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"Pneumonia, Viral - transmission"
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Personal protective effect of wearing surgical face masks in public spaces on self-reported respiratory symptoms in adults: pragmatic randomised superiority trial
by
Elstrøm, Petter
,
Iversen, Bjørn Gunnar
,
Solberg, Runar Barstad
in
Adult
,
Aged
,
Betacoronavirus
2024
AbstractObjectiveTo evaluate the personal protective effects of wearing versus not wearing surgical face masks in public spaces on self-reported respiratory symptoms over a 14 day period.DesignPragmatic randomised superiority trial.SettingNorway.Participants4647 adults aged ≥18 years: 2371 were assigned to the intervention arm and 2276 to the control arm.InterventionsParticipants in the intervention arm were assigned to wear a surgical face mask in public spaces (eg, shopping centres, streets, public transport) over a 14 day period (mask wearing at home or work was not mentioned). Participants in the control arm were assigned to not wear a surgical face mask in public places.Main outcome measuresThe primary outcome was self-reported respiratory symptoms consistent with a respiratory infection. Secondary outcomes included self-reported and registered covid-19 infection and self-reported sick leave.ResultsBetween 10 February 2023 and 27 April 2023, 4647 participants were randomised of whom 4575 (2788 women (60.9%); mean age 51.0 (standard deviation 15.0) years) were included in the intention-to-treat analysis: 2313 (50.6%) in the intervention arm and 2262 (49.4%) in the control arm. 163 events (8.9%) of self-reported symptoms consistent with respiratory infection were reported in the intervention arm and 239 (12.2%) in the control arm. The marginal odds ratio was 0.71 (95% confidence interval (CI) 0.58 to 0.87; P=0.001) favouring the face mask intervention. The absolute risk difference was −3.2% (95% CI −5.2% to −1.3%; P<0.001). No statistically significant effect was found on self- reported (marginal odds ratio 1.07, 95% CI 0.58 to 1.98; P=0.82) or registered covid-19 infection (effect estimate and 95% CI not estimable owing to lack of events in the intervention arm). Self-reported sick leave was equally distributed between the intervention and control groups (marginal odds ratio 1.00, 0.81 to 1.22; P=0.97).ConclusionWearing a surgical face mask in public spaces over 14 days reduces the risk of self-reported symptoms consistent with a respiratory infection, compared with not wearing a surgical face mask.Trial registrationClinicalTrials.gov NCT05690516.
Journal Article
Self-Reported Compliance With Personal Preventive Measures Among Chinese Factory Workers at the Beginning of Work Resumption Following the COVID-19 Outbreak: Cross-Sectional Survey Study
2020
Maintaining compliance with personal preventive measures is important to achieve a balance of COVID-19 pandemic control and work resumption.
The aim of this study was to investigate self-reported compliance with four personal measures to prevent COVID-19 among a sample of factory workers in Shenzhen, China, at the beginning of work resumption in China following the COVID-19 outbreak. These preventive measures included consistent wearing of face masks in public spaces (the workplace and other public settings); sanitizing hands using soap, liquid soap, or alcohol-based hand sanitizer after returning from public spaces or touching public installations and equipment; avoiding social and meal gatherings; and avoiding crowded places.
The participants were adult factory workers who had resumed work in Shenzhen, China. A stratified two-stage cluster sampling design was used. We randomly selected 14 factories that had resumed work. All full-time employees aged ≥18 years who had resumed work in these factories were invited to complete a web-based survey. Out of 4158 workers who had resumed work in these factories, 3035 (73.0%) completed the web-based survey from March 1 to 14, 2020. Multilevel logistic regression models were fitted.
