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1.
J Psychiatr Res ; 133: 113-118, 2021 01.
Article in English | MEDLINE | ID: covidwho-1065384

ABSTRACT

Firearm sales have surged during COVID-19, raising concerns about a coming wave of suicide deaths. Little is known, however, about the individuals considering acquiring firearms during the pandemic. Recent research has highlighted that individuals considering acquiring firearms may be motivated by exaggerated threat expectancies. In a sample of 3,500 Americans matched to 2010 United States Census data, we compared individuals intending to buy firearms in the coming 12 months (assessed in late June and early July 2020) to those undecided or not planning to acquire firearms on a range of demographic, anxiety, and firearm ownership variables. Our results indicated that those intending to acquire a firearm in the next twelve months are less tolerant of uncertainty, endorse exaggerated threat expectancies, and are experiencing more severe COVID-19 specific fears. Individuals intending to purchase firearms were also more likely to have experienced suicidal ideation in the past year, to have worked in law enforcement, and to have been considered essential workers during COVID-19. Furthermore, such individuals were more likely to already own firearms and to have purchased firearms during the opening months of the COVID-19 pandemic. Those intending to purchase firearms did not endorse lower perceived neighborhood safety, however, indicating that their intent to purchase firearms is unlikely to be driven by tangible threats in their immediate environment. These findings highlight that exaggerated fears may be motivating individuals to purchase firearms to diminish anxiety and that this trend may be particularly common among individuals who already own firearms.


Subject(s)
/psychology , Culture , Fear , Firearms , Intention , Ownership , Pandemics , Social Perception/psychology , Social Problems , Suicide/prevention & control , Suicide/psychology , Anxiety/psychology , Decision Making , Humans , Residence Characteristics , Safety
2.
J Occup Health ; 63(1): e12198, 2021 Jan.
Article in English | MEDLINE | ID: covidwho-1059413

ABSTRACT

OBJECTIVES: The health effects of telework, which was introduced extensively in the immediate context of the COVID-19 pandemic crisis in Japan, on teleworkers, their families, and non-teleworkers, are unknown. Accordingly, we developed a rapid health impact assessment (HIA) to evaluate positive and negative health effects of telework on these groups and recommended easily implementable countermeasures. METHODS: Immediately after an emergency was declared in Japan, we implemented a rapid, five-step HIA. We screened and categorized health effects of telework for the three above-mentioned groups, extracting their content, directionality, and likelihood. Following a scoping exercise to determine the HIA's overall implementation, five experienced occupational health physicians appraised and prioritized the screened items and added new items. We outlined specific countermeasures and disseminated the results on our website. A short-term evaluation was conducted by three external occupational health physicians and three nurses. RESULTS: Following screening and appraisal, 59, 29, and 27 items were listed for teleworkers, non-teleworkers, and family members of teleworkers, respectively, covering work, lifestyle, disease and medical care, and home and community. Targeted countermeasures focused on the work environment, business management, communications, and lifestyles for teleworkers; safety and medical guidelines, work prioritization, and regular communication for non-teleworkers; and shared responsibilities within families and communication outside families for family members of teleworkers. CONCLUSION: The HIA's validity and the countermeasures' practical applicability were confirmed by the external evaluators. They can be easily applied and adapted across diverse industries to mitigate the wider negative effects of telework and enhance its positive effects.


Subject(s)
Health Impact Assessment , Occupational Health , Attitude of Health Personnel , Communication , Computer Security , Exercise , Family , Health Impact Assessment/methods , Health Status , Humans , Japan , Life Style , Safety , Time Management , Work/psychology , Workplace/organization & administration
3.
Ann Glob Health ; 87(1): 5, 2021 01 05.
Article in English | MEDLINE | ID: covidwho-1038733

ABSTRACT

COVID-19 is now impacting every country in Africa and healthcare workers (HCWs) across the continent remain susceptible to professional burnout. We designed a 43-question survey addressing multiple aspects of the COVID-19 pandemic. The survey was anonymous, distributed via email and phone messaging to 13 countries in Africa. We obtained 489 analyzable responses. 49% off HCWs reported a decrease in income, with the majority experiencing between 1-25% salary reduction. Sixty-six percent reported some access to personal protective equipment (PPE), 20% had no access to PPE and only 14% reported proper access. Strikingly, the percentage reporting never feeling depressed changed from 61% before the pandemic to 31% during the pandemic, with an increase in daily depression from 2% to 20%. We found no association between depression and change in income, household size, availability of PPE or lockdown. Safety concerns related to stigma from being HCWs affected 56% of respondents.


