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3.
BMJ Open ; 10(10): e044566, 2020 10 05.
Article in English | MEDLINE | ID: covidwho-835491

ABSTRACT

OBJECTIVES: To analyse enrolment to interventional trials during the first wave of the COVID-19 pandemic in England and describe the barriers to successful recruitment in the circumstance of a further wave or future pandemics. DESIGN: We analysed registered interventional COVID-19 trial data and concurrently did a prospective observational study of hospitalised patients with COVID-19 who were being assessed for eligibility to one of the RECOVERY, C19-ACS or SIMPLE trials. SETTING: Interventional COVID-19 trial data were analysed from the clinicaltrials.gov and International Standard Randomized Controlled Trial Number databases on 12 July 2020. The patient cohort was taken from five centres in a respiratory National Institute for Health Research network. Population and modelling data were taken from published reports from the UK government and Medical Research Council Biostatistics Unit. PARTICIPANTS: 2082 consecutive admitted patients with laboratory-confirmed SARS-CoV-2 infection from 27 March 2020 were included. MAIN OUTCOME MEASURES: Proportions enrolled, and reasons for exclusion from the aforementioned trials. Comparisons of trial recruitment targets with estimated feasible recruitment numbers. RESULTS: Analysis of trial registration data for COVID-19 treatment studies enrolling in England showed that by 12 July 2020, 29 142 participants were needed. In the observational study, 430 (20.7%) proceeded to randomisation. 82 (3.9%) declined participation, 699 (33.6%) were excluded on clinical grounds, 363 (17.4%) were medically fit for discharge and 153 (7.3%) were receiving palliative care. With 111 037 people hospitalised with COVID-19 in England by 12 July 2020, we determine that 22 985 people were potentially suitable for trial enrolment. We estimate a UK hospitalisation rate of 2.38%, and that another 1.25 million infections would be required to meet recruitment targets of ongoing trials. CONCLUSIONS: Feasible recruitment rates, study design and proliferation of trials can limit the number, and size, that will successfully complete recruitment. We consider that fewer, more appropriately designed trials, prioritising cooperation between centres would maximise productivity in a further wave.


Subject(s)
Biomedical Research , Coronavirus Infections , Pandemics , Patient Selection , Pneumonia, Viral , Randomized Controlled Trials as Topic , Betacoronavirus/isolation & purification , Biomedical Research/organization & administration , Biomedical Research/statistics & numerical data , Coronavirus Infections/epidemiology , Coronavirus Infections/therapy , Eligibility Determination , Female , Health Services Accessibility/statistics & numerical data , Hospitalization/statistics & numerical data , Humans , Male , Middle Aged , Pneumonia, Viral/epidemiology , Pneumonia, Viral/therapy , Prospective Studies , Randomized Controlled Trials as Topic/methods , Randomized Controlled Trials as Topic/statistics & numerical data , Registries/statistics & numerical data , United Kingdom
4.
Medicine (Baltimore) ; 99(40): e22231, 2020 Oct 02.
Article in English | MEDLINE | ID: covidwho-835215

ABSTRACT

BACKGROUND: There is a worldwide outbreak of coronavirus disease 2019 (COVID-19), at present, accumulative attention has been paid to COVID-19 due to its global prevalence. Acupuncture may play a beneficial role in patients who suffer from COVID-19. In China and East Asia, acupuncture has been widely used to treat diverse diseases for thousands of years, as an important method of treatment now, it plays an indispensable role in the treatment of respiratory diseases in China. This study is designed to determine the efficacy and safety of acupuncture in COVID-19. METHODS: We will search the following sources for the Randomized controlled trials (RCT): The Cochrane Library, PubMed, EMBASE, Web of Science, Chinese Biomedical Literature Database (CBM), Chinese National Knowledge Infrastructure Database (CNKI), Chinese Science, and the Wanfang Database. All the above databases will be searched from the available date of inception until the latest issue. No language or publication restriction will be used. Primary outcomes will include chest CT and nucleic acid detection of respiratory samples. RESULTS: The results will provide a high-quality synthesis of current evidence for researchers in this subject area. CONCLUSION: The conclusion of our study will provide evidence to evaluate whether acupuncture is an effective treatments for patients suffering from COVID-19. PROSPERO REGISTRATION NUMBER: CRD42020180875.


