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Trials

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27/07/2020 World Report
Covidization of research: what are the risks?

NATURE

Authors
Madhukar Pai



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24/07/2020 Institutional Report
COVID-19 – Italian Medicine Agency approved a phase 1 clinical study o...

COVID-19 – Italian Medicine Agency approved a phase 1 clinical study on ReiThera vaccine in Italy

AIFA

Authors
AIFA


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19/07/2020 Articles
Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Rep...

Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report

THE NEW ENGLAND JOURNAL OF MEDICINE

Authors
The RECOVERY Collaborative Group



ABSTRACT
BACKGROUND Coronavirus disease 2019 (Covid-19) is associated with diffuse lung damage. Glucocorticoids may modulate inflammation-mediated lung injury and thereby reduce progression to respiratory failure and death.
METHODS In this controlled, open-label trial comparing a range of possible treatments in patients who were hospitalized with Covid-19, we randomly assigned patients to receive oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days or to receive usual care alone. The primary outcome was 28-day mortality. Here, we report the preliminary results of this comparison.
RESULTS A total of 2104 patients were assigned to receive dexamethasone and 4321 to receive usual care. Overall, 482 patients (22.9%) in the dexamethasone group and 1110 patients (25.7%) in the usual care group died within 28 days after randomization (age-adjusted rate ratio, 0.83; 95% confidence interval [CI], 0.75 to 0.93; P<0.001). The proportional and absolute between-group differences in mortality varied considerably according to the level of respiratory support that the patients were receiving at the time of randomization. In the dexamethasone group, the incidence of death was lower than that in the usual care group among patients receiving invasive mechanical ventilation (29.3% vs. 41.4%; rate ratio, 0.64; 95% CI, 0.51 to 0.81) and among those receiving oxygen without invasive mechanical ventilation (23.3% vs. 26.2%; rate ratio, 0.82; 95% CI, 0.72 to 0.94) but not among those who were receiving no respiratory support at randomization (17.8% vs. 14.0%; rate ratio, 1.19; 95% CI, 0.91 to 1.55).
CONCLUSIONS In patients hospitalized with Covid-19, the use of dexamethasone resulted in lower 28-day mortality among those who were receiving either invasive mechanical ventilation or oxygen alone at randomization but not among those receiving no respiratory support. (Funded by the Medical Research Council and National Institute for Health Research and others; RECOVERY ClinicalTrials.gov number, NCT04381936. opens in new tab; ISRCTN number, 50189673. opens in new tab.)

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15/07/2020 PERSPECTIVE
Improving Clinical Trial Enrollment — In the Covid-19 Era and Beyond

THE NEW ENGLAND JOURNAL OF MEDICINE

Authors
Crystal M. North, Michael L. Dougan, Chana A. Sacks



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04/07/2020 Guidelines
WHO discontinues hydroxychloroquine and lopinavir/ritonavir treatment ...

WHO discontinues hydroxychloroquine and lopinavir/ritonavir treatment arms for COVID-19

WORLD HEALTH ORGANIZATION

Authors
WORLD HEALTH ORGANIZATION


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02/07/2020 News
COVID Mothers Study: studio internazionale su COVID-19 in madri e bamb...

COVID Mothers Study: studio internazionale su COVID-19 in madri e bambini

ISTITUTO SUPERIORE DI SANITA'

Authors
Angela Giusti, Francesca Zambri, Francesca Marchetti


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01/07/2020 Reviews
Profiles of COVID-19 clinical trials in the Chinese Clinical Trial Reg...

Profiles of COVID-19 clinical trials in the Chinese Clinical Trial Registry

TAYLOR & FRANCIS ONLINE

Authors
Peng Xu ,Xiangyu Xing, Keying Yu, Zhiguo Lv,Huijing Cui,Yuhang Shi,Tianying Chang,Dongmei Zhang,Yibin Zhang,Kai Wang,Jing Lu,Qingxia Huang,Xiangyan Li,Yingzi Cui,Li Shi,Tan Wang,Junqi Niu, Jian Wang



ABSTRACT
The COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is a global public health crisis since its initial reports in China. Since no effective vaccine or drug has been developed to treat and combat the COVID-19, the current approaches for clinical management focus on supportive care. There is a pressing need for evidence-based interventions to address the devastating clinical and public health effects of the COVID-19 pandemic. The Chinese scientists supported by private and government resources have adopted extensive efforts to identify effective drugs against the virus. To date, a large number of clinical trials addressing various aspects of COVID-19 have been registered in the Chinese Clinical Trial Registry (ChiCTR), including more than 200 interventional studies. Under such an urgent circumstance, the scope and quality of these clinical studies vary significantly. Hence, this review aims to make a comprehensive analysis on the profiles of COVID-19 clinical trials registered in the ChiCTR, including a wide range of characteristics. Our findings will provide a useful summary on these clinical studies, since most of these studies will encounter major challenges from the design to completion. It will be a long road for the outcomes of these studies to be published and international collaboration will help the ultimate goals of developing new vaccines and antiviral drugs.

