Clinical Efficacy of Early Administration of Convalescent Plasma among COVID-19 Cases in Egypt

  1. Noha Asem
  2. Hossam Hosny Massoud
  3. Ihab Serag
  4. Mohamed Hassany
  5. Gehan ElAssal
  6. Akram Abdelbary
  7. Marwa Mohsen
  8. Amin Abdel Baki
  9. Samy Zaky
  10. Wagdy Amin
  11. Ehab Kamal
  12. Hamdy Ibrahem
  13. Ahmed Said Abdel Mohsen
  14. Mohamed Ibrahem
  15. Mohamed Ahmed Ali
  16. Nancy Elgendy
  17. Salwa Hassan
  18. Naguib Naguib Nassif Shenouda
  19. Mohamed Abdelhamed Fathy
  20. Hala Zaid

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Abstract

Background: The rapid worldwide spread of the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) or COVID-19 pandemic from its epicentre; Wuhan has led to an epidemiological breakdown. Egypt reported its first COVID-19 case on Feb 14, 20202,3. Thereafter, Egypt scaled-up preventive measures, with a partial lockdown starting on March 25. Several therapeutic agents along with Convalescent Plasma Transfusion are under investigation and data from Convalescent Plasma Transfusions (CPT) have been receiving a lot of attention, after Emergency approvals from the Food and Drug Administration (FDA) suggesting that it may provide a clinical effect in the treatment of SARS-COV-2 Importance: Early and effective treatment of COVID-19 is vital for control of SARS-CoV-2 infection Methods: -Designs: An interventional, single-arm, non-randomized clinical trial conducted in Egypt from April 15 to July 21, 2020.   -Settings: This was a multi-centre study conducted in 3 hospitals in Egypt.   -Participants: a total of 94 COVID-19 laboratory-confirmed patients using qRT-PCR were enrolled in the study.   -Intervention: All patients were administered with two plasma units (each unit is 200cc). The volume of donated plasma was 800cc.   -Main Outcome and Measures: Primary measure was the degree of clinical improvement among the COVID-19 patients who received CPT within seven days   Results: A total of 94 patients were enrolled who received CPT either within seven days or after seven days of hospitalization. 82 were severely ill, 12 were critically ill. The average age remained 58 years (±SD 15.1 years). Male were 69% and 49% patients got cured while 51% died with CFR 51%. 75% deaths were above 45years of age. The symptoms were dyspnoea (55%), fever (52%), cough (46%), and loss of taste and smell (21%), and cyanosis (15%). The most common co-morbidities among the <40 years remained Diabetes Mellitus (21%) and Asthma (14%). Among 40-60 years Hypertension (56%), Diabetes Mellitus (39%) and among >60 years age group Hypertension (57%) and Chronic Heart Disease (24%) were reported. CPT within seven days remained significant as compared with the  CPT after seven days with the number of days to cure (p=0.007) and ICU stay (P=0.008) among severely ill cured cases.   Conclusions: Among patients with COVID-19 and severe or critical illness, the use of CPT along with routine standard therapy resulted in a statistically significant improvement when administered within seven days of hospital admission. However, plasma transfusion, irrespective of days to transfusion may not help treat critically ill patients. The overall mean time to cure in severely ill patients was 15 days if CPT provided within seven days with 65% cure rate.   Trial Registration: Clinical Intervention identifier: MOHP_COVID-19_Ver1.1 registered April 2020 Keywords: Covid 19 pandemic, Convalescent plasma, SARS-CoV-2,

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  1. Version published to 10.3889/oamjms.2022.8057
  2. ScreenIT

    SciScore for 10.1101/2021.03.30.21254031: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: The study was approved by the Ministry of Health and Population Ethics Committees (MOHP-EC) and was registered in Egypt no. MOHP_COVID-19_Ver1.1.
    Consent: A total of 94 patients were finally enrolled in the study after exclusion of patients who did not meet the criteria and written informed consent was taken.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Units containing anti-SARS-CoV-2 antibodies but not qualified as high titer by the Ortho VITROS SARS- CoV-2 total antibody are considered low titer units.
    anti-SARS-CoV-2
    suggested: None

    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:
    Limitations: Due to the clinical features of included patients; the investigators could not conduct a randomized controlled trial. However, we understand that a controlled study may further help in establishing the dynamics of the viremia of SARS-CoV-2 while capturing the optimal transfusion time point. Additionally, all patients were also treated with multiple pharmaceutical agents including antibiotics, antivirals, and steroids requiring robust comparative analyses to clearly establish the effect of each treatment modality individually and collectively as well.

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

    IdentifierStatusTitle
    NCT04816942CompletedClinical Efficacy of Early Administration of Convalescent Pl…

    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

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  3. Version published to 10.1101/2021.03.30.21254031v1 on medRxiv