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1.
JAMA Netw Open ; 5(1): e2142210, 2022 01 04.
Article in English | MEDLINE | ID: covidwho-1611175

ABSTRACT

Importance: A surge of COVID-19 occurred from March to June 2021, in New Delhi, India, linked to the B.1.617.2 (Delta) variant of SARS-CoV-2. COVID-19 vaccines were rolled out for health care workers (HCWs) starting in January 2021. Objective: To assess the incidence density of reinfection among a cohort of HCWs and estimate the effectiveness of the inactivated whole virion vaccine BBV152 against reinfection. Design, Setting, and Participants: This was a retrospective cohort study among HCWs working at a tertiary care center in New Delhi, India. Exposures: Vaccination with 0, 1, or 2 doses of BBV152. Main Outcomes and Measures: The HCWs were categorized as fully vaccinated (with 2 doses and ≥15 days after the second dose), partially vaccinated (with 1 dose or 2 doses with <15 days after the second dose), or unvaccinated. The incidence density of COVID-19 reinfection per 100 person-years was computed, and events from March 3, 2020, to June 18, 2021, were included for analysis. Unadjusted and adjusted hazard ratios (HRs) were estimated using a Cox proportional hazards model. Estimated vaccine effectiveness (1 - adjusted HR) was reported. Results: Among 15 244 HCWs who participated in the study, 4978 (32.7%) were diagnosed with COVID-19. The mean (SD) age was 36.6 (10.3) years, and 55.0% were male. The reinfection incidence density was 7.26 (95% CI: 6.09-8.66) per 100 person-years (124 HCWs [2.5%], total person follow-up period of 1696 person-years as time at risk). Fully vaccinated HCWs had lower risk of reinfection (HR, 0.14 [95% CI, 0.08-0.23]), symptomatic reinfection (HR, 0.13 [95% CI, 0.07-0.24]), and asymptomatic reinfection (HR, 0.16 [95% CI, 0.05-0.53]) compared with unvaccinated HCWs. Accordingly, among the 3 vaccine categories, reinfection was observed in 60 of 472 (12.7%) of unvaccinated (incidence density, 18.05 per 100 person-years; 95% CI, 14.02-23.25), 39 of 356 (11.0%) of partially vaccinated (incidence density 15.62 per 100 person-years; 95% CI, 11.42-21.38), and 17 of 1089 (1.6%) fully vaccinated (incidence density 2.18 per 100 person-years; 95% CI, 1.35-3.51) HCWs. The estimated effectiveness of BBV152 against reinfection was 86% (95% CI, 77%-92%); symptomatic reinfection, 87% (95% CI, 76%-93%); and asymptomatic reinfection, 84% (95% CI, 47%-95%) among fully vaccinated HCWs. Partial vaccination was not associated with reduced risk of reinfection. Conclusions and Relevance: These findings suggest that BBV152 was associated with protection against both symptomatic and asymptomatic reinfection in HCWs after a complete vaccination schedule, when the predominant circulating variant was B.1.617.2.


Subject(s)
COVID-19/epidemiology , Health Personnel , Reinfection , SARS-CoV-2 , Adult , COVID-19/etiology , COVID-19/prevention & control , COVID-19 Vaccines/administration & dosage , Cohort Studies , Female , Humans , Immunogenicity, Vaccine , India/epidemiology , Male , Middle Aged , Surveys and Questionnaires , Tertiary Care Centers , Vaccines, Inactivated/administration & dosage , Virion/immunology , Young Adult
2.
Lung India ; 39(1): 16-26, 2022.
Article in English | MEDLINE | ID: covidwho-1604705

ABSTRACT

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.

