Publications by authors named "Francesca Bai"

Background: Long-COVID immunopathogenesis involves diverse factors. We longitudinally characterize hospitalized COVID-19 patients, examining the role of SARS-CoV-2 RNAemia and inflammation in immune dysregulation.

Methods: Hospitalized patients are evaluated during acute infection (T0), 3 months post-symptom onset (T1), and 3 years if symptoms persisted (T2).

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Background: Post COVID-19 condition (PCC) affects 10-40% of patients and is characterized by persisting symptoms at ≥ 4 weeks after SARS-CoV-2 infection. Symptoms can last 7 or even more months. How long PCC persists and any changes in its clinical phenotypes over time require further investigation.

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Background: Anti-SARS-CoV-2 neutralizing monoclonal antibodies (mAbs) have been shown to have clinical benefits in treating high-risk patients with mild-moderate COVID-19. SARS-CoV-2 RNA in serum (RNAemia), is usually associated with severe disease and deaths. This study evaluates real-life data on the effectiveness of mAbs therapies against SARS-CoV-2 infections by different viral variants, particularly in the presence of RNAemia, focusing on clinical outcomes.

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Background: Limited evidence exists on how bacterial and viral coinfections have developed since the SARS-CoV-2 Omicron variant emerged. We investigated whether community-onset coinfections in adult patients hospitalized with COVID-19 differed during the wild type, Alpha, Delta, and Omicron periods and whether such coinfections were associated with an increased risk of mortality.

Methods: We conducted a multinational cohort study including COVID-19 hospitalizations until 30 April 2023 in 5 European countries.

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Objectives: The interaction between HIV and COVID-19 resulted in a syndemic that showed an excess burden of disease for people with HIV (PWH). Four years of the COVID-19 pandemic have raised many unsolved questions about the optimal care of COVID-19 in PWH.

Methods: We performed a study using a three-round Delphi methodology involving a panel of physicians with expertise in HIV and COVID-19 infections.

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Scope: The emergence of post-COVID-19 condition (PCC) after SARS-CoV-2 infection underscores the critical need for preparedness in addressing future post-acute infection syndromes (PAIS), particularly those linked to epidemic outbreaks. The lack of standardized clinical and epidemiological data during the COVID-19 pandemic has significantly hindered timely diagnosis and effective treatment of PCC, highlighting the necessity of pre-emptively standardizing data collection in clinical studies to better define and manage future PAIS. In response, the Cohort Coordination Board, a consortium of European-funded COVID-19 research projects, has reviewed data from PCC studies conducted by its members.

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Article Synopsis
  • The study aimed to determine if switching from dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) reduces neuropsychiatric symptoms in HIV patients.
  • Conducted as a randomized trial, it involved 41 participants who had been stable on DTG/ABC/3TC and compared those who switched to BIC/FTC/TAF versus those who continued their current therapy.
  • Results indicated that switching improved sleep disorders among participants but did not significantly impact other neuropsychiatric symptoms, suggesting better tolerability with BIC-based therapy despite the small sample
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  • Post COVID-19 condition (PCC) refers to ongoing symptoms that persist for at least one month after recovering from acute COVID-19, and the study analyzed risks associated with different viral variants among 7,699 hospitalized patients.
  • The research found that the most common PCC symptoms were fatigue, brain fog, and respiratory issues, with the original wild-type virus being the most prevalent among participants, followed by Alpha, Delta, Gamma, and Omicron variants.
  • Results indicated that infection with Omicron was linked to a lower risk of developing PCC compared to the wild-type strain, while Alpha and Delta variants were associated with a higher risk; ICU admission was a significant factor influencing severity and PCC risk.
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Article Synopsis
  • A multicenter observational study named CONDIVIDIAMO analyzed the effectiveness of monoclonal antibodies (mAbs) in reducing COVID-19 hospitalizations among outpatients with risk factors for severe disease.
  • The study enrolled 1,534 participants and tracked outcomes over 28 days, recording hospitalizations and deaths, with results showing a 5.6% incidence of hospitalization or death after mAbs treatment.
  • Key risk factors identified for increased hospitalization included older age and immunodeficiency, highlighting the importance of targeting vulnerable populations for mAb treatment.
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Objective: Hospitalization for Covid-19 has been recognized as a potentially traumatic experience. This longitudinal cohort study assessed the impact of psychological intervention for Covid-19 patients on anxiety, depression, and post-traumatic stress disorder (PTSD).

