scholarly journals Occurrence of COVID-19 in priority groups receiving ChAdOx1 nCoV-19 coronavirus vaccine (recombinant): a preliminary analysis from north India

Author(s):  
Upinder Kaur ◽  
Sapna Bala ◽  
Bisweswar Ojha ◽  
Sumit Jaiswal ◽  
Sangeeta Kansal ◽  
...  

Abstract Background: In randomized controlled settings, vaccine efficacy close to 70% against symptomatic COVID-19 has been demonstrated by the ChAdOx1 nCoV-19 vaccine which is a recombinant chimpanzee adenovirus based vaccine expressing the SARS-CoV-2 spike protein. Post approval studies are however necessary to validate the findings in the real world.Methods: A prospective observational study is being conducted in a tertiary hospital of north India since 5th February 2021 with the primary objective of determining safety of COVID-19 vaccines and the secondary objective of assessing the rate of occurrence of COVID-19 in vaccinated group. High risk group comprising health care workers, other frontline workers (police, sanitary workers etc) and elderly citizens who were initially focus groups for vaccine roll-out in India, were enrolled in the study. The study included all vaccine recipients who provided consent and were enrolled at the time of receiving the first or second dose of COVISHIELD vaccine, and followed up telephonically.Results: Among 1650 enrolled vaccine recipients, 1500 participants of the study (Female/Male: 472/1028; mean age 38.8 years) completed at least 2 months of follow-up, after the second dose. The common comorbidities in study participants were hypertension (170, 11.3%), diabetes (142, 9.5%), and hypothyroidism (54, 3.6%). Of those who received a single dose of vaccine (n=65), laboratory confirmed SARS-CoV-2 infection was observed in 27 individuals (41.5%) and 3 were suspects. Severity wise, infections were mild in 21 out of 30 (70%) cases, moderate in five (16.7%) and severe in two (6.7%). Of those who received both doses of vaccine (n=1435), 388 were diagnosed as confirmed or suspect cases of SARS-CoV-2 infection. Of these 388, RT-PCR positivity was seen in 271 (18.9%) individuals, 82 (5.7%) were labelled as ‘suspects’ and 35 (2.4%) were RT-PCR negative suspects. Severity wise, majority of SARS-CoV-2 infections were ‘mild’ (331/388, 85.3%), followed by ‘moderate’ (33/388, 8.5%) and ‘severe’ (6/388, 1.5%). 404 out of the 1500 total participants were doctors including consultant/teaching faculty, resident doctors, and those in general practice. Among the 377 doctors who received both doses of vaccine, 160 were diagnosed as confirmed or suspect cases of SARS-CoV-2 infection. Of these, 131 (34.7%), 17 (4.5%) and 12 (3.2%) were laboratory confirmed cases, ‘suspects’ and RT-PCR negative suspects respectively. The infection was asymptomatic, ‘mild’, ‘moderate’ and ‘severe’ in 9 (5.6%), 130 (81.3%), 16 (10%) and 5 (3.1%) respectively. Breakthrough infections occurring at > 14 days after receiving the second dose were seen in 148 doctors who received both doses (39.2%), or 119 doctors (31.6%) if only laboratory confirmed cases were considered. Four deaths occurred in the study participants during the study period, two in partially vaccinated group and two in fully vaccinated group. Two of these participants, both in partially vaccinated group had developed SARS-CoV-2 infection during their follow-up.Conclusion: The disproportionately high occurrence of SARS-CoV-2 infection and COVID-19 in priority vaccinated groups in our study can be explained to some extent by the existence of variants such as the delta which might have escaped the vaccine generated immune protection. Despite the high incidence, the severity of COVID-19 was observed to be low. Since the ongoing study was primarily focused on adverse events following immunization (AEFIs) and enrolled only vaccinated individuals, the secondary outcome results lack a control unvaccinated group. However, the result of this preliminary analysis necessitates vigorous research on the performance of vaccines against variants, optimal timing of vaccination, need for boosters, and also optimal timings of effectiveness studies to guide future vaccination policy.