Subject(s)
Burnout, Professional/epidemiology , Depression/epidemiology , Health Personnel/psychology , Safety , Adult , Africa/epidemiology , Female , Humans , Income/statistics & numerical data , Male , Personal Protective Equipment/supply & distribution , Risk Factors , Social Stigma , Surveys and Questionnaires , Workload/psychology
5.
Int J Environ Res Public Health ; 18(2)2021 01 12.
Article in English | MEDLINE | ID: covidwho-1024578

ABSTRACT

The coronavirus disease (COVID-19) pandemic in 2020 resulted in widespread interruption of team sports training and competitions. Our aim was to review the recommendations and best practices in return to play in non-professional football after activity lockdown. The authors searched two electronic databases (PubMed, Web of Science) to extract studies published before September 15 2020. Twenty studies explained recommendations, considerations, or best practices in return to play in football, and all of them were clustered into three groups: (1) training load management (n = 10), (2) medical recommendations (n = 9), and (3) recovery related issues (n = 5). The way to establish a progression in training process should be based on training load management and managing the number of stimuli per time. Following the studies, this training process should be divided into three phases: phase 1-physical distancing should be maintained; phases 2 and 3-group training should start. Medical considerations were clustered into different groups: general, pre- and post- training, during training, education, planning to return to competition, and suggestions for post confinement weeks. In particular, social issues, strict hygiene questions, and continuous PCR testing should be considered in return to play over football season. Finally, since a correlation has been found between high-intensive training loads and immunoglobulin A, nutritional and lifestyle recovery strategies should be performed. Moreover, since immunosuppression has been related to congested schedules (<72 h between matches), football federations should avoid this situation.


Subject(s)
/diagnosis , Football/statistics & numerical data , Return to Sport , Safety , Soccer/statistics & numerical data , /epidemiology , Communicable Disease Control , Germany/epidemiology , Humans , Male , Practice Guidelines as Topic , Symptom Assessment/methods
8.
JAMA Netw Open ; 4(1): e2033484, 2021 01 04.
Article in English | MEDLINE | ID: covidwho-1006371

ABSTRACT

Importance: Violence is a significant public health problem that has become entwined with the coronavirus disease 2019 (COVID-19) pandemic. Objective: To describe individuals' concerns regarding violence in the context of the pandemic, experiences of pandemic-related unfair treatment, prevalence of and reasons for firearm acquisition, and changes in firearm storage practices due to the pandemic. Design, Setting, and Participants: This survey study used data from the 2020 California Safety and Well-being Survey, a probability-based internet survey of California adults conducted from July 14 to 27, 2020. Respondents came from the Ipsos KnowledgePanel, an online research panel with members selected using address-based sampling methods. Responses were weighted to be representative of the adult population of California. Main Outcomes and Measures: Topics included worry about violence for oneself before and during the pandemic; concern about violence for someone else due to a pandemic-related loss; experiences of unfair treatment attributed to the pandemic; firearm and ammunition acquisition due to the pandemic; and changes in firearm storage practices due to the pandemic. Results: Of 5018 invited panel members, 2870 completed the survey (completion rate, 57%). Among respondents (52.3% [95% CI, 49.5%-55.0%] women; mean [SD] age, 47.9 [16.9] years; 41.9% [95% CI, 39.3%-44.6%] White individuals), self-reported worry about violence for oneself was significantly higher during the pandemic for all violence types except mass shootings, ranging from a 2.8 percentage point increase for robbery (from 65.5% [95% CI, 62.8%-68.0%] to 68.2% [95% CI, 65.6%-70.7%]; P = .008) to a 5.6 percentage point increase for stray bullet shootings (from 44.5% [95% CI, 41.7%-47.3%] to 50.0% [47.3%-52.8%]; P < .001). The percentage of respondents concerned that someone they know might intentionally harm themselves was 13.1% (95% CI, 11.5%-15.3%). Of those, 7.5% (95% CI, 4.5%-12.2%) said it was because the other person had experienced a pandemic-related loss. An estimated 110 000 individuals (2.4% [95% CI, 1.1%-5.0%] of firearm owners in the state) acquired a firearm due to the pandemic, including 47 000 new owners (43.0% [95% CI, 14.8%-76.6%] of those who had acquired a firearm). Of owners who stored at least 1 firearm in the least secure way, 6.7% (95% CI, 2.7%-15.6%) said they had adopted this unsecure storage practice in response to the pandemic. Conclusions and Relevance: In this analysis of findings from the 2020 California Safety and Well-being Survey, the COVID-19 pandemic was associated with increases in self-reported worry about violence for oneself and others, increased firearm acquisition, and changes in firearm storage practices. Given the impulsive nature of many types of violence, short-term crisis interventions may be critical for reducing violence-related harm.


Subject(s)
Anxiety/epidemiology , Social Discrimination/statistics & numerical data , Violence/psychology , Adult , African Americans , Anxiety/psychology , Asian Americans , California/epidemiology , Commerce , European Continental Ancestry Group , Fear/psychology , Female , Firearms/statistics & numerical data , Hispanic Americans , Humans , Internet , Male , Middle Aged , Ownership , Police , Safety , Social Discrimination/ethnology , Surveys and Questionnaires
9.
Int J Nanomedicine ; 15: 10425-10434, 2020.
Article in English | MEDLINE | ID: covidwho-999917

