The Effectiveness of SARS-CoV-2 Vaccination in Preventing Severe Illness and Death - Real-world Data from a Cohort of Patients Hospitalized with COVID-19.

Background: While long-term studies on the correlates of protection, vaccine effectiveness, and enhanced surveillance are awaited for SARS-CoV-2 vaccine, studies on breakthrough infections help understand the nature and course of this illness among vaccinated individuals and guide in public health preparedness. This study aims to compare the differences in the hospitalization outcomes SARS-CoV-2 infection of fully vaccinated individuals with with those of unvaccinated and partially vaccinated individuals. Materials and Methods: Single institution observational cohort study. This study compared the differences in clinical, biochemical parameters and the hospitalization outcomes of 53 fully vaccinated individuals with those of unvaccinated (1464) and partially vaccinated (231) individuals, among a cohort of 2,080 individuals hospitalized with SARS-CoV-2 infection. Descriptive statistics and propensity-score weighted multivariate logistic regression analysis adjusting for clinical and laboratory parameters were used to compare the differences and to identify factors associated with outcomes. Results: Completing the course of vaccination protected individuals from developing severe COVID-19 as evidenced by lower proportions of those with hypoxia, abnormal levels of inflammatory markers, requiring ventilatory support, and death compared to unvaccinated and partially vaccinated individuals. There were no differences in these outcomes among patients who received either vaccine type approved in India. Conclusions: Efforts should be made to improve the vaccination rates as a timely measure to prepare for the upcoming waves of this highly transmissible pandemic. Vaccination rates of the communities may also guide in the planning of the health needs and appropriate use of medical resources.

A Correlation Analysis of Peripheral Oxygen Saturation and Arterial Oxygen Saturation Among COVID-19 Patients.

Background and objective It has been observed that peripheral oxygen saturation (SpO2) measured by pulse oximeter is consistently lower than arterial oxygen saturation (SaO2) measured directly by blood gas analysis. In this study, we aimed to evaluate the correlation between SpO2 and SaO2, and SpO2 and partial pressure of oxygen (PaO2), and compare the SpO2/FiO2 (SF) and PaO2/FiO2 (PF) ratios in patients with coronavirus disease 2019 (COVID-19). Methods In this observational study, SpO2 was recorded and arterial blood gas analysis was performed among 70 COVID-19 patients presenting on room air (FiO2 = 0.21). SaO2 and PaO2 were recorded from arterial blood gas analysis. The SF and PF ratios were then calculated. Results The strength of correlations between SpO2 and SaO2, and SpO2 and PaO2, were significant (p<0.001) and moderately positive [Pearson coefficient (r) = 0.68, 0.53]. SpO2 value (85%), i.e., SF ratio (404.7 or below), was the best estimate for mild ARDS (acute respiratory distress syndrome) [PF ratio (300 or below)] with a sensitivity of 80.6% and specificity of 53%. Conclusion A pulse oximeter is a vital tool in the diagnosis and management of COVID-19. In our study, SpO2 was found to have a positive correlation with SaO2 and PaO2 with acceptable sensitivity but low specificity in estimating mild ARDS. Therefore, pulse oximetry can be used as a tool for the early diagnosis of mild COVID-19 ARDS as per the given considerations and clinical correlation.

Airway management, procedural data, and in-hospital mortality records of patients undergoing surgery for mucormycosis associated with coronavirus disease (COVID-19).

