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Background. Since the outbreak of COVID-19 pandemic the scientific community efforts have been focused on finding a vaccine and a treatment for infected people. Several antivirals with activity against SARS-CoV-2 were investigated and since the end of 2021 orally administered antivirals have been used in positive patients. Methods. We conducted a retrospective, single-center study including data from 135 outpatients who resulted positive for SARS-CoV-2 and were selected according to AIFA criteria to receive Molnupiravir (M) or Nirmatrelvir/Ritonavir (N/R) in the InfectiousDiseaseClinic of the TorVergataHospital fromJanuary 2022 to February 2022. Results. Our cohort included 135 patients with a median age of 71 years (IQR 56,5 - 80,5), 51% were male, 91% received M and 9% received N/R. The median time of antiviral administration from symptoms onset was of 3,4 days. 75% of patients were vaccinated with booster dose, 19% were vaccinated with two doses and 7% were unvaccinated. The most frequent criteria of eligibility are summarized in Figure 1. Only 2 patients were hospitalized receiving oxygen support, 1 patient died, 84% of patients did not need hospitalization and 14% of the enrolled subjects were lost at follow up. Time of negativization at the nasopharyngeal swab (NPS) had a negative correlation to the value of anti-Spike (r=-0.29;p=0.01). The difference between cycle threshold (Ct) value ofNPS at T7 and Ct value at the first positive NPS (T0) was higher among not hospitalized (NH) vs hospitalized (H) patients, for Gene E [12.1 (SD 5.8) vs -1.7 (SD 10.8);p=0.02], Gene N [12.3 (SD 10.8) vs -0.9 (SD 11.6);p=0.01] and Gene RdRp [11.8 (SD 5.3) vs -1.5 (SD 11.1);p=0.01]. Anti-Spike were higher among NH vs H patients [1714 (SD 1044.7) vs [43 (SD 60.3);p=0.028]. Delta Ct E, delta Ct N and delta Ct RdRp were significantly higher in patients without neoplastic disease (p=0.04, p=0.02, p=0.01, respectively) and had a negative correlation with creatinine levels (r=-0.36, p< 0.001;r=-0.3, p=0.03;r=-0.32, p=0.02). Percentage of eligibility criteria of our patients The majority of patients had more than one criterion Conclusion. Oral antivirals represent a new effective treatment against COVID-19 in selected patients, reducing the time of negativization and the risk of hospitalization and death. Solid tumor or oncohematologic diseases are associated to a slower negativization of NPS.
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Background. To cope with the SARS-CoV-2 pandemic, several treatments were studied and out of these, monoclonal antibodies (MAbs) have shown efficacy to prevent the development of pneumonia after the infection Methods. We conducted a retrospective, single-center study including patients with SARS-CoV-2 infection, treated with MAbs (bamlanivimab/etesevimab (B/E), casirivimab/ imdevimab (C/I) or sotrovimab (S)) from March 2021 to February 2022 Results. We included 504 patients with a median age of 62 years (IQR 49-72), 51% were males and 66% had completed the vaccination schedule according to the current Italian regulations. The most frequent eligibility criteria are summarized in figure 1. As for MAbs combination, patients were treated with B/E (54%), followed by C/I (30%) and S (16%). Outcomes are shown in Table 1. Nasopharyngeal swab (NPS) negativization time had a positive correlation with patients' age (r=0.16;p=0.001), C-reactive protein (CRP) (r=0.26;p< 0.001) and creatinine values (r=0.22;p< 0.001) assessed at baseline (infusion day). Time to NPS negativization was 6.9 (95% C.I. [4.5-9.2]) days shorter for vaccinated compared to unvaccinated patients (p< 0.001). Patients treated with C/I had a negative NPS on average 4.5 (95% C.I.= [1.8-7.3] days earlier than patients treated with B/E;patients who received S reached negativization 6.0 (95% C.I.= [2.2, 9.9]) days earlier than those treated with B/E (p=0.004). Patients with positive outcome had a negative NPS on average 14.3 (95% C.I.= [6.8, 23.1)], 25.5 (95% C.I.= [18.9, 33.4] and 68.3 (95% C.I.= [47.7, 90.2]) days earlier than patients who needed hospitalization and patients who died (p< 0.001, p< 0.001, respectively). Unvaccinated patients had a higher rate of oxygen support need compared to vaccinated ones (p=0.006). Patients with worse outcomes were significantly older and had higher values of CRP and creatinine at baseline (p=0.04, p< 0.001, p< 0.001, respectively) Conclusion. MAbs reduce the risk of hospitalization in fragile patients. Vaccinated patients had shorter time of NPS negativization and lower probability of hospitalization. Older age, higher CRP and creatinine values assessed at baseline, correlated with worse outcomes. S was the most effective treatment amongst MAbs used in our study.
