A Phase III Randomized, Open-label, Multicenter Study to Determine the Safety and Efficacy of different MONoclonal Antibodies (MoAbs) to SARS-CoV-2 for the Early Treatment of COVID-19 in Non-hospitalized Adults - Monet

开始日期2021-11-18

申办/合作机构

Istituto Nazionale per le Malattie Infettive

NCT04791423 / Completed临床2/3期

A Phase II/III, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of GRAd-COV2 Vaccine in Adults Aged 18 Years and Older

Multicenter Study assessing the safety, efficacy, and immunogenicity of the candidate vaccine GRAd-COV2, compared to placebo, for the prevention of COVID-19. Participants will be adults ≥ 18 years of age who are healthy or have medically stable chronic diseases and are at increased risk for SARS-CoV-2 acquisition and COVID-19. In the phase II part approximately 900 participants will be randomized in a 1:1:1 ratio to receive i) 2 repeated (21 days apart) intramuscular (IM) doses of GRAd-COV2 at 1x10^11 viral particle (vp) (n = approximately 300 subjects) ii) 1 single IM dose of GRAd-COV2 at 2x10^11 vp plus 1 dose of placebo after 21 days (n= approximately 300 subject) or 2 doses of placebo (n = approximately 300 subjects) on day 1 and day 22. There will be 3 strata for randomization: ≥ 65 years, < 65 years and categorized to be at increased risk ("at risk") for the complications of COVID-19, and < 65 years "not at risk". Risk will be defined referring to the study participants' relevant past and current medical history. An independent Data Safety Monitoring Board will provide oversight, to ensure safe and ethical conduct of the Study; a Steering Committee will revise safety data (collected for 900 participants 1 week after dosing) and immunogenicity data (collected for 450 participants 5 weeks after the first dosing) generated in phase II part. Jointly DSMB and SC will recommend the expansion to phase III and the best regimen to be used.

开始日期2021-03-15

申办/合作机构

Reithera Srl

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2021-05-25·Cardiovascular Research1区 · 医学

Human cardiosphere-derived stromal cells exposed to SARS-CoV-2 evolve into hyper-inflammatory/pro-fibrotic phenotype and produce infective viral particles depending on the levels of ACE2 receptor expression

1区 · 医学

Article

作者: Capobianchi, Maria Rosaria ; Nardacci, Roberta ; Agrifoglio, Marco ; Colombo, Gualtiero Ivanoe ; Bernava, Giacomo ; Ferrari, Silvia ; Colavita, Francesca ; Poggio, Paolo ; Amendola, Alessandra ; Pesce, Maurizio ; Myasoedova, Veronika ; Songia, Paola ; Sberna, Giuseppe ; Piacentini, Mauro ; Garoffolo, Gloria ; Castilletti, Concetta ; Canzano, Paola

AbstractAimsPatients with severe respiratory syndrome caused by SARS-CoV-2 undergo cardiac complications due to hyper-inflammatory conditions. Although the presence of the virus has been detected in the myocardium of infected patients, and infection of induced pluripotent cell-derived cardiomyocytes has been demonstrated, the reported expression of Angiotensin-Converting Enzyme-2 (ACE2) in cardiac stromal cells suggests that SARS-CoV-2 may determine cardiac injury by sustaining productive infection and increasing inflammation.Methods and results We analysed expression of ACE2 receptor in primary human cardiac stromal cells derived from cardiospheres, using proteomics and transcriptomics before exposing them to SARS-CoV-2 in vitro. Using conventional and high sensitivity PCR methods, we measured virus release in the cellular supernatants and monitored the intracellular viral bioprocessing. We performed high-resolution imaging to show the sites of intracellular viral production and demonstrated the presence of viral particles in the cells with electron microscopy. We finally used RT–qPCR assays to detect genes linked to innate immunity and fibrotic pathways coherently regulated in cells after exposure to the virus.Conclusions Our findings indicate that cardiac stromal cells are susceptible to SARS-CoV-2 infection and produce variable viral yields depending on the extent of cellular ACE2 receptor expression. Interestingly, these cells also evolved towards hyper-inflammatory/pro-fibrotic phenotypes independently of ACE2 levels. Thus, SARS-CoV-2 infection of myocardial stromal cells could be involved in cardiac injury and explain the high number of complications observed in severe cases of COVID-19.