PURPOSE: Although unexpected airway difficulties are reported in patients with mucormycosis, the literature on airway management in patients with mucormycosis associated with Coronavirus disease is sparse. METHODS: In this retrospective case record review of 57 patients who underwent surgery for mucormycosis associated with coronavirus disease, we aimed to evaluate the demographics, airway management, procedural data, and in-hospital mortality records. RESULTS: Forty-one (71.9%) patients had a diagnosis of sino-nasal mucormycosis, fourteen (24.6%) patients had a diagnosis of rhino-orbital mucormycosis, and 2 (3.5%) patients had a diagnosis of palatal mucormycosis. A total of 44 (77.2%) patients had co-morbidities. The most common co-morbidities were diabetes mellitus in 42 (73.6%) patients, followed by hypertension in 21 (36.8%) patients, and acute kidney injury in 14 (28.1%) patients. We used the intubation difficulty scale score to assess intubating conditions. Intubation was easy to slightly difficult in 53 (92.9%) patients. In our study, mortality occurred in 7 (12.3%) patients. The median (range) mortality time was 60 (27-74) days. The median (range) time to hospital discharge was 53.5 (10-85) days. The median [interquartile range] age of discharged versus expired patients was 47.5 [41,57.5] versus 64 [47,70] years (P = 0.04), and median (interquartile range) D-dimer levels in discharged versus expired patients was 364 [213, 638] versus 2448 [408,3301] ng/mL (P = 0.03). CONCLUSION: In patients undergoing surgery for mucormycosis associated with the coronavirus disease, airway management was easy to slightly difficult in most patients. Perioperative complications can be minimized by taking timely and precautionary measures.

Effect of Meditation and Breathing Exercises on the Well-being of Patients with SARS-CoV-2 Infection under Institutional Isolation: A Randomized Control Trial.

OBJECTIVES: The corona virus disease-19 (COVID-19) pandemic has affected every domain of human health be it physical or mental. The uncertainty of disease progression in patients with SARS-CoV-2 infection can lead to major psychological and psychiatric concerns that should not be overlooked. The interventions should be directed to the vulnerable population to help them mitigate the stress and anxiety caused by the infection and isolation. We evaluated the effect of meditation and breathing exercises on the well-being of patients with SARS-CoV-2 infection under institutional isolation. MATERIALS AND METHODS: We conducted a randomized control trial on 84 subjects, 18 years and above, asymptomatic, or mildly symptomatic SARS-CoV-2 infected patients under institutional isolation. Subjects were randomly and equally divided into a control group and interventional group. We measured the depression, anxiety, and stress levels as well as quality of sleep in patients after 7 days of meditation and breathing exercises in the intervention group versus standard care in the control group. RESULTS: Meditation and breathing exercises had a statistically significant effect on the depression level (P < 0.001), stress level (P = 0.004), and the quality of sleep [trouble falling asleep (P = 0.007), trouble staying asleep (P = 0.004), and feel tired after waking up in the morning (P = 0.003)]. Further, the positive effect of intervention on the level of anxiety in patients under isolation was also observed; however, the difference was not found to be statistically significant (P = 0.528). CONCLUSION: Meditation and breathing exercises have positive effects on depression, stress levels, and quality of sleep in COVID-19 positive patients under strict institutional isolation.

Silent Hypoxia in Coronavirus disease-2019: Is it more dangerous? -A retrospective cohort study.

Background: Hypoxia in patients with COVID-19 is one of the strongest predictors of mortality. Silent hypoxia is characterised by the presence of hypoxia without dyspnoea. Silent hypoxia has been shown to affect the outcome in previous studies. Methods: This was a retrospective study of a cohort of patients with SARS-CoV-2 infection who were hypoxic at presentation. Clinical, laboratory and treatment parameters in patients with silent hypoxia and dyspnoeic hypoxia were compared. Multivariate logistic regression models were fitted to identify the factors predicting mortality. Results: Among 2080 patients with COVID-19 admitted to our hospital, 811 patients were hypoxic with SpO2 <94% at the time of presentation. Among them, 174 (21.45%) did not have dyspnoea since the onset of COVID-19 symptoms. Further, 5.2% of patients were completely asymptomatic for COVID-19 and were found to be hypoxic only on pulse oximetry. The case fatality rate in patients with silent hypoxia was 45.4% as compared to 40.03% in dyspnoeic hypoxic patients (P = 0.202). The odds ratio of death was 1.1 (95% CI: 0.41-2.97) in the patients with silent hypoxia after adjusting for baseline characteristics, laboratory parameters, treatment and in-hospital complications, which did not reach statistical significance (P = 0.851). Conclusion: Silent hypoxia may be the only presenting feature of COVID-19. As the case fatality rate is comparable between silent and dyspnoeic hypoxia, it should be recognised early and treated as aggressively. Because home isolation is recommended in patients with COVID-19, it is essential to use pulse oximetry in the home setting to identify these patients.