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Chiara Dentone ◽  
Antonio Vena ◽  
Maurizio Loconte ◽  
Federica Grillo ◽  
Iole Brunetti ◽  
...  

Abstract Background The primary objective of the study is to describe the cellular characteristics of bronchoalveolar lavage fluid (BALF) of COVID-19 patients requiring invasive mechanical ventilation; the secondary outcome is to describe BALF findings between survivors vs non-survivors. Materials and methods Patients positive for SARS-CoV-2 RT PCR, admitted to ICU between March and April 2020 were enrolled. At ICU admission, BALF were analyzed by flow cytometry. Univariate, multivariate and Spearman correlation analyses were performed. Results Sixty-four patients were enrolled, median age of 64 years (IQR 58–69). The majority cells in the BALF were neutrophils (70%, IQR 37.5–90.5) and macrophages (27%, IQR 7–49) while a minority were lymphocytes, 1%, TCD3+ 92% (IQR 82–95). The ICU mortality was 32.8%. Non-survivors had a significantly older age (p = 0.033) and peripheral lymphocytes (p = 0.012) were lower compared to the survivors. At multivariate analysis the percentage of macrophages in the BALF correlated with poor outcome (OR 1.336, CI95% 1.014–1.759, p = 0.039). Conclusions In critically ill patients, BALF cellularity is mainly composed of neutrophils and macrophages. The macrophages percentage in the BALF at ICU admittance correlated with higher ICU mortality. The lack of lymphocytes in BALF could partly explain a reduced anti-viral response.


2021 ◽  
Author(s):  
Manoj Shamkumar ◽  
Shiv Shankar ◽  
Babita Yadav ◽  
Sujata Rajan ◽  
Nitin Jindal ◽  
...  

BackgroundCOVID 19 pandemic has evolved as a unique unprecedented global health crisis that has affected severely the economies and daily lives of people. Despite the diligent worldwide efforts to contain it, there is an exponential rise in cases. Associated serious morbidity and mortality has continued the efforts towards a clinically proven prophylaxis and therapeutic strategy. In the absence of any effective approved treatment, drug repurposing of available drugs are underway across the globe for treating COVID 19 patients. AYUSH 64 is an antimalarial Ayurveda formulation repurposed in COVID 19 management due to its proven efficacy in malaria and influenza like illness.Trial Design: This was a prospective, open-label, single-arm, pilot study conducted at Ayurveda and Unani Tibbia College(A&U Tibbia ) and Hospital, Designated COVID-19 Health Center under Govt. of NCT of Delhi.Objective: The primary objective of the study was to assess the efficacy of AYUSH 64 in the management of asymptomatic, mild to moderate COVID-19 cases .However the secondary objectives were to assess clinical safety and to describe the clinical profile of COVID-19 with special reference to early symptoms, severity of disease, complications, course of disease, diagnostic investigations, biochemical & imaging abnormalities and patterns of clinical recovery.Methods:The study was conducted on 40 patients out of which maximum were asymptomatic and mild COVID-19 cases of either sex aged above 18 years admitted in the hospital with positive naso-pharyngeal swab test for SARS-CoV-2 (RT-PCR ) or Rapid antigen test. Ayush- 64 tablets in the dose of two tablets (500 mg) thrice a day after food with warm water was given to the participants for the period of 7 to 14 days but once the patient got RtPCR negative ,medicine was discontinued. The primary outcome of the study was negative status of SARS-CoV-2 on nasal or throat swab after 07 days or 14 days of intervention in a 2-day continuous real time RT-PCR test and changes in liver enzymes & renal functions. The secondary outcome of the study included the mean time (days) for clinical recovery as per clinical recovery criteria defined, number of symptomatic patients showing clinical recovery and improvement in selected laboratory parameters:, differential and total leukocyte counts, acute phase reactants, serum IL-6, Serological Protective Antibody Assay (IgE ,IgM and IgG).ResultsOut of 40 participants who were enrolled in the study, 36 (90%) completed the trial. Out of 36 participants, 69.44% participants after 07 days of AYUSH 64 intervention in the study became RT-PCR negative until 8th day and the rest 30.55 % participants completed the study in 14 days and they turned RT-PCR negative on 15th day. Out of 36 participants, 28 participants were symptomatic. 39.28% participants clinically recovered in 7 days of AYUSH-64 intervention and 53.5% participants clinically recovered in 14 days. Mean time for clinical recovery was 7.04 days (± 2.88 days standard deviation). No adverse drug reaction was found in any of the participants. Serious adverse event (SAE) was reported in two participants (5%) just another day after enrolment in the study, which was not related, to the trial drug and the same was informed to the sponsor.Conclusion Among asymptomatic and mild COVID-19 cases, the repurposing of AYUSH 64 was found efficacious and quite safe to alleviate infection with significant clinical improvement within 14 days. Subsequent research on larger scale is warranted for statistically robust evidences in the treatment of COVID-19.Trial Registration: CTRI/2020/05/025338- Clinical Trials Registry-India


