Symptomatic COVID-19 Disease Research Articles

Retinal and Corneal OCT Results of Patients Hospitalized and Treated in the Acute Phase of COVID-19.

Objective: This study aimed to assess changes in the morphology of the retina and cornea in patients treated and hospitalized during the acute active phase of SARS-CoV-2 infection. Methods: A total of 24 patients with symptomatic early COVID-19 disease and 38 healthy participants from a control group were enrolled in our study. Among them, 20 received oxygen therapy at flow rates ranging from 1-10 L, while four received high-flow intranasal oxygen therapy (HFNOT). Some patients were treated with other types of therapy, such as Remdesivir, COVID-19 convalescent plasma therapy, or Tocilizumab. In the study, we focused on the analysis of optical coherence tomography (OCT) images of the cornea and retina including corneal thickness, central retinal thickness, retinal nerve fiber layer (RNFL), and optic disc parameters. The measurements were acquired using Spectral-domain OCT REVO FC 130. Results: The analysis did not show significant changes between the examined ophthalmological parameters before and after therapy. Furthermore, there were no detected significant differences between the tested parameters of the retina and cornea in COVID-19-positive patients compared to the control group. Conclusions: No ophthalmological manifestations of COVID-19 disease were observed during the study. Taking into account the results of other publications, the lack of an unambiguous position on this topic requires further research.

Humoral immune response as an indicator for protection against Covid-19 after anti-SARS-COV2-booster vaccination in hematological and oncological patients.

Cancer patients are at a higher risk to develop severe COVID-19 symptoms after SARS-CoV-2 infection compared to the general population and regularly show an impaired immune response to SARS-CoV-2 vaccination. In our oncological center, 357 patients with hematological and oncological diseases were monitored for neutralizing antibodies from October 2021 over 12 months. All patients had received three anti-SARS-CoV-2 vaccinations with an mRNA-(Comirnaty/BionTech or Spikevax/Moderna) or a vector vaccine (Vakzevria/AstraZeneca or JCOVDEN/Johnson&Johnson). Neutralizing anti-SARS-CoV-2 IgG antibodies in the patients' sera were detected within 3 months before, 3-10 weeks and 5-7 months after the booster vaccination (third vaccination). 112 patients developed a breakthrough SARS-CoV-2 infection during the observation period. High anti-SARS-Cov-2 antibody levels before infection significantly protected against symptomatic Covid-19 disease (p = .003). The median antibody titer in patients with asymptomatic Covid-19 disease was 2080 BAU/ml (binding antibody units per Milliliter) and 765 BAU/ml in symptomatic patients. 98% of the solid tumor patients reached seroconversion after the booster vaccination in comparison to 79% of the hematological patients. High antibody titers of >2080 BAU/ml after the booster vaccination were detected in 61% of the oncological and 34.8% of the hematological patients. 7-10 months after the booster vaccination, the anti-SARS-CoV-2 antibody titer declined to an average of 849 BAU/ml. Considering the heterogenous humoral immune response of cancer patients observed in this study, an individual vaccination strategy based on regular measurement of anti-SARS-CoV-2 antibody levels should be considered in contrast to fixed vaccination intervals.

Investigating incidence of and factors associated with SARS-CoV-2 infection over a nine-month period in a highly-vaccinated healthcare worker cohort.

Healthcare workers (HCWs) are at increased risk of SARS-CoV-2 infection. This risk persists despite the implementation of mitigating factors, including vaccination. The ongoing impact of incident SARS-CoV-2 infection and symptomatic COVID-19 disease in vaccinated HCWs is poorly understood. We aimed to describe the epidemiology of incident SARS-CoV-2 infections, as well as investigating the serological, clinical and demographic factors associated with developing infection. This was a multi-centre prospective longitudinal study followed a HCW cohort over a nine-month period. Spike and nucleocapsid SARS-CoV-2 antibodies were measured at enrolment. Vaccination status, demographics and medical history were collated. Incident infection over the study period was recorded. Multivariable regression models investigated factors associated with nucleocapsid antibody status, incident infection and symptomatic infection. About 1260 participants took part, of whom n = 1006 were anti-nucleocapsid antibody positive. Negative anti-nucleocapsid antibody was associated with older age and having a known SARS-CoV-2 acquisition risk. There were n = 274 (22%) incident infections, with n = 225 (87%) diagnosed using antigen tests. Incident infections were associated with lower anti-nucleocapsid titres, increased time since previous SARS-CoV-2 infection, and having a known acquisition risk, but were not associated with vaccination status. This study demonstrates a high rate of incident SARS-CoV-2 infection amongst HCWs, despite broad vaccine coverage. There is a shift in diagnostics, from PCR to antigen testing. We identify at-risk groups for incident infection, and these should continue be targeted as part of risk reduction campaigns. Vaccination status and prior infection status alone are not surrogates for protection.