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Introduction Despite literature’s proofs about their safety, concerns arose regarding adverse events due to Covid-19 vaccines, including the possible impact on fertility, accentuated by misinformation and anti-vaccine campaigns. The aim of this study was to evaluate the Covid-19 vaccines’ impact on male and female fertility. Methods PubMed, Scopus, Web of Science, Cochrane and Embase databases were searched for eligible studies until March 7th, 2022. Primary studies investigating the Covid-19 vaccines impact on male and female fertility, were included. Studies’ quality was assessed by the Newcastle-Ottawa and the Before and After Quality Assessment scales for cohort and pre-post studies, respectively. Random-effect meta-analyses were performed for parameters considered in ≥ 2 studies, calculating means, p-values and 95% Confidence Intervals (CIs). I2 statistics was used to assess statistical heterogeneity. Results Out of 1406 studies screened, 20 studies were included in the systematic review. These studies, conducted in Israel (35%), USA (30%), Russia (25%), China (5%) and Italy (5%), were of poor (15%), moderate (75%) and good (10%) quality. Meta-analyses among five studies considering several vaccines were performed for pre- and post-vaccination sperm progressive motility ((49%, 95% CI 36-67% vs 49%, 95% CI 39-61%;p = 0.963) and concentration (64.39 mln/ml, 95% CI 47.51-87.28 and 72.00 mln/ml, 95% CI 51.22-101.21;p = 0.03). Subgroup meta-analyses based on the type of vaccine showed no significant difference: between vaccinated with mRNA vaccines and non-vaccinated regarding biochemical pregnancy rates;pre- and post-vaccination with Gam-COVID-Vac regarding testosterone, FSH and LH levels;pre- and post-vaccination with BNT162b2 vaccines regarding sperm volumes. Discussion There is no scientific proof of any association between Covid-19 vaccines and infertility in men or women. Misinformation and doubts about vaccines should be properly addressed. Key messages • The doubts regarding Covid-19 vaccines’ impact on both male and female fertility resulted to be unfounded. Covid-19 vaccines remain the most important weapon to fight the pandemic. • It is important to keep providing to public opinion and health care providers evidence-based scientific information, in order to effectively combat misinformation and anti-vaccines campaigns.
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Background Despite literature’s evidence about COVID-19 vaccines safety, concerns have arisen regarding adverse events, including the possible impact on fertility, accentuated by misinformation and anti-vaccine campaigns. The present study aims to answer the question: Is there any impact of COVID-19 vaccines on the fertility of men and women of reproductive age? Methods PubMed, Scopus, Web of Science, Cochrane and Embase databases were searched for eligible studies until June 8th, 2022. The search was restricted to articles regarding humans, published in any language, without additional restrictions. Studies’ quality was assessed by the Newcastle-Ottawa and the Before and After Quality Assessment scales for cohort and pre-post studies, respectively. Random-effect meta-analyses were performed for parameters considered in ≥2 studies, calculating means, p-values and 95% Confidence Intervals (CIs). Results Out of 1406 studies screened, 29 were included in the systematic review. These studies, conducted in Israel (24%), USA (20.7%), Russia (10.4%) China (3.5%), Italy (3.5%), North America and Turkey (3.5%) were of poor (13.8%), moderate (58.6%) and good (27.6%) quality. Meta-analyses were performed for pre- and post-vaccination sperm progressive motility (44%, 95% CI 42%-62% vs 43%, 95% CI 31%-59% p=0.07) and concentration (50.6 mln/ml, 95% CI 35.1-72.8 vs 55.4 mln/ml, 95% CI 37.4-82.2 p=0.12). Biochemical (0.51, 95% CI 0.40-0.65 vs 0.48, 95% CI 0.41-0.60 p=0.45) and clinical (0.45, 95% CI 0.37-0.54 vs 0.47, 95% CI 0.40-0.55 p=0.31) pregnancy rate did not differ among vaccinated and not vaccinated groups. Subgroup meta-analyses based on the type of vaccine showed no significant difference: between vaccinated with mRNA vaccines and non-vaccinated regarding biochemical pregnancy rates;pre- and post-vaccination with Gam-COVID-Vac regarding testosterone, FSH and LH levels;pre- and post-vaccination with BNT162b2 vaccines regarding sperm volumes. Conclusion Based on the studies published so far, there is no scientific proof of any association between COVID-19 vaccines and fertility impairment in men or women.
