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Factors Associated with Good Patient Outcomes Following Convalescent Plasma in COVID-19: A Prospective Phase II
Danyal Ibrahim1, Latha Dulipsingh2, Lisa Zapatka3
1Trinity Health of New England, Hartford, CT, USA. dibrahim@trinityhealthofne.org.
Insights
Early administration of convalescent plasma for COVID-19 (coronavirus disease 2019) in severe or critical patients shows potential for improved survival and recovery. This treatment appears safe, with few adverse events observed in the study.
Area of Science:
- Infectious Diseases
- Immunology
- Critical Care Medicine
Background:
- Coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2, has led to a global health crisis with high mortality.
- No established cure or standard treatment currently exists for COVID-19.
- This study investigated convalescent plasma as a potential therapeutic option for hospitalized COVID-19 patients.
Purpose of the Study:
- To assess the safety and efficacy of convalescent plasma in hospitalized patients with severe or critical COVID-19.
- To evaluate the impact of convalescent plasma on adverse events and hospital mortality.
- To explore secondary outcomes such as disease progression, recovery rates, and length of hospital stay.
Main Methods:
- A prospective, single-arm, open-label, phase II clinical trial was conducted.
- Convalescent plasma with a specific anti-SARS-CoV-2 IgG titer (1:320) was administered to adult patients.
- Primary endpoints included adverse events and hospital mortality; secondary endpoints focused on clinical recovery and hospital stay duration.
Main Results:
- Of 38 patients, 24 (63%) recovered and were discharged; 14 (37%) died.
- Patients receiving convalescent plasma early (severe illness) had significantly lower mortality (13% vs. 55%) and shorter hospital stays (15.4 vs. 33 days) compared to those treated later (critical illness).
- One transient transfusion reaction occurred; no other adverse effects were noted.
Conclusions:
- Convalescent plasma with adequate antibody titers is safe for treating COVID-19.
- Early administration of convalescent plasma may positively impact clinical outcomes, including recovery and survival.
- Further research is warranted to confirm these findings and optimize treatment protocols.
Introduction:
Coronavirus disease 2019 (COVID-19) is a viral respiratory syndrome caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This novel virus was discovered in Wuhan City, Hubei Province, China, in December 2019. As of September 6, 2020, confirmed cases have risen to more than 27,000,000 worldwide and more than 885,000 people have died. Currently, no cure or standard treatment for COVID-19 exists. We conducted a prospective single-arm open-label phase II clinical trial assessing the safety and efficacy of convalescent plasma in hospitalized patients with COVID-19.
Methods:
Convalescent plasma with sufficient total anti-SARS-CoV-2 IgG titer (1:320) obtained from recovered donors was administered to adult patients with either severe or critical COVID-19 illness. Primary outcomes were adverse events in association with plasma administration, and hospital mortality. Secondary outcomes included disease progression, recovery, length of stay, and hospital discharge.
Results:
Of the 38 patients included in the analysis, 24 (63%) recovered and were discharged, and 14 (37%) died. Patients who received convalescent plasma early in the disease course (severe illness group) as compared to the patients that received convalescent plasma later in the disease progression (critical illness group) had significantly lower hospital mortality 13% vs 55% (p < 0.02) and shorter mean hospital length of stay 15.4 vs 33 days (p < 0.01). One patient experienced a transient transfusion reaction. No other adverse effects of convalescent plasma infusion were observed.
Conclusions:
Our results suggest that convalescent plasma with adequate anti-SARS-CoV-2 antibody titer is safe and has the potential for positive impact on clinical outcomes including recovery and survival if given to patients early in the course of COVID-19 disease.
Trial Registration:
ClinicalTrials.gov. Identifier, NCT04343261, IND #19805.
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