3.
Preprint in English | Other preprints | ID: ppcovidwho-295883

ABSTRACT

Background Due to the unprecedented speed of SARS-CoV-2 vaccine development, their efficacy trials and issuance of emergency use approvals and marketing authorizations, additional scientific questions remain that need to be answered regarding vaccine effectiveness, vaccination regimens and the need for booster doses. While long-term studies on the correlates of protection, vaccine effectiveness, and enhanced surveillance are awaited, studies on breakthrough infections help us understand the nature and course of this illness among vaccinated individuals and guide in public health preparedness. Methods This observational cohort study aimed at comparing the differences in clinical, biochemical parameters and the hospitalization outcomes of 53 fully vaccinated individuals with those of unvaccinated (1,464) and partially vaccinated (231) individuals, among a cohort of 2,080 individuals hospitalized with SARS-CoV-2 infection. Results Completing the course of vaccination protected individuals from developing severe COVID-19 as evidence 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. Conclusion With a current rate of only 9.5% of the Indian population being fully vaccinated, 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. Research in context Evidence before this study The Government of India started vaccinating its citizens from the 16 th of January 2021, after emergency use authorization had been received for the use of two vaccines, BBV152, a COVID-19 vaccine based on the whole-virion SARS-CoV-2 vaccine strain NIV-2020-770, (Covaxin) and the recombinant replication-deficient chimpanzee adenovirus vector encoding the spike protein ChAdOx1 nCoV-19 Corona Virus Vaccine (Covishield). These have been approved by the Indian regulatory authority based on randomized controlled studies. In these studies, was found that the vaccines led to more than 90% reduction in symptomatic COVID-19 disease. However, there is scarce evidence of the efficacy of these vaccines in real-world scenarios. A few studies have looked at vaccinated cohorts such as health care workers in whom the vaccines had an efficacy similar to the RCTs. In a study of patients with SARS-CoV-2 infection admitted to a tertiary care hospital in New Delhi, it was found that mortality in fully vaccinated patients was 12.5% as compared to 31.5% in the unvaccinated cohort. Added-value of this study This cohort of hospitalized patients with SARS-CoV-2 infection was studied during the peak of the second wave of COVID-19 in India during which the delta variant of concern was the predominant infecting strain and had 26% patients who were partially vaccinated and 71.4% who were unvaccinated. Only 3% of the patients were fully vaccinated and developed a breakthrough infection. At the time of presentation, 13% of the individuals with breakthrough infection and 48·5% in the non-vaccinated group were hypoxic. Inflammatory markers were significantly lower in the completely vaccinated patients with breakthrough infection. The need for use of steroids and anti-viral agents such as remdesivir was also significantly low in the breakthrough infection group. A significantly less proportion of the individuals with breakthrough infection required oxygen supplementation or ventilatory support. Very few deteriorated or progressed to critical illness during their hospital stay. Only 3 individuals (5.7%) out of the 53 who developed breakthrough infection succumbed to illness while case fatality rates were significantly higher in the unvaccinated (22.8%) and pa tially vaccinated (19.5%) groups. Propensity score weighted multivariate logistic regression analysis revealed lower odds of developing hypoxia, critical illness or death in those who were completely vaccinated. Implications of all the available evidence The real-world effectiveness of the vaccines against SARS-CoV-2 seems to be similar to the randomized controlled trials. The vaccines are very effective in reducing the incidence of severe COVID-19, hypoxia, critical illness and death. The reduced need for oxygen supplementation, mechanical ventilation and the requirement of corticosteroids or other expensive medications such as anti-viral drugs could go a long way in redistributing scarce health care resources. All nations must move forward and vaccinate the citizens, as the current evidence suggests that ‘prevention is better than cure’.

4.
Bhatnagar, Tarun, Chaudhuri, Sirshendu, Ponnaiah, Manickam, Yadav, Pragya, Sabarinathan, R.; Sahay, Rima, Ahmed, Faheem, Aswathy, S.; Bhardwaj, Pankaj, Bilimale, Anil, Muthusamy, Santhosh Kumar, Logaraj, M.; Narlawar, Uday, Palanivel, C.; Patel, Prakash, Rai, Sanjay, Saxena, Vartika, Singh, Arvind, Thangaraj, Jeromie Wesley Vivian, Agarwal, Ashwini, Alvi, Yasir, Amoghashree, Ashok, P.; Babu, Dinesh, Bahurupi, Yogesh, Bhalavi, Sangita, Behera, Priyamadhaba, Biswas, Priyanka Pandit, Charan, Jaykaran, Chauhan, Nishant Kumar, Chetak, K. B.; Dar, Lalit, Das, Ayan, Deepashree, R.; Dhar, Minakshi, Dhodapkar, Rahul, Dipu, T. S.; Dudeja, Mridu, Dudhmal, Manisha, Gadepalli, Ravisekhar, Garg, Mahendra Kumar, Gayathri, A. V.; Goel, Akhil Dhanesh, Gowdappa, Basavana, Guleria, Randeep, Gupta, Manoj Kumar, Islam, Farzana, Jain, Mannu, Jain, Vineet, Jawahar, Lanord Stanley, Joshi, Rajendra, Kant, Shashi, Kar, Sitanshu Sekhar, Kalita, Deepjyoti, Khapre, Meenakshi, Khichar, Satyendra, Kombade, Sarika Prabhakar, Kohli, Sunil, Kumar, Abhinendra, Kumar, Anil, Kumar, Deepak, Kulirankal, Kiran, Leela, K. V.; Majumdar, Triparna, Mishra, Baijayantimala, Misra, Puneet, Misra, Sanjeev, Mohapatra, Prasanta Raghab, Murthy, Narayana, Nyayanit, Dimpal, Patel, Manish, Pathania, Monika, Patil, Savita, Patro, Binod Kumar, Jalandra, Ramniwas, Rathod, Pragati, Shah, Naimesh, Shete, Anita, Shukla, Deepak, Shwethashree, M.; Sinha, Smita, Surana, Ashish, Trikha, Anjan, Tejashree, A.; Venkateshan, Mahalingam, Vijaykrishnan, G.; Wadhava, Sarita, Wig, Naveet, Gupta, Nivedita, Abraham, Priya, Murhekar, Manoj.
Preprint in English | EuropePMC | ID: ppcovidwho-294258