2017 ◽  
Vol 3 ◽  
pp. 233372141770957 ◽  
Author(s):  
Enav Z. Zusman ◽  
Megan M. McAllister ◽  
Peggy Chen ◽  
Pierre Guy ◽  
Heather M. Hanson ◽  
...  

Objective: To test the effect of a follow-up clinic on urinary incontinence (UI) and nocturia among older adults with hip fracture. Method: Fifty-three older adults (≥65 years) 3 to 12 months following hip fracture were enrolled and randomized to receive usual care plus the intervention (B4), or usual care (UC) only. The B4 group received management by health professionals, with need-based referrals. UI, nocturia, and quality of life were measured with questionnaires at baseline, 6 months, and 12 months. Results: There were 48 participants included in this analysis, and at baseline, 44% of study participants self-reported UI. At final assessment, six out of 24 B4 participants and 12 out of 24 UC participants reported UI. Four out of five study participants reported nocturia at baseline; this did not decrease during the study. Discussion: Following hip fracture, many older adults report UI and most report nocturia. Health professionals should be aware of the high occurrence of urinary symptoms among older adults post hip fracture.


Thorax ◽  
2020 ◽  
Vol 76 (1) ◽  
pp. 61-63 ◽  
Author(s):  
Sang Hyun Ra ◽  
Joon Seo Lim ◽  
Gwang-un Kim ◽  
Min Jae Kim ◽  
Jiwon Jung ◽  
...  

BackgroundAsymptomatic individuals with SARS-CoV-2 infection have viable viral loads and have been linked to several transmission cases. However, data on the viral loads in such individuals are lacking. We assessed the viral loads in asymptomatic individuals with SARS-CoV-2 infection in comparison with those in symptomatic patients with COVID-19.MethodsStudy participants were recruited from a community facility designated for the isolation of patients with mild COVID-19 in South Korea. The presence of symptoms was evaluated with a questionnaire-based survey. Viral loads in the upper respiratory tract were measured with real-time reverse transcription-PCR (RT-PCR) targeting the E, RdRp and N genes of SARS-CoV-2, with a cycle threshold (Ct) value of 40 for determining positivity.ResultsIn 213 patients with SARS-CoV-2 infection, 41 (19%) had remained asymptomatic from potential exposure to laboratory confirmation and admission; of them, 39 (95%) underwent follow-up RT-PCR testing after a median 13 days. In 172 symptomatic patients, 144 (84%) underwent follow-up RT-PCR testing. Twenty-one (54%) asymptomatic individuals and 92 (64%) symptomatic patients tested positive for SARS-CoV-2 at follow-up. Asymptomatic individuals and symptomatic patients did not show any significant differences in the mean Ct values of the E (31.15 vs 31.43; p>0.99), RdRp (32.26 vs 32.93; p=0.92) and N (33.05 vs 33.28; p>0.99) genes.ConclusionApproximately one-fifth of the individuals without severe symptoms were asymptomatic, and their viral loads were comparable to those in symptomatic patients. A large proportion of mildly symptomatic patients with COVID-19 or asymptomatic individuals with SARS-CoV-2 showed persistent positive upper respiratory RT-PCR results at follow-up.