Materials And Methods: Of 386 Covid-19 patients enrolled, 127 completed HADS and PCL-5 questionnaires at 2 months (T1), 6 months (T2) and 12 months (T3) after hospital discharge.

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Introduction: We compared the effectiveness and virological clearance (VC) at day 7 (T7) post-treatment with molnupiravir, nirmatrelvir/ritonavir, and remdesivir in SARS-CoV-2-infected patients at high risk (HR) for clinical progression.

Methods: We conducted a retrospective study enrolling HR patients with mild-to-moderate COVID-19 (Jan-Oct 2022) treated with nirmatrelvir/ritonavir or molnupiravir or 3 days of remdesivir. We investigated clinical recovery at T7 (resolution of symptoms for ≥ 72 h or all-cause death), VC at T7 (PCR/antigenic negative nasopharyngeal swab), and median time to VC (days from symptom onset to the first negative swab).

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Background: HIV-associated neurocognitive disorders (HAND) still affects persons with HIV (PWH) and their pathogenesis is not completely understood. We aimed to explore the association between plasma and cerebrospinal fluid (CSF) markers of blood-brain barrier (BBB) impairment and HAND in untreated PWH.

Design: Cross-sectional study.

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Objectives: To assess the effectiveness of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) among people poorly represented in clinical trials and potentially at higher risk of suboptimal response to ART.

Methods: Observational cohort study on persons with HIV (PWH) enrolled in ICONA who started BIC/FTC/TAF as initial therapy or as switching regimen while virologically suppressed. Primary endpoint was time to treatment failure (TF): new AIDS/death or virological failure (VF) or discontinuation for toxicity/failure.

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Article Synopsis
  • - The study assessed the effectiveness of monoclonal antibodies Casirivimab and Imdevimab (CAS/IMV) in hospitalized patients with severe COVID-19, focusing on the risk of mechanical ventilation (MV) and death after 28 days.
  • - Conducted in Italy, the observational study included 480 patients for modeling and 157 for testing, finding that age, PaO/FiO ratio, lactate dehydrogenase (LDH), and platelet counts were significant predictors of MV or death.
  • - A risk score was developed from these predictors with good accuracy, indicating a lower mortality risk than previously reported; however, CAS/IMV is no longer in use.
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Background: Investigating outcomes of hospitalised COVID-19 patients throughout the pandemic is crucial to understand the impact of different SARS-CoV-2 variants. We compared 28-day in-hospital mortality of Wild-type, Alpha, Delta, and Omicron variant infections. Whether the difference in risk by variant varied by age was also evaluated.

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  • The study focused on comparing hospitalized vaccinated and non-vaccinated patients diagnosed with SARS-CoV-2 in three major hospitals in Northern Italy, investigating their clinical characteristics and outcomes.
  • Data analysis highlighted that vaccinated patients, despite having more serious underlying health issues, generally had milder COVID-19 symptoms and required less intensive care compared to non-vaccinated patients.
  • No significant difference in intra-hospital mortality rates was found between the two groups, indicating vaccination effectively reduces the likelihood of ICU admission but does not significantly impact overall survival rates in the hospital.
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  • The study aimed to evaluate the relationship between the plasma levels of efavirenz (EFV) and its metabolite 8-hydroxy-EFV (8-OH-EFV) with neurocognitive impairment and central nervous system (CNS) side effects in patients switching from EFV to rilpivirine.
  • Analysis of 104 patients showed that although higher levels of 8-OH-EFV were significantly linked to more CNS side effects, EFV levels only showed a marginal association with cognitive performance, particularly in executive and language functions.
  • The findings suggest that 8-OH-EFV may have a more pronounced impact on CNS side effects, while EFV's influence on cognitive function is less clear, indicating differing
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Background: Our aim was to estimate the rates of not achieving a robust/above-average humoral response to the COVID-19 mRNA vaccine in people living with HIV (PLWH) who received ≥2 doses and to investigate the role of the CD4 and CD4/CD8 ratio in predicting the humoral response.