Among the 3035 participants, 2938 (96.8%) and 2996 (98.7%) reported always wearing a face mask in the workplace and in other public settings, respectively, in the past month. However, frequencies of self-reported sanitizing hands (2152/3035, 70.9%), avoiding social and meal gatherings (2225/3035, 73.3%), and avoiding crowded places (1997/3035, 65.8%) were relatively low. At the individual level, knowledge about COVID-19 (adjusted odds ratios [AORs] from 1.16, CI 1.10-1.24, to 1.29, CI 1.21-1.37), perceived risk (AORs from 0.58, CI 0.50-0.68, to 0.85, CI 0.72-0.99) and severity (AOR 1.05, CI 1.01-1.09, and AOR 1.07, CI 1.03-1.11) of COVID-19, perceived effectiveness of preventive measures by the individual (AORs from 1.05, CI 1.00-1.10, to 1.09, CI 1.04-1.13), organization (AOR 1.30, CI 1.20-1.41), and government (AORs from 1.14, CI 1.04-1.25, to 1.21, CI 1.02-1.42), perceived preparedness for a potential outbreak after work resumption (AORs from 1.10, CI 1.00-1.21, to 1.50, CI 1.36-1.64), and depressive symptoms (AORs from 0.93, CI 0.91-0.94, to 0.96, CI 0.92-0.99) were associated with self-reported compliance with at least one personal preventive measure. At the interpersonal level, exposure to COVID-19-specific information through official media channels (AOR 1.08, CI 1.04-1.11) and face-to-face communication (AOR 0.90, CI 0.83-0.98) were associated with self-reported sanitizing of hands. The number of preventive measures implemented in the workplace was positively associated with self-reported compliance with all four preventive measures (AORs from 1.30, CI 1.08-1.57, to 1.63, CI 1.45-1.84).
Measures are needed to strengthen hand hygiene and physical distancing among factory workers to reduce transmission following work resumption. Future programs in workplaces should address these factors at multiple levels.
Journal Article
A randomized multicenter clinical trial to evaluate the efficacy of melatonin in the prophylaxis of SARS-CoV-2 infection in high-risk contacts (MeCOVID Trial): A structured summary of a study protocol for a randomised controlled trial
by
Villatoro, Jaime Monserrat
,
Arribas, José R.
,
García, Irene García
in
Adolescent
,
Adult
,
Aged
2020
Objectives
Primary objective: to evaluate the efficacy of melatonin as a prophylactic treatment on prevention of symptomatic SARS-CoV-2 infection among healthcare workers at high risk of SARS-CoV-2 exposure.
Secondary objectives:
To evaluate the efficacy of melatonin as a prophylactic treatment on prevention of asymptomatic SARS-CoV-2 infection.
To evaluate the efficacy of melatonin to prevent the development of severe COVID-19 in the participants enrolled in this study who develop SARS-CoV-2 infection along the trial.
To evaluate the duration of COVID-19 symptoms in participants receiving melatonin before the infection.
To evaluate seroconversion timing post-symptom onset.
Exploratory objectives
:
To compare severity of COVID-19 between men and women.
To evaluate the influence of sleep and diet on prevention from SARS-CoV-2 infection.
To evaluate the effect of melatonin on the incidence and characteristics of lymphopenia and increase of inflammatory cytokines related to COVID-19.
Trial design
This is a two-arm parallel randomised double-blind controlled trial to evaluate the efficacy of melatonin versus placebo in the prophylaxis of coronavirus disease 2019 among healthcare workers.
Participants
Inclusion Criteria:
Male or female participants ≥ 18 and ≤ 80 years of age.
Healthcare workers from the public and private Spanish hospital network at risk of SARS-CoV 2 infection.
Not having a previous COVID19 diagnosis.
Understanding the purpose of the trial and not having taken any pre-exposure prophylaxis (PrEP) including HIV PrEP from March 1
st
2020 until study enrolment.
Having a negative SARS-CoV 2 reverse-transcription PCR (RT-PCR) result or a negative serologic rapid test (IgM/IgG) result before randomization.
Premenopausal women must have a negative urinary pregnancy test in the 7 days before starting the trial treatment.
Premenopausal women and males with premenopausal couples must commit to using a high efficiency anticonceptive method.
Exclusion Criteria:
HIV infection.
Active hepatitis B infection.
Renal failure (CrCl < 60 mL/min/1.73 m2) or need for hemodialysis.
Osteoporosis.
Myasthenia gravis.
Pre-existent maculopathy.
Retinitis pigmentosa.
Bradycardia (less than 50 bpm).