Safety and efficacy of RCP recombinant spike protein covid-19 vaccine compared to Sinopharm BBIBP: A phase III, non-inferiority trial

BackgroundWe conducted a phase III, non-inferiority trial comparing safety and efficacy of RCP recombinant spike protein Covid-19 vaccine to BBIBP (Sinopharm). MethodsAdult Iranian population received RCP or BBIBP in a randomized, double blind and an additional non-randomized open labeled trial arms. Eligible participants signed a written informed consent and received two intramuscular injections three weeks apart. In the randomized arm, an intranasal dose of vaccine or adjuvant-only preparation were given to the RCP and BBIBP recipients at day 51 respectively. Participants were actively followed for up to 4 months for safety and efficacy outcomes. Primary outcome was PCR + symptomatic Covid-19 disease two weeks after the second dose. The non-inferiority margin was 10% of reported BBIBP vaccine efficacy (HR = 1.36). ResultsWe recruited 23,110 participants (7224 in the randomized and 15,886 in the non-randomized arm). We observed 604 primary outcome events during 4 months of active follow-up including 121 and 133 in the randomized and 157 and 193 cases in the non-randomized arms among recipients of RCP and BBIBP respectively. Adjusted hazard ratios for the primary outcome in those receiving RCP compared with BBIBP interval were 0.91 (0.71–1.16) and 0.62 (0.49–0.77) in the randomized and non-randomized arms respectively. The upper boundary of 99.1% confidence interval of HR = 0.91 (0.67–1.22) remained below the margin of non-inferiority in the randomized arm after observing the early stopping rules using O'Brien Fleming method. ConclusionOur study showed that the RCP efficacy is non-inferior and its safety profile is comparable to the BBIBP.

Data-driven automated classification algorithms for acute health conditions: applying PheNorm to COVID-19 disease.

Automated phenotyping algorithms can reduce development time and operator dependence compared to manually developed algorithms. One such approach, PheNorm, has performed well for identifying chronic health conditions, but its performance for acute conditions is largely unknown. Herein, we implement and evaluate PheNorm applied to symptomatic COVID-19 disease to investigate its potential feasibility for rapid phenotyping of acute health conditions. PheNorm is a general-purpose automated approach to creating computable phenotype algorithms based on natural language processing, machine learning, and (low cost) silver-standard training labels. We applied PheNorm to cohorts of potential COVID-19 patients from 2 institutions and used gold-standard manual chart review data to investigate the impact on performance of alternative feature engineering options and implementing externally trained models without local retraining. Models at each institution achieved AUC, sensitivity, and positive predictive value of 0.853, 0.879, 0.851 and 0.804, 0.976, and 0.885, respectively, at quantiles of model-predicted risk that maximize F1. We report performance metrics for all combinations of silver labels, feature engineering options, and models trained internally versus externally. Phenotyping algorithms developed using PheNorm performed well at both institutions. Performance varied with different silver-standard labels and feature engineering options. Models developed locally at one site also worked well when implemented externally at the other site. PheNorm models successfully identified an acute health condition, symptomatic COVID-19. The simplicity of the PheNorm approach allows it to be applied at multiple study sites with substantially reduced overhead compared to traditional approaches.

Mechanistic Insights on Viral Factors Involved in Asymptomatic COVID-19 Pathogenesis

Abstract: SARS-CoV-2 infection may cause asymptomatic, pre-symptomatic or symptomatic COVID-19 disease. While symptomatic infections are at the centre stage for disease diagnosis and treatment, asymptomatic and pre-symptomatic cases heighten the challenge of transmission tracking ultimately leading to failure of control interventions. Asymptomatic cases appear due to a variety of host and viral factors and contribute substantially to the total number of infections. Through this article, we have tried to assemble existing information about the role of viral factors and mechanisms involved in the development of asymptomatic COVID-19. The significance of ‘PLpro’- a protease of Nidovirales order that removes ubiquitin and ISG15 from host proteins to regulate immune responses against the virus and hence disease presentation has been highlighted. PL-pro dampens inflammatory and antiviral responses, leading to asymptomatic infection. 11083G>T-(L37F) mutation in ‘Nsp6’ of SARS-CoV-2 also diminishes the innate immune response leading to asymptomatic infections. It is, therefore, pertinent to understand the role of proteins like PLpro and Nsp6 in SARS-CoV-2 biology for the development of transmission control measures against COVID-19. This review focuses on viral molecular mechanisms that alter disease severity and highlights compounds that work against such regulatory SARS-CoV-2 proteins.

