpatient treatment and prophylaxis.

Cited by 60 publications

References 64 publications

COVID-19 convalescent plasma to treat hospitalised COVID-19 patients with or without underlying immunodeficiency: a randomized trial

COVID-19 convalescent plasma to treat hospitalised COVID-19 patients with or without underlying immunodeficiency: a randomized trial

Efficacy and Safety of COVID-19 Convalescent Plasma in Hospitalized Patients—An Open-Label Phase II Clinical Trial

Use of convalescent plasma therapy in hospitalised adult patients with non-critical COVID-19: a focus on the elderly from Hungary

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