2018 ◽  
Vol 100-B (2) ◽  
pp. 262-268 ◽  
Author(s):  
A. Puri ◽  
P. Ranganathan ◽  
A. Gulia ◽  
S. Crasto ◽  
R. Hawaldar ◽  
...  

Aims A single-centre prospective randomized trial was conducted to investigate whether a less intensive follow-up protocol would not be inferior to a conventional follow-up protocol, in terms of overall survival, in patients who have undergone surgery for sarcoma of the limb. Initial short-term results were published in 2014. Patients and Methods The primary objective was to show non-inferiority of a chest radiograph (CXR) group compared with a CT scan group, and of a less frequent (six-monthly) group than a more frequent (three-monthly) group, in two-by-two comparison. The primary outcome was overall survival and the secondary outcome was a recurrence-free survival. Five-year survival was compared between the CXR and CT scan groups and between the three-monthly and six-monthly groups. Of 500 patients who were enrolled, 476 were available for follow-up. Survival analyses were performed on a per-protocol basis (n = 412). Results The updated results recorded 12 (2.4%) local recurrences, 182 (36.8%) metastases, and 56 (11.3%) combined (local + metastases) recurrence at a median follow-up of 81 months (60 to 118). Of 68 local recurrences, 60 (88%) were identified by the patients themselves. The six-monthly regime (overall survival (OS) 54%, recurrence-free survival (RFS) 46%) did not lead to a worse survival and was not inferior to the three-monthly regime (OS 55%, RFS 47%) in terms of detecting recurrence. Although CT scans (OS 53%, RFS 54%) detected pulmonary metastasis earlier, it did not lead to a better survival compared with CXR (OS 56%, RFS 59%). Conclusion The overall survival of patients who are treated for a sarcoma of the limb is not inferior to those followed up with a less intensive regimen than a more intensive protocol, in terms of frequency of visits and mode of imaging. CXR at six-monthly intervals and patient education about examination of the site of the surgery will detect most recurrences without deleterious effects on the eventual outcome. Cite this article: Bone Joint J 2018;100-B:262–8.


Viruses ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 215
Author(s):  
Esmari Rossouw ◽  
Marieke Brauer ◽  
Pieter Meyer ◽  
Nicolette M. du Plessis ◽  
Theunis Avenant ◽  
...  

Background: Viral gastroenteritis remains a major cause of hospitalisation in young children. This study aimed to determine the distribution and diversity of enteric viruses in children ≤5 years, hospitalised with gastroenteritis at Kalafong Provincial Tertiary Hospital, Pretoria, South Africa, between July 2016 and December 2017. Methods: Stool specimens (n = 205) were screened for norovirus GI and GII, rotavirus, sapovirus, astrovirus and adenovirus by multiplex RT-PCR. HIV exposure and FUT2 secretor status were evaluated. Secretor status was determined by FUT2 genotyping. Results: At least one gastroenteritis virus was detected in 47% (96/205) of children. Rotavirus predominated (46/205), followed by norovirus (32/205), adenovirus (15/205), sapovirus (9/205) and astrovirus (3/205). Norovirus genotypes GI.3, GII.2, GII.3, GII.4, GII.7, GII.12, GII.21, and rotavirus strains G1P[8], G2P[4], G2P[6], G3P[4], G3P[8], G8P[4], G8P[6], G9P[6], G9P[8] and sapovirus genotypes GI.1, GI.2, GII.1, GII.4, GII.8 were detected; norovirus GII.4[P31] and rotavirus G3P[4] predominated. Asymptomatic norovirus infection (GI.3, GI.7, GII.4, GII.6, GII.13) was detected in 22% of 46 six-week follow up stools. HIV exposure (30%) was not associated with more frequent or severe viral gastroenteritis hospitalisations compared to unexposed children. Rotavirus preferentially infected secretor children (p = 0.143) and norovirus infected 78% secretors and 22% non-secretors. Conclusion: Rotavirus was still the leading cause of gastroenteritis hospitalisations, but norovirus caused more severe symptoms.