ABSTRACT

Background: India introduced BBV152/Covaxin and AZD1222/Covishield vaccines from January 2021. We estimated effectiveness of these vaccines against severe Coronavirus disease 2019 (COVID-19) among individuals aged >=45 years.<br><br>Methods: We did a multi-centric, hospital-based, case–control study between May and July 2021. Cases were severe COVID-19 patients and controls were COVID-19 negative individuals from 11 hospitals. Vaccine effectiveness (VE) was estimated for full (2 doses ≥14days) and partial (1 dose ≥21 days) vaccination;duration between two vaccine doses and against the Delta variant. We used a random effects logistic regression model to calculate adjusted odds ratios (aOR) with 95% CI after adjusting for relevant known confounders.<br><br>Findings: We enrolled 1,143 cases and 2,541 controls. The VE of full vaccination was 80% (95% CI: 73%-86%) with AZD1222/Covishield and 69% (95% CI: 54%-79%) with BBV152/Covaxin. The VE was highest for a gap of 6-8 weeks between two doses of AZD1222/Covishield (92%, 95% CI: 82%-96%) and BBV152/Covaxin (92%, 95% CI: 26%-99%). The VE estimates were similar against the Delta strain and sub-lineages.<br><br>Interpretation: BBV152/Covaxin and AZD1222/Covishield were effective against severe COVID-19 among the Indian population during the period of dominance of highly transmissible Delta variant in second wave of pandemic. An escalation of two-dose coverage with COVID-19 vaccines is critical to control the pandemic in the country.<br><br>Funding Information: Indian Council of Medical Research<br><br>Declaration of Interests: None to declare. <br><br>Ethics Approval Statement: We obtained written informed consent from all the participants or their legally authorized representatives. Study procedures were approved by the Institutional Human Ethics Committees of all participating institutions.<br><br>

5.
Cureus ; 13(11): e19882, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1551849

ABSTRACT

Background There is limited data on coronavirus disease 2019 (COVID-19) and latent tuberculosis infection (LTBI). Methodology We analyzed data of admitted COVID-19 patients evaluated for LTBI to examine the impact of LTBI on severity, laboratory parameters, and COVID-19 outcome. Prospectively collected data were analyzed for 60 patients who were administered the Mantoux tuberculosis skin test (TST) using five tuberculin units of purified protein derivative. All patients were administered TST irrespective of Bacille Calmette-Guérin (BCG) vaccination status. Comorbidities, clinical features, radiologic involvement, laboratory parameters, and clinical course were analyzed concerning LTBI. Results The mean age was 45.9 (±15.2) years, and 35 (58.3%) patients had non-severe disease. The vast majority (n = 56/60; 93.3%) had been vaccinated with single-dose BCG in infancy or early childhood, as per national immunization guidelines. LTBI was diagnosed in 15 (25%) patients. LTBI prevalence was lower in severe (n = 1/25; 4%) than non-severe (n = 14/35; 40%) COVID-19 (p = 0.01) patients. LTBI patients had lower percentage neutrophil count, higher lymphocyte percentage, higher monocyte count, lower neutrophil-lymphocyte (NL) ratio, lower alanine aminotransferase, lower C-reactive protein, and lesser radiologic involvement compared to those without LTBI (p < 0.05). Similarly, among the mild COVID-19 subgroup, those with LTBI had higher lymphocyte and monocyte counts and lesser radiologic involvement than those without LTBI (p < 0.05). Conclusions LTBI patients appear to have milder disease, higher lymphocyte and monocyte count, higher NL ratio, and lesser radiographic involvement. This observation needs to be studied in larger studies using interferon release assays.