2019-04-01·Clinics and Research in Hepatology and Gastroenterology4区 · 医学

Optimizing patient referral and center capacity in the management of chronic hepatitis C: Lessons from the Italian experience

4区 · 医学

Article

作者: Ippolito, Giuseppe ; Craxì, Antonio ; Pasqualetti, Patrizio ; Di Marco, Vito ; Angarano, Gioacchino ; Colombo, Massimo ; Gaeta, Giovanni Battista ; Di Perri, Giovanni ; Alberti, Alfredo ; Mangia, Alessandra

AIMSIn 2017 the Italian Drug Agency (Agenzia Italiana del Farmaco, AIFA) revised the criteria for access to therapy for patients with chronic hepatitis C as part of a three-year plan to eradicate HCV. We conducted a Delphi study to determine strategies to identify and treat patients with HCV and to develop through a shared pathway, a model to manage patient referral and optimize prescription center capacity with the overall aim of increasing access to therapy.METHODSThe process took place in two phases - Phase I (January 2017), before the criteria for treatment of HCV were revised and Phase II (May 2017) when AIFA developed a framework for the eradication of HCV infection in Italy. Two questionnaires were devised with Q1 administered in Phase I and Q2 in Phase II.RESULTSQ1 was sent to 823 hepatitis specialists working in 235 Italian HCV centers authorized to prescribe direct-acting antiviral drugs (DAAs). Overall, 167 centers (71%) participated with a good geographical representativeness (North 69%, Centre 74%; South and islands 70%). 548 prescribers (68.8%) provided responses to Q1 and 443 (80%) specialists who responded to Q1 completed Q2. Over 70% considered that to meet the new therapy targets local/regional networks need to be consolidated and reinforced with GPs providing the 'missing link' in current regional networks. Adherence to therapy was considered important by 75% of clinicians with reduction in follow-up intervals/length considered important by 65% - to free up staff/resources to manage increasing numbers of new patients. About 80% of respondents stated that medical personnel were principally involved in follow-up with follow-up having a significant impact on center capacity.CONCLUSIONEnhancing patient referral, the need for an increased role of GPs, increasing center capacity in particular medical personnel in outpatient centers and greater liaison between Hub centers and healthcare professionals currently managing high-risk groups as yet untreated, were factors that need to be streamlined in order to meet treatment targets for eradication of HCV.

2013-01-01·Open Journal of Nephrology

Modifications of Coronay Artery Calcifications (CAC) and Correlations with C Reactive Protein (CRP) Levels in Renal Recipients after the First Year of Transplantation

作者: De Paolis, Paolo ; Colonnelli, Roberto ; Favaro, Antonio ; Carriero, Concetta ; Iappelli, Massimo ; Di Giulio, Salvatore ; Mantella, Daniela ; Coen, Giorgio

The purpose of the present study was to determine the association between presence and progression of Coronary Artery Calcifications (CAC) quantified with Agatston Score (AS) and inflammatory index as CRP and other parameters in unselected renal transplant recipients.Forty-five patients were underwent a baseline Multislice CT (MSCT) at the time of renal transplant and a repeat evaluation 12-16 mo later.After second MSCT recipients were divided in three groups: Gr1 (26 patients) with absence of CAC at basal and second MSCT, Gr2 (11 patients) with reduction of CAC after one year and Gr3 (8 patients) with increased values of CAC after one year.Mean +/- Standard deviation of basal and after one year values of AS and CRP were resp.: Gr1: 2 +/- 3; 2 +/- 5 and 0.4 +/- 0.3; 0.55 +/- 0.67; Gr2: 317 +/- 288; 212 +/- 242 and 0.9 +/- 1.1; 0.55 +/- 0.6; Gr3: 854 +/- 1168; 1032 +/- 1153 and 0.8 +/- 0.8; 1.1 +/- 0.96.We found capacity of renal transplantation to protect against development of new calcium deposits in recipients without CAC at time of transplantation.While we confirmed association in Gr2 between reduction of CAC with reduction of CRP levels and in Gr3 between increased levels of CRP with increasing of CAC.Conclusion: In this preliminary study, renal transplantation appears to slow down or increasing CAC, in strict association with modifications of CRP levels.Long term studies are needed to confirm our preliminary data and to determine the effects of CAC on cardiovascular morbidity and mortality in renal transplant recipients.

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