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Article: Monoclonal Antibodies for Pre- and Postexposure Prophylaxis of COVID-19: Review of the Literature.

Vita, Serena / Rosati, Silvia / Ascoli Bartoli, Tommaso / Beccacece, Alessia / D'Abramo, Alessandra / Mariano, Andrea / Scorzolini, Laura / Goletti, Delia / Nicastri, Emanuele

Pathogens (Basel, Switzerland)

2022 Volume 11, Issue 8

Abstract: Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful microorganisms, including viruses such as Severe Acute Respiratory Syndrome-CoronaVirus-2 (SARS-CoV-2). The US Food and Drug Administration ( ... ...

Abstract	Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful microorganisms, including viruses such as Severe Acute Respiratory Syndrome-CoronaVirus-2 (SARS-CoV-2). The US Food and Drug Administration (FDA) and the European Medical Agency (EMA) have already authorized monoclonal antibodies of anti-SARS-CoV-2 to treat mild to moderate CoronaVIrus Disease-2019 (COVID-19) in patients at risk of developing severe disease. More recently, monoclonal antibodies anti-SARS-CoV-2 have been authorized for primary and secondary prophylaxis in patients at high risk of severe disease for background comorbidity. Primary or pre-exposure prophylaxis prevents COVID-19 in unexposed people, whereas secondary or postexposure prophylaxis prevent COVID-19 in recently exposed people to individuals with laboratory-confirmed SARS-CoV-2. This review focuses briefly on therapeutic indications of currently available monoclonal antibodies for COVID-19 pre- and postexposure prophylaxis and on the efficacy of convalescent plasma.
Language	English
Publishing date	2022-08-05
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2695572-6
ISSN	2076-0817
ISSN	2076-0817
DOI	10.3390/pathogens11080882
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Comment on the Potential Risks of Sexual and Vertical Transmission of COVID-19.

Scorzolini, Laura / Corpolongo, Angela / Castilletti, Concetta / Lalle, Eleonora / Mariano, Andrea / Nicastri, Emanuele

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2020 Volume 71, Issue 16, Page(s) 2298

MeSH term(s)	Betacoronavirus ; COVID-19 ; Coronavirus Infections/epidemiology ; Female ; Humans ; Infectious Disease Transmission, Vertical ; Pandemics ; Pneumonia, Viral/epidemiology ; SARS-CoV-2
Keywords	covid19
Language	English
Publishing date	2020-04-16
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciaa445
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Zs.A 1505: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Repurposing the estrogen receptor modulator raloxifene to treat SARS-CoV-2 infection.

Allegretti, Marcello / Cesta, Maria Candida / Zippoli, Mara / Beccari, Andrea / Talarico, Carmine / Mantelli, Flavio / Bucci, Enrico M / Scorzolini, Laura / Nicastri, Emanuele

Cell death and differentiation

2021 Volume 29, Issue 1, Page(s) 156–166

Abstract: The ongoing coronavirus disease 2019 (COVID-19) pandemic caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) necessitates strategies to identify prophylactic and therapeutic drug candidates to enter rapid clinical development. ...