Subject(s)
Acupuncture Therapy/methods , Betacoronavirus , Coronavirus Infections/therapy , Pneumonia, Viral/therapy , Female , Humans , Male , Meta-Analysis as Topic , Pandemics , Randomized Controlled Trials as Topic , Research Design , Systematic Reviews as Topic , Treatment Outcome
5.
Mymensingh Med J ; 29(2): 481-487, 2020 Apr.
Article in English | MEDLINE | ID: covidwho-829145

ABSTRACT

The rapid progression of corona virus disease in 2019 (COVID-19) pandemic has become an unprecedented global concern. This systemic review aimed at evaluating the available evidence on efficacy, safety to identify any promising role for compassionate use of remdesivir in patient suffered for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) as re-purposeful use. We searched PubMed, EMBASE, Cochrane Library for randomized controlled trials (RCTs), prospective case series studies and case reports that evaluated use of remdesivir in COVID-19. The outcomes were mortality, recovery rate, length of hospital stay and clinical outcome. Though the drug remdesivir (RDV) is not approved by the FDA, still the "Emergency Use Authorization" (EUA) for compassionate use in severe cases is endorsed. After vigorous searching, screening and sorting of completed and published scientific evidences in electronic database, there were only 2 randomized control trial (RCT), 2 uncontrolled trials found until April 2020. We also included 3 published case reports to analyze the validity use of RDV because of the scarcity of evidence based reports. Remdesivir was thought to be one of the promising options for treating the patients of COVID-19 based on few laboratory experiments and reports from some compassionate use and case reports. The safety and efficacy of this drug in COVID-19 cases require high-quality evidence from well-designed and adequately-powered clinical trials with proper sample size for precise decision.


Subject(s)
Adenosine Monophosphate/analogs & derivatives , Alanine/analogs & derivatives , Antiviral Agents , Betacoronavirus , Coronavirus Infections , Pandemics , Pneumonia, Viral , Adenosine Monophosphate/therapeutic use , Alanine/therapeutic use , Antiviral Agents/therapeutic use , Coronavirus Infections/drug therapy , Humans , Pneumonia, Viral/drug therapy , Prospective Studies , Randomized Controlled Trials as Topic
6.
Trials ; 21(1): 828, 2020 Oct 06.
Article in English | MEDLINE | ID: covidwho-818132

