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2.
J Cataract Refract Surg ; 46(9): 1297-1301, 2020 09.
Article in English | MEDLINE | ID: covidwho-780510

ABSTRACT

PURPOSE: To study propensity of aerosol and droplet generation during phacoemulsification using high-speed shadowgraphy and quantify its spread amid COVID-19 pandemic. SETTING: Aerosol and droplet quantification laboratory. DESIGN: Laboratory study. METHODS: In an experimental set-up, phacoemulsification was performed on enucleated goat eyes and cadaveric human corneoscleral rims mounted on an artificial anterior chamber. Standard settings for sculpt and quadrant removal mode were used on Visalis 100 (Carl Zeiss Meditec AG). Microincision and standard phacoemulsification were performed using titanium straight tips (2.2 mm and 2.8 mm in diameter). The main wound incisions were titrated equal to and larger than the sleeve size. High-speed shadowgraphy technique was used to detect the possible generation of any droplets and aerosols. The visualization and quantification of size of the aerosols and droplets along with calculation of their spread were the main outcome measures. RESULTS: In longitudinal phacoemulsification using a peristaltic pump device with a straight tip, no aerosol generation was seen in a closed chamber. In larger wounds, there was a slow leak at the main wound. The atomization of balanced salt solution was observed only when the phacoemulsification tip was completely exposed next to the ocular surface. Under this condition, the nominal size of the droplet was approximately 50 µm, and the maximum calculated spread was 1.3 m. CONCLUSIONS: There was no visible aerosol generation during microincision or standard phacoemulsification. Phacoemulsification is safe to perform in the COVID-19 era by taking adequate precautions against other modes of transmission.


Subject(s)
Aerosols/chemistry , Betacoronavirus , Coronavirus Infections/transmission , Infectious Disease Transmission, Patient-to-Professional/prevention & control , Microbubbles , Phacoemulsification/methods , Pneumonia, Viral/transmission , Animals , Coronavirus Infections/epidemiology , Diagnostic Imaging/methods , Goats , Models, Animal , Ophthalmologists , Pandemics , Pneumonia, Viral/epidemiology
5.
Medicine (Baltimore) ; 99(30): e21396, 2020 Jul 24.
Article in English | MEDLINE | ID: covidwho-684031

ABSTRACT

A large number of healthcare workers have been infected with coronavirus disease-2019 (COVID-19). We aimed to investigate their clinical and chest computed tomography (CT) characteristics.The clinical, laboratory test and CT features of 43 medical and hospital staff with confirmed COVID-19 (MP group, 26-70 years old) were retrospectively analyzed, and compared to 43 non-medical related patients (non-MP group, 26-71 years old). Follow-up CT characteristics were analyzed to assess the disease progression in the period of hospitalization.At admission, the main complaints of the MP group, including fever (81.4%), fatigue (48.8%) and cough (41.9%), were similar to the non-MP group. The C-reactive protein, erythrocyte sedimentation rate, and lactate dehydrogenase levels were higher in the non-MP group than the MP group (17.5 ±â€Š22.4 mg/L, 20.2 ±â€Š23.4 mm/H and 219 ±â€Š66U/L, respectively, P < .05). Ground-grass opacities, consolidation, interstitial thickening were common CT features of both groups. The severity of opacities on initial CT were less in the MP group (5.3 ±â€Š3.9 scores) than in the non-MP group (9.1 ±â€Š4.8 scores, P < .05). Before regular treatments, the sum score of the opacities showed weak to moderate correlations with duration, C-reactive protein, erythrocyte sedimentation rate and lactate dehydrogenase levels (R ranged from 0.341-0.651, P < .05). In the study time window, the duration from illness onset to when the most obvious pulmonary opacities were observed, according to CT findings, were similar in the MP group (13.3 ±â€Š6.6 days) and the non-MP group (13.8 ±â€Š5.1 days, P = .69). Mild to moderate anxiety and depression were observed in both groups.Despite greater knowledge of how to protect themselves than the general population, healthcare workers are also susceptible to COVID-19 infection. Occupational exposure is a very important factor. Healthcare workers have a higher vigilance about the infection in the early stage of the disease.