Early Fluvoxamine Reduces the Risk for Clinical Deterioration in Symptomatic Outpatients with COVID-19: A Real-World, Retrospective, before-after Analysis.

Fluvoxamine, a selective serotonin reuptake inhibitor with anti-inflammatory properties, has gained attention as a repurposed drug to treat COVID-19. We aimed to explore the potential benefit of fluvoxamine on outpatients with early SARS-CoV-2 infection. We performed a retrospective study of fluvoxamine adult outpatients with symptomatic COVID-19 disease of early onset (<5 days), in the context of an infectious diseases private practice, between September-December 2021, in Greece. Patients with disease duration ≥5 days, dyspnea and/or hypoxemia with oxygen saturation <94% in room air and pregnancy were excluded from the analysis. In total, 103 patients, 54 males/49 females with a median age of 47 years (39-56), were included in this study. Patient characteristics were balanced before and after the introduction of fluvoxamine. Two patients in the fluvoxamine arm (3.8%; 95% CI 0.4-13) had clinical deterioration compared to 8 patients in the standard of care group (16%; 95% CI 7.2-29.1, p < 0.04). After controlling for age, sex, body mass index > 30 and vaccination status, fluvoxamine was independently associated with a lower risk of clinical deterioration (adj. OR 0.12; 95% CI 0.02-0.70, p < 0.02). Adding on fluvoxamine to treatment for early symptomatic COVID-19 patients may protect them from clinical deterioration and hospitalization, and it is an appealing low-cost, low-toxicity option in the community setting and warrants further investigation.

Safety and efficacy of the FAKHRAVAC compared with BBIBP-Corv2 against SARS-CoV-2 in adults: a non-inferiority multi-center trial

BackgroundWe compared Fakhravac and BBIBP-Corv2 vaccines in a phase III trial.MethodWe conducted a multicenter, parallel-group, active-control, non-inferiority clinical trial with pragmatic considerations assessing the safety and efficacy of Fakhravac and BBIBP-Corv2 vaccines. We started with two randomized double-blind arms and added two non-randomized open-label arms (based on participant preference) because of slow recruitment. The adult population received 0.5 ml (10 µg per dose) intramuscular injections of Fakhravac or BBIBP-Corv-2 vaccines 21 days apart. The primary outcome was the occurrence of PCR-positive symptomatic Covid-19 disease 14 days or more after the second injection. A 10% non-inferiority margin to the reported 72.8% efficacy of BBIBP-Corv2 was assumed. Cox proportional hazard modeling was used to estimate hazard ratios and their 95% confidence intervals.ResultWe enrolled 24,056 adults in four groups (randomized-Fakhravac: 824, randomized-BBIBP-Corv2: 832; Non-randomized-Fakhravac: 19,429, Non-randomized-BBIBP-Corv2: 2971). All observed local and systemic adverse reactions were generally self-limited and resolved completely. We observed similar Serious Adverse Event (SAE) rates in the BBIBP-Corv2 (2.57, 95% CI 1.33–4.49) and Fakhravac (2.25, 95% CI 1.72–2.89) groups; none of which were related to the vaccines received. We recorded 9815 Medically Attendant Adverse Events (MAAE), 736 of which were categorized as somehow related. The rate of related MAAE in the Fakhravac was similar to the BBIBP-Corv2 groups (0.31 and 0.26 per 1000 person-day) in the randomized and considerably higher (0.24 and 0.07 per 1000 person-day) in the non-randomized arms. We observed 129 (35% of the 365 required by target sample size) events of PCR + symptomatic Covid-19 during four months of active follow-up in the randomized arm, demonstrating that those receiving the Fakhravac vaccine were significantly less likely (HR = 0.69; 95% CI 0.49–0.98) to be diagnosed with PCR + symptomatic Covid-19 compared with those receiving BBIBP-Corv2 vaccine. After adjusting for type I error using the O’Brien Fleming method, the Fakhravac vaccine was non-inferior to the BBIBP-Corv2 (assuming a 10% non-inferiority margin to the reported 72.8% BBIBP-Corv2 vaccine efficacy; HR < 1.35) (One-way test: HR = 0.66; 99.8% CI 0.38–1.15). In the non-randomized arm, the results were inconclusive (HR = 1.23; 95% CI 0.96–1.61). We observed 5 cases of hospitalized Covid-19 in the randomized arm, none of which occurred in the Fakhravac vaccine group. Those receiving the Fakhravac vaccine were four times less likely to go to the hospital because of a Covid-19 diagnosis (HR = 0.24; 95% CI 0.10–0.60). The vaccine efficacy of the Fakhravac vaccine is estimated to be 81.5% (95% CI 81–82.4%).ConclusionFakhravac inactivated SARS-CoV-2 vaccine has comparable safety and efficacy to the BBIBP-Corv2 vaccine.Trial registration This study was registered with the Iranian Registry of Clinical Trials (www.irct.ir: IRCT20210206050259N3).