Methods: We evaluated the humoral anti-SARS-CoV-2 response 1-month after the second and third doses of COVID-19 mRNA vaccine as a proportion of not achieving a robust/above-average response using two criteria: (i) a humoral threshold identified as a correlate of protection against SARS-CoV-2 (<90% vaccine efficacy): anti-RBD < 775 BAU/mL or anti-S < 298 BAU/mL, (ii) threshold of binding antibodies equivalent to average neutralization activity from the levels of binding (nAb titer < 1:40): anti-RBD < 870 BAU/mL or anti-S < 1591 BAU/mL. PLWH were stratified according to the CD4 count and CD4/CD8 ratio at first dose.

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Background: Severe acute respiratory syndrome coronavirus 2 (SARS CoV-2), the virus responsible for coronavirus disease 2019 (COVID-19), can lead to hospitalisation, particularly in elderly, immunocompromised, and non-vaccinated or partially vaccinated individuals. Although vaccination provides protection, the duration of this protection wanes over time. Additional doses can restore immunity, but the influence of viral variants, specific sequences, and vaccine-induced immune responses on disease severity remains unclear.

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Background: Post-COVID-19 condition refers to persistent or new onset symptoms occurring three months after acute COVID-19, which are unrelated to alternative diagnoses. Symptoms include fatigue, breathlessness, palpitations, pain, concentration difficulties ("brain fog"), sleep disorders, and anxiety/depression. The prevalence of post-COVID-19 condition ranges widely across studies, affecting 10-20% of patients and reaching 50-60% in certain cohorts, while the associated risk factors remain poorly understood.

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Objectives: Thanks to its long half-life, dalbavancin qualifies as an optimal drug for saving costs. We aimed to assess the cost and effectiveness of dalbavancin versus the standard of care (SoC).

Patients And Methods: We conducted a multicentre retrospective study, including all hospitalized or outpatients diagnosed with ABSSSIs at Padua University Hospital, Padua and San Paolo Hospital, Milan (1 January 2016 to 31 July 2020).

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Higher risk of cerebrospinal fluid escape (CVE) has been associated with the use of specific antiretroviral (ARV) classes, such as protease inhibitors. We assessed whether archived resistance-associated mutations (RAMs) can mediate this relationship by identifying patients treated with incompletely active antiretroviral regimens. A retrospective multicentric study on 282 adult people with HIV on antiretroviral therapy (ART) and available historical plasma genotype resistance testing (HGRT) for reverse transcriptase (RT) and protease genes between 2001 and 2021.

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Background: Among interleukin-6 inhibitors suggested for use in COVID-19, there are few robust evidences for the efficacy of sarilumab. Herein, we evaluated the efficacy and safety of sarilumab in severe COVID-19.

Methods: In this phase 3, open-labeled, randomized clinical trial, conducted at 5 Italian hospitals, adults with severe COVID-19 pneumonia (excluding mechanically ventilated) were randomized 2:1 to receive intravenous sarilumab (400 mg, repeatable after 12 h) standard of care (SOC) (arm A) or to continue SOC (arm B).

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Whether vaccination confers a protective effect against progression after hospital admission for COVID-19 remains to be elucidated. Observational study including all the patients admitted to San Paolo Hospital in Milan for COVID-19 in 2021. Previous vaccination was categorized as: none, one dose, full vaccination (two or three doses >14 days before symptoms onset).

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