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18/06/2020 Research
Studio randomizzato multicentrico in aperto sull’efficacia della sommi...

Studio randomizzato multicentrico in aperto sull’efficacia della somministrazione precoce del Tocilizumab in pazienti affetti da polmonite da COVID-19

AIFA

Authors
Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia


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17/06/2020 Press Release
COVID-19: STUDIO RANDOMIZZATO ITALIANO, NESSUN BENEFICIO DAL TOCILIZUM...

COVID-19: STUDIO RANDOMIZZATO ITALIANO, NESSUN BENEFICIO DAL TOCILIZUMAB

AIFA

Authors
AIFA


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05/06/2020 Comment
Retraction—Hydroxychloroquine or chloroquine with or without a macroli...

Retraction—Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis

The Lancet

Authors
Mandeep R Mehra, Frank Ruschitzka, Amit N Patel

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05/06/2020 News
No clinical benefit from use of hydroxychloroquine in hospitalised pat...

No clinical benefit from use of hydroxychloroquine in hospitalised patients with COVID-19

OXFORD UNIVERSITY

Authors
PETER HORBY, MARTIN LANDRAY


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05/06/2020 News
No clinical benefit from use of hydroxychloroquine in hospitalised pat...

No clinical benefit from use of hydroxychloroquine in hospitalised patients with COVID-19

OXFORD UNIVERSITY

Authors
PETER HORBY, MARTIN LANDRAY


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04/06/2020 Correspondence
Retraction: Cardiovascular Disease, Drug Therapy, and Mortality in Cov...

Retraction: Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19. N Engl J Med. DOI: 10.1056/NEJMoa2007621.

THE NEW ENGLAND JOURNAL OF MEDICINE

Authors
Mandeep R. Mehra, Sapan S. Desai, SreyRam Kuy, Timothy D. Henry, Amit N. Patel

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04/06/2020 Trials
Multi-Arm Therapeutic Study in Pre-ICU Patients Admitted with COVID-19

CCTU (CLINICAL CAMBRIDGE TRIALS UNIT)

Authors
TACTIC

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04/06/2020 MEDICAL NEWS & PERSPECTIVES
Challenge Trials—Could Deliberate Coronavirus Exposure Hasten Vaccine ...

Challenge Trials—Could Deliberate Coronavirus Exposure Hasten Vaccine Development?

JAMA

Authors
Rita Rubin

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03/06/2020 Editorial
A Randomized Trial of Convalescent Plasma for COVID-19—Potentially Hop...

A Randomized Trial of Convalescent Plasma for COVID-19—Potentially Hopeful Signals

JAMA

Authors
Arturo Casadevall, Michael J. Joyner, Liise-Anne Pirofski

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28/05/2020 Open Letter
An open letter to Mehra et al and The Lancet

ZENODO



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27/05/2020 EMERGENCIES
“Solidarity” clinical trial for COVID-19 treatments

WORLD HEALTH ORGANIZATION

Authors
WORLD HEALTH ORGANIZATION

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27/05/2020 Resource
A Mouse Model of SARS-CoV-2 Infection and Pathogenesis

SCIENCE DIRECT

Authors
Shi-Hui Sun, Qi Chen, Hong-Jing Gu, Yu-Sen Zhou, Cheng-Feng Qin, You-Chun Wang

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26/05/2020 Articles
The consequences of the COVID-19 pandemic on non-COVID-19 clinical tri...

The consequences of the COVID-19 pandemic on non-COVID-19 clinical trials

ELSEVIER

Authors
EmiliaBagiella, Deepak L.Bhatt, MarioGaudino

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26/05/2020 Editorial
A brief note on randomized controlled trials and compassionate/off-lab...

A brief note on randomized controlled trials and compassionate/off-label use of drugs in the early phases of the COVID-19 pandemic

DRUGS IN CONTEXT

Authors
Matteo Bassetti MD, Paolo Pelosi, Chiara Robba, Antonio Vena MD, Daniele Roberto Giacobbe



ABSTRACT
Randomized controlled trials (RCTs) are the best way to find effective and acceptable safe treatments for COVID-19 and any possible future outbreak. However, caution is needed when comparing the number of participants in RCTs with that of patients with COVID-19 treated with compassionate and/or off-label drugs to support the hypothesis that the latter are preferred by clinicians as an alternative to the former.

