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

Authors

  • Noha Asem Department of Public Health and Community Medicine, Cairo University, Cairo, Egypt; Ministry of Health and Population, Cairo, Egypt
  • Hossam Hosny Massoud Department of Pulmonology, Cairo University, Cairo, Egypt
  • Ihab Serag Ministry of Health and Population, Cairo, Egypt
  • Mohamed Hassany Department of Tropical Medicine, National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt
  • Gehan ElAssal Department of Pulmonology, Ain Shams University, Cairo, Egypt
  • Akram Abdelbary Department of Critical Care Medicine, Cairo University, Cairo, Egypt
  • Marwa Mohsen Ministry of Health and Population, Cairo, Egypt
  • Amin Abdel Baki Department of Tropical Medicine, National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt
  • Samy Zaky Department of Hepatogastroenterology and Infectious Diseases, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
  • Wagdy Amin Ministry of Health and Population, Cairo, Egypt
  • Ehab Kamal Ministry of Health and Population, Cairo, Egypt; Department of Tropical Medicine, Medical Division, National Research Center, Cairo, Egypt
  • Hamdy Ibrahem Ministry of Health and Population, Cairo, Egypt
  • Ahmed Said Abdel Mohsen Department of Critical Care Medicine, Cairo University, Cairo, Egypt
  • Mohamed Ibrahem Department of Clinical Biochemistry, Faculty of medicine, Cairo University, Cairo, Egypt
  • Mohamed Ahmed Ali Centre of Excellence for Influenza Viruses, National Research Centre, Giza, Egypt
  • Nancy Elgendy Ministry of Health and Population, Cairo, Egypt; Department of Clinical and Chemical Pathology, Faculty of Medicine, Cairo University, Giza, Egypt
  • Mohamed Elbadry Endemic Medicine Department, Faculty of Medicine, Helwan University, Cairo, Egypt
  • Salwa Hassan Ministry of Health and Population, Cairo, Egypt
  • Naguib Naguib Nassif Shenouda Ministry of Health and Population, Cairo, Egypt
  • Mohamed Abdelhamed Fathy Ministry of Health and Population, Cairo, Egypt
  • Hala Zaid Ministry of Health and Population, Cairo, Egypt

DOI:

https://doi.org/10.3889/oamjms.2022.8057

Keywords:

COVID-19 pandemic, Convalescent plasma, SARS-CoV-2

Abstract

BACKGROUND: The rapid worldwide spread of the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) or COVID-19 pandemic from its epicenter; Wuhan was first reported in December 2019. Egypt reported its first COVID-19 case on February 14, 2020. Thereafter, Egypt scaled-up preventive measures, with a partial lockdown starting on March 25. Several therapeutic agents along with convalescent plasma transfusion (CPT) are under investigation and data from CPTs have been receiving a lot of attention, after Emergency approvals from the Food and Drug Administration 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, and non-randomized clinical trial conducted in Egypt from April 15 to July 21, 2020. Settings: This was a multi-center study conducted in three hospitals in Egypt. Participants: A total of 94 COVID-19 laboratory-confirmed patients using quantitative real-time polymerase chain reaction were enrolled in the study. Intervention: All patients were administered with two plasma units (each unit is 200 cc). The volume of donated plasma was 800 cc. Main Outcome and measures: Primary measure was the degree of clinical improvement among the COVID-19 patients who received CPT within 7 days.

RESULTS: A total of 94 patients were enrolled who received CPT either within 7 days or after 7 days of hospitalization. 82 were severely ill and 12 were critically ill. The average age remained 58 years (±standard deviation 15.1 years). Male were 69% and 49% patients got cured while 51% died with case fatality rate 51%. Seventy-five percent deaths were above 45 years of age. The symptoms were dyspnea (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 7 days remained significant as compared with the CPT after 7 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 7 days with 65% cure rate.

TRIAL REGISTRATION: Clinical Intervention identifier: MOHP_COVID-19_Ver1.1 registered April 2020.

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References

COVID-19 Dashboard by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University. Available from: https://www.coronavirus.jhu.edu/map.html [Last accessed on 2020 Oct 24].