#5687 SARS-COV-2 PREEXPOSURE PROTECTS FROM IMMUNITY-FADING AFTER MRNA VACCINATION IN KIDNEY TRANSPLANT RECIPIENTS, DIALYSIS PATIENTS, AND MEDICAL PERSONNEL

Abstract Background and Aims Immunity development and fading after SARS-CoV-2mRNA vaccination differently affects high risk populations such as dialysis or renal transplant patients compared to general population. We hypothesized that COVID-19 preexposure influences not only vaccination dependent development of immunity but also protects from immunity fading depending on vaccine type and patient group. Method We evaluated two and nine months follow up data in our observational DIA-Vacc study exploring specific cellular (interferon-γ release assay = IGRA) or/and humoral immune responses after 2x SARS-CoV-2mRNA vaccination in 2615 participants including medical personnel (300 MP), dialysis patients (1831 DP), kidney transplant recipients (484 KTR). Study participants were separated into COVID-19 preexposure positive (n = 405) versus negative (n = 2210) groups, where symptomatic or asymptomatic COVID-19 disease before start of vaccination was confirmed by clinical symptoms, PCR positivity and/or Spike S1/core antiSARS-CoV-2 antibodies. Results Two months (T2) after first vaccination, seroconversion and T-cell immunity success rates for MP and DP were excellent (86-100%) and independent on COVID-preexposure. In KTR, vaccination-related seroconversion rate on T2 almost doubled with COVID-preexposure (84% versus 45% without), a result consistent with all different antibody measurements (IgA, IgG, or receptor binding domain-RBD). Nine months after first vaccination in COVID-19 negative study patients, the percentage of patients with RBD-antibody fading results &amp;gt;50% remained low in MP (18%), high in DP (53%) and intermediate in KTR (39%). In contrast, in all patient groups with COVID-19 preexposure RBD-antibody fading reactions &amp;gt;50% within nine months after vaccination were almost vanished (4% in MP, 8% in DP and 0% in KTR). COVID-19 preexposure in DP also reduced T-cell immunity fading as measured by IGRA, where only 9% of patients showed a &amp;gt;50% titer decrease compared to 34% of DP without any COVID-19 preexposure. Similar results were also seen regarding vaccination dependent regulation of antiSARS-Cov-2 IgG antibodies dependent on COVID-19 preexposure. These results are also reflected by increased mean antibody titers for IgG- and RBD-antibodies nine months after vaccination in all COVID-19 preexposed compared to non-exposed groups. In addition, the degree of antibody fading after vaccination was not just dependent on COVID-19 preexposure status but also on mRNA vaccine type being used. In MP with COVID-preexposure, 22% of BNT162b2mRNA but 0% of 1273-mRNA vaccinated study participants experienced RBD-antibody fading &amp;gt;50% within nine months after vaccination start. This significant difference was even greater in COVID-19 preexposed DP, in whom vaccination with BNT162b2mRNA caused RBD-antibody fading &amp;gt;50% in 36% compared to 6% of 1273-mRNA treated DP. The patient number in the KTR group was not high enough for a vaccine type comparison. This vaccine dependent influence on antibody fading is consistent with our results in patient groups without COVID-19 preexposure. Conclusion Long term immunity time course is markedly modified via COVID-preexposure in a mRNA vaccine dependent matter. Hybrid immunity after COVID-19 preexposure almost completely lacks immunity fading between two and nine months especially in 1273-mRNA vaccinated MP, DP, or KTR. Immune monitoring shows great individual variability dependent on personal patient history and should be especially used for pandemic patient management in vulnerable groups such as DP and KTR.

A phase 3, randomised, double-blind, placebo-controlled clinical trial evaluation of the efficacy and safety of a SARS-CoV-2 recombinant spike RBD protein vaccine in adults (ABDALA-3 study)