ABSTRACT

OBJECTIVES: Primary objectives • To assess the time from randomisation until an improvement within 84 days defined as two points on a seven point ordinal scale or live discharge from the hospital in high-risk patients (group 1 to group 4) with SARS-CoV-2 infection requiring hospital admission by infusion of plasma from subjects after convalescence of SARS-CoV-2 infection or standard of care. Secondary objectives • To assess overall survival, and the overall survival rate at 28 56 and 84 days. • To assess SARS-CoV-2 viral clearance and load as well as antibody titres. • To assess the percentage of patients that required mechanical ventilation. • To assess time from randomisation until discharge. TRIAL DESIGN: Randomised, open-label, multicenter phase II trial, designed to assess the clinical outcome of SARS-CoV-2 disease in high-risk patients (group 1 to group 4) following treatment with anti-SARS-CoV-2 convalescent plasma or standard of care. PARTICIPANTS: High-risk patients >18 years of age hospitalized with SARS-CoV-2 infection in 10-15 university medical centres will be included. High-risk is defined as SARS-CoV-2 positive infection with Oxygen saturation at ≤ 94% at ambient air with additional risk features as categorised in 4 groups: • Group 1, pre-existing or concurrent hematological malignancy and/or active cancer therapy (incl. chemotherapy, radiotherapy, surgery) within the last 24 months or less. • Group 2, chronic immunosuppression not meeting the criteria of group 1. • Group 3, age ≥ 50 - 75 years meeting neither the criteria of group 1 nor group 2 and at least one of these criteria: Lymphopenia < 0.8 x G/l and/or D-dimer > 1µg/mL. • Group 4, age ≥ 75 years meeting neither the criteria of group 1 nor group 2. Observation time for all patients is expected to be at least 3 months after entry into the study. Patients receive convalescent plasma for two days (day 1 and day 2) or standard of care. For patients in the standard arm, cross over is allowed from day 10 in case of not improving or worsening clinical condition. Nose/throat swabs for determination of viral load are collected at day 0 and day 1 (before first CP administration) and subsequently at day 2, 3, 5, 7, 10, 14, 28 or until discharge. Serum for SARS-Cov-2 diagnostic is collected at baseline and subsequently at day 3, 7, 14 and once during the follow-up period (between day 35 and day 84). There is a regular follow-up of 3 months. All discharged patients are followed by regular phone calls. All visits, time points and study assessments are summarized in the Trial Schedule (see full protocol Table 1). All participating trial sites will be supplied with study specific visit worksheets that list all assessments and procedures to be completed at each visit. All findings including clinical and laboratory data are documented by the investigator or an authorized member of the study team in the patient's medical record and in the electronic case report forms (eCRFs). INTERVENTION AND COMPARATOR: This trial will analyze the effects of convalescent plasma from recovered subjects with SARS-CoV-2 antibodies in high-risk patients with SARS-CoV-2 infection. Patients at high risk for a poor outcome due to underlying disease, age or condition as listed above are eligible for enrollment. In addition, eligible patients have a confirmed SARS-CoV-2 infection and O2 saturation ≤ 94% while breathing ambient air. Patients are randomised to receive (experimental arm) or not receive (standard arm) convalescent plasma in two bags (238 - 337 ml plasma each) from different donors (day 1, day 2). A cross over from the standard arm into the experimental arm is possible after day 10 in case of not improving or worsening clinical condition. MAIN OUTCOMES: Primary endpoints: The main purpose of the study is to assess the time from randomisation until an improvement within 84 days defined as two points on a seven-point ordinal scale or live discharge from the hospital in high-risk patients (group 1 to group 4) with SARS-CoV-2 infection requiring hospital admission by infusion of plasma from subjects after convalescence of a SARS-CoV-2 infection or standard of care. Secondary endpoints: • Overall survival, defined as the time from randomisation until death from any cause 28-day, 56-day and 84-day overall survival rates. • SARS-CoV-2 viral clearance and load as well as antibody titres. • Requirement mechanical ventilation at any time during hospital stay (yes/no). • Time until discharge from randomisation. • Viral load, changes in antibody titers and cytokine profiles are analysed in an exploratory manner using paired non-parametric tests (before - after treatment). RANDOMISATION: Upon confirmation of eligibility (patients must meet all inclusion criteria and must not meet exclusion criteria described in section 5.3 and 5.4 of the full protocol), the clinical site must contact a centralized internet randomization system ( https://randomizer.at/ ). Patients are randomized using block randomisation to one of the two arms, experimental arm or standard arm, in a 1:1 ratio considering a stratification according to the 4 risk groups (see Participants). BLINDING (MASKING): The study is open-label, no blinding will be performed. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total number of 174 patients is required for the entire trial, n=87 per group. TRIAL STATUS: Protocol version 1.2 dated 09/07/2020. A recruitment period of approximately 9 months and an overall study duration of approximately 12 months is anticipated. Recruitment of patients starts in the third quarter of 2020. The study duration of an individual patient is planned to be 3 months. After finishing all study-relevant procedures, therapy, and follow-up period, the patient is followed in terms of routine care and treated if necessary. Total trial duration: 18 months Duration of the clinical phase: 12 months First patient first visit (FPFV): 3rd Quarter 2020 Last patient first visit (LPFV): 2nd Quarter 2021 Last patient last visit (LPLV): 3rd Quarter 2021 Trial Report completed: 4th Quarter 2021 TRIAL REGISTRATION: EudraCT Number: 2020-001632-10, https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001632-10/DE , registered on 04/04/2020. 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. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2). The eCRF is attached (Additional file 3).


Subject(s)
Antibodies, Viral/blood , Betacoronavirus , Coronavirus Infections , Pandemics , Plasma/immunology , Pneumonia, Viral , Aged , Betacoronavirus/immunology , Betacoronavirus/isolation & purification , Clinical Trials, Phase II as Topic , Convalescence , Coronavirus Infections/diagnosis , Coronavirus Infections/immunology , Coronavirus Infections/therapy , Female , Humans , Immunization, Passive/methods , Male , Middle Aged , Monitoring, Physiologic/methods , Multicenter Studies as Topic , Pneumonia, Viral/diagnosis , Pneumonia, Viral/immunology , Pneumonia, Viral/therapy , Randomized Controlled Trials as Topic , Risk Adjustment , Severity of Illness Index
7.
Medicine (Baltimore) ; 99(39): e22316, 2020 Sep 25.
Article in English | MEDLINE | ID: covidwho-811172