Weight less than 40 Kg.
Participant with any immunosuppressive condition or hematological disease.
Treatment with drugs that may prolong QT in the last month before randomization for more than 7 days including: azithromycin, chlorpromazine, cisapride, clarithromycin, domperidone, droperidol, erythromycin, halofantrine, haloperidol, lumefantrine, mefloquine, methadone, pentamidine, procainamide, quinidine, quinine, sotalol, sparfloxacin, thioridazine, amiodarone.
Hereditary intolerance to galactose, Lapp lactase deficiency or glucose or galactose malabsorption.
Treatment with fluvoxamine.
Treatment with benzodiazepines or benzodiazepine analogues such as zolpidem, zopiclone or zaleplon.
Pregnancy.
Breastfeeding.
History of potentially immune derived diseases such as: lupus, Crohn's disease, ulcerative colitis, vasculitis or rheumatoid arthritis.
Insulin-dependent diabetes mellitus.
Known history of hypersensitivity to the study drug or any of its components.
Patients that should not be included in the study at the judgment of the research team.
Participants will be recruited from the following eight hospitals in Madrid, Spain: Hospital Universitario La Paz, Hospital Ramón y Cajal, Hospital Infanta Sofía, Hospital 12 de Octubre, Hospital Clínico San Carlos, Hospital Central de la defensa Gómez Ulla,Hospital de La Princesa and Hospital Infanta Leonor.
Intervention and comparator
Experimental: Melatonin (Circadin®, Exeltis Healthcare, Spain): 2 mg of melatonin orally before bedtime for 12 weeks.
Comparator
:
Identical looking placebo (Laboratorios Liconsa, Spain) orally before bedtime for 12 weeks.
Main outcomes
Number of SARS-CoV-2 (COVID-19) symptomatic infections confirmed by polymerase chain reaction (PCR) test or serologic test or according to each centre diagnosis protocol. Primary outcome will be measured until the end of treatment for each participant (until the date of the last dose taken by each patient).
Randomisation
Patients who meet all inclusion and no exclusion criteria will be randomised, stratified by centres, sex and age (<50 and ≥ 50 years old). The randomisation sequence was created using SAS version 9.4 statistical software (procedure ‘PROC PLAN’) with a 1:1 allocation. No randomisation seed was specified. The randomisation seed was generated taking the hour of the computer where the program was executed. Randomization will be done centrally through the electronic system RedCAP® in order to conceal the sequence until interventions are assigned
Blinding (masking)
Participants, caregivers, and those assessing the outcomes are blinded to group assignment.
Numbers to be randomised (sample size)
A total of 450 participants are planned to be enrolled in this clinical trial, 225 in the experimental arm and 225 in the placebo arm.
Trial Status
Protocol version 3.0, 17th of April 2020. Recruitment ongoing.
First participant was recruited on the 21st of April 2020. The final participant is anticipated to be recruited on the 31st of May 2020.
As of May 18th, 2020, a total of 312 participants have been enrolled (154 at Hospital La Paz, 85 at Hospital Infanta Sofía and 73 at Hospital 12 de Octubre).
Trial registration
EU Clinical Trials Register: 2020-001530-35; Date of trial registration: 13th of April 2020;
https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001530-35/ES
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.
Journal Article
Resuscitation of the patient with suspected/confirmed COVID-19 when wearing personal protective equipment: A randomized multicenter crossover simulation trial
2020
The aim of the study was to evaluate various methods of chest compressions in patients with suspected/confirmed SARS-CoV-2 infection conducted by medical students wearing full personal protective equipment (PPE) for aerosol generating procedures (AGP).
This was prospective, randomized, multicenter, single-blinded, crossover simulation trial. Thirty-five medical students after an advanced cardiovascular life support course, which included performing 2-min continuous chest compression scenarios using three methods: (A) manual chest compression (CC), (B) compression with CPRMeter, (C) compression with LifeLine ARM device. During resuscitation they are wearing full personal protective equipment for aerosol generating procedures.