Concerns of Health-care Professionals Managing COVID Patients under Institutional Isolation during COVID-19 Pandemic in India: A Descriptive Cross-sectional Study.

OBJECTIVE: Health-care professionals (HCPs) are the frontline warriors in the time of this uncertain and unpredictable crisis of COVID. They face many challenges while caring for these patients, yet they are expected to cope with it and deliver their duties for the betterment of humankind. Our primary aim was to identify and assess the concerns of HCPs working in COVID area in a tertiary institutional isolation center. METHODOLOGY: An online Google-based questionnaire survey was distributed through various social media platforms after approval of the institutional review board to a total of 100 HCPs who were treating and managing COVID-positive patients. RESULTS: Of 100 responses, 72% were concerned about the risk of infection to self and family, while 46% reported disruption of their daily activities at a personal level. At the institutional level, 17% were concerned about inadequate personal protective equipment-related challenges. 20% had inadequate knowledge and training about COVID. 16% of participants were anxious all the time, 11% feared all the time, and 12% had stress all the time while treating COVID patients. Connectedness and communication with family and friends, word of appreciation, music, and TV were few strategies to cope up with these challenges. CONCLUSION: There is a need to identify and address the concerns and challenges faced by HCPs and to develop a comprehensive strategy and guideline to provide a holistic care and to ensure their security in the workplace.

Clinical features, demography, and predictors of outcomes of SARS-CoV-2 infection at a tertiary care hospital in India: A cohort study.

BACKGROUND: The "second wave" of the COVID-19 pandemic hit India from early April 2021 to June 2021. We describe the clinical features, treatment trends, and baseline laboratory parameters of a cohort of patients with SARS-CoV-2 infection and their association with the outcome. METHODS: This was a retrospective cohort study. Multivariate logistic regression models were fitted to identify clinical and biochemical predictors of developing hypoxia, deterioration during the hospital stay, and death. RESULTS: A total of 2080 patients were included. The case fatality rate was 19.5%. Among the survivors, the median duration of hospital stay was 8 (5-11) days. Out of 853 (42.3%%) of patients who had COVID-19 acute respiratory distress syndrome at presentation, 340 (39.9%) died. Patients aged >45 years had higher odds of death as compared to the 18-44 years age group. Vaccination reduced the odds of death by 40% (odds ratio [OR] [95% confidence interval [CI]]: 0.6 [0.4-0.9], P = 0.032). Patients with hyper inflammation at baseline as suggested by leukocytosis (OR [95% CI]: 2.1 [1.5-3.1], P < 0.001), raised d-dimer >500 mg/dL (OR [95% CI]: 3.2 [2.2-4.7], P < 0.001), and raised C-reactive peptide >0.5 mg/L (OR [95% CI]: 3.7 [2.2-13], P = 0.037) had higher odds of death. Patients who were admitted in the 2nd week had lower odds and those admitted in the 3rd week had higher odds of death. CONCLUSION: This study shows that vaccination status and early admission during the inflammatory phase can change the course of illness of these patients. Improving vaccination rates and early admission of patients with moderate and severe COVID-19 can improve the outcomes.

Single-dose oral ivermectin in mild and moderate COVID-19 (RIVET-COV): A single-centre randomized, placebo-controlled trial.

INTRODUCTION: Ivermectin is an antiparasitic drug which has in-vitro efficacy in reducing severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) viral load. Hence, Ivermectin is under investigation as a repurposed agent for treating COVID-19. METHODS: In this pilot, double blind, randomized controlled trial, hospitalized patients with mild-to-moderate COVID-19 were assigned to a single oral administration of an elixir formulation of Ivermectin at either 24 mg or 12 mg dose, or placebo in a 1:1:1 ratio. The co-primary outcomes were conversion of RT-PCR to negative result and the decline of viral load at day 5 of enrolment. Safety outcomes included total and serious adverse events. The primary outcomes were assessed in patients who had positive RT-PCR at enrolment (modified intention-to-treat population). Safety outcomes were assessed in all patients who received the intervention (intention-to-treat population). RESULTS: Among the 157 patients randomized, 125 were included in modified intention-to-treat analysis. 40 patients each were assigned to Ivermectin 24 mg and 12 mg, and 45 patients to placebo. The RT-PCR negativity at day 5 was higher in the two Ivermectin arms but failed to attain statistical significance (Ivermectin 24 mg, 47.5%; 12 mg arm, 35.0%; and placebo arm, 31.1%; p-value = 0.30). The decline of viral load at day 5 was similar in each arm. No serious adverse events occurred. CONCLUSIONS: In patients with mild and moderate COVID-19, a single oral administration of Ivermectin did not significantly increase either the negativity of RT-PCR or decline in viral load at day 5 of enrolment compared with placebo.

