Mortality Reduction in ICU-Admitted COVID-19 Patients in Suriname after Treatment with Convalescent Plasma Acquired Via Gravity Filtration

  1. Rosita Bihariesingh
  2. Rosita Bihariesingh
  3. R Bansie
  4. J Froberg
  5. N Ramdhani
  6. R Mangroo
  7. D Bustamente
  8. E Diaz
  9. I Thakoer
  10. S Vreden
  11. Z Choudhry
  12. W Jansen Klomp
  13. D A Diavatopoulos
  14. A Nierich

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Abstract

Introduction: Although convalescent plasma (CP) treatment is a potential therapeutic option for patients with COVID-19, there is a paucity of data from intensive care unit (ICU) patients with COVID-19 in low-resource settings, such as Suriname. CP was produced by a novel gravity-based filtration method. Methods: In an open-label, multi-center, non-randomized prospective clinical trial, patients with severe or life- threatening COVID-19 symptoms (n=28) with CP treatment were compared with standard treatment alone (n=50). A pre-planned interim analysis is reported. The primary endpoint was a 28-day ICU mortality. Secondary endpoints were changes two days after treatment initiation in pulmonary oxygen exchange capacity (PF ratio) and chest x-ray (CXR) score. Results: Mortality occurred in 18% (CP: 5/28) vs. 36% (Control:18/50). CP treatment of severe COVID-19 resulted in a higher probability of survival, with a hazard ratio (HR) of 0.22 (95% CI, 0.074-0.067), correcting for age, the presence of diabetes and COVID-19 severity. In the severe group, CP resulted in an improved CXR score (P = 0.0013) and increase in PF ratio (P = 0.011) as compared to standard therapy. The gravity-based plasmapheresis method used for CP production was well-tolerated and no adverse events were observed in the donors. Discussion: CP therapy in combination with standard treatment resulted in 78% reduction of 28-day ICU mortality (HR = 0.22) compared to standard treatment alone. Both CXR-score and PF ratio changes represent effective indicators for the treatment effect of CP after two days. The novel CP production method was effective and represents a practical solution for Low- and middle-income countries to produce CP.

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  1. Version published to 10.31487/j.acr.2021.02.03
  2. ScreenIT

    SciScore for 10.1101/2021.04.14.21255104: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    EthicsIRB: Ethical approval was granted by the Suriname Ministry of Health’s Ethics Review Board (registration number:IGAP02-482020; ISRCTN18304314) and was performed in accordance with the declaration of Helsinki.
    Consent: The eligibility criteria included written informed consent given by the patient or next-of-kin, a PCR confirmed diagnosis of COVID-19, and admittance to the ICU due to progressive respiratory failure ranging between severe and life threatening ARDS based on the Berlin classification9.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    BlindingEach lung zone was scored between 0 and 3, leading to an overall “CXR-SCORE”, ranging from 0 to 18: Chest x-rays were examined immediately prior to (day 0) and two days after (day 2) CP administration, or on day 0 and day 2 following inclusion in de the control group by two independent radiologists blinded to group assignment.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Eligibility criteria for donating CP were a positive response measured as optical densitometry (OD) levels of the anti-SARS-CoV-2 total IgG antibody Wantai test13, being at least 14 days asymptomatic following resolution of COVID-19 and having two negative PCR-tests from nasopharyngeal swabs.
    anti-SARS-CoV-2 total IgG
    suggested: None
    Software and Algorithms
    SentencesResources
    General descriptive characteristics were assessed using SPSS for Windows (version 16.0; SPSS).
    SPSS
    suggested: (SPSS, RRID:SCR_002865)

    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:
    Another limitation is the relative small number of patients. Based on the results of this trial, new patients are being enrolled which may provide further evidence on the potential beneficial effects of CP. Further characterization of the CP used in this study is needed to fully ascertain its efficacy and correlate variation in plasma factors to clinical outcome in CP recipients. In summary, COVID-19 remains a global health threat and reliable treatment is crucial for reducing mortality and the burden on global health care. Access to CP therapy in a low-resource setting was enabled by the novel filtration device Hemoclear, which was easy to implement in an ICU setting and was used without adverse effects on both the donor as the CP recipients 41,42. Equitable access to such methods allows readiness in case of viral mutations or new pandemics. The use of simple and available methods such as chest x-ray and calculated PF ratios allowed early assessment of treatment effects. SARS-CoV-2-specific therapies, including CP from recovered patients, could be highly effective options to treat COVID-19 in the absence of widespread vaccination. As such, CP therapy may help bridge the gap until sufficient vaccination coverage has been reached.

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    ISRCTN18304314NANA

    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.

    About SciScore

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  3. Version published to 10.1101/2021.04.14.21255104v1 on medRxiv