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25/05/2020 Review Article
Certainty of success: three critical parameters in coronavirus vaccine...

Certainty of success: three critical parameters in coronavirus vaccine development

NATURE

Authors
David C. Kaslow

ABSTRACT

Vaccines for 17 viral pathogens have been licensed for use in humans. Previously, two critical biological parameters of the pathogen and the host–pathogen interaction—incubation period and broadly protective, relative immunogenicity—were proposed to account for much of the past successes in vaccine development, and to be useful in estimating the “certainty of success” of developing an effective vaccine for viral pathogens for which a vaccine currently does not exist. In considering the “certainty of success” in development of human coronavirus vaccines, particularly SARS-CoV-2, a third, related critical parameter is proposed—infectious inoculum intensity, at an individual-level, and force of infection, at a population-level. Reducing the infectious inoculum intensity (and force of infection, at a population-level) is predicted to lengthen the incubation period, which in turn is predicted to reduce the severity of illness, and increase the opportunity for an anamnestic response upon exposure to the circulating virus. Similarly, successfully implementing individual- and population-based behaviors that reduce the infectious inoculum intensity and force of infection, respectively, while testing and deploying COVID-19 vaccines is predicted to increase the “certainty of success” of demonstrating vaccine efficacy and controlling SARS-CoV-2 infection, disease, death, and the pandemic itself.

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22/05/2020 Articles
Safety, tolerability, and immunogenicity of a recombinant adenovirus t...

Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine...

THE LANCET

Authors
Feng-Cai Zhu, Yu-Hua Li, Xu-Hua Guan, Li-Hua Hou, Wen-Juan Wang, Jing-Xin Li, Shi-Po Wu, Bu-Sen Wang, Zhao Wang, Lei Wang, Si-Yue Jia, Hu-Dachuan Jiang, Ling Wang, Tao Jiang, Yi Hu, Jin-Bo Gou, Sha-Bei Xu, Jun-Jie Xu, Xue-Wen Wang, Wei Wang, Wei Chen

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22/05/2020 News and Events
Oxford COVID-19 vaccine to begin phase II/III human trials

UNIVERSITY OF OXFORD

Authors
UNIVERSITY OF OXFORD

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20/05/2020 Editorial
COVID-19 Clinical trials: quality matters more than quantity

WILEY ONLINE LIBRARY

Authors
Sergio Bonini, Giuseppe Maltese

ABSTRACT

Despite the ferment aroused in the scientific community by the COVID‐19 outbreak and the over 11,000 papers listed in PubMed, published evidence on safe and effective drugs has not progressed yet at the same speed of the pandemic. However, clinical research is rapidly progressing, as shown by the hundreds of registered clinical trials on candidate drugs for COVID‐19. Unfortunately, information on protocols of individual studies differs from registry to registry. Furthermore, study designs, criteria for stratification of patients and choice of outcomes are quite heterogeneous. All this makes data sharing and secondary analysis difficult.At last, small single centre studies and the use of drugs on a compassionate basis should be replaced by highly powered, multi‐centre, multi‐arm clinical trials, in orderto provide the required evidence of safety and efficacy of novel or repurposed candidate drugs. Hopefully, the efforts of clinical researchers in the fight against the SARS Cov‐2 will result into the identification of effective treatments. To make this possible, clinical research should be oriented by guidelines for more harmonized high‐quality studies and by a united commitment of the scientific community to share personal knowledge and data. Allergists and clinical immunologists should have a leading role in this unprecedent challenge.

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19/05/2020 Download File
covid-19 sperimentazioni in corso

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13/05/2020 Editorial
Coronavirus drugs trials need scale and collaboration

NATURE

Authors
NATURE

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12/05/2020 Editorial
Waste in covid-19 research

THE BMJ

Authors
Paul P Glasziou

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11/05/2020 Policy Form
A strategic approach to COVID-19 vaccine R&D