Subject(s)
Betacoronavirus , Coronavirus Infections/diagnostic imaging , Occupational Diseases/diagnostic imaging , Pneumonia, Viral/diagnostic imaging , Tomography, X-Ray Computed/methods , Adult , Aged , Coronavirus Infections/transmission , Coronavirus Infections/virology , Female , Health Personnel/statistics & numerical data , Humans , Infectious Disease Transmission, Patient-to-Professional , Lung/diagnostic imaging , Lung/pathology , Male , Middle Aged , Occupational Diseases/virology , Occupational Exposure/adverse effects , Pandemics , Pneumonia, Viral/transmission , Pneumonia, Viral/virology , Retrospective Studies
6.
Medwave ; 20(4): e7916, 2020 Jun 01.
Article in Spanish | MEDLINE | ID: covidwho-651724

ABSTRACT

Introduction: COVID-19 is a world public health problem due to its morbidity and mortality, especially in at-risk groups. The dental environment has a high risk of viral transmission; accordingly, this study aimed to identify recommendations based on the best available evidence for dental care during this pandemic. Methods: We performed a search for scientific evidence published since 2002 to March 23th 2020 in electronic databases (MEDLINE/PubMed, EMBASE, Cochrane, and Epistemonikos) and the web pages of the American Dental Association, Centers for Disease Control and Prevention Oral Health, the Ministry of Health in Chile and scientific societies. Results: We included nine published studies. The recommendations were the following: unrestricted use of personal protection elements, use of extraoral radiographic techniques, use of mouth rinses with 1% hydrogen peroxide or 0.2% iodine povidone, a four-hand technique with ongoing aspiration and the use of absorbable sutures. Furthermore, there is a consensus that non-urgent treatments should be postponed during periods of community transmission. Conclusions: Dental practitioners are exposed to a high risk of cross-infection, meaning they must implement recommendations based on the best available evidence to preserve the health of team members and the population they are caring for.


Subject(s)
Coronavirus Infections/prevention & control , Coronavirus Infections/transmission , Dental Care/standards , Infectious Disease Transmission, Patient-to-Professional/prevention & control , Infectious Disease Transmission, Professional-to-Patient/prevention & control , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Pneumonia, Viral/transmission , Humans , Practice Guidelines as Topic
7.
Emerg Med J ; 37(7): 398-399, 2020 Jul.
Article in English | MEDLINE | ID: covidwho-767959

ABSTRACT

Given the high risk of healthcare worker (HCW) infection with COVID-19 during aerosol-generating medical procedures, the use of a box barrier during intubation for protection of HCWs has been examined. Previous simulation work has demonstrated its efficacy in protecting HCWs from cough-expelled droplets. Our objective was to assess its ability to protect HCWs against aerosols generated during aerosol-generating medical procedures. We used a battery-powered vapouriser to assess movement of vapour with: (1) no barrier; (2) a box barrier; and (3) a box barrier and a plastic sheet covering the box and patient's body. We visualised the trajectory of vapour and saw that the vapour remained within the barrier space when the box barrier and plastic sheet were used. This is in contrast to the box barrier alone, where vapour diffused towards the feet of the patient and throughout the room, and to no barrier where the vapour immediately diffused to the laryngoscopist. This demonstrates that the box with the plastic sheet has the potential to limit the spread of aerosols towards the laryngoscopist, and thus may play a role in protecting HCWs during aerosol-generating medical procedures. This is of particular importance in the care of patients with suspected COVID-19.


Subject(s)
Coronavirus Infections/therapy , Infectious Disease Transmission, Patient-to-Professional/prevention & control , Intubation, Intratracheal/methods , Pneumonia, Viral/therapy , Protective Devices , Aerosols , Betacoronavirus , Coronavirus Infections/prevention & control , Humans , Pandemics/prevention & control , Pneumonia, Viral/prevention & control
9.
Rev Alerg Mex ; 67(2): 199-201, 2020.
Article in Spanish | MEDLINE | ID: covidwho-745631
10.
Antimicrob Resist Infect Control ; 9(1): 148, 2020 09 04.
Article in English | MEDLINE | ID: covidwho-745017