The pandemic of COVID-19 raised the urgent need for safe and efficacious vaccines against SARS-CoV-2. We evaluated the efficacy and safety of a new SARS-CoV-2 virus receptor-binding domain (RBD) vaccine. A phase 3, multicentre, randomised, double-blind, placebo-controlled trial was carried out at 18 clinical sites in three provinces of the south-eastern region of Cuba. Subjects (healthy or those with controlled chronic diseases) aged between 19 and 80 years, who gave written informed consent were eligible. Subjects were randomly assigned (1:1, in blocks) to two groups: placebo, and 50μg RBD vaccine (Abdala). The product was administered intramuscularly, 0.5mL in the deltoid region, in a three-dose immunization schedule at 0-14-28 days. The organoleptic characteristics and presentations of the vaccine and placebo were identical. All participants (subjects, clinical researchers, statisticians, laboratory technicians, and monitors) remained blinded during the study period. The main endpoint was to evaluate the efficacy of the Abdala vaccine in the prevention of symptomatic COVID-19. The trial is registered with the Cuban Public Registry of Clinical Trials, RPCEC00000359. Between March 22 to April 03, 2021, 48,290 subjects were included (24,144 and 24,146 in the placebo and Abdala groups, respectively) in the context of predominant D614G variant circulation. The evaluation of the main efficacy outcomes occurred during May-June 2021, starting at May 3rd, in the context of high circulation of mutant viruses, predominantly VOC Beta. The incidence of adverse reactions for individuals in the placebo and Abdala vaccine groups were 1227/24,144 (5.1%) and 1621/24,146 (6.7%), respectively. Adverse reactions were mostly mild, and from the injection site, which resolved in the first 24-48h. No severe adverse events with demonstrated cause-effect relationship attributable to the vaccine were reported. Symptomatic COVID-19 disease was confirmed in 142 participants in the placebo group (78.44 incidence per 1000 person-years, 95% confidence interval [CI], 66.07-92.46) and in 11 participants in Abdala vaccine group (6.05 incidence per 1000 person years; 95% CI 3.02-10.82). The Abdala vaccine efficacy against symptomatic COVID-19 was 92.28% (95% CI 85.74-95.82). Moderate/serious forms of COVID-19 occurred in 30 participants (28 in the placebo group and only 2 in the Abdala vaccine group) for a vaccine efficacy of 92.88% (95% CI 70.12-98.31). There were five critical patients (of which four died), all in the placebo group. The Abdala vaccine was safe, well tolerated, and highly effective, fulfilling the WHO target product profile for COVID-19 vaccines. Those results, along with its immunization schedule and the advantage of easy storage and handling conditions at 2-8°C, make this vaccine an option for the use in immunization strategies as a key tool for the control of the pandemic. Centre for Genetic Engineering and Biotechnology (CIGB), Havana, Cuba.

How Efficient Are Isolation Protocols? Outcome of Isolation Protocol in Surgery during COVID-19 Pandemic: A Single Institute Experience.

The timing of screening for SARS-CoV-2 preoperatively by RT-PCR/CBNAAT, isolation protocols in preoperative wards, operation theatres, and postoperative wards are not well established. Evaluating the effectiveness of maintaining three pathways of two COVID-19 negative pathways (1) immediate testing pathway (2) isolation, or quarantine for five days and testing prior to surgery pathway, and (3) the tested COVID-19-positive pathway, was the aim of the study. The primary objective was to assess the utility and outcome of the two COVID-19 negative pathways adopted before surgery in terms of infectivity (seroconversion; COVID-19 positivity rate before surgery and symptomatic COVID-19 disease after surgery). The secondary objective was to derive a practical protocol for isolation or quarantine for emergency and elective surgery. Enrolled patients were grouped based on the need for surgery; Group-1 emergency basis, Group-2 urgent basis, and Group-3 COVID-19 positive and the three channels were kept separate with separate dedicated healthcare staff for each channel. There were 199 (4.56%) COVID-19-positive patients, of whom 80 (40%) were operated. COVID-19 positivity rate was low in Group 2 (3% vs. Group 1, 11%). There was no seroconversion from negative to positive in our patients during the peri-operative period. COVID-19 positivity rate in Group-2 was significantly less. None of the COVID-19-negative patients turned symptomatic and the probability of seroconversion from COVID-19-negative was less during the peri-operative period. The isolation protocol of non-COVID-19 positive patients with the separate channel is effective.

Symptomatic COVID-19 in Pregnancy: Hospital Cohort Data between May 2020 and April 2021, Risk Factors and Medicolegal Implications.