SCIENC

Authors
Lawrence Corey, John R. Mascola, Anthony S. Fauci, Francis S. Collins

ABSTRACT

There is an unprecedented need to manufacture and distribute enough safe and effective vaccine to immunize an extraordinarily large number of individuals in order to protect the entire global community from the continued threat of morbidity and mortality from severe acute respiratory syndrome–coronavirus 2 (SARS-CoV-2). The global need for vaccine and the wide geographic diversity of the pandemic require more than one effective vaccine approach. Collaboration will be essential among biotechnology and pharmaceutical companies, many of which are bringing forward a variety of vaccine approaches (1). The full development pathway for an effective vaccine for SARS-CoV-2 will require that industry, government, and academia collaborate in unprecedented ways, each adding their individual strengths. We discuss one such collaborative program that has recently emerged: the ACTIV (Accelerating COVID-19 Therapeutic Interventions and Vaccines) public-private partnership. Spearheaded by the U.S. National Institutes of Health (NIH), this effort brings together the strengths of all sectors at this time of global urgency. We further discuss a collaborative platform for conducting harmonized, randomized controlled vaccine efficacy trials. This mechanism aims to generate essential safety and efficacy data for several candidate vaccines in parallel, so as to accelerate the licensure and distribution of multiple vaccine platforms and vaccines to protect against COVID-19 (coronavirus disease 2019). We currently know little about what constitutes a protective immune response against COVID-19. Data from SARS-CoV-1 patients as well as recently infected SARS-CoV-2 patients document relatively high levels of immune responses after infection, especially antibody responses to the surface (spike) protein that mediates entry into host cells. However, in vivo data on the type or level of immunity required to protect from subsequent re-infection, and the likely duration of that protection, are currently unknown. In animal models of SARS-CoV-1, immunization with recombinant subunit proteins and viral- and nucleic acid–vectored vaccines, as well as passive transfer of neutralizing antibodies to the spike protein, have been shown to be protective against experimental infection (2, 3). Endpoints vary from protection of infection to modification of viral replication and disease. These data bring optimism that a highly immunogenic vaccine will elicit the magnitude and quality of antibody responses required for protection. The role that T cell immunity plays in preventing acquisition or amelioration of early disease, either in animal challenge models or in human coronavirus disease, is unclear (4); this constitutes another reason why a diversity of vaccine approaches must be pursued. A high degree of safety is a primary goal for any widely used vaccine, and there is theoretical risk that vaccination could make subsequent SARS-CoV-2 infection more severe. This has been reported for feline coronaviruses and has been observed in some vaccine-challenge animal models of SARS-CoV-1 (5). These preclinical data suggest that the syndrome of vaccine-associated enhanced respiratory disease results from a combination of poorly protective antibodies that produce immune complex deposition together with a T helper cell 2 (TH2)–biased immune response. The potential mechanism behind vaccine-induced immune enhancement and the means to minimize this risk have recently been reviewed (6). It will be important to construct conformationally correct antigens to elicit functionally effective antibodies—a lesson learned from vaccine-induced enhanced lower respiratory illness among infants receiving a formalin-inactivated respiratory syncytial virus (RSV) vaccine. Animal models of SARS-CoV-2 infection are currently being developed, and these models can be used to better understand the immune responses associated with protection (7).

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11/05/2020 Viewpoint
Clinical trials for COVID-19 should include sex as a variable

THE JOURNAL OF CLINICAL INVESTIGATION

Authors
Evelyne Bischof, Jeannette Wolfe, and Sabra L. Klein

ABSTRACT

This Viewpoint calls on investigators that are developing and testing therapeutic and prophylactic approaches for COVID-19 to design studies that are inclusive of male-female differences.

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08/05/2020 News Releases
NIH clinical trial testing antiviral remdesivir plus anti-inflammatory...

NIH clinical trial testing antiviral remdesivir plus anti-inflammatory drug baricitinib for COVID-19 begins

National Institutes of Health (NIH)

Authors
National Institutes of Health (NIH)

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07/05/2020 Special Articles
Post-exposure prophylaxis or pre-emptive therapy for severe acute resp...

Post-exposure prophylaxis or pre-emptive therapy for severe acute respiratory syndrome...

SPRINGER LINK

Authors
Sylvain A. Lother, Mahsa Abassi, Alyssa Agostinis, Ananta S. Bangdiwala, Matthew P. Cheng, Glen Drobot, Nicole Engen, Kathy H. Hullsiek, Lauren E. Kelly, Todd C. Lee, FIDSA, Sarah M. Lofgren, Lauren J. MacKenzie, Nicole Marten RN, Emily G. McDonald, Elizabeth C. Okafor, Katelyn A. Pastick, Matthew F. Pullen , Radha Rajasingham, Ilan Schwartz, Caleb P. Skipper, Alexis F. Turgeon, Ryan Zarychanski, David R. Boulware

ABSTRACT

Background The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in December 2019 causing the coronavirus disease (COVID-19) pandemic. Currently, there is a lack of evidence-based therapies to prevent COVID-19 following exposure to the virus, or to prevent worsening of symptoms following confirmed infection. We describe the design of a clinical trial of hydroxychloroquine for post-exposure prophylaxis (PEP) and pre-emptive therapy (PET) for COVID-19.