ABSTRACT

Purpose: The public fear associated with the novel coronavirus (SARS-CoV-2) pandemic has triggered recently a significant proliferation of supplements touted as potential cures against bacteria and viruses. Colloidal silver has particularly benefited from this rush given its empirically and scientifically documented anti-bacterial and anti-viral actions. The lack of standards in the unregulated supplements industry remains a major roadblock in evaluating the quality and consistency of marketed products or assessing the accuracy of the information provided by manufacturers. This study is the first scientifically rigorous attempt to evaluate commercial silver colloidal products offered for sale on the internet. Methods: Fourteen of the most popular colloidal silver products purchased from Amazon (www.amazon.com) were evaluated using state-of-the-art analytical techniques widely accepted as gold standards for investigating the properties (size, shape) and the dispersion of silver nanoparticles. Results: Commercial samples were analysed using UV-Vis, FE-SEM and AAS techniques. In general, the Ag concentration was very close to those claimed by the manufacturer. The colorless product shows no absorbance in the UV-Vis analysis. The FESEM and STEM images confirmed the conclusions of the UV-Vis analysis. Conclusion: The results of this evaluation show clearly that 70% of the commercial products evaluated contain only ionic silver. Despite the evidence showing that silver nanoparticles are not present, eight of these products are promoted by the manufacturers as 'colloidal silver'. Considering the extensive scientific research showing major differences between silver ionic and silver nanoparticles in terms of mechanisms of action, efficacy and safety, it is clear that this misrepresentation impacts the consumers and must be addressed. This study serves as blueprint for a scientific protocol to be followed by manufacturers for characterizing their silver supplements.


Subject(s)
Anti-Bacterial Agents/chemistry , Silver/chemistry , Anti-Bacterial Agents/adverse effects , Anti-Bacterial Agents/pharmacology , Humans , Metal Nanoparticles/chemistry , Safety , Silver/adverse effects , Silver/pharmacology
10.
Int J Environ Res Public Health ; 17(24)2020 12 15.
Article in English | MEDLINE | ID: covidwho-979099

ABSTRACT

In this work, the application of the Lean 6S methodology is exposed, which includes the Safety-Security activity in response to the demands caused by the epidemiological situation due to exposure to SARS-CoV-2, as well as its implementation through a standardized process in n higher education environment in the engineering field. The application of methodologies based on lean principles in the organizational system of an educational institution, causes an impact on the demands of organizational efficiency, where innovation and continuous improvement mark the path to success. The Lean 6S methodology, based on the development of six phases, guarantees, thanks to the impact of all its phases and especially of three of them: cleaning, standardize and safety, the control of the health risk against SARS-CoV-2. This guarantee is achieved through the permanent review of safety in the workplace. The areas of selected implementation to verify the effect have been the essential spaces for the development of the teaching activity: center accesses, learning rooms and practical laboratories. The laboratories are adapted to the security and organization conditions that are required in the regulations required by the Occupational Risk Prevention Services against exposure to SARS-CoV-2, since the appropriate protective equipment for the risk level is reviewed, the ordering of the workstations, the class attendance through the shifts organization and the rearrangement of the common places where the maintenance of a minimum interpersonal safety distance between the teaching staff, auxiliary services and students is guaranteed. The effort of the teaching staff in terms of following the established rules is notably increased. To balance this dedication, it is necessary to increase and rely on auxiliary personnel who guarantee rules compliance control in different spaces than the classroom and the laboratory.


Subject(s)
Education, Continuing , Efficiency, Organizational , Pandemics , Workplace , Humans , Laboratories , Safety
12.
Med Hypotheses ; 146: 110452, 2021 Jan.
Article in English | MEDLINE | ID: covidwho-965499

ABSTRACT

Statins and proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors interfere with several pathophysiological pathways of coronavirus disease 2019 (COVID-19). Statins may have a direct antiviral effect on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by inhibiting its main protease. Statin-induced up-regulation of angiotensin-converting enzyme 2 (ACE2) may also be beneficial, whereas cholesterol reduction might significantly suppress SARS-CoV-2 by either blocking its host-cell entry through the disruption of lipid rafts or by inhibiting its replication. Available human studies have shown beneficial effects of statins and PCSK9 inhibitors on pneumonia and sepsis. These drugs may act as immunomodulators in COVID-19 and protect against major complications, such as acute respiratory distress syndrome and cytokine release syndrome. Considering their antioxidative, anti-arrhythmic, antithrombotic properties and their beneficial effect on endothelial dysfunction, along with the increased risk of mortality of patients at high cardiovascular risk infected by SARS-CoV-2, statins and PCSK9 inhibitors might prove effective against the cardiovascular and thromboembolic complications of COVID-19. On the whole, randomized clinical trials are needed to establish routine use of statins and PCSK9 inhibitors in the treatment of SARS-CoV-2 infection. In the meantime, it is recommended that lipid-lowering therapy should not be discontinued in COVID-19 patients unless otherwise indicated.


Subject(s)
/drug therapy , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Proprotein Convertase 9/antagonists & inhibitors , Serine Proteinase Inhibitors/therapeutic use , Antiviral Agents/adverse effects , Antiviral Agents/therapeutic use , /physiopathology , Cardiovascular Diseases/prevention & control , Endothelium, Vascular/drug effects , Endothelium, Vascular/physiopathology , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects , Immunity, Innate/drug effects , Models, Biological , Pandemics , Pneumonia, Viral/drug therapy , /pathogenicity , Safety , Sepsis/drug therapy , Serine Proteinase Inhibitors/adverse effects , Thromboembolism/prevention & control
13.
Prim Care Companion CNS Disord ; 22(6)2020 Nov 12.
Article in English | MEDLINE | ID: covidwho-941739

ABSTRACT

Objective: India is combating a large-scale migrant crisis in many states during the coronavirus disease 2019 (COVID-19) pandemic. The objective of this study was to identify migrant workers needs and perceptions regarding lockdown while staying in a shelter home during the COVID-19 crisis. Methods: This exploratory study was conducted with 54 migrants staying in a makeshift shelter home in Chandigarh, India. Three discussions were conducted with groups consisting of 15-20 participants to maintain social distancing. Five discussion questions were designed to facilitate group discussions. Results: One important theme among migrants was their eagerness to return to their native homes. Participants were also concerned about pending agriculture-related work, their families back home, and job insecurity. Most of the migrants supported the government-mandated lockdown and agreed that they would follow all instructions. Conclusions: Physiologic requirements, safety, and security were the predominant needs of the migrant workers while staying in the shelter home during lockdown. The participants feared contracting COVID-19 and were uncertain about when and how they would return to their native homes.