Abstract	The ongoing coronavirus disease 2019 (COVID-19) pandemic caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) necessitates strategies to identify prophylactic and therapeutic drug candidates to enter rapid clinical development. This is particularly true, given the uncertainty about the endurance of the immune memory induced by both previous infections or vaccines, and given the fact that the eradication of SARS-CoV-2 might be challenging to reach, given the attack rate of the virus, which would require unusually high protection by a vaccine. Here, we show how raloxifene, a selective estrogen receptor modulator with anti-inflammatory and antiviral properties, emerges as an attractive candidate entering clinical trials to test its efficacy in early-stage treatment COVID-19 patients.
MeSH term(s)	Angiotensin-Converting Enzyme 2/metabolism ; Anti-Inflammatory Agents/therapeutic use ; Antiviral Agents/therapeutic use ; COVID-19/drug therapy ; Drug Repositioning ; Estradiol/therapeutic use ; Estrogen Receptor Modulators/therapeutic use ; Estrogens/metabolism ; Female ; Humans ; Male ; Raloxifene Hydrochloride/therapeutic use ; SARS-CoV-2/drug effects ; Sex Factors
Chemical Substances	Anti-Inflammatory Agents ; Antiviral Agents ; Estrogen Receptor Modulators ; Estrogens ; Raloxifene Hydrochloride (4F86W47BR6) ; Estradiol (4TI98Z838E) ; ACE2 protein, human (EC 3.4.17.23) ; Angiotensin-Converting Enzyme 2 (EC 3.4.17.23)
Language	English
Publishing date	2021-08-17
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	1225672-9
ISSN	1476-5403 ; 1350-9047
ISSN (online)	1476-5403
ISSN	1350-9047
DOI	10.1038/s41418-021-00844-6
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Article ; Online: Lymphofollicular lesions associated with monkeypox (Mpox) virus proctitis.

Mazzotta, Valentina / Scorzolini, Laura / Falasca, Laura / Lionetti, Raffaella / Aguglia, Camilla / Kontogiannis, Dimitra / Colombo, Daniele / Colavita, Francesca / De Palo, Maria Grazia / Carletti, Fabrizio / Mondi, Annalisa / Pinnetti, Carmela / Maffongelli, Gaetano / Garbuglia, Anna Rosa / Baldini, Francesco / Corpolongo, Angela / Maggi, Fabrizio / D'Offizi, Gianpiero / Girardi, Enrico /

Vaia, Francesco / Nicastri, Emanuele / Del Nonno, Franca / Antinori, Andrea

International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases

2023 Volume 130, Page(s) 48–51

Abstract: In the recent 2022 monkeypox (Mpox) global outbreak, cases have been mostly documented among men who have sex with men. Proctitis was reported in almost 14% of cases. In this study, four Mpox-confirmed cases requiring hospitalizations for severe ... ...

Abstract	In the recent 2022 monkeypox (Mpox) global outbreak, cases have been mostly documented among men who have sex with men. Proctitis was reported in almost 14% of cases. In this study, four Mpox-confirmed cases requiring hospitalizations for severe proctitis were characterized by clinical, virological, microbiological, endoscopic, and histological aspects. The study showed the presence of lymphofollicular lesions associated with Mpox virus rectal infection for the first time.
MeSH term(s)	Male ; Humans ; Mpox (monkeypox) ; Monkeypox virus ; Homosexuality, Male ; Sexual and Gender Minorities ; Proctitis/drug therapy
Language	English
Publishing date	2023-02-27
Publishing country	Canada
Document type	Case Reports
ZDB-ID	1331197-9
ISSN	1878-3511 ; 1201-9712
ISSN (online)	1878-3511
ISSN	1201-9712
DOI	10.1016/j.ijid.2023.02.021
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Article: Comment of the potential risks of sexual and vertical transmission of Covid-19 infection

Scorzolini, Laura / Corpolongo, Angela / Castilletti, Concetta / Lalle, Eleonora / Mariano, Andrea / Nicastri, Emanuele

Clin. infect. dis

Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #66419
Database	COVID19

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Article ; Online: Differential diagnosis of illness in patients under investigation for the novel coronavirus (SARS-CoV-2), Italy, February 2020.

Bordi, Licia / Nicastri, Emanuele / Scorzolini, Laura / Di Caro, Antonino / Capobianchi, Maria Rosaria / Castilletti, Concetta / Lalle, Eleonora

Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin

2020 Volume 25, Issue 8

Abstract: A novel coronavirus (SARS-CoV-2) has been identified as the causative pathogen of an ongoing outbreak of respiratory disease, now named COVID-19. Most cases and sustained transmission occurred in China, but travel-associated cases have been reported in ... ...