Medha MA, El Kassas M. COVID-19 in Egypt: Uncovered figures or a different situation? J Glob Health. 2020;10(1):010368. https://doi.org/10.7189/jogh.10.010368 PMid:32566159 DOI: https://doi.org/10.7189/jogh.10.010368

Hassany M, Abdel-Razek W, Asem N, AbdAllah M, Zaid H. Estimation of COVID-19 burden in Egypt. Lancet Infect Dis. 2020;20(8):896-7. https://doi.org/10.1016/s1473-3099(20)30319-4 PMid:32353346 DOI: https://doi.org/10.1016/S1473-3099(20)30319-4

Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, et al. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: A living systematic review. Cochrane Database Syst Rev. 2020;10:CD013600. https://doi.org/10.1002/14651858.cd013600.pub3 PMid:33044747 DOI: https://doi.org/10.1002/14651858.CD013600.pub2

Masoud HH, Elassal G, Zaky S. Management Protocol for COVID-19 PATIENTS. Egypt: Ministry of health and Population (MOHP); 2020. Available from: http://www.mohp.gov.eg/JobsDetails.aspx?job_id=3061 [Last accessed on 2021 Jan 12].

Graham BS, Ambrosino DM. History of passive antibody administration for prevention and treatment of infectious diseases. Curr Opin HIV AIDS. 2015;10(3):129-34. https://doi.org/10.1097/coh.0000000000000154 PMid:25760933 DOI: https://doi.org/10.1097/COH.0000000000000154

Marano G, Vaglio S, Pupella S, Facco G, Catalano L, Liumbruno GM, et al. Convalescent plasma: New evidence for an old therapeutic tool? Blood Transfus. 2016;14(2):152-7. https://doi.org/10.1111/trf.13329 PMid:26674811 DOI: https://doi.org/10.1111/trf.13329

Cheng Y, Wong Y, Soo YO, Wong WS, Lee CK, Ng MH, et al. Use of convalescent plasma therapy in SARS patients in Hong Kong.Eur J Clin Microbiol Infect Dis. 2005;24(1):44-6. https://doi.org/10.1007/s10096-004-1271-9 PMid:15616839 DOI: https://doi.org/10.1007/s10096-004-1271-9

Amanat F, White KM, Miorin L, Strohmeier S, McMahon M, Meade P, et al. An in vitro microneutralization assay for SARS-CoV-2 serology and drug screening. Curr Protoc Microbiol. 2020;58(1):e108. https://doi.org/10.1002/cpmc.108 PMid:32585083 DOI: https://doi.org/10.1002/cpmc.108

Ortho Clinical Diagnostics-FDA. Available from: https://www.fda.gov/media/136967/download [Last accessed on 2020 Oct 06].

Research C for BE, Investigational. COVID-19 Convalescent Plasmad emergency INDs. FDA; 2020. Available from: http://www.fda.gov/vaccinesblood-biologics/investigational-new-drug-ind-or-device-exemption-ideprocess-cber/investigational-covid-19-convalescent-plasma-emergency-inds [Last accessed on 2020 May 15]. https://doi.org/10.1002/9780470456187.ch4 DOI: https://doi.org/10.1002/9780470456187.ch4

NIH. US National Library of Medicine. Available from: https://www.clinicaltrials.gov/ct2/results?cond¼COVID-19&term¼randomizedþconvalescentþplasma&cntry¼&state¼&city¼&dist¼&Search¼Search&type¼Intr [Last accessed on 2020 May 15].

Bloch EM, Shoham S, Casadevall A, Sachais BS, Shaz B, Winters JL, et al. Deployment of convalescent plasma for the prevention and treatment of COVID-19. J Clin Invest. 2020;130(6):2757-65. PMid:32254064 DOI: https://doi.org/10.1172/JCI138745

Duan K, Liu B, Li C, Zhang H, Yu T, Qu J, et al. Effectiveness of convalescent plasma therapy in severe COVID-19 patients. Proc Natl Acad Sci U S A. 2020;117(17):9490-6 https://doi.org/10.1101/2020.03.16.20036145 PMid:32253318 DOI: https://doi.org/10.1073/pnas.2004168117

World Health Organization. Use of Convalescent whole blood or plasma collected from patients recovered from Ebola virus disease for transfusion, as an empirical treatment during outbreaks. Interim Guidance Natl Health Authorities Blood Transfusion Services, Version 1.0 September 2014. Geneva: World Health Organization; 2014. p. 1e-19.