Subject(s)
Coronavirus Infections , Emergency Shelter , Needs Assessment , Pandemics , Pneumonia, Viral , Transients and Migrants , Adolescent , Adult , Betacoronavirus , Drinking Water , Female , Focus Groups , Food Supply , Humans , India , Male , Mental Health , Perception , Qualitative Research , Safety , Uncertainty , Young Adult
14.
Trials ; 21(1): 943, 2020 Nov 23.
Article in English | MEDLINE | ID: covidwho-940032

ABSTRACT

OBJECTIVES: Primary Objective • To assess the efficacy of herbal extracts in boosting innate immunity of patients with COVID-19 infection. Secondary Objectives • To assess the efficacy of herbal extracts in restoring respiratory health • To assess the efficacy of Cap. IP in early recovery of patients and decline in viral load • To assess the safety of herbal extracts TRIAL DESIGN: This is a single centre, randomized, 2-arm, parallel group, double blind, 1:1 ratio, controlled, exploratory trial with a study period of 30 days from the day of enrolment. PARTICIPANTS: Patients attending the COVID treatment centre at Yashwantrao Chavan Memorial Hospital, Nehrunagar, Pimpri, Pune, India were screened for their participation in the study. Patients who were known COVID-19 positive (with positive RT-PCR), eligible and willing were enrolled in the study. INTERVENTION AND COMPARATOR: The intervention in the trial has a background in 'Ayurved'. Intervention Arm: Two capsules, Investigational Product (IP) - 1 - 400mg and Investigational Product - 2 - 450mg, containing herbal extracts (a blend of water and CO2 extracts) of Shunthi (Zingiber officinale (Ginger), Vidanga (Embelia ribes), Yashtimadhu (Glycyrrhiza glabra), Haritaki (Terminalia chebula), Guduchi (Tinospora cordifolia), Shatavari (Asparagus racemosus), Aamalaki (Emblica officinalis), Pippali (Piper longum) and calcined Zinc, Shankha bhasma. Placebo Arm: Edible starch ~ 450 mg. The look and feel of IP and of Placebo boxes were very similar. Patients are to take two capsules (one each of IP-1 and IP-2) twice a day for 15 days, and from the 16th day, one capsule of IP-2 twice a day up-to day 30. Capsules are to be administered orally with plain water. The IP is to be taken with all other concomitant medicines prescribed by the treating physician/doctor. The dose of each component in the IP is very safe to administer. The investigational products are registered products with the Indian Government and have been used for more than 6 months in various health conditions but not for COVID-19. MAIN OUTCOMES: Primary Outcome: Efficacy of the herbal extracts in COVID 19 positive patients (in declining viral load: time-point: 4 days and early recovery) Secondary Outcomes: Efficacy of the herbal extracts as an immune-modulator - TH1, TH2, Th17, IL6, NK Cells and CD markers; Immunoglobulin IGG (Serum); Immunoglobulin IGM (Serum) - at 30 days. Efficacy of the investigational product in reducing sequela of the disease Safety analysis (Liver Function Test and Kidney Function Test) including serious allergic reaction of: rash, itching/swelling, severe dizziness, trouble breathing. RANDOMISATION: An alphanumeric coded set of IP/Placebo containers will be used. Participants will be automatically randomized to two groups in the ratio 1:1. BLINDING (MASKING): Participants, caregivers and investigators were blinded. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of more than 60 and up to 75 patients were to be enrolled in the study into the two groups, considering drop-outs. 72 were enrolled with 37 into the intervention group and 35 into the placebo group. TRIAL STATUS: Protocol number: CoviQuest-01 Protocol version number: 1.2 Protocol Date: 1st July 2020 The recruitment period is completed for the trial. Date of 1st patient enrolment was 11th Aug 2020 and the last patient was enrolled on 3rd of September 2020. This is to state that it was a late submission from authors for publication of the protocol to the BMC, after enrolment in the study was over. Last Participant's last follow-up is scheduled on 5th October 2020 TRIAL REGISTRATION: The trial was prospectively registered with the CTRI (Clinical Trial Registry of India). Registration number is CTRI/2020/07/026570 . Registered on 14 July 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Subject(s)
Betacoronavirus/drug effects , Coronavirus Infections/drug therapy , Coronavirus Infections/immunology , Immunity, Innate/drug effects , Plant Extracts/therapeutic use , Pneumonia, Viral/drug therapy , Pneumonia, Viral/immunology , Administration, Oral , Betacoronavirus/genetics , Case-Control Studies , Coronavirus Infections/epidemiology , Coronavirus Infections/virology , Humans , India/epidemiology , Pandemics , Placebos/administration & dosage , Plant Extracts/administration & dosage , Pneumonia, Viral/epidemiology , Pneumonia, Viral/virology , Safety , Severity of Illness Index , Treatment Outcome , Viral Load/drug effects
15.
Trials ; 21(1): 935, 2020 Nov 19.
Article in English | MEDLINE | ID: covidwho-934299