Abstract	A novel coronavirus (SARS-CoV-2) has been identified as the causative pathogen of an ongoing outbreak of respiratory disease, now named COVID-19. Most cases and sustained transmission occurred in China, but travel-associated cases have been reported in other countries, including Europe and Italy. Since the symptoms are similar to other respiratory infections, differential diagnosis in travellers arriving from countries with wide-spread COVID-19 must include other more common infections such as influenza and other respiratory tract diseases.
MeSH term(s)	Algorithms ; Betacoronavirus/genetics ; Betacoronavirus/isolation & purification ; COVID-19 ; COVID-19 Testing ; Clinical Laboratory Techniques ; Coronavirus Infections/diagnosis ; Coronavirus Infections/epidemiology ; Diagnosis, Differential ; Disease Outbreaks ; Humans ; Influenza, Human/diagnosis ; Italy/epidemiology ; Mass Screening ; Molecular Diagnostic Techniques/methods ; Molecular Diagnostic Techniques/standards ; Pneumonia, Viral/diagnosis ; Pneumonia, Viral/epidemiology ; Population Surveillance ; Respiratory Tract Infections/diagnosis ; SARS-CoV-2 ; Travel
Keywords	covid19
Language	English
Publishing date	2020-02-26
Publishing country	Sweden
Document type	Journal Article
ZDB-ID	1338803-4
ISSN	1560-7917 ; 1025-496X
ISSN (online)	1560-7917
ISSN	1025-496X
DOI	10.2807/1560-7917.ES.2020.25.8.2000170
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Zs.A 5066: Show issues

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ab Jg. 2022: Lesesaal (EG)

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Article: Monoclonal Antibodies for Pre- and Postexposure Prophylaxis of COVID-19: Review of the Literature

Vita, Serena / Rosati, Silvia / Ascoli Bartoli, Tommaso / Beccacece, Alessia / D’Abramo, Alessandra / Mariano, Andrea / Scorzolini, Laura / Goletti, Delia / Nicastri, Emanuele

Pathogens. 2022 Aug. 05, v. 11, no. 8

2022

Abstract: Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful microorganisms, including viruses such as Severe Acute Respiratory Syndrome-CoronaVirus-2 (SARS-CoV-2). The US Food and Drug Administration ( ... ...

Abstract	Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful microorganisms, including viruses such as Severe Acute Respiratory Syndrome-CoronaVirus-2 (SARS-CoV-2). The US Food and Drug Administration (FDA) and the European Medical Agency (EMA) have already authorized monoclonal antibodies of anti-SARS-CoV-2 to treat mild to moderate CoronaVIrus Disease-2019 (COVID-19) in patients at risk of developing severe disease. More recently, monoclonal antibodies anti-SARS-CoV-2 have been authorized for primary and secondary prophylaxis in patients at high risk of severe disease for background comorbidity. Primary or pre-exposure prophylaxis prevents COVID-19 in unexposed people, whereas secondary or postexposure prophylaxis prevent COVID-19 in recently exposed people to individuals with laboratory-confirmed SARS-CoV-2. This review focuses briefly on therapeutic indications of currently available monoclonal antibodies for COVID-19 pre- and postexposure prophylaxis and on the efficacy of convalescent plasma.
Keywords	COVID-19 infection ; Food and Drug Administration ; Severe acute respiratory syndrome coronavirus 2 ; comorbidity ; disease prevention ; disease severity ; immune system ; people ; risk ; therapeutics
Language	English
Dates of publication	2022-0805
Publishing place	Multidisciplinary Digital Publishing Institute
Document type	Article
ZDB-ID	2695572-6
ISSN	2076-0817
ISSN	2076-0817
DOI	10.3390/pathogens11080882
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: A phase 2 randomized, double-blinded, placebo-controlled, multicenter trial evaluating the efficacy and safety of raloxifene for patients with mild to moderate COVID-19.