ABSTRACT

BACKGROUND: There is a worldwide outbreak of COVID-19, as the number of patients increases. External treatment of traditional Chinese medicine includes acupuncture, massage, fire needle, cupping, and other alternative therapies. Currently, there are no relevant articles for systematic review. METHODS: We will search the randomized controlled trials related to the external treatment of traditional Chinese medicine (such as, acupuncture, massage, etc) and COVID-19 from inception to June 2020. The following database is our focus area: the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, Web of Science, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, and Wan-Fang Database. All published randomized controlled trials in English or Chinese related to massage for COVID-19 will be included. Primary outcomes include the influence of external treatment of traditional Chinese medicine on the patients with COVID-19. Secondary outcomes include accompanying symptoms (such as myalgia, expectoration, stuffiness, runny nose, pharyngalgia, anhelation, chest distress, dyspnea, crackles, headache, nausea, vomiting, anorexia, diarrhea) disappear rate, negative COVID-19 results rate on 2 consecutive occasions (not on the same day), average hospitalization time, Clinical curative effect, and improved quality of life. RESULTS: The results will provide a high-quality synthesis of current evidence for researchers in this subject area. CONCLUSION: The conclusion of our study will provide evidence to judge whether external treatment of traditional Chinese medicine is an effective intervention on the patients with COVID-19. PROSPERO REGISTRATION NUMBER: CRD42020181336.


Subject(s)
Coronavirus Infections/therapy , Medicine, Chinese Traditional/methods , Pneumonia, Viral/therapy , Age Factors , Betacoronavirus , Body Weights and Measures , Humans , Pandemics , Quality of Life , Randomized Controlled Trials as Topic , Research Design , Sex Factors
9.
Trials ; 21(1): 827, 2020 Oct 02.
Article in English | MEDLINE | ID: covidwho-810387

ABSTRACT

OBJECTIVES: We aimed to test our hypothesis that additional administration of traditional Japanese (Kampo) medicine, kakkonto (kakkon-to: KT) and shosaikotokakikyosekko (sho-saiko-to-ka-kikyo-sekko: SSKKS), is more effective in relieving symptoms and preventing the onset of severe infection in mild-to-moderate COVID-19 patients compared to those treated only with conventional treatment. TRIAL DESIGN: The study is designed as a multi-center, interventional, parallel-group, randomized (1:1 ratio), investigator-sponsored, two-arm study. PARTICIPANTS: Patients and inpatients will be recruited from 8 Japanese academic and non-academic hospitals. The inclusion and exclusion criteria are as follows: Inclusion criteria: 1. Diagnosed as positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 2. Clinical stages of mild-to-moderate COVID-19 3. Symptomatic 4. ≥ 20 years of age 5. Male or female 6. Ability to communicate in Japanese 7. Outpatients and inpatients 8. Provided informed consent Exclusion criteria: 1. Difficulty in providing informed consent due to dementia, psychosis, or psychiatric symptoms 2. Allergic to Kampo or Western medicines used in this study 3. Pregnant and lactating 4. Unable to follow up 5. Participating in another clinical trial or interventional study 6. Hypokalemic or taking oral furosemide or steroids 7. Determined unsuitable for this study by the physician INTERVENTION AND COMPARATOR: Patients in the control group will receive conventional treatment with antipyretics, painkillers, or antitussives for symptoms that occurred after they contracted the SARS-CoV-2 infection. Patients in the Kampo group will receive 2.5 g of KT (TJ-1@TSUMURA and Co.) and 2.5 g of SSKKS (TJ-109@TSUMURA and Co.) 3 times a day, orally, for 14 days in addition to the conventional treatment as mentioned above. MAIN OUTCOMES: The number of days till at least one of the symptoms (fever, cough, sputum, malaise, shortness of breath) improves in the first 14 days of treatment. To assess the cough, sputum, malaise, and shortness of breath, a numeric rating scale will be used to define improvement in terms of a 2-point decrease in the number of days from the start of treatment for at least 2 days. Fever will be defined as an improvement when the temperature is less than 37 °C. RANDOMIZATION: Patients are randomized (1:1 ratio) to each group using the minimization method, with balancing of the arms with severity of disease stage and patient age (< 65, 65 to < 75, or ≥ 75 years). Computer-generated random numbers will be used for the minimization method. BLINDING (MASKING): Open-label with no blinding NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): The main research hypothesis of this study is that the combination of Kampo medicine and conventional treatment will significantly improve the patients' symptoms (fever, fatigue, cough, sputum, and shortness of breath) during the first 14 days of treatment as compared with conventional treatment alone. Concerning the analysis of the primary endpoint, the duration of time before improvement of at least one of the common cold-like symptoms (fever, malaise, cough, sputum, and shortness of breath) will be estimated using the Kaplan-Meier method, and the survival curves will be compared between groups using the log-rank test. Assuming this method of analysis and based on previous studies reporting the efficacy of Kampo medicine for COVID-19 and H1N1 influenza patients, the median survival time in the Kampo medicine group is estimated as 3 days; this time will be 1.5 times longer in the control group. Assuming a one-sided significance level of 5%, a power of 70%, and an allocation ratio of 1:1, the required sample size is calculated as 126 cases. To compensate for a loss in follow-up, we plan to include 150 cases in both groups (Kampo group = 75, control group = 75). TRIAL STATUS: Protocol version 1.2 as of August 20, 2020 Recruitment start (expected): October 1, 2020 Recruitment finish (expected): October 31, 2023 TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCT) jRCTs021200020 . Registered on August 25, 2020 FULL PROTOCOL: The full protocol is attached as an additional file and is accessible from the Trials website (Additional file 1). In the interest of expediting the 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)
Antiviral Agents/therapeutic use , Betacoronavirus/drug effects , Coronavirus Infections/drug therapy , Drugs, Chinese Herbal/therapeutic use , Medicine, Kampo , Pneumonia, Viral/drug therapy , Antiviral Agents/adverse effects , Betacoronavirus/pathogenicity , Coronavirus Infections/diagnosis , Coronavirus Infections/virology , Drug Therapy, Combination , Drugs, Chinese Herbal/adverse effects , Female , Host-Pathogen Interactions , Humans , Japan , Male , Multicenter Studies as Topic , Pandemics , Pneumonia, Viral/diagnosis , Pneumonia, Viral/virology , Randomized Controlled Trials as Topic , Severity of Illness Index , Time Factors , Treatment Outcome
11.
N Z Med J ; 133(1522): 138-143, 2020 09 25.
Article in English | MEDLINE | ID: covidwho-807307