ABSTRACT

BACKGROUND: Healthcare workers (HCWs) are on the front line of the COVID-19 outbreak, and their constant exposure to infected patients and contaminated surfaces puts them at risk of acquiring and transmitting the infection. Therefore, they must employ protective measures. In practice, HCWs in Israel were not fully prepared for this sudden COVID-19 outbreak. This research aimed to identify and compare: (1) Israeli HCWs' perceptions regarding the official COVID-19 guidelines' applicability and their protective value, and (2) HCWs executives' response to HWCs' concern regarding personal protective equipment (PPE) shortage. METHODS: A mixed-methods sequential explanatory design consists of: (1) An online survey of 242 HCWs about the application of the guidelines and PPE, and (2) Personal interviews of 15 HCWs executives regarding PPE shortage and the measures they are taking to address it. RESULTS: A significant difference between the perceived applicability and protective value was found for most of the guidelines. Some of the guidelines were perceived as more applicable than protective (hand hygiene, signage at entrance, alcohol rub sanitizers at entrance, and mask for contact with symptomatic patients). Other were perceived as less applicable than protective (prohibited gathering of over 10 people, maintaining a distance of 2 m', and remote services). CONCLUSIONS: HCWs need the support of the healthcare authorities not only to provide missing equipment, but also to communicate the risk to them. Conveying the information with full transparency, while addressing the uncertainty element and engaging the HCWs in evaluating the guidelines, are critical for establishing trust.


Subject(s)
Coronavirus Infections/prevention & control , Health Personnel/psychology , Infection Control/methods , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Adult , Attitude of Health Personnel , Betacoronavirus/isolation & purification , Coronavirus Infections/epidemiology , Coronavirus Infections/transmission , Coronavirus Infections/virology , Cross Infection/epidemiology , Cross Infection/prevention & control , Cross Infection/transmission , Cross Infection/virology , Female , Guideline Adherence/standards , Guideline Adherence/statistics & numerical data , Health Knowledge, Attitudes, Practice , Humans , Infectious Disease Transmission, Patient-to-Professional/prevention & control , Israel/epidemiology , Male , Middle Aged , Personal Protective Equipment , Pneumonia, Viral/epidemiology , Pneumonia, Viral/transmission , Pneumonia, Viral/virology , Surveys and Questionnaires
11.
Cancer Cytopathol ; 128(9): 597-598, 2020 09.
Article in English | MEDLINE | ID: covidwho-743640
13.
J Law Med ; 27(4): 856-864, 2020 Aug.
Article in English | MEDLINE | ID: covidwho-743544

ABSTRACT

Front-line health care personnel, including anaesthetists, otolaryngologists, and other health professionals dealing with acute cases of coronavirus, face a high risk of infection and thus mortality. The scientific evidence establishes that to protect them, hospital protocols should require that wearing of the highest levels of personal protective equipment (PPE) be available for doctors and nurses performing aerosol-generating procedures, such as intubation, sputum induction, open suctioning of airways, bronchoscopy, etc. of COVID-19 patients. Although several international bodies have issued recommendations for a very high-level PPE to be used when these procedures are undertaken, the current PPE guidelines in Australia have tended to be more relaxed, and hospital authorities relying on them might not comply with legal obligations to their employee health care workers. Failure to provide high-level PPE in many hospitals is of concern for a large number of health care workers; this article examines the scientific literature on the topic and provides a legal perspective on hospital authorities' possible liability in negligence.


Subject(s)
Coronavirus Infections , Infectious Disease Transmission, Patient-to-Professional , Pandemics , Personal Protective Equipment , Pneumonia, Viral , Australia , Betacoronavirus , Humans
14.
Trials ; 21(1): 754, 2020 Aug 31.
Article in English | MEDLINE | ID: covidwho-742452