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BACKGROUND: Despite literature's evidence about COVID-19 vaccines' safety, concerns have arisen regarding adverse events, including the possible impact on fertility, accentuated by misinformation and anti-vaccine campaigns. The present study aims to answer the question: Is there any impact of COVID-19 vaccines on the fertility of men and women of reproductive age? METHODS: PubMed, Scopus, Web of Science, Cochrane and Embase databases were searched for eligible studies until June 8th, 2022. The search was restricted to articles regarding humans, published in any languages, without additional restrictions. Studies' quality was assessed by the Newcastle-Ottawa and the Before and After Quality Assessment scales for cohort and pre-post studies, respectively. Random-effect meta-analyses were performed for parameters considered in ≥ 2 studies, calculating means, p-values and 95 % Confidence Intervals (CIs). RESULTS: Out of 1406 studies screened, 29 were included in the systematic review. These studies, conducted in Israel (34.5 %), USA (24.1 %), Russia (20.7 %) China (10.3 %), Italy (3.5 %), North America (3.5%) and Turkey (3.5 %) were of poor (34.5 %), moderate (58.6 %) and good (6.9 %) quality. Meta-analyses were performed for pre- and post-vaccination sperm progressive motility (44 %, 95 % CI 42 %-62 % vs 43 %, 95 % CI 31 %-59 % p = 0.07) and concentration (50.6 mln/ml, 95 % CI 35.1-72.8 vs 55.4 mln/ml, 95 % CI 37.4-82.2p = 0.12). Biochemical (0.51, 95 % CI 0.40-0.66 vs 0.60, 95 % CI 0.53-0.68p = 0.45) and clinical (0.45, 95 % CI 0.37-0.54 vs 0.47, 95 % CI 0.40-0.55 p = 0.31) pregnancy rate did not differ among vaccinated and not vaccinated groups. Subgroup meta-analyses based on the type of vaccine showed no significant difference: between vaccinated with mRNA vaccines and non-vaccinated regarding biochemical pregnancy rates; pre- and post-vaccination with Gam-COVID-Vac regarding testosterone, FSH and LH levels; pre- and post-vaccination with BNT162b2 vaccines regarding sperm volumes. CONCLUSION: Based on the studies published so far, there is no scientific proof of any association between COVID-19 vaccines and fertility impairment in men or women.
Subject(s)
COVID-19 Vaccines , COVID-19 , BNT162 Vaccine , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Female , Fertility , Follicle Stimulating Hormone , Humans , Male , Pregnancy , Semen , TestosteroneABSTRACT
Considering the importance of evidence on interventions to tackle mental health problems in healthcare workers (HCWs) during pandemics, we conducted a systematic review, aiming to identify and summarize the implemented interventions to deal with mental health issues of HCWs during infectious disease outbreaks and report their effectiveness. Web of Science, PubMed, Cochrane, Scopus, CINAHL and PsycInfo electronic databases were searched until October 2nd, 2020. Primary-data articles, describing any implemented interventions and their effectiveness were considered pertinent. Studies were screened according to the inclusion/exclusion criteria and subsequently data extraction was performed. Twenty-four articles, referring to SARS, Ebola, Influenza AH1N1 and COVID-19 were included. Interventions addressing mental health issues in HCWs during pandemics/epidemics were grouped into four categories: 1) informational support (training, guidelines, prevention programs), 2) instrumental support (personal protective equipment, protection protocols); 3) organizational support (manpower allocation, working hours, re-organization of facilities/structures, provision of rest areas); 4) emotional and psychological support (psychoeducation and training, mental health support team, peer-support and counselling, therapy, digital platforms and tele-support). These results might be helpful for researchers, stakeholders, and policymakers to develop evidence-based sustainable interventions and guidelines, aiming to prevent or reduce the immediate and long-term effect of pandemics on mental health status of HCWs.