6.
J Med Virol ; 94(1): 303-309, 2022 01.
Article in English | MEDLINE | ID: covidwho-1544346

ABSTRACT

Emerging evidence shows co-infection with atypical bacteria in coronavirus disease 2019 (COVID-19) patients. Respiratory illness caused by atypical bacteria such as Mycoplasma pneumoniae, Chlamydia pneumoniae, and Legionella pneumophila may show overlapping manifestations and imaging features with COVID-19 causing clinical and laboratory diagnostic issues. We conducted a prospective study to identify co-infections with SARS-CoV-2 and atypical bacteria in an Indian tertiary hospital. From June 2020 to January 2021, a total of 194 patients with laboratory-confirmed COVID-19 were also tested for atypical bacterial pathogens. For diagnosing M. pneumoniae, a real-time polymerase chain reaction (PCR) assay and serology (IgM ELISA) were performed. C. pneumoniae diagnosis was made based on IgM serology. L. pneumophila diagnosis was based on PCR or urinary antigen testing. Clinical and epidemiological features of SARS-CoV-2 and atypical bacteria-positive and -negative patient groups were compared. Of the 194 patients admitted with COVID-19, 17 (8.8%) were also diagnosed with M. pneumoniae (n = 10) or C. pneumoniae infection (n = 7). Confusion, headache, and bilateral infiltrate were found more frequently in the SARS CoV-2 and atypical bacteria co-infection group. Patients in the M. pneumoniae or C. pneumoniae co-infection group were more likely to develop ARDS, required ventilatory support, had a longer hospital length of stay, and higher fatality rate compared to patients with only SARS-CoV-2. Our report highlights co-infection with bacteria causing atypical pneumonia should be considered in patients with SARS-CoV-2 depending on the clinical context. Timely identification of co-existing pathogens can provide pathogen-targeted treatment and prevent fatal outcomes of patients infected with SARS-CoV-2 during the current pandemic.


Subject(s)
Atypical Bacterial Forms/isolation & purification , COVID-19/pathology , Chlamydophila Infections/epidemiology , Coinfection/epidemiology , Legionnaires' Disease/epidemiology , Pneumonia, Mycoplasma/epidemiology , Adolescent , Adult , Aged , Aged, 80 and over , Chlamydophila pneumoniae/isolation & purification , Female , Humans , India , Legionella pneumophila/isolation & purification , Length of Stay , Male , Middle Aged , Mycoplasma pneumoniae/isolation & purification , Prospective Studies , SARS-CoV-2 , Severity of Illness Index , Young Adult
7.
Lancet Infect Dis ; 2021 Nov 23.
Article in English | MEDLINE | ID: covidwho-1537189

ABSTRACT

BACKGROUND: BBV152 is a whole-virion inactivated SARS-CoV-2 vaccine that has been deployed in India. The results of the phase 3 trial have shown clinical efficacy of BBV152. We aimed to evaluate the effectiveness of BBV152 against symptomatic RT-PCR-confirmed SARS-CoV-2 infection. METHODS: We conducted a test-negative, case-control study among employees of the All India Institute of Medical Sciences (a tertiary care hospital in New Delhi, India), who had symptoms suggestive of COVID-19 and had an RT-PCR test for SARS-CoV-2 during the peak of the second wave of the COVID-19 pandemic in India between April 15 and May 15, 2021. Cases (test-positives) and controls (test-negatives) were matched (1:1) on the basis of age and gender. The odds of vaccination with BBV152 were compared between cases and controls and adjusted for level of occupational exposure (to COVID-19), previous SARS-CoV-2 infection, and calendar time, using conditional logistic regression. The primary outcome was effectiveness of two doses of BBV152 (with the second dose received at least 14 days before testing) in reducing the odds of symptomatic RT-PCR-confirmed SARS-CoV-2 infection, expressed as (1 - odds ratio) × 100%. FINDINGS: Between April 15 and May 15, 2021, 3732 individuals had an RT-PCR test. Of these, 2714 symptomatic employees had data on vaccination status, and 1068 matched case-control pairs were available for analysis. The adjusted effectiveness of BBV152 against symptomatic COVID-19 after two doses administered at least 14 days before testing was 50% (95% CI 33-62; p<0·0001). The adjusted effectiveness of two doses administered at least 28 days before testing was 46% (95% CI 22-62) and administered at least 42 days before testing was 57% (21-76). After excluding participants with previous SARS-CoV-2 infections, the adjusted effectiveness of two doses administered at least 14 days before testing was 47% (95% CI 29-61). INTERPRETATION: This study shows the effectiveness of two doses of BBV152 against symptomatic COVID-19 in the context of a huge surge in cases, presumably dominated by the potentially immune-evasive delta (B.1.617.2) variant of SARS-CoV-2. Our findings support the ongoing roll-out of this vaccine to help control the spread of SARS-CoV-2, while continuing the emphasis on adherence to non-pharmacological measures. FUNDING: None. TRANSLATION: For the Hindi translation of the abstract see Supplementary Materials section.