Pregnancy does not appear to increase susceptibility to SARS-CoV-2 infection, but some physiological changes, such as the reduction of residual functional volumes, elevation of the diaphragm, and impaired cellular immunity, may increase the risk of severe disease and result in a higher risk of complications. The article's primary objective is to evaluate the factors associated with symptomatic COVID-19 disease in pregnancy. The secondary objective is to describe maternal and neonatal outcomes and cases of vertical transmission of the infection. All pregnant women hospitalized with SARS-CoV2 infection were included in a prospective study in the UOC of Obstetrics and Gynecology, AOOR Villa Sofia-Cervello, Palermo, between May 2020 and April 2021. The patients who requested the termination of the pregnancy according to Law 194/78 were excluded. We included 165 pregnancies with a total number of 134 deliveries. Overall, 88.5% of the patients were asymptomatic at the time of admission and 11.5% were symptomatic. Of them, 1.8% of the patients required hospital admission in the intensive care unit. Symptoms occurrences were positively associated with the increase in maternal BMI (OR 1.17; p = 0.002), the prematurity (OR 4.71; p = 0.022), and at a lower birth weight (OR 0.99; p = 0.007). One infant tested positive for SARS-CoV2 nasopharyngeal swab; 11.4% of newborns had IgG anti SARS-CoV2 at birth; IgM was positive in 2.4% of newborns. There was no difference statistically significant difference in the vertical transmission of the infection among the group of symptomatic pregnant women and that of asymptomatic pregnant women.

Past SARS-CoV-2 infection protection against re-infection: a systematic review and meta-analysis

Understanding the level and characteristics of protection from past SARS-CoV-2 infection against subsequent re-infection, symptomatic COVID-19 disease, and severe disease is essential for predicting future potential disease burden, for designing policies that restrict travel or access to venues where there is a high risk of transmission, and for informing choices about when to receive vaccine doses. We aimed to systematically synthesise studies to estimate protection from past infection by variant, and where data allow, by time since infection. In this systematic review and meta-analysis, we identified, reviewed, and extracted from the scientific literature retrospective and prospective cohort studies and test-negative case-control studies published from inception up to Sept 31, 2022, that estimated the reduction in risk of COVID-19 among individuals with a past SARS-CoV-2 infection in comparison to those without a previous infection. We meta-analysed the effectiveness of past infection by outcome (infection, symptomatic disease, and severe disease), variant, and time since infection. We ran a Bayesian meta-regression to estimate the pooled estimates of protection. Risk-of-bias assessment was evaluated using the National Institutes of Health quality-assessment tools. The systematic review was PRISMA compliant and was registered with PROSPERO (number CRD42022303850). We identified a total of 65 studies from 19 different countries. Our meta-analyses showed that protection from past infection and any symptomatic disease was high for ancestral, alpha, beta, and delta variants, but was substantially lower for the omicron BA.1 variant. Pooled effectiveness against re-infection by the omicron BA.1 variant was 45·3% (95% uncertainty interval [UI] 17·3-76·1) and 44·0% (26·5-65·0) against omicron BA.1 symptomatic disease. Mean pooled effectiveness was greater than 78% against severe disease (hospitalisation and death) for all variants, including omicron BA.1. Protection from re-infection from ancestral, alpha, and delta variants declined over time but remained at 78·6% (49·8-93·6) at 40 weeks. Protection against re-infection by the omicron BA.1 variant declined more rapidly and was estimated at 36·1% (24·4-51·3) at 40 weeks. On the other hand, protection against severe disease remained high for all variants, with 90·2% (69·7-97·5) for ancestral, alpha, and delta variants, and 88·9% (84·7-90·9) for omicron BA.1 at 40 weeks. Protection from past infection against re-infection from pre-omicron variants was very high and remained high even after 40 weeks. Protection was substantially lower for the omicron BA.1 variant and declined more rapidly over time than protection against previous variants. Protection from severe disease was high for all variants. The immunity conferred by past infection should be weighed alongside protection from vaccination when assessing future disease burden from COVID-19, providing guidance on when individuals should be vaccinated, and designing policies that mandate vaccination for workers or restrict access, on the basis of immune status, to settings where the risk of transmission is high, such as travel and high-occupancy indoor settings. Bill & Melinda Gates Foundation, J Stanton, T Gillespie, and J and E Nordstrom.

A Systematic Review and Meta-Analysis on the Real-World Effectiveness of COVID-19 Vaccines against Infection, Symptomatic and Severe COVID-19 Disease Caused by the Omicron Variant (B.1.1.529).

Real-world data on the effectiveness of COVID-19 vaccines against the Omicron variant (B.1.1.529) is limited. This systematic review aimed to investigate the real-world effectiveness and durability of protection conferred by primary course and booster vaccines against confirmed Omicron infection, and severe outcomes. We systematically searched literature up to 1 August 2022. Meta-analysis was performed with the DerSimonian-Laird random-effects model to estimate the pooled vaccine effectiveness (VE). Overall, 28 studies were included representing 11 million individuals. The pooled VE against Omicron infection was 20.4% (95%CI: 12.1-28.7%) and 23.4% (95%CI: 13.5-33.3%) against symptomatic infection with variation based on vaccine type and age groups. VE sharply declined from 28.1% (95%CI: 19.1-37.1%) at three months to 3.9% (95%CI: -24.8-32.7%) at six months. Similar trends were observed for symptomatic Omicron infection. A booster dose restored protection against Omicron infection up to 51.1% (95%CI: 43.8-58.3%) and 57.3% (95%CI: 54.0-60.5%) against symptomatic infection within three months; however, this waned to 32.8% (95%CI: 16.8-48.7%) within six months. VE against severe Omicron infection following the primary course was 63.6% (95%CI: 57.5-69.7%) at three months, decreased to 49% (95%CI: 35.7-63.4%) within six months, and increased to 86% after the first or second booster dose.