ABSTRACT

The Health and Disability Code precludes any research involving a competent patient without the informed consent of the participant. A learning health system requires rigorous evaluation of both new and established clinical practice, including low-risk components of usual care pathways. When comparing two accepted practices, the only way to control for unknown confounders is by randomisation. In some limited circumstances, particularly when comparing groups or clusters of patients, this comparison can only practicably be undertaken without consent. The current Code impedes a learning health system and is detrimental to the health of New Zealanders. It urgently needs updating.


Subject(s)
Informed Consent , Learning Health System , Randomized Controlled Trials as Topic , Coronavirus Infections , Electronic Health Records , Humans , Learning Health System/legislation & jurisprudence , Learning Health System/standards , New Zealand , Pandemics , Pneumonia, Viral , Randomized Controlled Trials as Topic/economics , Randomized Controlled Trials as Topic/standards , Referral and Consultation
13.
Cochrane Database Syst Rev ; 7: CD011845, 2020 07 02.
Article in English | MEDLINE | ID: covidwho-796440

ABSTRACT

BACKGROUND: Heart failure (HF) is a chronic disease with significant impact on quality of life and presents many challenges to those diagnosed with the condition, due to a seemingly complex daily regimen of self-care which includes medications, monitoring of weight and symptoms, identification of signs of deterioration and follow-up and interaction with multiple healthcare services. Education is vital for understanding the importance of this regimen, and adhering to it. Traditionally, education has been provided to people with heart failure in a face-to-face manner, either in a community or a hospital setting, using paper-based materials or video/DVD presentations. In an age of rapidly-evolving technology and uptake of smartphones and tablet devices, mHealth-based technology (defined by the World Health Organization as mobile and wireless technologies to achieve health objectives) is an innovative way to provide health education which has the benefit of being able to reach people who are unable or unwilling to access traditional heart failure education programmes and services. OBJECTIVES: To systematically review and quantify the potential benefits and harms of mHealth-delivered education for people with heart failure. SEARCH METHODS: We performed an extensive search of bibliographic databases and registries (CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, IEEE Xplore, ClinicalTrials.gov and WHO International Clinical Trials Registry Platform (ICTRP) Search Portal), using terms to identify HF, education and mHealth. We searched all databases from their inception to October 2019 and imposed no restriction on language of publication. SELECTION CRITERIA: We included studies if they were conducted as a randomised controlled trial (RCT), involving adults (≥ 18 years) with a diagnosis of HF. We included trials comparing mHealth-delivered education such as internet and web-based education programmes for use on smartphones and tablets (including apps) and other mobile devices, SMS messages and social media-delivered education programmes, versus usual HF care. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, assessed risks of bias, and extracted data from all included studies. We calculated the mean difference (MD) or standardised mean difference (SMD) for continuous data and the odds ratio (OR) for dichotomous data with a 95% confidence interval (CI). We assessed heterogeneity using the I2 statistic and assessed the quality of evidence using GRADE criteria. MAIN RESULTS: We include five RCTs (971 participants) of mHealth-delivered education interventions for people with HF in this review. The number of trial participants ranged from 28 to 512 participants. Mean age of participants ranged from 60 years to 75 years, and 63% of participants across the studies were men. Studies originated from Australia, China, Iran, Sweden, and The Netherlands. Most studies included participants with symptomatic HF, NYHA Class II - III. Three studies addressed HF knowledge, revealing that the use of mHealth-delivered