8.
J Med Virol ; 2021 Nov 16.
Article in English | MEDLINE | ID: covidwho-1520244

ABSTRACT

Emerging reports of SARS-CoV-2 breakthrough infections entail methodical genomic surveillance for determining the efficacy of vaccines. This study elaborates genomic analysis of isolates from breakthrough infections following vaccination with AZD1222/Covishield and BBV152/Covaxin. Variants of concern B.1.617.2 and B.1.1.7 responsible for cases surge in April-May 2021 in Delhi, were the predominant lineages among breakthrough infections.

9.
Lancet Infect Dis ; 21(5): 637-646, 2021 05.
Article in English | MEDLINE | ID: covidwho-1510469

ABSTRACT

BACKGROUND: To mitigate the effects of COVID-19, a vaccine is urgently needed. BBV152 is a whole-virion inactivated SARS-CoV-2 vaccine formulated with a toll-like receptor 7/8 agonist molecule adsorbed to alum (Algel-IMDG) or alum (Algel). METHODS: We did a double-blind, multicentre, randomised, controlled phase 1 trial to assess the safety and immunogenicity of BBV152 at 11 hospitals across India. Healthy adults aged 18-55 years who were deemed healthy by the investigator were eligible. Individuals with positive SARS-CoV-2 nucleic acid and/or serology tests were excluded. Participants were randomly assigned to receive either one of three vaccine formulations (3 µg with Algel-IMDG, 6 µg with Algel-IMDG, or 6 µg with Algel) or an Algel only control vaccine group. Block randomisation was done with a web response platform. Participants and investigators were masked to treatment group allocation. Two intramuscular doses of vaccines were administered on day 0 (the day of randomisation) and day 14. Primary outcomes were solicited local and systemic reactogenicity events at 2 h and 7 days after vaccination and throughout the full study duration, including serious adverse events. Secondary outcome was seroconversion (at least four-fold increase from baseline) based on wild-type virus neutralisation. Cell-mediated responses were evaluated by intracellular staining and ELISpot. The trial is registered at ClinicalTrials.gov (NCT04471519). FINDINGS: Between July 13 and 30, 2020, 827 participants were screened, of whom 375 were enrolled. Among the enrolled participants, 100 each were randomly assigned to the three vaccine groups, and 75 were randomly assigned to the control group (Algel only). After both doses, solicited local and systemic adverse reactions were reported by 17 (17%; 95% CI 10·5-26·1) participants in the 3 µg with Algel-IMDG group, 21 (21%; 13·8-30·5) in the 6 µg with Algel-IMDG group, 14 (14%; 8·1-22·7) in the 6 µg with Algel group, and ten (10%; 6·9-23·6) in the Algel-only group. The most common solicited adverse events were injection site pain (17 [5%] of 375 participants), headache (13 [3%]), fatigue (11 [3%]), fever (nine [2%]), and nausea or vomiting (seven [2%]). All solicited adverse events were mild (43 [69%] of 62) or moderate (19 [31%]) and were more frequent after the first dose. One serious adverse event of viral pneumonitis was reported in the 6 µg with Algel group, unrelated to the vaccine. Seroconversion rates (%) were 87·9, 91·9, and 82·8 in the 3 µg with Algel-IMDG, 6 µg with Algel-IMDG, and 6 µg with Algel groups, respectively. CD4+ and CD8+ T-cell responses were detected in a subset of 16 participants from both Algel-IMDG groups. INTERPRETATION: BBV152 led to tolerable safety outcomes and enhanced immune responses. Both Algel-IMDG formulations were selected for phase 2 immunogenicity trials. Further efficacy trials are warranted. FUNDING: Bharat Biotech International.


Subject(s)
COVID-19 Vaccines/immunology , COVID-19/prevention & control , SARS-CoV-2/immunology , Adolescent , Adult , Antibodies, Neutralizing/blood , Antibodies, Viral/blood , COVID-19 Vaccines/adverse effects , Double-Blind Method , Female , Humans , Immunoglobulin G/blood , Male , Middle Aged , Toll-Like Receptor 7/agonists , Toll-Like Receptor 8/agonists , Vaccination , Vaccines, Inactivated/immunology , Young Adult
11.
Transplant Proc ; 2021 Oct 02.
Article in English | MEDLINE | ID: covidwho-1482999