The median chest compression depth using manual CC, CPRMeter and LifeLine ARM varied and amounted to 40 (38-45) vs. 45 (40-50) vs. 51 (50-52) mm, respectively (p = 0.002). The median chest compression rate was 109 (IQR; 102-131) compressions per minute (CPM) for manual CC, 107 (105-127) CPM for CPRMeter, and 102 (101-102) CPM for LifeLine ARM (p = 0.027). The percentage of correct chest recoil was the highest for LifeLine ARM - 100% (95-100), 80% (60-90) in CPRMeter group, and the lowest for manual CC - 29% (26-48).
According to the results of this simulation trial, automated chest compression devices (ACCD) should be used for chest compression of patients with suspected/confirmed COVID-19. In the absence of ACCD, it seems reasonable to change the cardiopulmonary resuscitation algorithm (in the context of patients with suspected/confirmed COVID-19) by reducing the duration of the cardiopulmonary resuscitation cycle from the current 2-min to 1-min cycles due to a statistically significant reduction in the quality of chest compressions among rescuers wearing PPE AGP.
Journal Article
Contamination and washing of cloth masks and risk of infection among hospital health workers in Vietnam: a post hoc analysis of a randomised controlled trial
by
Dung, Tham Chi
,
Seale, Holly
,
Rahman, Bayzidur
in
Adult
,
Betacoronavirus
,
Coronavirus Infections - epidemiology
2020
BackgroundIn a previous randomised controlled trial (RCT) in hospital healthcare workers (HCWs), cloth masks resulted in a higher risk of respiratory infections compared with medical masks. This was the only published RCT of cloth masks at the time of the COVID-19 pandemic.ObjectiveTo do a post hoc analysis of unpublished data on mask washing and mask contamination from the original RCT to further understand poor performance of the two-layered cotton cloth mask used by HCWs in that RCT.Setting14 secondary-level/tertiary-level hospitals in Hanoi, Vietnam.ParticipantsA subgroup of 607 HCWs aged ≥18 years working full time in selected high-risk wards, who used a two-layered cloth mask and were part of a randomised controlled clinical trial comparing medical masks and cloth masks.InterventionWashing method for cloth masks (self-washing or hospital laundry). A substudy of contamination of a sample of 15 cloth and medical masks was also conducted.Outcome measureInfection rate over 4 weeks of follow up and viral contamination of masks tested by multiplex PCR.ResultsViral contamination with rhinovirus was identified on both used medical and cloth masks. Most HCW (77% of daily washing) self-washed their masks by hand. The risk of infection was more than double among HCW self-washing their masks compared with the hospital laundry (HR 2.04 (95% CI 1.03 to 4.00); p=0.04). There was no significant difference in infection between HCW who wore cloth masks washed in the hospital laundry compared with medical masks (p=0.5).ConclusionsUsing self-reported method of washing, we showed double the risk of infection with seasonal respiratory viruses if masks were self-washed by hand by HCWs. The majority of HCWs in the study reported hand-washing their mask themselves. This could explain the poor performance of two layered cloth masks, if the self-washing was inadequate. Cloth masks washed in the hospital laundry were as protective as medical masks. Both cloth and medical masks were contaminated, but only cloth masks were reused in the study, reiterating the importance of daily washing of reusable cloth masks using proper method. A well-washed cloth mask can be as protective as a medical mask.Trial resgistration numberACTRN12610000887077.
Journal Article
Using BCG vaccine to enhance non-specific protection of health care workers during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial in Denmark
by
Bjerregaard-Andersen, Morten
,
Oedegaard, Emilie Sundhaugen
,
Mohamed, Libin
in
Absenteeism
,
Bacterial infections
,
BCG Vaccine - administration & dosage
2020
Objectives:
The Bacille Calmette-Guérin (BCG) vaccine against tuberculosis is associated with non- specific protective effects against other infections, and significant reductions in all-cause morbidity and mortality have been reported. We aim to test whether BCG vaccination may reduce susceptibility to and/or the severity of COVID-19 and other infectious diseases in health care workers (HCW) and thus prevent work absenteeism.
The primary objective is to reduce absenteeism due to illness among HCW during the COVID-19 pandemic. The secondary objectives are to reduce the number of HCW that are infected with SARS-CoV-2, and to reduce the number of hospital admissions among HCW during the COVID-19 pandemic.
