Safety and immunogenicity of inactive vaccines as booster doses for COVID-19 in Türkiye: A randomized trial.

Protective neutralizing antibody titers reduce in time after COVID-19 vaccinations, as in individuals who have had COVID-19. This study aimed to evaluate the safety and immunogenicity of CoronaVac and TURKOVAC vaccines used as a booster dose after CoronaVac primary vaccination. This double-blind, randomized, controlled, phase II, multicenter study included healthy male and female adults (18-60 years) who were vaccinated with two doses of CoronaVac vaccine and did not exceed the duration of at least 90 days and a maximum of 270 days from the second dose of vaccination. Among 236 eligible volunteers, 222 were recruited for randomization between July 12, 2021 and September 10, 2021; 108 and 114 were randomized to the TURKOVAC and CoronaVac arms, respectively. The primary endpoint was adverse events (AEs) (ClinicalTrials.gov; Identifier: NCT04979949). On day 28, at the neutralizing antibody threshold of 1/6, the positivity rate reached 100% from 46.2% to 98.2% from 52.6% in the TURKOVAC and CoronaVac arms, respectively, against the Wuhan variant and the positivity rate reached 80.6% from 8.7% in the TURKOVAC arm vs. 71.9% from 14.0% in the CoronaVac arm against the Delta variant. IgG spike antibody positivity rate increased from 57.3% to 98.1% and from 57.9% to 97.4% in the TURKOVAC and CoronaVac arms, respectively. The TURKOVAC and CoronaVac arms were comparable regarding the frequency of overall AEs. Both vaccines administered as booster yielded higher antibody titers with acceptable safety profiles.

What is the context? The timing of the primary and booster doses for each vaccine differs.We aimed to evaluate the safety and immunogenicity of CoronaVac and TURKOVAC vaccines used as homologous booster dose after CoronaVac primary vaccination.What is new? The neutralizing antibody titers against the Wuhan variant decreased below 1/6- the seropositivity threshold value- in more than 55% of the participants 4 months after administration of two doses of CoronaVac vaccine.Immunogenicity was re-stimulated and the neutralizing antibody titers increased rapidly and markedly with the administration of the CoronaVac or TURKOVAC as a booster dose 4 months after the second dose.While the increase in neutralizing antibodies against the Wuhan variant was similar with both CoronaVac and TURKOVAC, more antibodies developed against the Delta variant with TURKOVAC.What is the impact? With the Hybrid COV-RAPEL TR study, after the primary vaccination consisting of two doses of inactivated vaccine, antibody titers decreased in the long term; however, higher antibody titers are achieved than the primary vaccination after the booster dose administered after 4­6 month interval.Booster application with TURKOVAC provides antibodies at least as much as the CoronaVac booster dose, with an acceptable safety profile.

Comparison of anakinra and tocilizumab in management of severe COVID-19: a retrospective cohort study.

BACKGROUND: Studies regarding effectiveness of anakinra and tocilizumab treatments in coronavirus disease 2019 (COVID-19) have contradictory results. Furthermore, there is scarce comparative data regarding superiority of any agent. To further elucidate any superiority between these two agents, we retrospectively investigated and compared outcomes in hospitalized COVID-19 patients of our inpatient cohort who received anakinra or tocilizumab. METHODS: This study was designed as a single-center, retrospective, cross-sectional cohort study. Hospitalized patients with confirmed diagnosis of COVID-19 who had Brescia-COVID respiratory severity scale score ≥3 and hyperinflammation (defined as elevation of C reactive protein ≥50 g/L or ferritin ≥700 ng/mL) and received anakinra or tocilizumab in addition to standard care were enrolled in the study. Length of hospital stay after initiation of antiinflammatory treatment, need for mechanical ventilation, need for intensive care unit admission, mortality were set as primary outcomes and compared between tocilizumab and anakinra recipients after propensity score matching. RESULTS: One hundred and six patients were placed in each group after propensity score matching. In the anakinra group, relative risk reduction for intensive care unit admission was 50% when compared to the tocilizumab group and the number needed to treat to avert an intensive care unit admission was 3 (95% CI, 2-5). In terms of mortality, a 52% relative risk reduction was observed with anakinra treatment and the number needed to treat to avert an intensive care unit admission was 8 (95% CI, 4-50). Significantly more patients were observed to receive glucocorticoids in the anakinra group. DISCUSSION: Anakinra administration in severe COVID-19 patients was significantly associated with better survival and greater clinical improvement compared to the tocilizumab administration in our study. Increased rate of glucocorticoid use in the anakinra group might have contributed to better outcomes.