ABSTRACT

OBJECTIVES: The GETAFIX trial will test the hypothesis that favipiravir is a more effective treatment for COVID-19 infection in patients who have early stage disease, compared to current standard of care. This study will also provide an important opportunity to investigate the safety and tolerability of favipiravir, the pharmacokinetic and pharmacodynamic profile of this drug and mechanisms of resistance in the context of COVID-19 infection, as well as the effect of favipiravir on hospitalisation duration and the post COVID-19 health and psycho-social wellbeing of patients recruited to the study. TRIAL DESIGN: GETAFIX is an open label, parallel group, two arm phase II/III randomised trial with 1:1 treatment allocation ratio. Patients will be randomised to one of two arms and the primary endpoint will assess the superiority of favipiravir plus standard treatment compared to standard treatment alone. PARTICIPANTS: This trial will recruit adult patients with confirmed positive valid COVID-19 test, who are not pregnant or breastfeeding and have no prior major co-morbidities. This is a multi-centre trial, patients will be recruited from in-patients and outpatients from three Glasgow hospitals: Royal Alexandra Hospital; Queen Elizabeth University Hospital; and the Glasgow Royal Infirmary. Patients must meet all of the following criteria: 1. Age 16 or over at time of consent 2. Exhibiting symptoms associated with COVID-19 3. Positive for SARS-CoV-2 on valid COVID-19 test 4. Point 1, 2, 3, or 4 on the WHO COVID-19 ordinal severity scale at time of randomisation. (Asymptomatic with positive valid COVID-19 test, Symptomatic Independent, Symptomatic assistance needed, Hospitalized, with no oxygen therapy) 5. Have >=10% risk of death should they be admitted to hospital as defined by the ISARIC4C risk index: https://isaric4c.net/risk 6. Able to provide written informed consent 7. Negative pregnancy test (women of childbearing potential*) 8. Able to swallow oral medication Patients will be excluded from the trial if they meet any of the following criteria: 1. Renal impairment requiring, or likely to require, dialysis or haemofiltration 2. Pregnant or breastfeeding 3. Of child bearing potential (women), or with female partners of child bearing potential (men) who do not agree to use adequate contraceptive measures for the duration of the study and for 3 months after the completion of study treatment 4. History of hereditary xanthinuria 5. Other patients judged unsuitable by the Principal Investigator or sub-Investigator 6. Known hypersensitivity to favipiravir, its metabolites or any excipients 7. Severe co-morbidities including: patients with severe hepatic impairment, defined as: • greater than Child-Pugh grade A • AST or ALT > 5 x ULN • AST or ALT >3 x ULN and Total Bilirubin > 2xULN 8. More than 96 hours since first positive COVID-19 test sample was taken 9. Unable to discontinue contra-indicated concomitant medications This is a multi-centre trial, patients will be recruited from in-patients and outpatients from three Glasgow hospitals: Royal Alexandra Hospital; Queen Elizabeth University Hospital; and the Glasgow Royal Infirmary. INTERVENTION AND COMPARATOR: Patients randomised to the experimental arm of GETAFIX will receive standard treatment for COVID-19 at the discretion of the treating clinician plus favipiravir. These patients will receive a loading dose of favipiravir on day 1 of 3600mg (1800mg 12 hours apart). On days 2-10, patients in the experimental arm will receive a maintenance dose of favipiravir of 800mg 12 hours apart (total of 18 doses). Patients randomised to the control arm of the GETAFIX trial will receive standard treatment for COVID-19 at the discretion of the treating clinician. MAIN OUTCOMES: The primary outcome being assessed in the GETAFIX trial is the efficacy of favipiravir in addition to standard treatment in patients with COVID-19 in reducing the severity of disease compared to standard treatment alone. Disease severity will be assessed using WHO COVID 10 point ordinal severity scale at day 15 +/- 48 hours. All randomised participants will be followed up until death or 60 days post-randomisation (whichever is sooner). RANDOMISATION: Patients will be randomised 1:1 to the experimental versus control arm using computer generated random sequence allocation. A minimisation algorithm incorporating a random component will be used to allocate patients. The factors used in the minimisation will be: site, age (16-50/51-70/71+), history of hypertension or currently obsess (BMI>30 or obesity clinically evident; yes/no), 7 days duration of symptoms (yes/no/unknown), sex (male/female), WHO COVID-19 ordinal severity score at baseline (1/2or 3/4). BLINDING (MASKING): No blinding will be used in the GETAFIX trial. Both participants and those assessing outcomes will be aware of treatment allocation. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): In total, 302 patients will be randomised to the GETAFIX trial: 151 to the control arm and 151 to the experimental arm. There will be an optional consent form for patients who may want to contribute to more frequent PK and PD sampling. The maximum number of patients who will undergo this testing will be sixteen, eight males and eight females. This option will be offered to all patients who are being treated in hospital at the time of taking informed consent, however only patients in the experimental arm of the trial will be able to undergo this testing. TRIAL STATUS: The current GETAFIX protocol is version 4.0 12th September 2020. GETAFIX opened to recruitment on 26th October 2020 and will recruit patients over a period of approximately six months. TRIAL REGISTRATION: GETAFIX was registered on the European Union Drug Regulating Authorities Clinical Trials (EudraCT) Database on 15th April 2020; Reference number 2020-001904-41 ( https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001904-41/GB ). GETAFIX was registered on ISRCTN on 7th September 2020; Reference number ISRCTN31062548 ( https://www.isrctn.com/ISRCTN31062548 ). FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (see Additional file 2).