Hypothesis: BCG vaccination of HCW will reduce absenteeism by 20% over a period of 6 months.
Trial design:
Placebo-controlled, single-blinded, randomised controlled trial, recruiting study participants at several geographic locations. The BCG vaccine is used in this study on a different indication than the one it has been approved for by the Danish Medicines Agency, therefore this is classified as a phase III study.
Participants:
The trial will recruit 1,500 HCW at Danish hospitals.
To be eligible for participation, a subject must meet the following criteria: Adult (≥18 years); Hospital personnel working at a participating hospital for more than 22 hours per week.
A potential subject who meets any of the following criteria will be excluded from participation in this study:
Known allergy to components of the BCG vaccine or serious adverse events to prior BCG administration
Known prior active or latent infection with
Mycobacterium tuberculosis (M. tuberculosis)
or other mycobacterial species
Previous confirmed COVID-19
Fever (>38 C) within the past 24 hours
Suspicion of active viral or bacterial infection
Pregnancy
Breastfeeding
Vaccination with other live attenuated vaccine within the last 4 weeks
Severely immunocompromised subjects. This exclusion category comprises:
a) subjects with known infection by the human immunodeficiency virus (HIV-1)
b) subjects with solid organ transplantation
c) subjects with bone marrow transplantation
d) subjects under chemotherapy
e) subjects with primary immunodeficiency
f) subjects under treatment with any anti-cytokine therapy within the last year
g) subjects under treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months
h) Active solid or non-solid malignancy or lymphoma within the prior two years
Direct involvement in the design or the execution of the BCG-DENMARK-COVID trial
Intervention and comparator:
Participants will be randomised to BCG vaccine (BCG-Denmark, AJ Vaccines, Copenhagen, Denmark) or placebo (saline). An adult dose of 0.1 ml of resuspended BCG vaccine (intervention) or 0.1 ml of sterile 0.9% NaCl solution (control) is administered intradermally in the upper deltoid area of the right arm. All participants will receive one injection at inclusion, and no further treatment of study participants will take place.
Main outcomes:
Main study endpoint: Days of unplanned absenteeism due to illness within 180 days of randomisation.
Secondary study endpoints: The cumulative incidence of documented COVID-19 and the cumulative incidence of hospital admission for any reason within 180 days of randomisation.
Randomisation:
Randomisation will be done centrally using the REDCap tool with stratification by hospital, sex and age groups (+/- 45 years of age) in random blocks of 4 and 6. The allocation ratio is 1:1.
Blinding (masking):
Participants will be blinded to treatment. The participant will be asked to leave the room while the allocated treatment is prepared. Once ready for injection, vaccine and placebo will look similar, and the participant will not be able to tell the difference.
The physicians administering the treatment are not blinded.
Numbers to be randomised (sample size):
Sample size: N=1,500. The 1,500 participants will be randomised 1:1 to BCG or placebo with 750 participants in each group.
Trial Status:
Current protocol version 5.1, from July 6, 2020.
Recruitment of study participants started on May 18, 2020 and we anticipate having finished recruiting by the end of December 2020.
Trial registration:
The trial was registered with EudraCT on April 16, 2020, EudraCT number: 2020-001888-90, and with ClinicalTrials.gov on May 1, 2020, registration number NCT04373291.
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.
Keywords:
COVID-19, Randomised controlled trial, Protocol, BCG vaccine, NSEs/Non-specific effects of vaccines, Heterologous effects of vaccines, Health care workers, Pandemic, Immune training.
Journal Article
How to deal with a temporary suspension and restarting your trial: our experiences and lessons learnt
by
Wileman, Samantha
,
McDonald, Alison
,
Davidson, Tracey
in
Abdomen
,
Betacoronavirus - pathogenicity
,
Biomedicine
2020
Whilst the issues around early termination of randomised controlled trials (RCTs) are well documented in the literature, trials can also be temporarily suspended with the real prospect that they may subsequently restart. There is little guidance in the literature as to how to manage such a temporary suspension. In this paper, we describe the temporary suspension of a trial within our clinical trials unit because of concerns over the safety of transvaginal synthetic mesh implants. We also describe the challenges, considerations, and lessons learnt during the suspension that we are now applying in the current COVID-19 pandemic which has led to activities in many RCTs across the world undergoing a temporary suspension.
