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A Randomized Controlled Study Assessing Convalescent Immunoglobulins vs Convalescent Plasma for Hospitalized Patients
Yasmin Maor1,2, Eilat Shinar3, Marina Izak2,3
1Infectious Disease Unit, Wolfson Medical Center, Holon, Israel.
Insights
Convalescent immunoglobulins (cIgGs) did not prove noninferior to convalescent plasma (CP) on day 14 for COVID-19 patients. However, cIgGs showed superiority by day 28, especially for unvaccinated individuals.
Area of Science:
- Immunology
- Infectious Diseases
- Clinical Medicine
Background:
- The comparative efficacy of convalescent immunoglobulins (cIgGs) versus convalescent plasma (CP) for treating COVID-19 remains unclear.
- High-risk patients with early symptoms of coronavirus 2019 (COVID-19) were the focus of this comparative study.
Purpose of the Study:
- To determine if convalescent immunoglobulins (cIgGs) are superior or noninferior to convalescent plasma (CP) in treating COVID-19 patients.
- To evaluate clinical improvement, survival rates, and mechanical ventilation needs at 14 and 28 days post-treatment.
Main Methods:
- A randomized controlled trial involving 319 high-risk COVID-19 patients (symptoms ≤10 days) assigned to receive either cIgGs or CP.
- Primary endpoint: WHO scale improvement on day 14. Secondary endpoints: survival, improvement, and ventilation status on day 28, analyzed for vaccinated and unvaccinated subgroups.
Main Results:
- cIgGs failed to meet the primary noninferiority endpoint on day 14 (P = .026).
- By day 28, cIgGs demonstrated superiority in patient improvement (81.9% vs 70.6%, P < .001).
- Unvaccinated patients receiving cIgGs showed significantly better improvement (84.1% vs 66.1%, P = .024) and survival trends (89.9% vs 77.4%, P = .066) by day 28.
Conclusions:
- While not meeting the initial noninferiority goal, convalescent immunoglobulins (cIgGs) proved superior to convalescent plasma (CP) by day 28 for COVID-19 treatment.
- cIgGs offer a promising therapeutic option, particularly for unvaccinated individuals, in the evolving landscape of COVID-19 variants.
Background:
It is unknown whether convalescent immunoglobulins (cIgGs) are better than convalescent plasma (CP) for patients with coronavirus 2019 (COVID-19).
Methods:
In this randomized controlled trial, we assigned high risk COVID-19 patients with ≤10 days of symptoms, to receive cIgGs or CP. The primary endpoint was improvement on day 14 according to the World Health Organization scale. Secondary endpoints were survival on day 14, and improvement, survival, and percent of ventilated patients on day 28, and treatment response in unvaccinated and vaccinated patients.
Results:
A total of 319 patients were included: 166 received cIgGs and 153 CP. Median age was 64 to 66 years. A total of 112 patients (67.5%) in the cIgG group and 103 patients (67.3%) in the CP group reached the primary endpoint. Difference between groups was 0.1 (95% confidence interval, -10.1 to 10.4; P = .026), failing to reach noninferiority. More patients receiving cIgG improved by day 28 (136 patients [81.9%] and 108 patients [70.6%], respectively; 95% confidence interval, 1.9-20.7; P < .001; for superiority P = .018). Seventeen patients in the cIgG group (10.2%) and 25 patients (16.3%) in the CP group required mechanical ventilation (P = .136). Sixteen (9.6%) and 23 (15%) patients, respectively, died (P = .172). More unvaccinated patients improved by day 28 in the cIgG group (84.1% vs 66.1%; P = .024), and survival was better in the cIgG group (89.9% vs 77.4%; P = .066).
Conclusions:
cIgGs failed to reach the primary noninferiority endpoint on day 14 but was superior to CP on day 28. Survival and improvement by day 28 in unvaccinated patients treated with cIgGs were better. In the face of new variants, cIgGs are a viable option for treating COVID-19.
Trial Registration Number:
My Trials MOH_2021-01-14_009667.
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