ABSTRACT

OBJECTIVES: To evaluate the effect of the combination of hydroxychloroquine (HCQ) and standard personal protective equipment (PPE) compared to the use of standard personal protective equipment alone on the proportion of laboratory confirmed COVID-19 infections among frontline healthcare workers(HCWs) in India TRIAL DESIGN: HOPE is an investigator initiated multi-centre open-label parallel group randomized controlled trial. PARTICIPANTS: All HCWs currently working in an environment with direct exposure to patients with confirmed COVID-19 infection are eligible to participate in the trial. The trial aims to be conducted across 20-30 centres (public and private hospitals) in India. HCWs who decline consent, who have a confirmed COVID-19 infection, those who are already on chloroquine/HCQ for any indication, or if pregnant or breast-feeding, or have known QT prolongation or are on medications that when taken with HCQ can prolong the QTc will be excluded. INTERVENTION AND COMPARATOR: The interventions to be compared in this trial are standard practice (use of recommended PPE) and HCQ plus standard practice. In the standard practice arm, HCWs will use recommended PPE as per institutional guidelines and based on their roles. They will be discouraged from taking HCQ to prevent contamination and contacted every week for the duration of the study to ascertain if they have taken any HCQ. Any such use will be reported as a protocol violation. In the intervention arm, HCWs will be administered 800mg of HCQ as a loading dose on the day of randomization (as two 400mg doses 12hrs apart) and subsequently continued on 400mg once a week for 12 weeks. This will be in addition to the use of recommended PPE as per institutional guidelines and based on their roles. HCWs will collect the drug once every week from designated research and pharmacy staff at site. A weekly phone reminder will be provided to participants in this arm to ensure compliance. An ECG will be performed between 4-6 weeks in this arm and if the QTc is prolonged (greater than 450milliseconds), the drug will be stopped. Follow-up will however continue. Participants in both arms will receive a weekly phone call for evaluation of the primary outcome, to monitor protocol compliance and development of any adverse events (in the HCQ group). MAIN OUTCOMES: Participants will be followed on a weekly basis. The primary outcome is the proportion of HCWs developing laboratory confirmed COVID-19 infection within 6 months of randomization. We will also evaluate a number of secondary outcomes, including hospitalization related to suspected/confirmed COVID-19 infection, intensive care unit or high-dependency unit admission due to suspected/confirmed COVID-19 infection, all-cause mortality, need for organ support ( non-invasive or invasive ventilation, vasopressors and renal replacement therapy), ICU and hospital length of stay, readmission, days off work and treatment-related adverse events. RANDOMISATION: Randomisation will be conducted through a password-protected, secure website using a central, computer-based randomisation program. Randomisation will be stratified by participating institutions and by the role of HCW - nursing, medical and other. Participants will be randomised 1:1 to either standard practice only or HCQ plus standard practice. Allocation concealment is maintained by central web-based randomisation BLINDING (MASKING): This is an unblinded study: study assigned treatment will be known to the research team and participant. Bias will be mitigated through an objective end point (laboratory confirmed COVID-19 infection). NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of 6,950 HCWs will be enrolled (3475 to the intervention) and (3475 to the standard practice group) to detect a 25% relative reduction, or 2.5% absolute reduction, in the infection rate from an estimated baseline infection rate of 10%, with 80% statistical power using a two-sided test at 5% level of significance. Available data from China and Italy indicate that the rate of infection among frontline healthcare workers varies between 4% to 12%. We therefore assumed a baseline infection rate of 10% among HCWs. This sample size allows for a potential loss to follow-up rate of 10% and a potential non-compliance rate of 10% in both the treatment and control arms. TRIAL STATUS: HOPE protocol version 3.0 dated June 3rd 2020. Recruitment started on 29th June 2020 and currently 56 participants have been enrolled. Planned completion of enrolment is January 31st 2021. TRIAL REGISTRATION: Clinical Trials Registry of India: CTRI/2020/05/025067 (prospectively registered) Date of registration: 6th May 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expedited 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 (Additional file 2).


Subject(s)
Coronavirus Infections/prevention & control , Enzyme Inhibitors/therapeutic use , Health Personnel , Hydroxychloroquine/therapeutic use , Infectious Disease Transmission, Patient-to-Professional/prevention & control , Occupational Diseases/prevention & control , Pandemics/prevention & control , Personal Protective Equipment , Pneumonia, Viral/prevention & control , Betacoronavirus , Chemoprevention , Coronavirus Infections/transmission , Humans , India , Pneumonia, Viral/transmission
15.
J Int Med Res ; 48(8): 300060520949772, 2020 Aug.
Article in English | MEDLINE | ID: covidwho-742337

ABSTRACT

OBJECTIVE: This study was performed to introduce an easy method of surgical smoke evacuation for patients with confirmed or suspected COVID-19 undergoing emergency surgery. METHODS: An easy, inexpensive, protective, and practical surgical smoke evacuation device/system was developed and is herein described. RESULTS: The use of this surgical smoke evacuation device/system in open surgery is convenient and effective. It allows for easy, economic, useful, and protective surgical smoke evacuation. CONCLUSIONS: COVID-19 infection causes direct mortality and morbidity, and its incidence has recently increased. Protection from electrosurgery-related smoke is recommended particularly during the current pandemic. This surgical smoke evacuation device/system is easy to use and provides a convenient and effective method of smoke evacuation during both open surgery and all cauterization interventions.