There were three key phases within the temporary suspension: the decision to suspend, implementation of the suspension, and restarting. Each of these phases presented individual challenges which are discussed within this paper, along with the lessons learnt. There were obvious challenges around recruitment, delivery of the intervention, and follow-up. Additional challenges included communication between stakeholders, evolving risk assessment, updates to trial protocol and associated paperwork, maintaining site engagement, data-analysis, and workload within the trial team and Sponsor organisation.
Based on our experience of managing a temporary suspension, we developed an action plan and guidance (see Additional File 1) for managing a significant trial event, such as a temporary suspension. We have used this document to help us manage the suspension of activities within our portfolio of trials during the current COVID-19 pandemic.
Journal Article
Efficacy of hydroxychloroquine for post-exposure prophylaxis to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among adults exposed to coronavirus disease (COVID-19): a structured summary of a study protocol for a randomised controlled trial
2020
Objectives
Primary Objective
• To test the efficacy of Hydroxychloroquine (HCQ) (400 mg orally daily for 3 days then 200 mg orally daily for an additional 11 days, to complete 14 days) to prevent incident SARS-CoV-2 infection, compared to ascorbic acid among contacts of persons with SARS-CoV-2 infection
Secondary objectives
• To determine the safety and tolerability of HCQ as SARS-CoV-2 Post-exposure Prophylaxis (PEP) in adults
• To test the efficacy of HCQ (400 mg orally daily for 3 days then 200 mg orally daily for an additional 11 days, to complete 14 days) to prevent incident SARS-CoV-2 infection 2 weeks after completing therapy, compared to ascorbic acid among contacts of persons with SARS-CoV-2 infection
• To test the efficacy of HCQ to shorten the duration of SARS-CoV-2 shedding among those with SARS-CoV-2 infection in the HCQ PEP group
• To test the efficacy of HCQ to prevent incident COVID-19
Trial design
This is a randomized, multi-center, placebo-equivalent (ascorbic acid) controlled, blinded study of HCQ PEP for the prevention of SARS-CoV-2 infection in adults exposed to the virus.
Participants
This study will enroll up to 2000 asymptomatic adults 18 to 80 years of age (inclusive) at baseline who are close contacts of persons with polymerase chain reaction (PCR)-confirmed SARS-CoV-2 or clinically suspected COVID-19 and a pending SARS-CoV-2 PCR test. This multisite trial will be conducted at seven sites in Seattle (UW), Los Angeles (UCLA), New Orleans (Tulane), Baltimore (UMB), New York City (NYU), Syracuse (SUNY-Upstate), and Boston (BMC).
Inclusion criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Men or women 18 to 80 years of age inclusive, at the time of signing the informed consent
Willing and able to provide informed consent
Had a close contact of a person (index) with known PCR-confirmed SARS-CoV-2 infection or index who is currently being assessed for COVID-19
Close contact is defined as:
Household contact (i.e., residing with the index case in the 14 days prior to index diagnosis or prolonged exposure within a residence/vehicle/enclosed space without maintaining social distance)
Medical staff, first responders, or other care persons who cared for the index case without personal protection (mask and gloves)
Less than 4 days since last exposure (close contact with a person with SARS-CoV-2 infection) to the index case
Access to device and internet for Telehealth visits
Not planning to take HCQ in addition to the study medication
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply:
Known hypersensitivity to HCQ or other 4-aminoquinoline compounds
Currently hospitalized
Symptomatic with subjective fever, cough, or shortness of breath
Current medications exclude concomitant use of HCQ
Concomitant use of other anti-malarial treatment or chemoprophylaxis, including chloroquine, mefloquine, artemether, or lumefantrine.