Methods We will conduct two nested multicentre international double-blind randomized placebo-controlled clinical trials of hydroxychloroquine for: 1) PEP of asymptomatic household contacts or healthcare workers exposed to COVID-19 within the past four days, and 2) PET for symptomatic outpatients with COVID-19 showing symptoms for less than four days. We will recruit 1,500 patients each for the PEP and PET trials. Participants will be randomized 1:1 to receive five days of hydroxychloroquine or placebo. The primary PEP trial outcome will be the incidence of symptomatic COVID-19. The primary PET trial outcome will be an ordinal scale of disease severity (not hospitalized, hospitalized without intensive care, hospitalization with intensive care, or death). Participant screening, informed consent, and follow-up will be exclusively internet-based with appropriate regulatory and research ethics board approvals in Canada and the United States.

Discussion These complementary randomized-controlled trials are innovatively designed and adequately powered to rapidly answer urgent questions regarding the effectiveness of hydroxychloroquine to reduce virus transmission and disease severity of COVID-19 during a pandemic. In-person participant follow-up will not be conducted to facilitate social distancing strategies and reduce risks of exposure to study personnel. Innovative trial approaches are needed to urgently assess therapeutic options to mitigate the global impact of this pandemic.

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06/05/2020 Institutional
Key criteria for the ethical acceptability of COVID-19 human challenge...

Key criteria for the ethical acceptability of COVID-19 human challenge studies

WORLD HEALTH ORGANIZATION

Authors
WORLD HEALTH ORGANIZATION

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05/05/2020 Letter
Overwhelming COVID-19 Clinical Trials: Call for Prospective Meta-Analy...

Overwhelming COVID-19 Clinical Trials: Call for Prospective Meta-Analyses

SCIENCE DIRECT

Authors
ZhongrenMa, JiayeLiu, QiuweiPan

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05/05/2020 Articles
A cluster randomised trial of cloth masks compared with medical masks ...

A cluster randomised trial of cloth masks compared with medical masks in healthcare workers

BMJ

Authors
C Raina MacIntyre, Holly Seale, Tham Chi Dung, Nguyen Tran Hien, Phan Thi Nga, Abrar Ahmad Chughtai, Bayzidur Rahman, Dominic E Dwyer, Quanyi Wang

ABSTRACT

Objective: The aim of this study was to compare the efficacy of cloth masks to medical masks in hospital healthcare workers (HCWs). The null hypothesis is that there is no difference between medical masks and cloth masks.

Setting: 14 secondary-level/tertiary-level hospitals in Hanoi, Vietnam.

Participants: 1607 hospital HCWs aged ≥18 years working full-time in selected high-risk wards. Intervention: Hospital wards were randomised to: medical masks, cloth masks or a control group (usual practice, which included mask wearing). Participants used the mask on every shift for 4 consecutive weeks. Main outcome measure: Clinical respiratory illness (CRI), influenza-like illness (ILI) and laboratory- confirmed respiratory virus infection.

Results: The rates of all infection outcomes were highest in the cloth mask arm, with the rate of ILI statistically significantly higher in the cloth mask arm (relative risk (RR)=13.00, 95% CI 1.69 to 100.07) compared with the medical mask arm. Cloth masks also had significantly higher rates of ILI compared with the control arm. An analysis by mask use showed ILI (RR=6.64, 95% CI 1.45 to 28.65) and laboratory- confirmed virus (RR=1.72, 95% CI 1.01 to 2.94) were significantly higher in the cloth masks group compared with the medical masks group. Penetration of cloth masks by particles was almost 97% and medical masks 44%.

Conclusions: This study is the first RCT of cloth masks, and the results caution against the use of cloth masks. This is an important finding to inform occupational health and safety. Moisture retention, reuse of cloth masks and poor filtration may result in increased risk of infection. Further research is needed to inform the widespread use of cloth masks globally. However, as a precautionary measure, cloth masks should not be recommended for HCWs, particularly in high-risk situations, and guidelines need to be updated.

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04/05/2020 Editorial
Randomized Clinical Trials and COVID-19

JAMA

Authors
Howard Bauchner; Phil B. Fontanarosa

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01/05/2020 Articles
Renin–Angiotensin–Aldosterone System Blockers and the Risk of Covid-19

THE NEW ENGLAND JOURNAL OF MEDICINE

Authors
Giuseppe Mancia, Federico Rea, Monica Ludergnani, Giovanni Apolone,,and Giovanni Corrao,

ABSTRACT

A potential association between the use of angiotensin-receptor blockers (ARBs) and angiotensin-converting–enzyme (ACE) inhibitors and the risk of coronavirus disease 2019 (Covid-19) has not been well studied.