education programmes showed no evidence of a difference in HF knowledge compared to usual care (MD 0.10, 95% CI -0.2 to 0.40, P = 0.51, I2 = 0%; 3 studies, 411 participants; low-quality evidence). One study assessing self-efficacy reported that both study groups had high levels of self-efficacy at baseline and uncertainty in the evidence for the intervention (MD 0.60, 95% CI -0.57 to 1.77; P = 0.31; 1 study, 29 participants; very low-quality evidence).Three studies evaluated HF self-care using different scales. We did not pool the studies due to the heterogenous nature of the outcome measures, and the evidence is uncertain. None of the studies reported adverse events. Four studies examined health-related quality of life (HRQoL). There was uncertainty in the evidence for the use of mHealth-delivered education on HRQoL (MD -0.10, 95% CI -2.35 to 2.15; P = 0.93, I2 = 61%; 4 studies, 942 participants; very low-quality evidence). Three studies reported on HF-related hospitalisation. The use of mHealth-delivered education may result in little to no difference in HF-related hospitalisation (OR 0.74, 95% CI 0.52 to 1.06; P = 0.10, I2 = 0%; 3 studies, 894 participants; low-quality evidence). We downgraded the quality of the studies due to limitations in study design and execution, heterogeneity, wide confidence intervals and fewer than 500 participants in the analysis. AUTHORS' CONCLUSIONS: We found that the use of mHealth-delivered educational interventions for people with HF shows no evidence of a difference in HF knowledge; uncertainty in the evidence for self-efficacy, self-care and health-related quality of life; and may result in little to no difference in HF-related hospitalisations. The identification of studies currently underway and those awaiting classification indicate that this is an area of research from which further evidence will emerge in the short and longer term.


Subject(s)
Health Education/methods , Heart Failure/therapy , Telemedicine/methods , Aged , Female , Health Knowledge, Attitudes, Practice , Hospitalization , Humans , Male , Middle Aged , Quality of Life , Randomized Controlled Trials as Topic , Self Care , Self Efficacy , Uncertainty
14.
Virol J ; 17(1): 141, 2020 09 24.
Article in English | MEDLINE | ID: covidwho-791891

ABSTRACT

BACKGROUND: The COVID-19 causing coronavirus is an enveloped RNA virus that utilizes an enzyme RNA dependent RNA polymerase for its replication. Favipiravir (FVP) triphosphate, a purine nucleoside analog, inhibits that enzyme. We have conducted this systematic review and meta-analysis on efficacy and safety of the drug FVP as a treatment for COVID-19. METHODS: Databases like Pubmed, Pubmed Central, Scopus, Embase, Google Scholar, preprint sites, and clinicaltirals.gov were searched. The studies with the standard of care (SOC) and FVP as a treatment drug were considered as the treatment group and the SOC with other antivirals and supportive care as the control group. Quantitative synthesis was done using RevMan 5.4. Clinical improvement, negative conversion of reverse transcription-polymerase chain reaction (RT-PCR), adverse effects, and oxygen requirements were studied. RESULTS: We identified a total of 1798 studies after searching the electronic databases. Nine in the qualitative studies and four studies in the quantitative synthesis met the criteria. There was a significant clinical improvement in the FVP group on the 14th day compared to the control group (RR 1.29, 1.08-1.54). Clinical deterioration rates were less likely in the FVP group though statistically not significant (OR 0.59, 95% CI 0.30-1.14) at the endpoint of study (7-15 days). The meta-analysis showed no significant differences between the two groups on viral clearance (day 14: RR 1.06, 95% CI 0.84-1.33), non-invasive ventilation or oxygen requirement (OR 0.76, 95% CI 0.42-1.39), and adverse effects (OR 0.69, 0.13-3.57). There are 31 randomized controlled trials (RCTs) registered in different parts of the world focusing FVP for COVID-19 treatment. CONCLUSION: There is a significant clinical and radiological improvement following treatment with FVP in comparison to the standard of care with no significant differences on viral clearance, oxygen support requirement and side effect profiles.