2015 ◽  
Vol 24 (3) ◽  
pp. 74-85
Author(s):  
Sandra M. Grether

Individuals with Rett syndrome (RS) present with a complex profile. They benefit from a multidisciplinary approach for diagnosis, treatment, and follow-up. In our clinic, the Communication Matrix © (Rowland, 1990/1996/2004) is used to collect data about the communication skills and modalities used by those with RS across the lifespan. Preliminary analysis of this data supports the expected changes in communication behaviors as the individual with RS ages and motor deficits have a greater impact.


2007 ◽  
Vol 177 (4S) ◽  
pp. 360-360
Author(s):  
Ana Agud ◽  
Maria J. Ribal ◽  
Lourdes Mengual ◽  
Mercedes Marin-Aguilera ◽  
Laura Izquierdo ◽  
...  

Author(s):  
Göran Friman

Objective: To describe the distribution of risk, diagnosis and pharmacological treatments for diabetes and hypertension after seven years among patients provided with opportunistic medical screening in a dental setting. Material and Methods: The initial screening’s 170 participants were asked to take part in a seven-year follow-up study. Data were collected through self-reported information in a written health declaration. Outcome measures: • Number of study participants who had passed away • Prescription of antidiabetics or antihypertensives • Changes in weight and height to calculate body mass index (BMI) Results: The follow-up study consisted of 151 participants. Twenty had passed away. The risk needs for medicating with antihypertensive drugs after seven years for those not receiving pharmacological treatment at the initial screening was 3.7 times greater (p=0.025 CI 1.2-11.3) for participants with a diastolic blood pressure (BP) ≥ 90 mm Hg (85 for diabetics) than for the others. The risk was 3.9 times greater (p=0.020 CI 1.2-12.6) for those with a systolic BP of 140-159 mm Hg and 54.2 times greater (p<0.0001 CI 9.8-300.3) for those with a systolic BP ≥ 160 mm Hg than for those with a systolic BP 140 mm Hg. There were no changes in BMI. Conclusion: At least one in ten cases of incorrect medication or undiagnosed hypertension may be identifiable through opportunistic medical screening


2020 ◽  
Vol 16 (4) ◽  
pp. 327-333
Author(s):  
Shannon Armstrong-Kempter ◽  
Lucinda Beech ◽  
Sarah J. Melov ◽  
Adrienne Kirby ◽  
Roshini Nayyar

Background: The discovery of the benefits of antenatal corticosteroids (ACS) for preterm infants was one of the most significant developments in obstetric care. However, due to the difficulty in predicting preterm delivery, optimal use of ACS, is challenging. Objective: To describe prescribing practices for antenatal corticosteroids (ACS) at a tertiary hospital over five years to determine whether ACS were received at optimal timing; to determine patient characteristics of women receiving ACS at optimal timing; to determine patient characteristics of those who did not receive ACS as indicated and to examine the trend in ACS prescribing over the study period. Methods: We performed a retrospective study of all deliveries from January 2011 to December 2015. The rates of ACS prescription for each group of women (preterm, late preterm, and term) were recorded and analysed. Results: A total of 65% of women who delivered before 34 weeks’ gestation received ACS. Of these women, 63% delivered within 7 days of receiving ACS. Women most likely to receive ACS with optimal timing were primiparous (relative risk [RR], 1.25 [CI, 1.08-1.45]), or women diagnosed with pre-eclampsia (RR, 1.34 [CI 1.10-1.63]), preterm premature rupture of membranes (RR, 1.33 [CI, 1.15-1.54]) or threatened preterm labour (RR, 1.42 [CI, 1.22-1.65]). Conclusion: A significant number of women and babies are exposed to ACS without commensurate benefit, and a significant number who deliver preterm do not receive ACS. The percentage of preterm and term infants receiving ACS should be determined to optimise service delivery.


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