Subject(s)
Coronavirus Infections/surgery , Electrocoagulation/instrumentation , Electrosurgery/instrumentation , Pneumonia, Viral/surgery , Suction/instrumentation , Betacoronavirus/pathogenicity , Coronavirus Infections/pathology , Coronavirus Infections/transmission , Coronavirus Infections/virology , Electrocoagulation/methods , Electrosurgery/methods , Humans , Infectious Disease Transmission, Patient-to-Professional/prevention & control , Pandemics , Pneumonia, Viral/pathology , Pneumonia, Viral/transmission , Pneumonia, Viral/virology , Smoke/prevention & control
16.
Rev Soc Bras Med Trop ; 53: e20200358, 2020.
Article in English | MEDLINE | ID: covidwho-740414

ABSTRACT

INTRODUCTION: The spread of the 2019 coronavirus disease (COVID-19) has generated the collapse of health care systems and significant impacts on the health of the workers involved in combatting the disease worldwide. METHODS: We conducted an integrative literature review focusing on the alternatives implemented to develop care for frontline health care workers in times of COVID-19. RESULTS: Fifteen articles disclosed the importance of physical and mental care for workers. CONCLUSIONS: A sensitive view of the health care worker's care is urgently needed to maintain the quality of health service offered to the population and preserve the health of frontline workers.


Subject(s)
Coronavirus Infections/epidemiology , Coronavirus Infections/prevention & control , Coronavirus , Health Personnel/psychology , Infectious Disease Transmission, Patient-to-Professional/prevention & control , Personal Protective Equipment , Pneumonia, Viral/prevention & control , Betacoronavirus , Humans , Pandemics , Pneumonia, Viral/epidemiology
17.
Ann Ital Chir ; 91: 273-276, 2020.
Article in English | MEDLINE | ID: covidwho-739593

ABSTRACT

CASE REPORT: A 64-year-old woman presented to our emergency department during the outbreak of the covid-19 emergency in Italy with syncope, anosmia, mild dyspnoea and atypical chest and dorsal pain. A chest CT scan showed an acute type B aortic dissection (ATBAD) and bilateral lung involvement with ground-glass opacity, compatible with interstitial pneumonia. Nasopharyngeal swabs resulted positive for SARS-CoV-2. For the persistence of chest pain, despite the analgesic therapy, we decided to treat her with a TEVAR. Patient's chest and back pain resolved during the first few days after the procedure. No surgical or respiratory complications occurred and the patient was discharged 14 days after surgery. DISCUSSION: By performing the operation under local anesthesia, it was possible to limit both the staff inside the operatory room and droplet/aerosol release. Since we had to perform the operation in a hemodynamics room, thanks to the limited extension of the endoprosthesis and the good caliber of the right vertebral artery we were able to reduce the risk of spinal cord ischemia despite the lack of a revascularization of the left subclavian artery. CONCLUSIONS: A minimally invasive total endovascular approach allows, through local anesthesia and percutaneous access, to avoid surgical cut down and orotracheal intubation. This, combined with a defined management protocol for infected patients, seems to be a reasonable way to perform endovascular aortic procedures in urgent setting, even in a SARSCoV- 2 positive patient. KEY WORDS: COVID-19, Dissection, TEVAR.