METHODS We carried out a population-based case–control study in the Lombardy region of Italy. A total of 6272 case patients in whom infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was confirmed between February 21 and March 11, 2020, were matched to 30,759 beneficiaries of the Regional Health Service (controls) according to sex, age, and municipality of residence. Information about the use of selected drugs and patients’ clinical profiles was obtained from regional databases of health care use. Odds ratios and 95% confidence intervals for associations between drugs and infection, with adjustment for confounders, were estimated by means of logistic regression.

RESULTS Among both case patients and controls, the mean (±SD) age was 68±13 years, and 37% were women. The use of ACE inhibitors and ARBs was more common among case patients than among controls, as was the use of other antihypertensive and non-antihypertensive drugs, and case patients had a worse clinical profile. Use of ARBs or ACE inhibitors did not show any association with Covid-19 among case patients overall (adjusted odds ratio, 0.95 [95% confidence interval {CI}, 0.86 to 1.05] for ARBs and 0.96 [95% CI, 0.87 to 1.07] for ACE inhibitors) or among patients who had a severe or fatal course of the disease (adjusted odds ratio, 0.83 [95% CI, 0.63 to 1.10] for ARBs and 0.91 [95% CI, 0.69 to 1.21] for ACE inhibitors), and no association between these variables was found according to sex.

CONCLUSIONS In this large, population-based study, the use of ACE inhibitors and ARBs was more frequent among patients with Covid-19 than among controls because of their higher prevalence of cardiovascular disease. However, there was no evidence that ACE inhibitors or ARBs affected the risk of COVID-19.

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24/04/2020 Correspondence
A real-time dashboard of clinical trials for COVID-19

The Lancet

Authors
Kristian Thorlund, Louis Dron, Jay Park, Grace Hsu, Jamie I Forrest, Edward J Mills

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07/04/2020 Letter
A new clinical trial to test high-dose vitamin C in patients with COVI...

A new clinical trial to test high-dose vitamin C in patients with COVID-19

BMC

Authors
Anitra C. Carr

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07/04/2020 Articles
Randomised Evaluation of Covid-19 therapy (Recovery)

UNIVERSITY OF OXFORD

Authors
RECOVERY STAFF

Background:
In early 2020, as this protocol was being developed, there were no approved treatments for COVID-19, a disease induced by the novel coronavirus SARSCoV-2 that emerged in China in late 2019. The UK New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG) advised that several possible treatments should be evaluated, including Lopinavir-Ritonavir, low-dose corticosteroids, and hydroxychloroquine. These groups also advised that other treatments will soon emerge that require evaluation. A World Health Organization (WHO) expert group issued broadly similar advice.

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02/04/2020 Comment
Global coalition to accelerate COVID-19 clinical research in resource-...

Global coalition to accelerate COVID-19 clinical research in resource-limited settings

The Lancet

Authors
COVID-19 Clinical Research Coalition

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01/04/2020 Link
Vaccines and treatments for COVID-19: List of all COVID 19 Clinical Tr...

Vaccines and treatments for COVID-19: List of all COVID 19 Clinical Trials...

GOVERNMENT OF CANADA

Authors
GOVERNMENT OF CANADA

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01/04/2020 Link
Sperimentazioni cliniche - COVID-19

AIFA

Authors
AIFA

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01/04/2020 Link
Public health emergency SOLIDARITY trial of treatments for COVID-19 in...

Public health emergency SOLIDARITY trial of treatments for COVID-19 infection in hospitalized patients

BMC

BMC

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01/04/2020 Link
THE PRINCIPAL TRIAL - Evaluating potential treatments for COVID-19 inf...

THE PRINCIPAL TRIAL - Evaluating potential treatments for COVID-19 infection in older people

UNIVERSITY OF OXFORD

Authors
UNIVERSITY OF OXFORD

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01/04/2020 Link
About the COVID-19 Vaccine Trials

UK Oxford Vaccine Trial

Authors
UNIVERSITY OF OXFORD

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01/04/2020 Link
REMAP-CAP response to the novel COVID-19 pandemic

UK REMAP

Authors
REMAP-CAP

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27/03/2020 News
Covid-19: what treatments are being investigated?