Subject(s)
Amides/therapeutic use , Antiviral Agents/therapeutic use , Coronavirus Infections/drug therapy , Pneumonia, Viral/drug therapy , Pyrazines/therapeutic use , Adult , Amides/administration & dosage , Amides/pharmacokinetics , Amides/pharmacology , Antiviral Agents/administration & dosage , Antiviral Agents/pharmacokinetics , Antiviral Agents/pharmacology , Betacoronavirus/genetics , Betacoronavirus/isolation & purification , Case-Control Studies , Coronavirus Infections/classification , Coronavirus Infections/epidemiology , Coronavirus Infections/virology , Female , Hospitalization , Humans , Male , Pandemics/classification , Pneumonia, Viral/classification , Pneumonia, Viral/epidemiology , Pneumonia, Viral/virology , Pyrazines/administration & dosage , Pyrazines/pharmacokinetics , Pyrazines/pharmacology , Safety , Scotland/epidemiology , Severity of Illness Index , Treatment Outcome
16.
Trials ; 21(1): 934, 2020 Nov 19.
Article in English | MEDLINE | ID: covidwho-934298

ABSTRACT

OBJECTIVES: Zilucoplan (complement C5 inhibitor) has profound effects on inhibiting acute lung injury post COVID-19, and can promote lung repair mechanisms that lead to improvement in lung oxygenation parameters. The purpose of this study is to investigate the efficacy and safety of Zilucoplan in improving oxygenation and short- and long-term outcome of COVID-19 patients with acute hypoxic respiratory failure. TRIAL DESIGN: This is a phase 2 academic, prospective, 2:1 randomized, open-label, multi-center interventional study. PARTICIPANTS: Adult patients (≥18y old) will be recruited at specialized COVID-19 units and ICUs at 9 Belgian hospitals. The main eligibility criteria are as follows: 1) Inclusion criteria: a. Recent (≥6 days and ≤16 days) SARS-CoV-2 infection. b. Chest CT scan showing bilateral infiltrates within the last 2 days prior to randomisation. c. Acute hypoxia (defined as PaO2/FiO2 below 350 mmHg or SpO2 below 93% on minimal 2 L/min supplemental oxygen). d. Signs of cytokine release syndrome characterized by either high serum ferritin, or high D-dimers, or high LDH or deep lymphopenia or a combination of those. 2) Exclusion criteria: e. Mechanical ventilation for more than 24 hours prior to randomisation. f. Active bacterial or fungal infection. g. History of meningococcal disease (due to the known high predisposition to invasive, often recurrent meningococcal infections of individuals deficient in components of the alternative and terminal complement pathways). INTERVENTION AND COMPARATOR: Patients in the experimental arm will receive daily 32,4 mg Zilucoplan subcutaneously and a daily IV infusion of 2g of the antibiotic ceftriaxone for 14 days (or until hospital discharge, whichever comes first) in addition to standard of care. These patients will receive additional prophylactic antibiotics until 14 days after the last Zilucoplan dose: hospitalized patients will receive a daily IV infusion of 2g of ceftriaxone, discharged patients will switch to daily 500 mg of oral ciprofloxacin. The control group will receive standard of care and a daily IV infusion of 2g of ceftriaxone for 1 week (or until hospital discharge, whichever comes first), to control for the effects of antibiotics on the clinical course of COVID-19. MAIN OUTCOMES: The primary endpoint is the improvement of oxygenation as measured by mean and/or median change from pre-treatment (day 1) to post-treatment (day 6 and 15 or at discharge, whichever comes first) in PaO2/FiO2 ratio, P(A-a)O2 gradient and a/A PO2 ratio. (PAO2= Partial alveolar pressure of oxygen, PaO2=partial arterial pressure of oxygen, FiO2=Fraction of inspired oxygen). RANDOMISATION: Patients will be randomized in a 2:1 ratio (Zilucoplan: control). Randomization will be done using an Interactive Web Response System (REDCap). BLINDING (MASKING): In this open-label trial neither participants, caregivers, nor those assessing the outcomes will be blinded to group assignment. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of 81 patients will be enrolled: 54 patients will be randomized to the experimental arm and 27 patients to the control arm. TRIAL STATUS: ZILU-COV protocol Version 4.0 (June 10 2020). Participant recruitment started on June 23 2020 and is ongoing. Given the uncertainty of the pandemic, it is difficult to predict the anticipated end date. TRIAL REGISTRATION: The trial was registered on Clinical Trials.gov on May 11th, 2020 (ClinicalTrials.gov Identifier: NCT04382755 ) and on EudraCT (Identifier: 2020-002130-33 ). FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Subject(s)
Complement C5/antagonists & inhibitors , Coronavirus Infections/complications , Hypoxia/drug therapy , Pneumonia, Viral/complications , Respiratory Insufficiency/drug therapy , Acute Disease , Adult , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/therapeutic use , Belgium/epidemiology , Betacoronavirus/isolation & purification , Case-Control Studies , Ceftriaxone/administration & dosage , Ceftriaxone/therapeutic use , Coronavirus Infections/epidemiology , Coronavirus Infections/physiopathology , Coronavirus Infections/virology , Cytokine Release Syndrome/blood , Cytokine Release Syndrome/drug therapy , Drug Therapy, Combination , Humans , Infusions, Intravenous , Injections, Subcutaneous , Oxygen/blood , Pandemics , Pneumonia, Viral/epidemiology , Pneumonia, Viral/physiopathology , Pneumonia, Viral/virology , Prospective Studies , Safety , Treatment Outcome
17.
J Pediatric Infect Dis Soc ; 9(5): 551-563, 2020 Nov 10.
Article in English | MEDLINE | ID: covidwho-919284

