Safety and Efficacy of Convalescent Plasma to Treat Severe COVID-19: Protocol for the Saudi Collaborative Multicenter Phase II Study (Preprint)

• DOI: 10.2196/preprints.23543
• Publication Date: 2020-08-17T21:02:28Z
• Authors: Mohammed Albalawi; Syed Ziauddin Ahm...; Nawal AlShehry; Ahmed AlAskar; Abdul Rehman Zia ...; Rania Nagib Moham...; Abdul Salam; Ahmed AlSagheir; Nour AlMozain; Ghada Elgohary; Khalid Batarfi; Alia Alfaraedi; Osamah Khojah; Rehab Al-Ansari; Mona Alfaraj; Afra Dayel; Ahmed Al Bahrani; Arwa Nabhan Abdel...; Hind Alhumaidan; Jawaher M Al-Otaibi; Ghazala Radwi; Abdulrahman Raizah; Hind Shatry; Sara Alsaleh; Hazzaa AlZahrani; Hani Al-Hashmi
• Keywords: Pandemic; Convalescent plasma

<sec> <title>BACKGROUND</title> The COVID-19 pandemic is expected to cause significant morbidity and mortality. development of an effective vaccine will take several months become available, its affordability unpredictable. Transfusion convalescent plasma (CP) may provide passive immunity. Based on initial data from China, a group hematologists, infectious disease specialists, intensivists drafted this protocol in March 2020. </sec> <title>OBJECTIVE</title> aim study test the feasibility, safety, efficacy CP treating patients with across Saudi Arabia. <title>METHODS</title> Eligible be recruited for infusion according inclusion criteria. As has proven moving target as far management concerned, we use current definitions Ministry Health (MOH) guidelines diagnosis, treatment, recovery. All recipients receive supportive including all available recommended therapies MOH guidelines. donors who have fully recovered their recovery criteria detailed qualify blood regulations except history recent past. We also presence SARS-CoV-2 antibodies by rapid test, aliquots archived future antibody titration. Due perceived benefit CP, randomization was not considered. However, compare outcome cohort treated those did due lack consent or availability. In national collaborative study, there likelihood finding exactly matched control patients. Hence, plan perform propensity score matching comparator major characteristics. collect demographic, clinical, laboratory characteristics both groups outcomes. A total sample size 575 patients, 115 460 controls (1:4 ratio), sufficient detect clinically important hospital stay 30-day mortality difference between two 80% power 5% level significance. <title>RESULTS</title> At present, patient recruitment still ongoing, interim analysis first 40 shared soon. <title>CONCLUSIONS</title> paper, present multicenter phase II Arabia assessing potential severe COVID-19. publish report comparators <title>CLINICALTRIAL</title> ClinicalTrials.gov NCT04347681; https://clinicaltrials.gov/ct2/show/NCT04347681 <title>INTERNATIONAL REGISTERED REPORT</title> PRR1-10.2196/23543