Subject(s)
Amides/therapeutic use , Antiviral Agents/therapeutic use , Betacoronavirus/drug effects , Coronavirus Infections/drug therapy , Pneumonia, Viral/drug therapy , Pyrazines/therapeutic use , Amides/adverse effects , Antiviral Agents/adverse effects , Betacoronavirus/enzymology , Clinical Trials, Phase II as Topic , Clinical Trials, Phase III as Topic , Coronavirus Infections/virology , DNA-Directed RNA Polymerases/antagonists & inhibitors , Databases, Factual , Enzyme Inhibitors/therapeutic use , Humans , Pandemics , Pneumonia, Viral/virology , Pyrazines/adverse effects , Randomized Controlled Trials as Topic , Standard of Care , Treatment Outcome
15.
Crit Care ; 24(1): 571, 2020 09 23.
Article in English | MEDLINE | ID: covidwho-788736

ABSTRACT

Coronavirus disease (COVID-19) is an emerging viral infection that is rapidly spreading across the globe. SARS-CoV-2 belongs to the same coronavirus class that caused respiratory illnesses such as severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). During the SARS and MERS outbreaks, many frontline healthcare workers were infected when performing high-risk aerosol-generating medical procedures as well as when providing basic patient care. Similarly, COVID-19 disease has been reported to infect healthcare workers at a rate of ~ 3% of cases treated in the USA. In this review, we conducted an extensive literature search to develop practical strategies that can be implemented when providing respiratory treatments to COVID-19 patients, with the aim to help prevent nosocomial transmission to the frontline workers.


Subject(s)
Coronavirus Infections/prevention & control , Cross Infection/prevention & control , Infection Control/methods , Infectious Disease Transmission, Patient-to-Professional/prevention & control , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Respiratory Distress Syndrome, Adult/therapy , Aerosols/adverse effects , Coronavirus Infections/transmission , Humans , Meta-Analysis as Topic , Observational Studies as Topic , Pneumonia, Viral/transmission , Randomized Controlled Trials as Topic , Respiratory Distress Syndrome, Adult/virology , Systematic Reviews as Topic
16.
Medicine (Baltimore) ; 99(38): e22345, 2020 Sep 18.
Article in English | MEDLINE | ID: covidwho-787430

ABSTRACT

BACKGROUND: At the end of 2019, peoples normal lives were disrupted by a sudden plague (COVID-19), the huge impact of COVID-19 on society has never been appeared. How to effectively prevent and treat COVID-19 is a concern for all health care workers. Exercise as a green and cheap complementary therapy, which has been proven to improve the immune capacity of the body and prevent infection. The main purpose of this study is to provide a reliable methodological guidance and credible evidence for exercise on COVID-19 therapeutic. METHODS: This protocol is guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols. We will search the following database sources for the Randomized controlled trials: the Cochrane Library, PubMed, EMBASE, Web of Science, Chinese Biomedical Literature Database (CBM), Chinese National Knowledge Infrastructure Database (CNKI), Chinese Science and the Wanfang Database. All randomized controlled trials of exercise therapy for COVID-19 in the above database will be considered for inclusion, and high-quality articles will be screened for data extraction and analysis, to summarize the therapeutic effect of exercise on COVID-19 patients. RESULTS: In this study, we hope to find strong evidence for the treatment of COVID-19 by exercise. CONCLUSION: The conclusion of our study will provide credible evidence to judge whether exercise is an effective intervention on the COVID-19 patients therapeutic, and guide future researches.PROSPERO registration number: CRD42020200883.


