Treatment of severe COVID-19 with convalescent plasma in Bronx, NYC
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Abstract
Convalescent plasma with severe acute respiratory disease coronavirus 2 (SARS-CoV-2) antibodies (CCP) may hold promise as a treatment for coronavirus disease 2019 (COVID-19). We compared the mortality and clinical outcome of patients with COVID-19 who received 200 mL of CCP with a spike protein IgG titer ≥ 1:2430 (median 1:47,385) within 72 hours of admission with propensity score–matched controls cared for at a medical center in the Bronx, between April 13 and May 4, 2020. Matching criteria for controls were age, sex, body mass index, race, ethnicity, comorbidities, week of admission, oxygen requirement, D-dimer, lymphocyte counts, corticosteroid use, and anticoagulation use. There was no difference in mortality or oxygenation between CCP recipients and controls at day 28. When stratified by age, compared with matched controls, CCP recipients less than 65 years had 4-fold lower risk of mortality and 4-fold lower risk of deterioration in oxygenation or mortality at day 28. For CCP recipients, pretransfusion spike protein IgG, IgM, and IgA titers were associated with mortality at day 28 in univariate analyses. No adverse effects of CCP were observed. Our results suggest CCP may be beneficial for hospitalized patients less than 65 years, but data from controlled trials are needed to validate this finding and establish the effect of aging on CCP efficacy.
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SciScore for 10.1101/2020.12.02.20242909: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Patients or their legally authorized representatives provided informed consent prior to treatment.
IRB: Study approval: The retrospective cohort study, the donor plasma procurement protocol and the use of the expanded access protocol was approved by the Albert Einstein College of Medicine Institutional Review Board.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Cell Line Authentication not detected. Table 2: Resources
Antibodies Sentences Resources Exploratory outcomes were associations between pre-CCP SARS-CoV-2 antibody titers and mortality at day 28. SARS-CoV-2suggested: NoneLog-transformed… SciScore for 10.1101/2020.12.02.20242909: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Patients or their legally authorized representatives provided informed consent prior to treatment.
IRB: Study approval: The retrospective cohort study, the donor plasma procurement protocol and the use of the expanded access protocol was approved by the Albert Einstein College of Medicine Institutional Review Board.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Cell Line Authentication not detected. Table 2: Resources
Antibodies Sentences Resources Exploratory outcomes were associations between pre-CCP SARS-CoV-2 antibody titers and mortality at day 28. SARS-CoV-2suggested: NoneLog-transformed SARS-CoV-2 spike protein antibody titers were individually added to select models to evaluate their association with each outcome. Log-transformed SARS-CoV-2 spike proteinsuggested: NoneExperimental Models: Cell Lines Sentences Resources Briefly, CCP samples were serially diluted and incubated with pre-titrated amounts of virus for 1 hr at RT, plasma-virus mixtures were added to 96-well plates (Corning) containing monolayers of Vero cells, incubated for 7 hr at 37°C/5% CO2, fixed with 4% paraformaldehyde (Sigma) in PBS, washed with PBS, and stored in PBS containing Hoechst-33342 (1:2,000 dilution; Invitrogen) Verosuggested: NoneSoftware and Algorithms Sentences Resources The serum half-maximal inhibitory concentration (NC50) was calculated using a nonlinear regression analysis with GraphPad Prism software. GraphPad Prismsuggested: (GraphPad Prism, RRID:SCR_002798)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:A major limitation of this study is its retrospective and non-randomized study design. The retrospectively identified controls differed in baseline characteristics from the cases, most notably in baseline oxygen requirement, proportion of corticosteroid use and baseline lymphocyte counts, suggesting a mismatch in severity of illness due to selection bias. While propensity score matching and multivariable analysis with adjustments were done to correct for confounding variables, there likely were additional latent and unmeasured variables that were not adjusted for. In addition, time-dependent variables such as hospital bed capacity during surge conditions and advances in clinical practice, such as use of proning techniques, lung protective ventilation strategies, improvement in sedation, may not have been accounted for in our analysis, despite matching and adjusting for baseline week. In addition, poor or absent documentation of oxygen requirement and inconsistencies in obtaining inflammatory markers during the height of the pandemic resulted in missing data, precluding a more complete analysis. Finally, since we could not obtain antibody data for controls, we cannot assess CCP effects on antibody levels. In summary, we report that CCP administration within 72 hours of hospitalization demonstrated a possible signal of reduced mortality in patients < 65 years. Similar to others, we found CCP was safe with no adverse events directly attributable to transfusion (21, 73, 74). Alth...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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