Subject(s)
Aneurysm, Dissecting/surgery , Aortic Aneurysm, Thoracic/surgery , Betacoronavirus/isolation & purification , Blood Vessel Prosthesis Implantation/methods , Coronavirus Infections/prevention & control , Endovascular Procedures/methods , Infection Control/methods , Infectious Disease Transmission, Patient-to-Professional/prevention & control , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Anesthesia, Local , Aneurysm, Dissecting/complications , Antibiotic Prophylaxis , Anticoagulants/therapeutic use , Antiviral Agents/therapeutic use , Aortic Aneurysm, Thoracic/complications , Contraindications, Procedure , Coronavirus Infections/complications , Coronavirus Infections/drug therapy , Coronavirus Infections/transmission , Darunavir/therapeutic use , Diabetes Mellitus, Type 2/complications , Drug Therapy, Combination , Enoxaparin/therapeutic use , Female , Humans , Hydroxychloroquine/therapeutic use , Intraoperative Complications/prevention & control , Intubation, Intratracheal/adverse effects , Middle Aged , Nasopharynx/virology , Operating Rooms , Patient Isolation , Pneumonia, Viral/complications , Pneumonia, Viral/drug therapy , Pneumonia, Viral/transmission , Ritonavir/therapeutic use , Spinal Cord Ischemia/prevention & control , Vertebral Artery/surgery
18.
Ann Ital Chir ; 91: 235-238, 2020.
Article in English | MEDLINE | ID: covidwho-739563

ABSTRACT

The present pandemic caused by the SARS COV-2 coronavirus is still ongoing, although it is registered a slowdown in the spread for new cases. The main environmental route of transmission of SARS-CoV-2 is through droplets and fomites or surfaces, but there is a potential risk of virus spread also in smaller aerosols during various medical procedures causing airborne transmission. To date, no information is available on the risk of contagion from the peritoneal fluid with which surgeons can come into contact during the abdominal surgery on COVID-19 patients. We have investigated the presence of SARS-CoV-2 RNA in the peritoneal cavity of patients affected by COVID-19, intraoperatively and postoperatively. KEY WORDS: Covid-19, Laparotomy, Surgery.


Subject(s)
Ascitic Fluid/virology , Betacoronavirus/isolation & purification , Coronavirus Infections/transmission , Infectious Disease Transmission, Patient-to-Professional/prevention & control , Intestinal Perforation/surgery , Laparotomy , Pandemics , Pneumonia, Viral/transmission , Sigmoid Diseases/surgery , Viremia/transmission , Aerosols , Aged, 80 and over , Coronavirus Infections/blood , Coronavirus Infections/complications , Coronavirus Infections/prevention & control , Cross-Sectional Studies , Diverticulum/complications , Fatal Outcome , Female , Humans , Intestinal Perforation/blood , Intestinal Perforation/complications , Intestinal Perforation/virology , Intraoperative Period , Nasopharynx/virology , Pandemics/prevention & control , Pneumonia, Viral/blood , Pneumonia, Viral/complications , Pneumonia, Viral/prevention & control , Postoperative Period , Prospective Studies , RNA, Viral/isolation & purification , Risk , Serum/virology , Sigmoid Diseases/blood , Sigmoid Diseases/complications , Sigmoid Diseases/virology , Viremia/virology
19.
Clin Orthop Surg ; 12(3): 286-290, 2020 Sep.
Article in English | MEDLINE | ID: covidwho-736771

ABSTRACT

The novel coronavirus disease 2019 (COVID-19), which began in Wuhan, China, has rapidly flared up all over the world, evolving into a pandemic. During these critical times, we should give emphasis on infection prevention for the health care staff as well as appropriate patient management in order to maintain the health care system. We report our experience in protecting a surgical team from COVID-19 infection during a bipolar hemiarthroplasty in an infected patient. This case highlights the importance of appropriate protection of the health care staff and education in minimizing the risk of transmission of the infection and maintaining the health care system.


Subject(s)
Betacoronavirus , Coronavirus Infections/prevention & control , Femoral Neck Fractures/surgery , Hemiarthroplasty , Infection Control/organization & administration , Infectious Disease Transmission, Patient-to-Professional/prevention & control , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Aged, 80 and over , Coronavirus Infections/diagnosis , Coronavirus Infections/transmission , Femoral Neck Fractures/microbiology , Humans , Male , Personal Protective Equipment , Pneumonia, Viral/diagnosis , Pneumonia, Viral/transmission , Republic of Korea
20.
Trials ; 21(1): 754, 2020 Aug 31.
Article in English | MEDLINE | ID: covidwho-736432