History of retinopathy of any etiology
Psoriasis
Porphyria
Known bone marrow disorders with significant neutropenia (polymorphonuclear leukocytes <1500) or thrombocytopenia (<100 K)
Concomitant use of digoxin, cyclosporin, cimetidine, amiodarone, or tamoxifen
Known moderate or severe liver disease
Known long QT syndrome
Severe renal impairment
Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of the study drugs or planned use during the study period
Intervention and comparator
Households will be randomized 1:1 (at the level of household), with close contact participants receiving one of the following therapies:
•HCQ 400 mg orally daily for 3 days then 200 mg orally daily for an additional 11 days
•Placebo-like control (ascorbic acid) 500 mg orally daily for 3 days then 250 mg orally daily for 11 days
Main outcomes
The primary outcome of the study is the incidence of SARS-CoV-2 infection through day 14 among participants who are SARS-CoV-2 negative at baseline by randomization group.
Randomisation
Participants will be randomized in a 1:1 ratio to HCQ or ascorbic acid at the level of the household (all eligible participants in 1 household will receive the same intervention). The randomization code and resulting allocation list will be generated and maintained by the Study Statistician. The list will be blocked and stratified by site and contact type (household versus healthcare worker).
Blinding (masking)
This is a blinded study.
HCQ and ascorbic acid will appear similar, and taste will be partially masked as HCQ can be bitter and ascorbic acid will be sour.
The participants will be blinded to their randomization group once assigned. Study team members, apart from the Study Pharmacist and the unblinded statistical staff, will be blinded. Laboratory staff are blinded to the group allocation.
Numbers to be randomised (sample size)
The sample size for the study is
N
=2 000 participants randomized 1:1 to either HCZ (
n
=1 000) and ascorbic acid (
n
=1 000).
Trial status
Protocol version: 1.2
05 April 2020
Recruitment is ongoing, started March 31 and anticipated end date is September 30, 2020.
Trial registration
ClinicalTrials.gov, Protocol Registry Number:
NCT04328961
Date of registration: April 1, 2020, retrospectively registered
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.
Journal Article
Impact of an e-learning module on personal protective equipment knowledge in student paramedics: a randomized controlled trial
by
Stuby, Loric
,
Gartner, Birgit
,
Iten, Anne
in
Adult
,
Allied Health Personnel - education
,
Allied Health Personnel - standards
2020
Background
Prehospital professionals such as emergency physicians or paramedics must be able to choose and adequately don and doff personal protective equipment (PPE) in order to avoid COVID-19 infection. Our aim was to evaluate the impact of a gamified e-learning module on adequacy of PPE in student paramedics.
Methods
This was a web-based, randomized 1:1, parallel-group, triple-blind controlled trial. Student paramedics from three Swiss schools were invited to participate. They were informed they would be presented with both an e-learning module and an abridged version of the current regional prehospital COVID-19 guidelines, albeit not in which order. After a set of 22 questions designed to assess baseline knowledge, the control group was shown the guidelines before answering a set of 14 post-intervention questions. The e-learning group was shown the gamified e-learning module right after the guidelines, and before answering post-intervention questions. The primary outcome was the difference in the percentage of adequate choices of PPE before and after the intervention.
Results
The participation rate was of 71% (98/138). A total of 90 answer sets was analyzed. Adequate choice of PPE increased significantly both in the control (50% [33;83] vs 25% [25;50],
P
= .013) and in the e-learning group (67% [50;83] vs 25% [25;50],
P
= .001) following the intervention. Though the median of the difference was higher in the e-learning group, there was no statistically significant superiority over the control (33% [0;58] vs 17% [− 17;42],
P
= .087). The e-learning module was of greatest benefit in the subgroup of student paramedics who were actively working in an ambulance company (42% [8;58] vs 25% [− 17;42],
P
= 0.021). There was no significant effect in student paramedics who were not actively working in an ambulance service (0% [− 25;33] vs 17% [− 8;50],
P
= .584).
Conclusions
The use of a gamified e-learning module increases the rate of adequate choice of PPE only among student paramedics actively working in an ambulance service. In this subgroup, combining this teaching modality with other interventions might help spare PPE and efficiently protect against COVID-19 infection.
Journal Article