Nicastri, Emanuele / Marinangeli, Franco / Pivetta, Emanuele / Torri, Elena / Reggiani, Francesco / Fiorentino, Giuseppe / Scorzolini, Laura / Vettori, Serena / Marsiglia, Carolina / Gavioli, Elizabeth Marie / Beccari, Andrea R / Terpolilli, Giuseppe / De Pizzol, Maria / Goisis, Giovanni / Mantelli, Flavio / Vaia, Francesco / Allegretti, Marcello

EClinicalMedicine

2022 Volume 48, Page(s) 101450

Abstract: Background: Current available therapeutic options for Coronavirus Disease-2019 (COVID-19) are primarily focused on treating hospitalized patients, and there is a lack of oral therapeutic options to treat mild to moderate outpatient COVID-19 and prevent ... ...

Abstract	Background: Current available therapeutic options for Coronavirus Disease-2019 (COVID-19) are primarily focused on treating hospitalized patients, and there is a lack of oral therapeutic options to treat mild to moderate outpatient COVID-19 and prevent clinical progression. Raloxifene was found as a promising molecule to treat COVID-19 due to its activity to modulate the replication of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and act as an immunomodulator to decrease proinflammatory cytokines. Methods: This was a phase 2 multicenter, randomized, placebo-controlled trial to evaluate the efficacy and safety of raloxifene in adult patients with mild to moderate COVID-19 between October 2020 to June 2021 in five centers located in Italy. This was a planned 2/3 adaptive study, but due to operational difficulties, the study was discontinued during the phase 2 study segment. Participants were randomized 1:1:1 to receive oral placebo, raloxifene 60 mg, or raloxifene 120 mg by self-administration for a maximum of two weeks. The primary outcomes were the proportion of patients with undetectable SARS-CoV-2 via nasopharyngeal swabs at day 7 and the proportion of patients who did not require supplemental oxygen therapy or mechanical ventilation on day 14. Safety was assessed. The trial is registered (EudraCT 2021-002,476-39, and ClinicalTrials.gov: NCT05172050). Findings: A total of 68 participants were enrolled and randomized to placebo ( Interpretation: Raloxifene showed evidence of effect in the primary virologic endpoint in the treatment of early mild to moderate COVID-19 patients shortening the time of viral shedding. The safety profile was consistent with that reported for other indications. Raloxifene may represent a promising pharmacological option to prevent or mitigate COVID-19 disease progression. Funding: The study was funded by Dompé Farmaceutici SpA and supported by the funds from the European Commission - Health and Consumers Directorate General, for the Action under the Emergency Support Instrument- Grant to support clinical testing of repurposed medicines to treat SARS-COV-2 patients (PPPA-ESI-CTRM-2020-SI2.837140), and by the COVID-2020-12,371,675 Ricerca finalizzata and line 1 Ricerca Corrente COVID both funded by Italian Ministry of Health.
Language	English
Publishing date	2022-05-12
Publishing country	England
Document type	Journal Article
ISSN	2589-5370
ISSN (online)	2589-5370
DOI	10.1016/j.eclinm.2022.101450
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Article ; Online: Systematic analysis of direct antiglobulin test results in post-artesunate delayed haemolysis.

Ascoli Bartoli, Tommaso / Lepore, Luciana / D'Abramo, Alessandra / Adamo, Giovanna / Corpolongo, Angela / Scorzolini, Laura / Giancola, Maria Letizia / Bevilacqua, Nazario / Palazzolo, Claudia / Mariano, Andrea / Ippolito, Giuseppe / Buffet, Pierre / Nicastri, Emanuele

Malaria journal

2021 Volume 20, Issue 1, Page(s) 206

Abstract: Background: Post-artesunate delayed haemolysis (PADH) is common after severe malaria episodes. PADH is related to the "pitting" phenomenon and the synchronous delayed clearance of once-infected erythrocytes, initially spared during treatment. However, ... ...

