Clinical and laboratory evaluation of patients with SARS-CoV-2 pneumonia treated with high-titer convalescent plasma
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SciScore for 10.1101/2020.07.20.20156398: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Individuals who agreed to participate and gave informed consent were evaluated at the John Theurer Cancer Center where they underwent a physical examination, completed a donor health questionnaire, had a nasopharyngeal swab for SARS-CoV-2 and blood drawn for complete blood count and chemistry, infectious disease markers, and HLA antibodies for female donors.
IRB: Study registration: The study is registered with ClinicalTrials.gov NTC04343755, FDA IND approval obtained 4/4/2020 and approved by our Institutional Review Board.Randomization not detected. Blinding not detected. Power Analysis The design for each track had a type I error rate of 0.1 with … SciScore for 10.1101/2020.07.20.20156398: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Individuals who agreed to participate and gave informed consent were evaluated at the John Theurer Cancer Center where they underwent a physical examination, completed a donor health questionnaire, had a nasopharyngeal swab for SARS-CoV-2 and blood drawn for complete blood count and chemistry, infectious disease markers, and HLA antibodies for female donors.
IRB: Study registration: The study is registered with ClinicalTrials.gov NTC04343755, FDA IND approval obtained 4/4/2020 and approved by our Institutional Review Board.Randomization not detected. Blinding not detected. Power Analysis The design for each track had a type I error rate of 0.1 with statistical power of at least 0.8. Sex as a biological variable Individuals who agreed to participate and gave informed consent were evaluated at the John Theurer Cancer Center where they underwent a physical examination, completed a donor health questionnaire, had a nasopharyngeal swab for SARS-CoV-2 and blood drawn for complete blood count and chemistry, infectious disease markers, and HLA antibodies for female donors. Cell Line Authentication not detected. Table 2: Resources
Antibodies Sentences Resources Prospective plasma donors were included if they were aged 18 to 60 years, had a history of a positive nasopharyngeal swab for COVID-19 or a positive antibody test, were at least 14 days from resolution of symptoms, had one subsequent negative swab, were found to have high titers of neutralizing antibodies against SARS-CoV-2 (>1:500), and met institutional and FDA regulations for donation of blood products. SARS-CoV-2suggested: NoneExperimental Models: Cell Lines Sentences Resources Final assay conditions were 30,000 Vero E6 cells per well and virus at a MOI of 0.01-0.05 in 200 ul. Vero E6suggested: NoneResults 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:Limitation of this study: Our study was limited by the lack of randomization to a control group, and the access to patients early in the disease course, where antiviral interventions is presumed to be of greatest impact. Our study was also not powered or designed to evaluate the optimal donor antiviral titer level, or the optimal dose of IgM and IgG to be infused. We are conducting a randomized study of convalescent plasma in high-risk patients with early onset disease with the aim of reducing hospitalizations.
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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