Introduction
Universal coverage of vaccines alone cannot be relied upon to protect at-risk populations in lower- and middle-income countries against the impact of the coronavirus disease 2019 (COVID-19) pandemic and newer variants. Live vaccines, including Bacillus Calmette–Guérin (BCG), are being studied for their effectiveness in reducing the incidence and severity of COVID-19 infection.
Methods
In this multi-centre quadruple-blind, parallel assignment randomised control trial, 495 high-risk group adults (aged 18–60 years) were randomised into BCG and placebo arms and followed up for 9 months from the date of vaccination. The primary outcome was the difference in the incidence of COVID-19 infection at the end of 9 months. Secondary outcomes included the difference in the incidence of severe COVID-19 infections, hospitalisation rates, intensive care unit stay, oxygen requirement and mortality at the end of 9 months. The primary analysis was done on an intention-to-treat basis, while safety analysis was done per protocol.
Results
There was no significant difference in the incidence rates of cartridge-based nucleic acid amplification test (CB-NAAT) positive COVID-19 infection [odds ratio (OR) 1.08, 95% confidence interval (CI) 0.54–2.14] in the two groups, but the BCG arm showed a statistically significant decrease in clinically diagnosed (symptomatic) probable COVID-19 infections (OR 0.38, 95% CI 0.20–0.72). Compared with the BCG arm, significantly more patients developed severe COVID-19 pneumonia (CB-NAAT positive) and required hospitalisation and oxygen in the placebo arm (six versus none;
p
= 0.03). One patient belonging to the placebo arm required intensive care unit (ICU) stay and died. BCG had a protective efficacy of 62% (95% CI 28–80%) for likely symptomatic COVID-19 infection.
Conclusions
BCG is protective in reducing the incidence of acute respiratory illness (probable symptomatic COVID-19 infection) and severity of the disease, including hospitalisation, in patients belonging to the high-risk group of COVID-19 infection, and the antibody response persists for quite a long time. A multi-centre study with a larger sample size will help to confirm the findings in this study.
Clinical Trials Registry
Clinical Trials Registry India (CTRI/2020/07/026668).
Supplementary Information
The online version contains supplementary material available at 10.1007/s40121-022-00703-y.
To determine the cardiopulmonary changes in the survivors of acute COVID-19 infection at 3–6 month and 6–12 month. We followed up 53 patients out of which 28 (52%) had mild COVID-19 and 25 (48%) had severe COVID-19. The first follow-up was between 3 month after diagnosis up to 6 month and second follow-up between 6 and 12 month from the date of diagnosis of acute COVID-19. They were monitored using vital parameters, pulmonary function tests, echocardiography and a chest computed tomography (CT) scan. We found improvement in diffusing capacity for carbon monoxide (DLCO) with a median of 52% of predicted and 80% of predicted at the first and second follow-up, respectively. There was improvement in the CTSS in severe group from 22 (18–24) to 12 (10–18; p-0.001). Multivariable logistic regression revealed increased odds of past severe disease with higher CTSS at follow-up (OR-1.7 [CI 1.14–2.77];
P
= 0.01). Correlation was found between CTSS and DLCO at second follow-up (
r
2
= 0.36;
p
< 0.01). Most of patients recovered from COVID-19 but
a
subgroup of patients continued to have persistent radiological and pulmonary function abnormalities necessitating a structured follow-up.
Tension pneumocephalus is a rare and life-threatening neurosurgical emergency in the setting of blunt or penetrating head trauma, especially in those with craniofacial fractures, which emergency physicians should be aware about. Early identification and appropriate treatment measures including supine positioning, 100% oxygen via mask, early neurosurgery consultation and, if required, operative intervention are paramount to optimal neurological and survival outcome. Definitive diagnosis requires imaging usually in the form of computed tomography (CT) head and serial monitoring of neurological status, optic nerve sheath diameter measurement and repeat imaging, essential to identify patients who might have features of increased pressure on brain matter, which could lead to adverse neurological and clinical outcomes. We present two cases of tension pneumocephalus with the characteristic Mount Fuji sign on CT head, who were managed nonoperatively with optimal neurological outcome. In patients with severe head or maxillofacial trauma presenting to emergency department, CT should be evaluated for signs of tension pneumocephalus, and such patients need to be closely observed for complications of pressure effect on brain matter to ensure optimal neurological and survival outcomes.
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