Abstract	Background: Post-artesunate delayed haemolysis (PADH) is common after severe malaria episodes. PADH is related to the "pitting" phenomenon and the synchronous delayed clearance of once-infected erythrocytes, initially spared during treatment. However, direct antiglobulin test (DAT) positivity has been reported in several PADH cases, suggesting a contribution of immune-mediated erythrocyte clearance. The aim of the present study was to compare clinical features of cases presenting a positive or negative DAT. Methods: Articles reporting clinical data of patients diagnosed with PADH, for whom DAT had been performed, were collected from PubMed database. Data retrieved from single patients were extracted and univariate analysis was performed in order to identify features potentially related to DAT results and steroids use. Results: Twenty-two studies reporting 39 PADH cases were included: median baseline parasitaemia was 20.8% (IQR: 11.2-30) and DAT was positive in 17 cases (45.5%). Compared to DAT-negative individuals, DAT-positive patients were older (49.5 vs 31; p = 0.01), had a higher baseline parasitaemia (27% vs 17%; p = 0.03) and were more commonly treated with systemic steroids (11 vs 3 patients, p = 0.002). Depth and kinetics of delayed anaemia were not associated with DAT positivity. Conclusions: In this case series, almost half of the patients affected by PADH had a positive DAT. An obvious difference between the clinical courses of patients presenting with a positive or negative DAT was lacking. This observation suggests that DAT result may not be indicative of a pathogenic role of anti-erythrocytes antibodies in patients affected by PADH, but it may be rather a marker of immune activation.
MeSH term(s)	Adult ; Antimalarials/administration & dosage ; Artesunate/administration & dosage ; Coombs Test/statistics & numerical data ; Female ; Hemolysis/drug effects ; Humans ; Malaria, Falciparum/drug therapy ; Malaria, Vivax/drug therapy ; Male ; Middle Aged ; Parasitemia/drug therapy ; Young Adult
Chemical Substances	Antimalarials ; Artesunate (60W3249T9M)
Language	English
Publishing date	2021-04-29
Publishing country	England
Document type	Journal Article ; Systematic Review
ISSN	1475-2875
ISSN (online)	1475-2875
DOI	10.1186/s12936-021-03735-w
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Article ; Online: Aero-Medical Evacuation during SARS-CoV-2 Pandemic

Domenico Benvenuto / Tommaso Ascoli Bartoli / Ambrogio Curtolo / Claudia Palazzolo / Serena Vita / Andrea Mariano / Laura Scorzolini / Giuseppe Ippolito / Luisa Marchioni / Federico Cerini / Gianpiero D’Offizi / Francesco Vaia / Emanuele Nicastri

Journal of Clinical Medicine, Vol 12, Iss 1, p

Extraordinary Measure or Emerging Treatment Option?

2022 Volume 133

Abstract: Aero-medical evacuation has been considered as a feasible and safe treatment option during COVID pandemic, particularly when the needs of affected patients exceed what local clinics and hospitals are supposed to provide. In this article, we analyzed the ... ...

Abstract	Aero-medical evacuation has been considered as a feasible and safe treatment option during COVID pandemic, particularly when the needs of affected patients exceed what local clinics and hospitals are supposed to provide. In this article, we analyzed the clinical course of 17 patients medically evacuated to the “L. Spallanzani” Institute in Rome, Italy from foreign countries, mainly Africa and Eastern Europe, who had COVID-19 pneumonia with, or without, coinfections such as malaria, HIV, tuberculosis and microbiologically confirmed sepsis syndrome. The aero-medical evacuation of patients with infectious diseases has become one of the greatest medical achievements we have reached during this pandemic; in fact, only two patients with life threatening coinfections have died. Although logistically difficult and cost consuming, medical evacuation should be considered as a treatment option more than a single extraordinary measure, especially among complex cases that require specific technical and human resources.
Keywords	medical evacuation ; COVID-19 ; infectious diseases ; Medicine ; R
Language	English
Publishing date	2022-12-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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