Surviving COVID-19 is Half the Battle; Living Life with Perceived Stigma is Other Half: A Cross-Sectional Study.

BACKGROUND: Year 2020 started with global health crisis known as COVID-19. In lack of established tools and management protocols, COVID-19 had become breeding ground for fear and confusion, leading to stigma toward affected individuals. METHOD: A cross-sectional study was conducted to estimate prevalence of stigma in discharged COVID-19 patients from a COVID hospital in India. Participants were approached telephonically using a semistructured questionnaire to record their experiences. Questions were asked regarding stigma at six major domains of daily life. Among total 1,673 discharged participants, 600 were conveniently selected and out of them 311 responded on telephonic interviews. RESULT: We found that 182 (58.52%) participants (95% CI: 53.04-64.00) have self-perceived stigma, 163 (52.41%) participants (95% CI: 46.86-57.96) experienced quarantine-related stigma, 222 (71.38%) participants (95% CI: 66.36-76.40) experienced neighborhood stigma, 214 (68.81%) participants (95% CI: 63.66-73.95) experienced stigma while going out in marketplaces, 180 (57.88%) participants (95% CI: 52.39-63.37) experienced stigma at their work place, and 207 (66.56%) participants (95% CI: 61.31-71.80) reported stigma experienced by their family members. With a total of 84.5% (95% CI: 80.06-88.39) participants experiencing stigma at some domain and about 42.8% of participants facing stigma at all six domains. The commonest noted cause of stigma was fear of getting infected, reported by 184 (59.2%) participants. CONCLUSION: This study shows high prevalence of stigma in COVID-19 patients suffering in their common domains of daily lives.

The incidence of anosmia in patients with laboratory-confirmed COVID 19 infection in India: An observational study.

BACKGROUND AND AIMS: Acute loss of smell or anosmia is a common and sometimes the only symptom observed in patients with coronavirus disease-2019 (COVID-19). The objective of the study was to determine the prevalence, time of onset, and duration of anosmia in patients with COVID-19 infection and the association of anosmia with other symptoms and eosinophil count. MATERIAL AND METHODS: Two hundred patients with laboratory-confirmed COVID-19 infection, who were asymptomatic or mildly symptomatic were assessed for olfaction with a nonirritant odor. The presence of anosmia was recorded, and a questionnaire integrating the anosmia reporting tool was filled. Patients with anosmia/hyposmia were followed telephonically at 7 and 14 days for resolution of anosmia and other symptoms. The presence of anosmia was correlated with eosinophil count. RESULTS: Of the 200 COVID-19 patients, 87% were symptomatic. More than half of the patients had fever (56%). Anosmia was observed in 30% of the patients and hyposmia in 4% of patients. In 41% of the patients, olfactory loss was reported before diagnosis. The mean duration of anosmia was 7.8 (± 5) days; 97% of patients recovered with a resolution of symptoms within 2 weeks. Ageusia was the most commonly and significantly associated symptom with anosmia (66%, n = 45) followed by sore throat (41%), and rhinorrhea (28%). The symptoms in both the sexes were comparable. Absolute eosinophil count of <40/µL was observed in 59 patients (29.5%) and an absolute eosinophil count of 0 in 17 patients (8.5%). Among the 68 anosmic patients, 36 (47%) patients had eosinopenia, which was statistically significant. CONCLUSION: Anosmia is an early and sometimes the only symptom in approximately one-third of the patients with COVID-19 infection. Eosinophil count should be checked in anosomic patient with suspicion of COVID-19 infection. Objective tools for olfactory and gustatory assessment should be brought into practice for early and prompt diagnosis to control the spread of the disease.

Efficacy and safety of pegylated interferon alfa-2b in moderate COVID-19: A phase II, randomized, controlled, open-label study.