Immunoglobulin G antibody immune response profile following infection with SARS-CoV-2 in COVID-19 Egyptian patients

This study aimed to report the dynamic profile of IgG-specific antibodies to SARS-CoV-2 infection for 6 months after infection. We conducted a prospective study, recruited 33 recently confirmed covid -19 patients and collected 6 samples from each patient. The first samples were collected one month from the start of symptoms and subsequent samples collected at 30 days interval. We measured the IgG by chemiluminescent immunoassay (CLIA). According to the disease severity, patients were categorized as asymptomatic 4 (12.1%), mild 14 (42,4%), moderate 9 (27.3%), and severe 6 (18.2%). Patients were 12 (35.3%) females and 21 (64.7%) males. The mean IgG levels maintained a high level till the second month (92.81 ± 110.15 AU/ml) from the onset of symptoms followed by a gradual decrease till the sixth month after infection (17.42 ± 22.61 AU/ml). The patients with severe symptoms significantly exhibited the highest IgG levels, reached the highest level (mean=237.44 ± 164.13 AU/ml) at the second month. While the lowest levels were detected among the asymptomatic patients (mean= 3.04 ± 2.94 AU/ml) at the second month. Older age correlated with higher IgG antibody level (r= 0.350 p=0.046); however, sex was not related to IgG level. In conclusion, Symptomatic COVID-19 disease is followed by protective immunity for more than 6 months. Immunity in asymptomatic patients is low and fades rapidly than symptomatic cases. Patients with severe disease had significantly higher IgG levels compared to mild, moderate, or asymptomatic patients.

The Differential Impact of COVID-19 Pandemic on Sexual Behavior of Eligible Couples in Urban and Rural India

Background: Intimacy during sexual contact with a person with symptomatic or asymptomatic COVID-19 disease carries the risk of its transmission. COVID-19 has been therefore found to adversely impact the sexual behavior in people in various countries. A discussion on sexual health is often tabooed in India, leading to less research evidence from India. Aim: We tried to study and compare the impact of COVID-19 pandemic on the sexual behavior of urban- and rural-based eligible couples. Methods: Eligible couples were randomly selected from the urban and rural field practice area of a Medical College of West Bengal (India). They were interviewed using a data collection schedule for their sexual practices adopted during the pandemic. Urban vs rural sexual behavior was compared using chi-square test. Results: Majority didn’t report any change in sexual desire compared to prepandemic days. However, scope of sexual contact had significantly reduced among urbanites ( P = .036); fear of contracting COVID-19 during sexual intimacy was more among them as well ( P = .047). The rural respondents reported significantly higher desire for parenthood ( P = .018), though their contraceptive behavior was not significantly different from the urban counterparts. Many used means other than sexual intercourse for sexual gratification, which had remained similar to the prepandemic times. Conclusion: The sexual behavior of urban and rural participants was found to be significantly different on many fronts, probably due to better COVID-19 awareness among urban residents as well as other prevalent social stigma and restrictions that were less commonly encountered in rural participants.

Subarachnoid block in parturients with mild COVID-19 disease for Caesarean delivery- A case series

The obstetric population has been most vulnerable in this COVID-19 pandemic. We could not retrieve any study evaluating the safety and efficacy of anaesthetic techniques in parturients with COVID-19 undergoing caesarean delivery (CD) from South Asian Sub-continent. We, herein present the detailed clinical analysis and anaesthetic management of a case series of seven parturient with COVID-19 undergoing CD under subarachnoid block (SAB) in a tertiary care designated COVID hospital in the city of Delhi between June and December 2020. Herein, we report 7 parturients with mild COVID-19 disease undergoing CD under SAB. Our observations are that the use of SAB was associated with transient haemodynamic perturbations in terms of hypotension in 3 patients and bradycardia in one patient. The neonatal outcome was observed to be favourable. To conclude, our experience is that SAB is safe and effective for parturient with mildly symptomatic COVID-19 disease; however, was found to be associated with transient haemodynamic changes exclusively in parturients with anaemia.