The BMJ

Authors
Elisabeth Mahase

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25/03/2020 Link
Trial of Treatments for COVID-19 in Hospitalized Adults (DisCoVeRy)

U.S NATIONAL LIBRARY OF MEDICINE

Authors
U.S NATIONAL LIBRARY OF MEDICINE

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18/03/2020 Articles
TOCIVID-19 Studio multicentrico su efficacia e sicurezza di tocilizuma...

TOCIVID-19 Studio multicentrico su efficacia e sicurezza di tocilizumab nel trattamento di pazienti affetti da polmonite da COVID-19

NULL

Authors
Francesco Perrone, Paolo Ascierto, Anna Maria Marata, Roberto Parrella, Patrizia Popoli, Maria Carmela Piccirillo, Luigi Atripaldi, Marco Cascella, Massimo Costantini, Giovanni Dolci, Nicola Facciolongo, Fiorentino Fragranza, Marco Massari, Vincenzo Montesarchio, Cristina Mussini,Emanuele Alberto Negri

Titolo dello studio
Studio multicentrico su efficacia e sicurezza di Tocilizumab nel trattamento di pazienti affetti da polmonite da COVID-19

Sigla dello studio
TOCIVID-19

Obiettivo dello studio
Valutare l’efficacia e la sicurezza di Tocilizumab in pazienti affetti da polmonite da COVID-19

Background
- la polmonite rappresenta la complicanza più frequente e grave in corso di infezione da coronavirus
- IL-6 è uno dei mediatori dell’infiammazione che consegue alla risposta
immunitaria contro il virus che si realizza a livello degli alveoli polmonari; tale risposta immunitaria e la conseguente “tempesta citochinica” finiscono con il produrre un significativo danno al parenchima polmonare con una interstiziopatia che riduce notevolmente la funzionalità respiratoria
- Tocilizumab è un anticorpo monoclonale ricombinante umanizzato diretto contro il recettore dell’IL-6
- In una esperienza resa nota dai ricercatori Cinesi (Xiaoling Xu, Mingfeng Han, Tiantian Li et al. Effective Treatment of Severe COVID-19 Patients with Tocilizumab. chinaXiv: 202003.00026v1) il tocilizumab ha prodotto incoraggianti benefici clinici e nei parametri di laboratorio in una casistica di 21 pazienti affetti da polmonite severa o critica COVID-19
- Tali risultati hanno dato luogo al disegno di una sperimentazione randomizzata (tocilizumab vs controllo) che dovrebbe chiudersi entro la metà del mese di maggio 2020.

Obiettivo primario
Ridurre la mortalità in corso di polmonite da COVID-19

Disegno del progetto di studio
Questo progetto è stato scritto al momento della pandemia da coronavirus e mentre in Italia il numero di persone che si infettano o sono ricoverate in ospedale per complicanze respiratorie è drammaticamente in aumento. Pertanto, lo scenario clinico e operativo è estremamente variabile e si prevede che rimarrà tale per un tempo imprevedibile. Inoltre, sono disponibili pochissime prove concrete sul decorso della malattia e molti endpoint intermedi prima dell'uso del farmaco sperimentale. Pertanto, è accettato in anticipo che il presente protocollo potrebbe richiedere ripetute modifiche per conformarsi all'evoluzione delle conoscenze sulla pandemia, sul tasso di complicanze e sullo scenario terapeutico per i pazienti che sviluppano polmonite. Si prevede quindi un elevato grado di adattamento, che sarà discusso rigorosamente con il comitato indipendente di monitoraggio dei dati che sarà nominato subito dopo l'approvazione del protocollo.

Disegno dello studio
Al suo concepimento, il progetto di studio include uno studio di fase 2 a braccio singolo e uno studio di coorte osservazionale parallelo, che arruolano pazienti con polmonite COVID-19.

Studio di fase 2
Questo è uno studio multicentrico, a braccio singolo, in aperto, di fase 2. Tutti i pazienti arruolati sono trattati con tocilizumab. Il tasso di mortalità a un mese è l'endpoint primario.
Dai dati disponibili, si può presumere che la mortalità a 1 mese per la popolazione definita dai criteri di selezione sia di circa il 15 % (P0). Per verificare l'ipotesi che il farmaco sperimentale possa dimezzare il tasso di mortalità (dal 15% al 7,5%, P1), sono necessari 330 pazienti per verificare l'ipotesi con una potenza del 99% e un errore alfa bilaterale del 5%.

Studio di coorte osservazionale
Questa coorte di osservazione prospettica / retrospettiva includerà pazienti che non sono eleggibili per lo studio di fase 2 perché:
a) condizioni di emergenza o limiti infrastrutturali o operativi hanno impedito la registrazione prima della somministrazione del farmaco sperimentale o b) erano stati intubati più di 24 ore prima della registrazione.