OBJECTIVE: To evaluate the efficacy and safety of pegylated interferon alfa-2b (PEG IFN-α2b) along with the standard of care (SOC) in subjects with moderate COVID-19. METHODS: In this phase 2, randomized, open-label study, adult subjects aged ≥18 years with RT-PCR confirmed COVID-19 with moderate symptoms were randomized in a 1:1 to receive PEG IFN-α2b plus SOC, or SOC alone. The primary endpoint was improvement in clinical status on day 15, measured by the WHO 7-point ordinal scale. RESULTS: Forty subjects were randomized to PEG IFN-α2b plus SOC (n = 20) and SOC (n = 20). Overall, 19 (95.00%) subjects in PEG IFN-α2b plus SOC had achieved clinical improvement on day 15 compared to 13 (68.42%) subjects in SOC (p < 0.05). Overall, 80% and 95% of subjects in the PEG IFN-α2b plus SOC group had a negative RT-PCR result on day 7 and day 14, respectively, compared to 63% and 68% in the SOC group. Adverse events (AEs) were reported for eleven subjects in the PEG IFN-α2b plus SOC group and eight subjects in the SOC group. All reported AEs were mild. CONCLUSION: The significant improvement in clinical status on day 15 is likely due to faster viral reduction compared to SOC with the PEG IFN-α2b treated moderate COVID-19 subjects showing a difference as early as day seven and becoming significant by day 14.

Clinico-demographic profile & hospital outcomes of COVID-19 patients admitted at a tertiary care centre in north India.

BACKGROUND & OBJECTIVES: In December 2019, a novel coronavirus (SARS-CoV-2) emerged in China and rapidly spread globally including India. The characteristic clinical observations and outcomes of this disease (COVID-19) have been reported from different countries. The present study was aimed to describe the clinico-demographic characteristics and in-hospital outcomes of a group of COVID-19 patients in north India. METHODS: This was a prospective, single-centre collection of data regarding epidemiological, demographic, clinical and laboratory parameters, management and outcome of COVID-19 patients admitted in a tertiary care facility in north India. Patient outcomes were recorded as death, discharge and still admitted. RESULTS: Data of 144 patients with COVID-19 were recorded and analyzed. The mean age of the patients was 40.1±13.1 yr, with 93.1 per cent males, and included 10 (6.9%) foreign nationals. Domestic travel to or from affected States (77.1%) and close contact with COVID-19 patients in congregations (82.6%) constituted the most commonly documented exposure. Nine (6.3%) patients were smokers, with a median smoking index of 200. Comorbidities were present in 23 (15.9%) patients, of which diabetes mellitus (n=16; 11.1%) was the most common. A significant proportion of patients had no symptoms (n=64; 44.4%); among the symptomatic, cough (34.7%) was the most common symptom followed by fever (17.4%) and nasal symptoms (2.15%). Majority of the patients were managed with supportive treatment with hydroxychloroquine and azithromycin given on a case-to-case basis. Only five (3.5%) patients required oxygen supplementation, four (2.8%) patients had severe disease requiring intensive care, one required mechanical ventilation and mortality occurred in two (1.4%) patients. The time to reverse transcription-polymerase chain reaction (RT-PCR) negativity was 16-18 days. INTERPRETATION & CONCLUSIONS: In this single-centre study of 144 hospitalized patients with confirmed COVID-19 in north India, the characteristic findings included younger age, high proportion of asymptomatic patients, long time to PCR negativity and low need for intensive care unit care.

Psychosocial Burdens of a Renal Transplant Recipient with COVID-19.

The impact of COVID-19 on transplant recipients is yet to be fully understood. Apart from the physical implications, little has been discussed regarding the psychosocial burden it exerts on the already chronically ill patients. Here, we discuss a case of a 40-year-old male who received kidney transplantation 2 years ago and has tested positive for COVID-19. At the time of admission, he presented with mild symptoms and subsequently developed fever for which he had been managed conservatively. However, a comprehensive approach addressing psychosocial, emotional, and spiritual domains from a palliative care physician's perspective is often overlooked, whether in times of COVID-19 or not and this report aims to identify and assess such gaps.