Expression of SARS-Cov-2 Entry Factors in Patients with Chronic Hepatitis.

Chronic hepatitis (CH) of dysmetabolic or viral etiology has been associated with poor prognosis in patients who experienced the severe acute respiratory coronavirus virus-2 (SARS-Cov-2) infection. We aimed to explore the impact of SARS-Cov-2 infection on disease severity in a group of patients with CH. Forty-two patients with CH of different etiology were enrolled (median age, 56 years; male gender, 59%). ACE2 and TMPRSS2 were measured in plasma samples of all patients by ELISA and in the liver tissue of a subgroup of 15 patients by Western blot. Overall, 13 patients (31%) experienced SARS-Cov-2 infection: 2/15 (15%) had CHB, 5/12 (39%) had CHC, and 6/15 (46%) had non-alcoholic fatty liver disease (NAFLD). Compared to viral CH patients, NAFLD subjects showed higher circulating ACE2 levels (p = 0.0019). Similarly, hepatic expression of ACE2 was higher in subjects who underwent SARS-Cov-2 infection compared to the counterpart, (3.24 ± 1.49 vs. 1.49 ± 1.32, p = 0.032). Conversely, hepatic TMPRSS2 was significantly lower in patients who experienced symptomatic COVID-19 disease compared to asymptomatic patients (p = 0.0038). Further studies are necessary to understand the impact of COVID-19 in patients with pre-existing liver diseases.

Photodynamic Inactivation of Symptomatic COVID-19 Disease In A Married Couple

Photodynamic Inactivation of Symptomatic COVID-19 Disease In A Married Couple

BNT162b2 COVID-19 vaccination uptake, safety, effectiveness and waning in children and young people aged 12-17 years in Scotland.

BackgroundThe two-dose BNT162b2 (Pfizer-BioNTech) vaccine has demonstrated high efficacy against COVID-19 disease in clinical trials of children and young people (CYP). Consequently, we investigated the uptake, safety, effectiveness and waning of the protective effect of the BNT162b2 against symptomatic COVID-19 in CYP aged 12–17 years in Scotland.MethodsThe analysis of the vaccine uptake was based on information from the Turas Vaccination Management Tool, inclusive of Mar 1, 2022. Vaccine safety was evaluated using national data on hospital admissions and General Practice (GP) consultations, through a self-controlled case series (SCCS) design, investigating 17 health outcomes of interest. Vaccine effectiveness (VE) against symptomatic COVID-19 disease for Delta and Omicron variants was estimated using a test-negative design (TND) and S-gene status in a prospective cohort study using the Scotland-wide Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II) surveillance platform. The waning of the VE following each dose of BNT162b2 was assessed using a matching process followed by conditional logistic regression.FindingsBetween Aug 6, 2021 and Mar 1, 2022, 75.9% of the 112,609 CYP aged 16–17 years received the first and 49.0% the second COVID-19 vaccine dose. Among 237,681 CYP aged 12–15 years, the uptake was 64.5% and 37.2%, respectively. For 12–17-year-olds, BNT162b2 showed an excellent safety record, with no increase in hospital stays following vaccination for any of the 17 investigated health outcomes. In the 16–17-year-old group, VE against symptomatic COVID-19 during the Delta period was 64.2% (95% confidence interval [CI] 59.2–68.5) at 2–5 weeks after the first dose and 95.6% (77.0–99.1) at 2–5 weeks after the second dose. The respective VEs against symptomatic COVID-19 in the Omicron period were 22.8% (95% CI -6.4–44.0) and 65.5% (95% CI 56.0–73.0). In children aged 12–15 years, VE against symptomatic COVID-19 during the Delta period was 65.4% (95% CI 61.5–68.8) at 2–5 weeks after the first dose, with no observed cases at 2–5 weeks after the second dose. The corresponding VE against symptomatic COVID-19 during the Omicron period were 30.2% (95% CI 18.4–40.3) and 81.2% (95% CI 77.7–84.2). The waning of the protective effect against the symptomatic disease began after five weeks post-first and post-second dose.InterpretationDuring the study period, uptake of BNT162b2 in Scotland has covered more than two-thirds of CYP aged 12–17 years with the first dose and about 40% with the second dose. We found no increased likelihood of admission to hospital with a range of health outcomes in the period after vaccination. Vaccination with both doses was associated with a substantial reduction in the risk of COVID-19 symptomatic disease during both the Delta and Omicron periods, but this protection began to wane after five weeks.FundingUK Research and Innovation (Medical Research Council); Research and Innovation Industrial Strategy Challenge Fund; Chief Scientist's Office of the Scottish Government; Health Data Research UK; National Core Studies – Data and Connectivity.