ABSTRACT

The coronavirus disease 2019 (COVID-19) pandemic has created many challenges for pediatric solid organ transplant (SOT) recipients and their families. As the pandemic persists, patients and their families struggle to identify the best and safest practices for resuming activities as areas reopen. Notably, decisions about returning to school remain difficult. We assembled a team of pediatric infectious diseases (ID), transplant ID, public health, transplant psychology, and infection prevention and control specialists to address the primary concerns about school reentry for pediatric SOT recipients in the United States. Based on available literature and guidance from national organizations, we generated consensus statements pertaining to school reentry specific to pediatric SOT recipients. Although data are limited and the COVID-19 pandemic is highly dynamic, our goal was to create a framework from which providers and caregivers can identify the most important considerations for each pediatric SOT recipient to promote a safe return to school.


Subject(s)
Coronavirus Infections/transmission , Disease Transmission, Infectious/prevention & control , Pneumonia, Viral/transmission , Schools , Transplant Recipients , Child , Coronavirus Infections/prevention & control , Humans , Organ Transplantation , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Risk Factors , Safety , United States
18.
JAMA Netw Open ; 3(10): e2026373, 2020 10 01.
Article in English | MEDLINE | ID: covidwho-893184

ABSTRACT

Importance: Policy makers have relaxed restrictions for certain nonessential industries, including construction, jeopardizing the effectiveness of social distancing measures and putting already at-risk populations at greater risk of coronavirus disease 2019 (COVID-19) infection. In Texas, Latinx populations are overly represented among construction workers, and thus have elevated rates of exposure that are compounded by prevalent high-risk comorbidities and lack of access to health care. Objective: To assess the association between construction work during the COVID-19 pandemic and hospitalization rates for construction workers and the surrounding community. Design, Setting, and Participants: This decision analytical model used a mathematical model of COVID-19 transmission, stratified by age and risk group, with construction workers modeled explicitly. The model was based on residents of the Austin-Round Rock metropolitan statistical area, with a population of 2.17 million. Based on 500 stochastic simulations for each of 15 scenarios that varied the size of the construction workforce and level of worksite transmission risk, the association between continued construction work and hospitalizations was estimated and then compared with anonymized line-list hospitalization data from central Texas through August 20, 2020. Exposures: Social distancing interventions, size of construction workforce, and level of disease transmission at construction worksites. Main Outcomes and Measures: For each scenario, the total number of COVID-19 hospitalizations and the relative risk of hospitalization among construction workers was projected and then compared with relative risks estimated from reported hospitalization data. Results: Allowing unrestricted construction work was associated with an increase of COVID-19 hospitalization rates through mid-August 2020 from 0.38 per 1000 residents to 1.5 per 1000 residents and from 0.22 per 1000 construction workers to 9.3 per 1000 construction workers. This increased risk was estimated to be offset by safety measures (such as thorough cleaning of equipment between uses, wearing of protective equipment, limits on the number of workers at a worksite, and increased health surveillance) that were associated with a 50% decrease in transmission. The observed relative risk of hospitalization among construction workers compared with other occupational categories among adults aged 18 to 64 years was 4.9 (95% CI, 3.8-6.2). Conclusions and Relevance: The findings of this study suggest that unrestricted work in high-contact industries, such as construction, is associated with a higher level of community transmission, increased risks to at-risk workers, and larger health disparities among members of racial and ethnic minority groups.


Subject(s)
Construction Industry , Coronavirus Infections/etiology , Hospitalization , Occupational Exposure/adverse effects , Pandemics , Pneumonia, Viral/etiology , Adolescent , Adult , Betacoronavirus , Comorbidity , Continental Population Groups , Coronavirus Infections/epidemiology , Coronavirus Infections/ethnology , Coronavirus Infections/virology , Ethnic Groups , Female , Hispanic Americans , Humans , Male , Middle Aged , Minority Groups , Pneumonia, Viral/epidemiology , Pneumonia, Viral/ethnology , Pneumonia, Viral/virology , Residence Characteristics , Risk Factors , Safety , Texas/epidemiology , Workplace , Young Adult
20.
Trials ; 21(1): 881, 2020 Oct 26.
Article in English | MEDLINE | ID: covidwho-892371