ABSTRACT

The coronavirus disease 2019 (COVID-19) vaccine and its utility in solid organ transplantation need to be timely revised and updated. These guidelines have been formalized by the experts-the apex technical committee members of the National Organ and Tissue Transplant Organization and the heads of transplant societies-for the guidance of transplant communities. We recommend that all personnel involved in organ transplantation should be vaccinated as early as possible and continue COVID-19-appropriate behavior despite a full course of vaccination. For specific guidelines of recipients, we suggest completing the full schedule before transplantation whenever the clinical condition permits. We also suggest a single dose, rather than proceeding unvaccinated for transplant, in case a complete course is not feasible. If vaccination is planned before surgery, we recommend a gap of at least 2 weeks between the last dose of vaccine and surgery. For those not vaccinated before transplant, we suggest waiting 4 to 12 weeks after transplant. For the potential living donors, we recommend the complete vaccination schedule before transplant. However, if this is not feasible, we suggest receiving at least a single dose of the vaccine 2 weeks before donation. We suggest that suitable transplant patients and those on the waiting list should accept a third dose of the vaccine when one is offered to them. We recommend that organs from a deceased donor with suspected/proven vaccine-induced thrombotic thrombocytopenia should be avoided and are justified only in cases of emergency situations with informed consent and counseling.

12.
Br J Radiol ; 94(1126): 20210187, 2021 Oct 01.
Article in English | MEDLINE | ID: covidwho-1430508

ABSTRACT

OBJECTIVES: The World Health Organization (WHO) has declared coronavirus disease 2019 (COVID-19) as pandemic in March 2020. Currently there is no specific effective treatment for COVID-19. The major cause of death in COVID-19 is severe pneumonia leading to respiratory failure. Radiation in low doses (<100 cGy) has been known for its anti-inflammatory effect and therefore, low dose radiation therapy (LDRT) to lungs can potentially mitigate the severity of pneumonia and reduce mortality. We conducted a pilot trial to study the feasibility and clinical efficacy of LDRT to lungs in the management of patients with COVID-19. METHODS: From June to Aug 2020, we enrolled 10 patients with COVID-19 having moderate to severe risk disease [National Early Warning Score (NEWS) of ≥5]. Patients were treated as per the standard COVID-19 management guidelines along with LDRT to both lungs with a dose of 70cGy in single fraction. Response assessment was done based on the clinical parameters using the NEWS. RESULTS: All patients completed the prescribed treatment. Nine patients had complete clinical recovery mostly within a period ranging from 3 to 7 days. One patient, who was a known hypertensive, showed clinical deterioration and died 24 days after LDRT. No patients showed the signs of acute radiation toxicity. CONCLUSION: The results of our pilot study suggest that LDRT is feasible in COVID-19 patients having moderate to severe disease. Its clinical efficacy may be tested by conducting randomized controlled trials. ADVANCES IN KNOWLEDGE: LDRT has shown promising results in COVID-19 pneumonia and should be researched further through randomized controlled trials.


Subject(s)
COVID-19/radiotherapy , Pneumonia, Viral/radiotherapy , Adult , Aged , Early Warning Score , Feasibility Studies , Female , Humans , Male , Middle Aged , Pandemics , Pilot Projects , Pneumonia, Viral/virology , Radiotherapy Dosage , SARS-CoV-2
13.
Journal of Medical Virology ; n/a(n/a), 2021.
Article in English | Wiley | ID: covidwho-1410037

ABSTRACT

Abstract Emerging evidence shows co-infection with atypical bacteria in coronavirus disease 2019 (COVID-19) patients. Respiratory illness caused by atypical bacteria such as Mycoplasma pneumoniae, Chlamydia pneumoniae, and Legionella pneumophila may show overlapping manifestations and imaging features with COVID-19 causing clinical and laboratory diagnostic issues. We conducted a prospective study to identify co-infections with SARS-CoV-2 and atypical bacteria in an Indian tertiary hospital. From June 2020 to January 2021, a total of 194 patients with laboratory-confirmed COVID-19 were also tested for atypical bacterial pathogens. For diagnosing M. pneumoniae, a real-time polymerase chain reaction (PCR) assay and serology (IgM ELISA) were performed. C. pneumoniae diagnosis was made based on IgM serology. L. pneumophila diagnosis was based on PCR or urinary antigen testing. Clinical and epidemiological features of SARS-CoV-2 and atypical bacteria-positive and -negative patient groups were compared. Of the 194 patients admitted with COVID-19, 17 (8.8%) were also diagnosed with M. pneumoniae (n?=?10) or C. pneumoniae infection (n?=?7). Confusion, headache, and bilateral infiltrate were found more frequently in the SARS CoV-2 and atypical bacteria co-infection group. Patients in the M. pneumoniae or C. pneumoniae co-infection group were more likely to develop ARDS, required ventilatory support, had a longer hospital length of stay, and higher fatality rate compared to patients with only SARS-CoV-2. Our report highlights co-infection with bacteria causing atypical pneumonia should be considered in patients with SARS-CoV-2 depending on the clinical context. Timely identification of co-existing pathogens can provide pathogen-targeted treatment and prevent fatal outcomes of patients infected with SARS-CoV-2 during the current pandemic.