Knowledge, attitudes, and behaviors of residents and specialists working in tertiary healthcare institutions about drug allergy

Aims: We evaluated the knowledge, attitudes, and behaviors of residents and specialists working in tertiary healthcare institutions about drug allergy. Methods: Residents and specialist medical doctors working at a tertiary health institution were included in the study. A questionnaire consisting of questions evaluating occupational and demographic characteristics, knowledge, attitudes, and behaviors about drug allergy was prepared and administered to the participants. Result: Only 26 (21.3%) of the participants had attended any training on drug allergies. Of the participants, 73 (59.8%) felt competent in taking and interpreting an accurate allergy history for drugs. Of the participants, 107 (87.7%) knew that it is often impossible to reach a definite conclusion about drug allergy based on anamnesis alone. Only half of the participants stated that they could spare enough time for detailed anamnesis about drug allergy in their daily practice. Only 19 (15.6%) of the participants stated that they referred patients with suspected drug allergies to an allergist at a rate of 90-100%. When the answers of the assistant and specialists were compared;the proportion of respondents to the question of the most important drug classes responsible for allergic reactions, including antibiotics and aspirin/other NSAIDs (28.9% vs. 67.7%;p<.001). And the rate of those who responded corticosteroids+antihistamines+adrenaline to the question of the most recommended drug classes to treat drug allergies was found to be higher in specialist physicians (19.8% vs. 71%;p<.001). Conclusion: This cross-sectional study showed a low level of awareness, knowledge, and competency in the management of drug allergies among residents and specialists from different fields.

Hydroxychloroquine shortened hospital stay and reduced intensive care unit admissions in hospitalized COVID-19 patients.

INTRODUCTION: Effectiveness of hydroxychloroquine against SARS-CoV-2 has been highly controversial. In our research, we aimed to investigate the effects of hydroxychloroquine on disease outcomes in hospitalized patients with COVID-19. METHODOLOGY: A total of 393 hospitalized patients with COVID-19 were retrospectively assigned to the standard of care therapy group (n = 180) or the standard of care plus hydroxychloroquine group (n = 213). The standard of care therapy comprised favipiravir, low molecular weight heparin, acetylsalicylic acid. Status of oxygenation at baseline and on the seventh day, laboratory tests at baseline and at discharge were recorded. Length of hospital stay, administration of anti-inflammatory treatment, admission to the intensive care unit and 28th day mortality were set as primary endpoints. RESULTS: There were no statistically significant differences between groups in terms of oxygen delivery route and mortality after seven days of treatment (p = 0.592). C-reactive protein levels of the standard of care plus hydroxychloroquine group were significantly lower than that of the standard of care group at discharge (p = 0.034). Patients in the standard of care plus hydroxychloroquine group had shorter hospital stay (p = 0.007). The standard of care plus hydroxychloroquine group was favored over standard of care group in terms of rate of intensive care unit admissions (21.7% vs. 10.8%; relative risk with 95% CI = 0.49 [0.31-0.80], p = 0.003). CONCLUSIONS: Hydroxychloroquine in addition to standard of care was associated with less intensive care unit admissions, early discharge and greater C-reactive protein reduction. There was no difference in 28-day mortality.

Reducing length of hospital stay with colchicine.

INTRODUCTION: Colchicine is an ancient agent with well-known anti-inflammatory effects and commonly used in treatment of hyperinflammatory conditions. It has been argued that colchicine could be an appropriate treatment option in COVID-19 to control hyperinflammatory response. Here in this study, we aimed to investigate the impact of colchicine on outcomes of COVID-19 in our inpatient cohort. METHODOLOGY: In this retrospective cohort study, hospitalized COVID-19 patients were investigated. Demographics, comorbidities, COVID-19 symptoms, laboratory findings on admission and discharge, baseline and seventh day oxygenation status, rates of mortality, intensive care unit admission, administration of other anti-inflammatory treatments and length of hospital stay were compared between patients who received standard of care medications and who received colchicine additionally. RESULTS: Three hundred and thirty-six patients were included in the study (171 standard of care, 165 standard of care plus colchicine). The median length of hospital stay in colchicine group was significantly shorter. Rates of admission to intensive care unit, anti-inflammatory treatment administration and mortality did not differentiate between standard of care and colchicine groups. However, reduced rates of mortality and ICU admission were observed in patients who received colchicine with a dose of 1 mg/day when compared to patients who received 0.5 mg/day. CONCLUSIONS: Our study demonstrated that COVID-19 patients who received colchicine in addition to standard of care had shorter hospital stay. Our results further support the use of colchicine in treatment of COVID-19, particularly with a dose of 1 mg/day.

