Operational protocol for donation of anti‐COVID‐19 convalescent plasma in Italy

Franchini, Massimo; Marano, Giuseppe; Velati, Claudio; Pati, Ilaria; Pupella, Simonetta; Liumbruno, Giancarlo Maria

doi:10.1111/vox.12940

Cited by 50 publications

(52 citation statements)

References 4 publications

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“…Although neither the U.S. Food and Drug Administration (FDA) (24) nor the European Center for Disease Control (ECDC) is recommending pathogen reduction technologies (PRT) for CP (25), several national authorities consider that, under emergency settings, donor screening and conventional viral nucleic acid testing (NAT) (i.e., HIV, hepatitis C virus [HCV], and hepatitis B virus [HBV] NAT) would not be enough to ensure CP safety (12). Under this scenario, additional virological testing and PRT approximately double the final cost of the therapeutic dose.…”

Section: Technologies To Virally Reduce Plasma (Pathogen Inactivation)mentioning

confidence: 99%

“…Convalescent donor testing for neutralizing antibodies is mandatory in upstream donor selection. Donor selection is generally based on neutralizing antibody titer, as assessed with a plaque reduction neutralization test (PRNT) ( 12 ), which requires a viable isolate, replication-competent cell lines, and skilled personnel. Since PRNT takes time to be set up and requires expensive facilities, in resource-poor settings or in time-sensitive scenarios, collection based on a retrospective PRNT or, alternatively, on an enzyme-linked immunosorbent assay (ELISA) targeting the recombinant receptor binding domains (RBDs) of the viral antireceptor has often been implemented; under these circumstances, studies have suggested that ELISA ratios/indexes have good correlations with PRNT titers; e.g., the Euroimmun ELISA IgG score detected 60% of samples with PRNT titers of >1:100, with 100% specificity using a signal/cutoff reactivity index of 9.1 ( 13 ).…”

Section: Cp Donor Recruitment Strategiesmentioning

confidence: 99%

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Convalescent Plasma Therapy for COVID-19: State of the Art

Focosi¹,

et al. 2020

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SUMMARY Convalescent plasma (CP) therapy has been used since the early 1900s to treat emerging infectious diseases; its efficacy was later associated with the evidence that polyclonal neutralizing antibodies can reduce the duration of viremia. Recent large outbreaks of viral diseases for which effective antivirals or vaccines are still lacking has renewed the interest in CP as a life-saving treatment. The ongoing COVID-19 pandemic has led to the scaling up of CP therapy to unprecedented levels. Compared with historical usage, pathogen reduction technologies have now added an extra layer of safety to the use of CP, and new manufacturing approaches are being explored. This review summarizes historical settings of application, with a focus on betacoronaviruses, and surveys current approaches for donor selection and CP collection, pooling technologies, pathogen inactivation systems, and banking of CP. We additionally list the ongoing registered clinical trials for CP throughout the world and discuss the trial results published thus far.

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Section: Technologies To Virally Reduce Plasma (Pathogen Inactivation)mentioning

confidence: 99%

Section: Cp Donor Recruitment Strategiesmentioning

confidence: 99%

Convalescent Plasma Therapy for COVID-19: State of the Art

Focosi¹,

et al. 2020

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“…the viral RNA-dependent RNA polymerase inhibitor remdesivir, chloroquine, hydroxychloroquine (Gao et al, 2020;Luo et al, 2020), are being evaluated in accelerated clinical trials (Gao et al, 2020). Increased attention is being devoted to convalescent plasma collected from recovered COVID-19 patients, which at this time represents the only available highly-specific and promising antiviral option currently under clinical trials (Franchini et al, 2020).…”

mentioning

confidence: 99%

Repositioning Chromones for Early Anti-inflammatory Treatment of COVID-19

Sestili

Stocchi

2020

Front. Pharmacol.

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The COVID-19 pandemic is posing an unprecedented sanitary threat. In the absence of specific vaccines and anti-SARS-CoV-2 drugs, medicines that may assist in tackling the emergency and limiting the high number of fatalities are urgently needed. The repositioning of available drugs to treat COVID-19 is the only and rapid option in the face of the lack of direct antiviral agents and vaccines available. In this light it is important to focus on available drugs, which, based on their pharmacodynamics, could plausibly attenuate viral growth as well as COVID-19's worst complications. This is the case of chloroquine and tocilizumab which seem to limit virus replication and the severity of interstitial pneumonia, respectively. However, these treatments, particularly those aimed at containing inflammation, are still reserved for the most severe cases. This commentary elaborates on the pharmacological rationale of repositioning the mast cell stabilizer chromones as an adjunctive treatment for SARS-CoV-2 infection, and proposes their practical clinical testing as an early, safe, and cost-effective anti-inflammatory intervention in COVID-19 to limit the eventual secondary progression toward life-threatening respiratory complications.

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“…Additional molecular tests for detection of hepatitis A virus, hepatitis E virus, and parvovirus B19, and neutralizing titer for SARS-CoV-2 will be performed according to the recommendations from Italian National Blood Center (CNS) for donation of anti-COVID-19 convalescent plasma. 19 Pathogen reduction of plasma is also performed before freezing or transfusion. Every plasmapheresis is divided into two 250 to 300 mL units, each of which is used to treat one patient with severe COVID-19 infection.…”

mentioning

confidence: 99%

“…This could generate a problem for recovered health care personnel who thus must donate plasma before their return to operational medical COVID units. 19,20 A consistent proportion of convalescent plasma donors is represented by recovered periodic voluntary blood donors belonging to blood donor associations and this is very important as it increases the safety of collected blood. Potential convalescent plasma donors are retrieved from a local registry of patients who were infected with COVID-19 and are usually contacted by telephone by a doctor or health care personnel who performs an initial anamnestic screening to discover possible contraindications to plasma donations.…”

mentioning

confidence: 99%