ABSTRACT

OBJECTIVES: To evaluate the effect of the combination of hydroxychloroquine (HCQ) and standard personal protective equipment (PPE) compared to the use of standard personal protective equipment alone on the proportion of laboratory confirmed COVID-19 infections among frontline healthcare workers(HCWs) in India TRIAL DESIGN: HOPE is an investigator initiated multi-centre open-label parallel group randomized controlled trial. PARTICIPANTS: All HCWs currently working in an environment with direct exposure to patients with confirmed COVID-19 infection are eligible to participate in the trial. The trial aims to be conducted across 20-30 centres (public and private hospitals) in India. HCWs who decline consent, who have a confirmed COVID-19 infection, those who are already on chloroquine/HCQ for any indication, or if pregnant or breast-feeding, or have known QT prolongation or are on medications that when taken with HCQ can prolong the QTc will be excluded. INTERVENTION AND COMPARATOR: The interventions to be compared in this trial are standard practice (use of recommended PPE) and HCQ plus standard practice. In the standard practice arm, HCWs will use recommended PPE as per institutional guidelines and based on their roles. They will be discouraged from taking HCQ to prevent contamination and contacted every week for the duration of the study to ascertain if they have taken any HCQ. Any such use will be reported as a protocol violation. In the intervention arm, HCWs will be administered 800mg of HCQ as a loading dose on the day of randomization (as two 400mg doses 12hrs apart) and subsequently continued on 400mg once a week for 12 weeks. This will be in addition to the use of recommended PPE as per institutional guidelines and based on their roles. HCWs will collect the drug once every week from designated research and pharmacy staff at site. A weekly phone reminder will be provided to participants in this arm to ensure compliance. An ECG will be performed between 4-6 weeks in this arm and if the QTc is prolonged (greater than 450milliseconds), the drug will be stopped. Follow-up will however continue. Participants in both arms will receive a weekly phone call for evaluation of the primary outcome, to monitor protocol compliance and development of any adverse events (in the HCQ group). MAIN OUTCOMES: Participants will be followed on a weekly basis. The primary outcome is the proportion of HCWs developing laboratory confirmed COVID-19 infection within 6 months of randomization. We will also evaluate a number of secondary outcomes, including hospitalization related to suspected/confirmed COVID-19 infection, intensive care unit or high-dependency unit admission due to suspected/confirmed COVID-19 infection, all-cause mortality, need for organ support ( non-invasive or invasive ventilation, vasopressors and renal replacement therapy), ICU and hospital length of stay, readmission, days off work and treatment-related adverse events. RANDOMISATION: Randomisation will be conducted through a password-protected, secure website using a central, computer-based randomisation program. Randomisation will be stratified by participating institutions and by the role of HCW - nursing, medical and other. Participants will be randomised 1:1 to either standard practice only or HCQ plus standard practice. Allocation concealment is maintained by central web-based randomisation BLINDING (MASKING): This is an unblinded study: study assigned treatment will be known to the research team and participant. Bias will be mitigated through an objective end point (laboratory confirmed COVID-19 infection). NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of 6,950 HCWs will be enrolled (3475 to the intervention) and (3475 to the standard practice group) to detect a 25% relative reduction, or 2.5% absolute reduction, in the infection rate from an estimated baseline infection rate of 10%, with 80% statistical power using a two-sided test at 5% level of significance. Available data from China and Italy indicate that the rate of infection among frontline healthcare workers varies between 4% to 12%. We therefore assumed a baseline infection rate of 10% among HCWs. This sample size allows for a potential loss to follow-up rate of 10% and a potential non-compliance rate of 10% in both the treatment and control arms. TRIAL STATUS: HOPE protocol version 3.0 dated June 3rd 2020. Recruitment started on 29th June 2020 and currently 56 participants have been enrolled. Planned completion of enrolment is January 31st 2021. TRIAL REGISTRATION: Clinical Trials Registry of India: CTRI/2020/05/025067 (prospectively registered) Date of registration: 6th May 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expedited 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 (Additional file 2).


Subject(s)
Coronavirus Infections/prevention & control , Enzyme Inhibitors/therapeutic use , Health Personnel , Hydroxychloroquine/therapeutic use , Infectious Disease Transmission, Patient-to-Professional/prevention & control , Occupational Diseases/prevention & control , Pandemics/prevention & control , Personal Protective Equipment , Pneumonia, Viral/prevention & control , Betacoronavirus , Chemoprevention , Coronavirus Infections/transmission , Humans , India , Pneumonia, Viral/transmission
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