Should timing be considered before abandoning convalescent plasma in covid-19? Results from the Turkish experience.

INTRODUCTIONS: Results with convalescent plasma therapy in coronavirus disease 2019 (COVID-19) have been contradictory. Timing seems to be an important factor for COVID-19 convalescent plasma(CCP) to be effective. Aim of this study is to compare disease outcomes in hospitalized COVID-19 patients who were treated with CCP within first three or seven days of symptoms to patients with symptoms longer than seven days. MATERIAL AND METHODS: A multicenter retrospective study was conducted to evaluate disease outcomes in hospitalized COVID-19 patients who received CCP in addition to standard of care (SOC) approach. Patients were subgrouped according to time of CCP administration; within three days of symptoms, seven days of symptoms and after seven days of symptoms. A control group was formed from age, gender and comorbidity matched hospitalized patients who received SOC treatments without CCP. Length of hospital stay, rates of anti-inflammatory treatment initiation, intensive care unit (ICU) admission and mortality was set as outcome measures. RESULTS: A total of 223 patients were enrolled in this study, 113 patients received CCP (38 within three days, 63 within seven days, 50 after seven days of symptom onset). Rate of anti-inflammatory treatment initiation was significantly lower (38.1 % vs 62.7 %, p = 0.002, relative risk, 0.60,73; 95 % confidence interval [CI], 0.42 to 0.85) and length of hospital stay was significantly shorter (median(IQR) 8(4) days vs 9.5(5.25) days, p = 0.0025) in patients who received CCP within seven days of symptom onset when compared to SOC group. CONCLUSION: CCP therapy may provide better outcomes when applied within seven days of symptoms.

Compliance to not only prone but also lateral and supine positioning improves outcome in hospitalised COVID-19 patients.

BACKGROUND: Positioning of the patient is a common strategy to increase oxygenation in the management of acute respiratory distress syndrome. The aim of this study is to demonstrate the effects of our positioning approach on disease outcomes in COVID-19 patients with respiratory failure, by comparing patients compliant to positioning and not. METHODS: COVID-19 patients who were admitted to our internal medicine inpatient clinic and developed hypoxaemia and underwent positioning during hospital stay were retrospectively investigated for compliance to positioning. Rates of mortality, intensive care unit admission, intubation, initiation of anti-inflammatory treatment and length of hospital stay were compared between patients with and without compliance to positioning. RESULTS: A total of 144 patients were enrolled in this study (97 compliant with positioning, 47 incompliant with positioning). Rates of ICU admission (7.2% vs 25.5%, p < .001), anti-inflammatory treatment initiation (68% vs 97.9%, p < .001) and length of hospital stay (5 (2-16) days vs 12 (3-20) days, p < .001) were significantly reduced in patients compliant with positioning. CONCLUSION: Prone or other positioning should be considered in patients with noninvasive oxygen support for the potential to reduce rates of intensive care unit admissions, airway interventions, anti-inflammatory treatment initiation and mortality.

A single center experience of intravenous immunoglobulin treatment in Covid-19.

BACKGROUND: Intravenous immunoglobulins (IVIg) have been used in management of severe Covid-19. Here in this study, we report our single-center experience regarding IVIg treatment in management of severe Covid-19. MATERIALS AND METHOD: Among hospitalized adult Covid-19 patients between April 1 and December 31, 2020, patients with confirmed diagnosis of Covid-19 who had Brescia-COVID respiratory severity scale score ≥ 3, hyperinflammation and received IVIg treatment in addition to standard of care were retrospectively investigated. We grouped IVIg recipients into three according to reasons for IVIg administration: Group 1 patients requiring anti-inflammatory treatment but complicated with secondary infection and/or sepsis , group 2 patients with Covid-19 related complications including progressive disease refractory to other anti-inflammatory agents, myocarditis, adult multisystem inflammatory syndrome, hemophagocytic lymphohystiocytosis like syndrome and group 3 patients with other complications non-specific to Covid-19. Mortality and clinical data was compared among groups. RESULTS: A total of 46 IVIg recipients were enrolled. Group 1 comprised 17 (36.9%), group 2 comprised 18 (39.1%) and group 3 comprised 11 (23.9%) patients. No significant differences in means of age, gender and comorbidities were observed among groups. Mortality was significantly lower in group 3 when compared to group 1 (64.7% vs 18.2%, p = 0.016) and close to significance when compared to group 2 (50% vs 18.2% p = 0.087). CONCLUSIONS: IVIg seemed to be used mostly in severe, refractory and complicated cases in our population. As a rescue agent in severe cases refractory to other anti-inflammatory strategies, 33.7% survival rate was observed with IVIg.