Le stesse informazioni pianificate per la coorte di fase 2 sono in linea di principio richieste anche per lo studio di coorte osservazionale. La dimensione del campione dello studio osservazionale non è definita a priori e la coorte si chiuderà alla fine del progetto complessivo.

Dimensione del campione
Nella coorte di fase 2 verranno arruolati 330 pazienti. Nella coorte osservazionale il campione non è definito a priori.

Popolazione oggetto di studio
Popolazione in studio: pazienti con polmonite da COVID-19 con deficit di saturazione dell’ossigeno e che richiedono assistenza in regime di ricovero.

Principali criteri di inclusione
1. Qualsiasi genere
2. Nessun limite di età
3. Consenso informato per la partecipazione allo studio (NB. il consenso può essere orale se non è possibile esprimere un consenso scritto. Se il soggetto non è in grado di fornire un consenso informato e un rappresentante autorizzato non è disponibile in tempi molto brevi, il che, a giudizio dell'Investigatore, comprometterebbe il potenziale effetto salvavita del trattamento, il trattamento stesso può essere somministrato senza consenso. Il consenso a rimanere nella ricerca dovrebbe essere richiesto non appena le condizioni del paziente lo consentiranno)
4. Diagnosi virologica dell'infezione da Sars-CoV2 (real-time PCR)
5. Ricoverato in ospedale a causa della diagnosi clinica/strumentale di polmonite
6. Saturazione di ossigeno a riposo in aria ambiente ≤93% (valida per pazienti non intubati e sia per lo studio di fase 2 che per la coorte osservazionale)
7. Intubato meno di 24 ore prima della registrazione (eleggibile solo per la fase 2 - il criterio nr. 6 non si applica in questo caso)
8. Intubato più di 24 ore prima della registrazione (eleggibile solo per la coorte osservazione - il criterio nr. 6 non si applica in questo caso)
9. I pazienti già trattati con tocilizumab prima della registrazione sono eleggibili per la coorte osservazionale solo se è valido un criterio tra i nr. 6, 7, 8

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18/03/2020 Articles
Core Outcome Set for Clinical Trials on Coronavirus Disease 2019 (COS-...

Core Outcome Set for Clinical Trials on Coronavirus Disease 2019 (COS-COVID)

SCIENCE DIRECT

Authors
X. Jin, B. Pang, J. Zhang et al.

ABSTRACT

Since its outbreak in December 2019, a series of clinical trials on Coronavirus Disease 2019 (COVID-19) have been registered or carried out. However, the significant heterogeneity and less critical outcomes of such trials may be leading to a waste of research resources. This study aimed to develop a core outcome set (COS) for clinical trials on COVID-19 in order to tackle the outcome issues. The study was conducted according to the Core Outcome Measures in Effectiveness Trials (COMET) handbook (version 1.0), a guideline for COS development. A research group was set up that included experts in respiratory and critical medicine, traditional Chinese medicine, evidence-based medicine, clinical pharmacology, and statistics, in addition to medical journal editors. Clinical trial registry websites (chictr.org.cn and clinicaltrials.gov) were searched to retrieve clinical trial protocols and outcomes in order to form an outcome pool. A total of 78 clinical trial protocols on COVID-19 were included and 259 outcomes were collected. After standardization, 132 outcomes were identified within seven different categories, of which 58 were selected to develop a preliminary outcome list for further consensus. After two rounds of Delphi survey and one consensus meeting, the most important outcomes for the different clinical classifications of COVID-19 were identified and determined to constitute the COS for clinical trials on COVID-19 (COS-COVID). The COS-COVID includes one outcome for the mild type (time to 2019-nCoV reverse transcription-polymerase chain reaction (RT-PCR) negativity), four outcomes for the ordinary type (length of hospital stay, composite events, score of clinical symptoms, and time to 2019-nCoV RT-PCR negativity), five outcomes for the severe type (composite events, length of hospital stay, arterial oxygen partial pressure (PaO2)/fraction of inspired oxygen (FiO2), duration of mechanical ventilation, and time to 2019-nCoV RT-PCR negativity), one outcome for critical type (all-cause mortality), and one outcome for rehabilitation period (pulmonary function). The COS-COVID is currently the most valuable and practical clinical outcome set for the evaluation of intervention effect, and is useful for evidence assessment and decision-making. With a deepening understanding of COVID-19 and application feedback, the COS-COVID should be continuously updated.

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