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Subcutaneous Tocilizumab in Adults With Severe and Critical Covid-19: A Prospective Open-Label Uncontrolled Multicenter Trial Publisher Pubmed



Malekzadeh R1 ; Abedini A2 ; Mohsenpour B3 ; Sharifipour E4 ; Ghasemian R5 ; Javadmousavi SA6 ; Khodashahi R7 ; Darban M8 ; Kalantari S9 ; Abdollahi N10 ; Salehi MR11 ; Rezaei Hosseinabadi A12 ; Khorvash F13 ; Valizadeh M14 Show All Authors
Authors
  1. Malekzadeh R1
  2. Abedini A2
  3. Mohsenpour B3
  4. Sharifipour E4
  5. Ghasemian R5
  6. Javadmousavi SA6
  7. Khodashahi R7
  8. Darban M8
  9. Kalantari S9
  10. Abdollahi N10
  11. Salehi MR11
  12. Rezaei Hosseinabadi A12
  13. Khorvash F13
  14. Valizadeh M14
  15. Dastan F2, 15
  16. Yousefian S2, 15
  17. Hosseini H16
  18. Anjidani N17
  19. Tabarsi P14

Source: International Immunopharmacology Published:2020


Abstract

Potential therapeutic approaches in coronavirus disease 2019 (COVID-19) comprise antiviral and immunomodulatory agents; however, no immunomodulator drug has been approved. This multicenter, prospective, open-label, uncontrolled study aimed to assess the use of subcutaneous tocilizumab in adult patients with severe and critical COVID-19. Tocilizumab was added to the standard care of therapy at a dose of 324 mg (<100 kg bodyweight) or 486 mg (≥100 kg bodyweight). The study endpoints were all-cause mortality rate, changes in oxygen-support level, oxygen saturation, body temperature, respiratory rate, and laboratory variables during the study, and drug safety. Of 126 patients enrolled, 86 had severe and 40 had critical disease. Most patients were male (63.49%) and aged below 65 (78.57%). By day 14 of the study, 4.65% (4/86) of severe patients and 50.00% (20/40) of critical patients died. By the end, 6.98% (6/86) of severe patients and 60.00% (24/40) of critical patients died. Outcomes concerning three additional endpoints (oral temperature, oxygen saturation, and respiratory rate) were significantly improved as early as three days after tocilizumab administration in both groups of subjects, more considerably in severe patients. Significant improvement in the required level of oxygenation was reported in severe patients seven days after tocilizumab administration. No tocilizumab-related serious adverse event occurred in this study. Subcutaneous tocilizumab might improve some clinical parameters and reduce the risk of death in COVID-19 patients, particularly if used in the early stages of respiratory failure. © 2020
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