Subject(s)
Disease Outbreaks/statistics & numerical data , Health Personnel/psychology , Health Personnel/statistics & numerical data , Infections/epidemiology , Mental Health/statistics & numerical data , COVID-19/epidemiology , Cohort Studies , Cross-Sectional Studies , Hemorrhagic Fever, Ebola/epidemiology , Humans , Influenza, Human/epidemiology , Severe Acute Respiratory Syndrome/epidemiologyABSTRACT
Background Several countries facing the COVID-19 pandemic were not prepared to manage it. Public health mitigation strategies, ranging from isolation of infected cases to implementation of national lockdowns, proved their effectiveness for the outbreaks control. However, the adjustment of public health measures is crucial during transition phases to avoid new outbreaks. To address the need for designing evidence-based strategies, we performed a systematic review, identifying healthcare systems approaches, experiences and recommendations used to manage COVID-19 and other epidemics. Methods PubMed, Web of Science, Scopus and Cochrane were searched to retrieve eligible studies of any study design, published in English until April 17th, 2020. Double-blinded screening process was conducted by titles/abstracts and subsequently eligible full-texts were read and pertinent data were extracted. We performed a narrative analysis of each implemented strategy. Results We included a total of 24 articles addressing the public health strategies implemented for respiratory viral infections outbreaks as COVID-19, influenza A H1N1, MERS and SARS. The identified strategies are ascribable to two main categories: healthcare systems management at a national level and healthcare providers strategies at a local level. The key components of the transition strategies regarded the implementation of evidence-based contextual policies, intrahospital management approaches, community healthcare facilities, non-pharmaceutical interventions, enhanced surveillance, workplace preventive measures, mental health interventions and communication plans. Conclusions The identified healthcare systems strategies applied worldwide to face epidemics or pandemics, are a useful knowledge base to inform decision-makers about control measures to be used in the transition phases of COVID-19 and beyond. Key messages Healthcare systems strategies that can be implemented to manage pandemics/epidemics transition phases are a useful knowledge base to inform policy makers about the most effective solutions to adopt. The evidence reporting the healthcare systems management of respiratory viruses epidemics/pandemics, show the lack of a common and shared approach and more evidence-based research is needed.
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Background Extended evidence has established that healthcare workers face several mental health problems during a disease outbreak, which could have a long-term impact. To address these issues, elaboration and implementation of psychological/psychiatric interventions or strategies is of utmost importance. In this context, this systematic review aimed at identifying strategies to manage mental health issues in healthcare workers during infectious disease outbreaks. Methods PubMed, Cochrane, Scopus and Web of Science were searched to retrieve pertinent articles published in English until May 2020. Articles reporting measures, interventions, strategies, or recommendations to manage mental health problems in healthcare workers during an infectious disease outbreak, of any study design were included. The quality assessment was performed according to the study design of the included articles. Results Our search strategy produced a total of 2358 articles. After the screening process 33 articles met the inclusion criteria, addressing COVID-19 (40%), followed by SARS (21%) and Ebola Virus (15%). The findings emphasized that organisations should follow an evidence-based approach and establish comprehensive programs to assist hospital staff during disease outbreaks. The preliminary results show that the creation of a psychological response team, training, e-learning, courses, psychosocial counselling, screening instruments and telemedicine activities could improve the capacity of response and coping, and reduce mental health issues in healthcare workers. Conclusions To minimize the psychological impact of future infectious disease outbreaks, evidence-based intervention strategies should be implemented to retain mental health among healthcare workers. Our results may provide the necessary insights that could be applied during the COVID-19 pandemic. Key messages During infectious disease outbreaks healthcare workers are faced with mental health issues, that need to be addressed through tailored interventions offering coping strategies and increase resilience. Mental health related interventions or strategies include the implementation of professional training, psychosocial counselling, courses, and the creation of a psychological response team.