ABSTRACT

OBJECTIVES: The BCG vaccine, widely used in Brazil in new-borns, induces adjuvant protection for several diseases, including childhood virus infections. BCG activates monocytes and innate memory NK cells which are crucial for the antiviral immune response. Therefore, strategies to prevent COVID-19 in health workers (HW) should be carried out to prevent them becoming unwell so that they can continue to work during the pandemic. The hypothesis is that BCG will improve the innate immune response and prevent symptomatic infection or COVID-19 severity. The primary objective is to verify the effectiveness and safety of the BCG vaccine to prevent or reduce incidence of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection in the city of Goiânia (Brazil) among HW previously vaccinated with BCG and also its severity and mortality during the pandemic of the disease. Secondary objectives are to estimate the incidence of COVID-19 among these professionals and the innate immune response elicited to BCG. TRIAL DESIGN: This a phase II trial for repositioning BCG as a preventive strategy against COVID-19. The trial is an open-label, parallel-group randomised clinical trial, comparing HW vaccinated with BCG and HW not vaccinated. PARTICIPANTS: The trial will recruit 800 HW of Goiânia - Goiás, Brazil to reach a total of 400 HW included after comorbidities questioning and laboratorial evaluation. Eligibility criteria: Any HW presenting BCG vaccination scar with direct contact with suspected COVID-19 patients for at least 8 hours per week, whether in hospital beds, ICU, or in transportation or admission (nurses, doctors, physiotherapists, nutritionists, receptionists, etc.) who have negative IgM and IgG COVID-19 test. Participants with any of the following characteristics will be excluded: - Have had in the last fifteen days any signs or symptoms of virus infection, including COVID-19; - Have had fever in the last fifteen days; - Have been vaccinated fifteen days before the inclusion; - Have a history or confirmation of any immunosuppressive disease such as HIV, presented solid tumour in the last two years or autoimmune diseases; - Are under preventive medication with antibiotics, steroid anti-inflammatories, or chemotherapy; - Have less than 500 neutrophils per mL of blood; - Have previously been diagnosed with tuberculosis; - Are breastfeeding or pregnant; - Are younger than 18 years old; - Are participating as an investigator in this clinical trial. INTERVENTION AND COMPARATOR: HW will be randomized into the BCG vaccinated group or the BCG unvaccinated control group. The BCG vaccinated group will receive in the right arm, intradermally, a one off dose of 0.1 mL corresponding to approximately 2 x105 to 8 x105 CFU of live, freeze-dried, attenuated BCG Moscow 361-I, Bacillus Calmette Guerin vaccine (Serum Institute of India PVT. LTD.). The unvaccinated control group will not be vaccinated. The HW allocated in both groups will be followed up at specific times points until 180 days post inclusion. The vaccinated and control groups will be compared according to COVID-19 related outcomes. MAIN OUTCOMES: The primary outcomes are the incidence coefficient of infection by SARS-CoV-2 determined by RT-PCR of naso-oropharyngeal swab specimen or rapid lateral flow IgG and IgM test, and presence of general COVID-19 symptoms, disease severity and admission to hospital during the 180 days of follow up. The secondary outcome is the innate immune response elicited 15-20 days after vaccination. RANDOMISATION: The vaccine vial contains approximately 10 doses. In order to optimize the vaccine use, the randomisation was performed in blocks of 20 participants using the platform randomization.com [ http://www.jerrydallal.com/random/permute.htm ]. The randomization was prepared before any HW inclusion. The results were printed and inserted in sealed envelopes that were numbered with BCG-001 to BCG-400. The printed results as well the envelopes had the same numbers. At the time of the randomisation, each participant that meets the inclusion criteria will receive a consecutive participant number [BCG-001-BCG-400]. The sealed envelope with the assigned number, blinded to the researchers, will be opened in front of the participant and the arm allocation will be known. BLINDING (MASKING): There is no masking for the participants or for the healthcare providers. The study will be blinded to the laboratory researchers and to those who will be evaluating the outcomes and performing the statistical analyses. In this case, only the participant identification number will be available. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): Four hundred heath workers will be randomised in two groups. Two hundred participants will be vaccinated, and 200 participants will not be vaccinated. TRIAL STATUS: The protocol approved by the Brazilian Ethical Committee is the seventh version, number CAAE: 31783720.0.0000.5078. The trial has been recruiting since September 20th, 2020. The clinical trial protocol was registered on August 5th, 2020. It is estimated that recruitment will finish by March 2021. TRIAL REGISTRATION: The protocol number was registered on August 5th, 2020 at REBEC (Registro Brasileiro de Ensaios Clínicos). Register number: RBR-4kjqtg and WHO trial registration number UTN: U1111-1256-3892. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Subject(s)
BCG Vaccine/administration & dosage , Coronavirus Infections/prevention & control , Immunity, Innate/immunology , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Betacoronavirus/immunology , Brazil/epidemiology , Case-Control Studies , Coronavirus Infections/epidemiology , Coronavirus Infections/immunology , Coronavirus Infections/virology , Cross Protection/immunology , Follow-Up Studies , Health Personnel/statistics & numerical data , Hospitalization/statistics & numerical data , Humans , Immunization, Secondary/methods , Immunoglobulin G/blood , Immunoglobulin M/blood , Incidence , Injections, Intradermal , Killer Cells, Natural/immunology , Pneumonia, Viral/epidemiology , Pneumonia, Viral/immunology , Pneumonia, Viral/virology , Reverse Transcriptase Polymerase Chain Reaction/methods , Safety , Treatment Outcome
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