Hegerova L, Gooley T, Sweerus KA, Maree CL. Use of convalescent plasma in hospitalized patients with Covid-19: Case series. Blood. 2020;136(6):759-62. https://doi.org/10.1182/blood.2020006964 PMid:32559767 DOI: https://doi.org/10.1182/blood.2020006964

Shen C, Wang Z, Zhao F. Treatment of 5 critically ill patients with COVID-19 with convalescent plasma. JAMA. 2020;323(16):1582-9. PMid:32219428 DOI: https://doi.org/10.1001/jama.2020.4783

Hung IF, To KK, Lee CK, Lee KL, Chan K, Yan WW, et al. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011;52(4):447-456 PMid:21248066 DOI: https://doi.org/10.1093/cid/ciq106

Dobkin C, Finkelstein A, Kluender R, Notowidigdo MJ. The economic consequences of hospital admissions. Am Econ Rev. 2018;102(2):308-52. https://doi.org/10.1257/aer.20161038 PMid:30091560 DOI: https://doi.org/10.1257/aer.20161038

Xia X, Kening L, Wu L. Improved clinical symptoms and mortality on severe/critical COVID-19 patients utilizing convalescent plasma transfusion. Blood. 2020;136(6):755-9. PMid:32573724 DOI: https://doi.org/10.1182/blood.2020007079

Gold MS, Sehayek D, Gabrielli S, Zhang X, McCusker C, Ben- Shoshan M. COVID-19 and comorbidities: A systematic review and meta-analysis. Postgrad Med. 2020;132(8):749-55. https://doi.org/10.1080/00325481.2020.1786964 PMid:32573311 DOI: https://doi.org/10.1080/00325481.2020.1786964

Heneghan C, Brassey J, Jefferson T. SARS-CoV-2 Viral Load and the Severity of COVID-19. Available form: https://www.cebm.net/covid-19/sars-cov-2-viral-load-and-the-severity-of-covid-19 [Last accessed on 2020 Nov 12]. https://doi.org/10.1111/odi.14118/v2/review1 DOI: https://doi.org/10.1111/ODI.14118/v2/review1

Ng KT, Oong XY, Lim SH, Chook JB, Takebe Y, Chan YF, et al. Viral load and sequence analysis reveal the symptom severity, diversity, and transmission clusters of rhinovirus infections. Clin Infect Dis. 2018;67(2):261-8. DOI: https://doi.org/10.1093/cid/ciy063

Gharbharan A, Jordans CC, GeurtsvanKessel C, den Hollander JG, Karim F, Mollema FP, et al. Effects of potent neutralizing antibodies from convalescent plasma in patients hospitalized for severe SARS-CoV-2 infection. Nat Commun. 2021;12(1):3189. https://doi.org/10.1038/s41467-021-23469-2 DOI: https://doi.org/10.21203/rs.3.rs-105265/v1

Eckhardt CM, Cummings MJ, Rajagopalan KN, Borden S. Evaluating the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in severely ill adults with COVID-19: A structured summary of a study protocol for a randomized controlled trial. Trials. 2020;21:499. https://doi.org/10.1186/s13063-020-04877-z PMid:33203476 DOI: https://doi.org/10.1186/s13063-020-04877-z

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Published

2022-03-01

How to Cite

1.
Asem N, Massoud HH, Serag I, Hassany M, ElAssal G, Abdelbary A, Mohsen M, Baki AA, Zaky S, Amin W, Kamal E, Ibrahem H, Mohsen ASA, Ibrahem M, Ali MA, Elgendy N, Elbadry M, Hassan S, Shenouda NNN, Fathy MA, Zaid H. Clinical Efficacy of Early Administration of Convalescent Plasma among COVID-19 Cases in Egypt. Open Access Maced J Med Sci [Internet]. 2022 Mar. 1 [cited 2024 Apr. 23];10(B):1698-705. Available from: https://oamjms.eu/index.php/mjms/article/view/8057

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