Safety and Efficacy of Convalescent Plasma for Severe COVID-19: Interim Report of a Multicenter Phase II Study from Saudi Arabia

Nawal AlShehry, Syed Ziauddin A Zaidi, Ahmed AlAskar, Abdurahman Al Odayani, Jawaher Mubarak Alotaibi, Ahmed AlSagheir, Ayman Al-Eyadhy, Saud Balelah, Abdul Salam, Abdul Rehman Zia Zaidi, Diea Alawami, Mohammed S Alshahrani, Nour AlMozain, Yem M Abulhamayel, Reem Al Qunfoidi, Mona Alfaraj, Nahid Qushmaq, Rehab Alansari, Afra Dayel, Ghada Elgohary, Ahmed Al Bahrani, Arwa A Nabhan Abdelhameed, Hazza Abdullah AlZahrani, Hanan Alturkistani, Nada AlShehry, Mohammed Abdulhameed Albalawi, Ibrahim Elalfy, Hind Alhumaidan, Hani Al-Hashmi, KSA COVID-19 Convalescent Plasma Study Group, Nawal AlShehry, Syed Ziauddin A Zaidi, Ahmed AlAskar, Abdurahman Al Odayani, Jawaher Mubarak Alotaibi, Ahmed AlSagheir, Ayman Al-Eyadhy, Saud Balelah, Abdul Salam, Abdul Rehman Zia Zaidi, Diea Alawami, Mohammed S Alshahrani, Nour AlMozain, Yem M Abulhamayel, Reem Al Qunfoidi, Mona Alfaraj, Nahid Qushmaq, Rehab Alansari, Afra Dayel, Ghada Elgohary, Ahmed Al Bahrani, Arwa A Nabhan Abdelhameed, Hazza Abdullah AlZahrani, Hanan Alturkistani, Nada AlShehry, Mohammed Abdulhameed Albalawi, Ibrahim Elalfy, Hind Alhumaidan, Hani Al-Hashmi, KSA COVID-19 Convalescent Plasma Study Group

Abstract

Objective: To present the interim findings from a national study investigating the safety and efficacy of convalescent plasma (CP) containing detectable IgG antibodies as a treatment strategy for severe coronavirus disease 2019 (COVID-19).

Trial design and participants: An open label, two-arm, phase-II clinical trial conducted across 22 hospitals from Saudi Arabia. The intervention group included 40 adults (aged ≥18 years) with confirmed severe COVID-19 and the control group included 124 patients matched using propensity score for age, gender, intubation status, and history of diabetes and/or hypertension. Intervention group included those (a) with severe symptoms (dyspnea; respiratory rate, ≥30/min; SpO2, ≤93%, PaO2/FiO2 ratio, <300; and/or lung infiltrates >50% within 24-48 h), (b) requiring intensive care unit (ICU) care or (c) experiencing life-threatening conditions. The control group included confirmed severe COVID-19 patients of similar characteristics who did not consent for CP infusion or were not able to receive CP due to its nonavailability.

Interventions: The intervention group participants were infused 300 ml (200-400 ml/treatment dose) CP at least once, and if required, daily for up to 5 sessions, along with receiving the best standard of care. The control group only received the best standard of care.

Outcomes: The primary endpoints were safety and ICU length of stay (LOS). The secondary endpoints included 30-day mortality, days on mechanical ventilation and days to clinical recovery.

Results: CP transfusion did not result in any adverse effects. There was no difference in the ICU LOS (median 8 days in both groups). The mortality risk was lower in the CP group: 13% absolute risk reduction (P = 0.147), hazard ratio (95% confidence interval): 0.554 (0.299-1.027; P = 0.061) by log-rank test. There was no significant difference in the days on mechanical ventilation and days to clinical recovery.

Conclusion: CP containing detectable antibodies is a safe strategy and may result in a decrease in mortality in patients with severe COVID-19. The results of the completed trial with a larger study sample would provide more clarity if this difference in mortality is significant.

Trial registration: ClinicalTrials.gov Identifier: NCT04347681; Saudi Clinical Trials Registry No.: 20041102.

Keywords: Antibodies; COVID-19; SARS-CoV-2; Saudi Arabia; convalescent plasma.

Conflict of interest statement

There are no conflicts of interest.

Copyright: © 2020 Saudi Journal of Medicine & Medical Sciences.

Figures

Figure 1
Figure 1
Logistic cycle of convalescent plasma procurement from donor, processing and transfusion to COVID-19 patient
Figure 2
Figure 2
Survival probability between CP group and matched control patients
Figure 3
Figure 3
Sub-group survival probability of the CP group

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