14.
J Infect Chemother ; 27(12): 1743-1749, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1370593

ABSTRACT

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.


Subject(s)
COVID-19 , Ivermectin , Humans , SARS-CoV-2 , Treatment Outcome , Viral Load
15.
Indian J Psychol Med ; 43(5): 428-435, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-1354667

ABSTRACT

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.

16.
Expert Rev Respir Med ; 15(10): 1367-1375, 2021 10.
Article in English | MEDLINE | ID: covidwho-1338604

ABSTRACT

OBJECTIVES: To study the histopathology of patients dying of COVID-19 using post-mortem minimally invasive sampling techniques. METHODS: This was a single-center observational study conducted at JPNATC, AIIMS. Thirty-seven patients who died of COVID-19 were enrolled. Post-mortem percutaneous biopsies were taken from lung, heart, liver, kidney and stained with hematoxylin and eosin. Immunohistochemistry was performed using CD61 and CD163. SARS-CoV-2 virus was detected using IHC with primary antibodies. RESULTS: The mean age was 48.7 years and 59.5% were males. Lung histopathology showed diffuse alveolar damage in 78% patients. Associated bronchopneumonia was seen in 37.5% and scattered microthrombi in 21% patients. Immunopositivity for SARS-CoV-2 was observed in Type II pneumocytes. Acute tubular injury with epithelial vacuolization was seen in 46% of renal biopsies. Seventy-one percent of liver biopsies showed Kupffer cell hyperplasia and 27.5% showed submassive hepatic necrosis. CONCLUSIONS: Predominant finding was diffuse alveolar damage with demonstration of SARS-CoV-2 protein in the acute phase. Microvascular thrombi were rarely identified in any organ. Substantial hepatocyte necrosis, Kupffer cell hypertrophy, microvesicular, and macrovesicular steatosis unrelated to microvascular thrombi suggested that liver might be a primary target of COVID-19.


Subject(s)
COVID-19 , Autopsy , Humans , Lung , Male , Middle Aged , SARS-CoV-2 , Tertiary Care Centers
17.
Microbiol Spectr ; 9(1): e0016321, 2021 09 03.
Article in English | MEDLINE | ID: covidwho-1319383

ABSTRACT

Emerging evidence indicates that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-infected individuals are at an increased risk for coinfections; therefore, physicians need to be cognizant about excluding other treatable respiratory pathogens. Here, we report coinfection with SARS-CoV-2 and other respiratory pathogens in patients admitted to the coronavirus disease (COVID) care facilities of an Indian tertiary care hospital. From June 2020 through January 2021, we tested 191 patients with SARS-CoV-2 for 33 other respiratory pathogens using an fast track diagnostics respiratory pathogen 33 (FTD-33) assay. Additionally, information regarding other relevant respiratory pathogens was collected by reviewing their laboratory data. Overall, 13 pathogens were identified among patients infected with SARS-CoV-2, and 46.6% (89/191) of patients had coinfection with one or more additional pathogens. Bacterial coinfections (41.4% [79/191]) were frequent, with Staphylococcus aureus being the most common, followed by Klebsiella pneumoniae. Coinfections with SARS-CoV-2 and Pneumocystis jirovecii or Legionella pneumophila were also identified. The viral coinfection rate was 7.3%, with human adenovirus and human rhinovirus being the most common. Five patients in our cohort had positive cultures for Acinetobacter baumannii and K. pneumoniae, and two patients had active Mycobacterium tuberculosis infection. In total, 47.1% (90/191) of patients with coinfections were identified. The higher proportion of patients with coinfections in our cohort supports the systemic use of antibiotics in patients with severe SARS-CoV-2 pneumonia with rapid de-escalation based on respiratory PCR/culture results. The timely and simultaneous identification of coinfections can contribute to improved health of COVID-19 patients and enhanced antibiotic stewardship during the pandemic. IMPORTANCE Coinfections in COVID-19 patients may worsen disease outcomes and need further investigation. We found that a higher proportion of patients with COVID-19 were coinfected with one or more additional pathogens. A better understanding of the prevalence of coinfection with other respiratory pathogens in COVID-19 patients and the profile of pathogens can contribute to effective patient management and antibiotic stewardship during the current pandemic.


Subject(s)
COVID-19/epidemiology , Coinfection/epidemiology , Coinfection/microbiology , Coinfection/virology , Acinetobacter baumannii , Adenoviruses, Human , Adolescent , Adult , Aged , Aged, 80 and over , Anti-Bacterial Agents , Antimicrobial Stewardship , COVID-19/diagnosis , Coinfection/drug therapy , Enterovirus , Female , Humans , India/epidemiology , Klebsiella pneumoniae , Male , Middle Aged , Mycobacterium tuberculosis , Pandemics , SARS-CoV-2 , Tuberculosis/epidemiology , Young Adult
18.
Indian J Med Res ; 153(5&6): 619-628, 2021 05.
Article in English | MEDLINE | ID: covidwho-1310159

ABSTRACT

Background & objectives: India witnessed a massive second surge of COVID-19 cases since March 2021 after a period of decline from September 2020. Data collected under the National Clinical Registry for COVID-19 (NCRC) were analysed to describe the differences in demographic and clinical features of COVID-19 patients recruited during these two successive waves. Methods: The NCRC, launched in September 2020, is an ongoing multicentre observational initiative, which provided the platform for the current investigation. Demographic, clinical, treatment and outcome data of hospitalized, confirmed COVID-19 patients were captured in an electronic data portal from 41 hospitals across India. Patients enrolled during September 1, 2020 to January 31, 2021 and February 1 to May 11, 2021 constituted participants of the two successive waves, respectively. Results: As on May 11, 2021, 18961 individuals were recruited in the registry, 12059 and 6903 reflecting in-patients from the first and second waves, respectively. Mean age of the patients was significantly lower in the second wave [48.7 (18.1) yr vs. 50.7 (18.0) yr, P<0.001] with higher proportion of patients in the younger age group intervals of <20, and 20-39 yr. Approximately 70 per cent of the admitted patients were ≥ 40 yr of age in both waves of the pandemic. The proportion of males were slightly lower in second wave as compared to the first [4400 (63.7%) vs. 7886 (65.4%), P=0.02]. Commonest presenting symptom was fever in both waves. In the second wave, a significantly higher proportion [2625 (48.6%) vs. 4420 (42.8%), P<0.003] complained of shortness of breath, developed ARDS [422(13%) vs. 880 (7.9%), P<0.001], required supplemental oxygen [1637 (50.3%) vs. 4771 (42.7%), P<0.001], and mechanical ventilation [260 (15.9%) vs. 530 (11.1%), P<0.001]. Mortality also significantly increased in the second wave [OR: 1.35 (95% CI: 1.19, 1.52)] in all age groups except in <20 yr. Interpretation & conclusions: The second wave of COVID-19 in India was slightly different in presentation than the first wave, with a younger demography, lesser comorbidities, and presentation with breathlessness in greater frequency.


Subject(s)
COVID-19 , Pandemics , Hospitalization , Humans , Male , Registries , SARS-CoV-2
20.
Curr Probl Diagn Radiol ; 50(6): 842-855, 2021.
Article in English | MEDLINE | ID: covidwho-1294548

ABSTRACT

Coronavirus Disease 2019 (COVID-19) disease has rapidly spread around the world after initial identification in Wuhan, China, in December 2019. Most common presentation is mild or asymptomatic disease, followed by pneumonia, and rarely- multiorgan failure and Acute Respiratory Distress Syndrome (ARDS). Knowledge about the pathophysiology, imaging and treatment of this novel virus is rapidly evolving due to ongoing worldwide research. Most common imaging modalities utilized during this pandemic are chest radiography and HRCT with findings of bilateral peripheral, mid and lower zone GGO and/or consolidation, vascular enlargement and crazy paving. HRCT is also useful for prognostication and follow-up of severely ill COVID-19 patients. Portable radiography allows follow-up of ICU patients & obviates the need of shifting critically ill patients and disinfection of CT room. As the pandemic has progressed, numerous neurologic manifestations have been described in COVID-19 including stroke, white matter hyperintensities and demyelination on MRI. Varying abdominal presentations have been described, which on imaging either show evidence of COVID-19 pneumonia in lung bases or show abdominal findings including bowel thickening and vascular thrombosis. Numerous thrombo-embolic and cardiovascular complications have also been described in COVID-19 including arterial and venous thrombosis, pulmonary embolism and myocarditis. It is imperative for radiologists to be aware of all the varied faces of this disease on imaging, as they may well be the first physician to suspect the disease. This article aims to review the multimodality imaging manifestations of COVID-19 disease in various organ systems from head to toe.


Subject(s)
COVID-19 , Humans , Radiologists , SARS-CoV-2 , Toes , Tomography, X-Ray Computed
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