Subject(s)
Betacoronavirus , Coronavirus Infections/therapy , Exercise Therapy/methods , Pneumonia, Viral/therapy , Coronavirus Infections/virology , Humans , Meta-Analysis as Topic , Pandemics , Pneumonia, Viral/virology , Randomized Controlled Trials as Topic , Research Design , Systematic Reviews as Topic , Treatment Outcome
17.
JMIR Mhealth Uhealth ; 8(9): e22079, 2020 09 21.
Article in English | MEDLINE | ID: covidwho-781941

ABSTRACT

BACKGROUND: A necessary shift from in-person to remote delivery of psychotherapy (eg, teletherapy, eHealth, videoconferencing) has occurred because of the COVID-19 pandemic. A corollary benefit is a potential fit in terms of the need for equitable and timely access to mental health services in remote and rural locations. Owing to COVID-19, there may be an increase in the demand for timely, virtual delivery of services among trauma-affected populations, including public safety personnel (PSP; eg, paramedics, police, fire, correctional officers), military members, and veterans. There is a lack of evidence on the question of whether digital delivery of trauma-therapies for military members, veterans, and PSP leads to similar outcomes to in-person delivery. Information on barriers and facilitators and recommendations regarding digital-delivery is also scarce. OBJECTIVE: This study aims to evaluate the scope and quality of peer-reviewed literature on psychotherapeutic digital health interventions delivered remotely to military members, veterans, and PSP and synthesize the knowledge of needs, gaps, barriers to, and facilitators for virtual assessment of and virtual interventions for posttraumatic stress injury. METHODS: Relevant studies were identified using MEDLINE (Medical Literature Analysis and Retrieval System Online), EMBASE (Excerpta Medica dataBASE), APA (American Psychological Association) PsycINFO, CINAHL (Cumulative Index of Nursing and Allied Health Literature) Plus with Full Text, and Military & Government Collection. For collation, analysis, summarizing, and reporting of results, we used the CASP (Critical Skills Appraisal Program) qualitative checklist, PEDro (Physiotherapy Evidence Database) scale, level of evidence hierarchy, PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews), and narrative synthesis. RESULTS: A total of 38 studies were included in this review. Evidence for the effectiveness of digital delivery of prolonged exposure therapy, cognitive processing therapy, behavioral activation treatment with therapeutic exposure to military members, veterans, and PSP was rated level 1a, whereas evidence for cognitive behavioral therapy was conflicting. The narrative synthesis indicated that virtual delivery of these therapies can be as effective as in-person delivery but may reduce stigma and cost while increasing access to therapy. Issues of risk, safety, potential harm (ie, suicidality, enabling avoidance), privacy, security, and the match among the therapist, modality, and patient warrant further consideration. There is a lack of studies on the influences of gender, racial, and cultural factors that may result in differential outcomes, preferences, and/or needs. An investigation into other therapies that may be suitable for digital delivery is needed. CONCLUSIONS: Digital delivery of trauma therapies for military members, veterans, and PSP is a critical area for further research. Although promising evidence exists regarding the effectiveness of digital health within these populations, many questions remain, and a cautious approach to more widespread implementation is warranted.


Subject(s)
Emergency Responders/psychology , Military Personnel/psychology , Stress Disorders, Post-Traumatic/therapy , Telemedicine , Veterans/psychology , Coronavirus Infections/epidemiology , Humans , Pandemics , Pneumonia, Viral/epidemiology , Randomized Controlled Trials as Topic , Treatment Outcome
19.
Trials ; 21(1): 799, 2020 Sep 17.
Article in English | MEDLINE | ID: covidwho-771913

ABSTRACT

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 Trialswebsite (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 , Betacoronavirus/pathogenicity , Coronavirus Infections/prevention & control , Health Personnel , Occupational Health , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Vaccination , Absenteeism , BCG Vaccine/adverse effects , Betacoronavirus/immunology , Coronavirus Infections/immunology , Coronavirus Infections/transmission , Coronavirus Infections/virology , Denmark , Female , Humans , Male , Multicenter Studies as Topic , Patient Admission , Pneumonia, Viral/immunology , Pneumonia, Viral/transmission , Pneumonia, Viral/virology , Randomized Controlled Trials as Topic , Sick Leave , Single-Blind Method , Time Factors , Treatment Outcome
20.
PLoS One ; 15(9): e0239235, 2020.
Article in English | MEDLINE | ID: covidwho-771765

ABSTRACT

New evidence on the COVID-19 pandemic is being published daily. Ongoing high-quality assessment of this literature is therefore needed to enable clinical practice to be evidence-based. This review builds on a previous scoping review and aimed to identify associations between disease severity and various clinical, laboratory and radiological characteristics. We searched MEDLINE, CENTRAL, EMBASE, Scopus and LILACS for studies published between January 1, 2019 and March 22, 2020. Clinical studies including ≥10 patients with confirmed COVID-19 of any study design were eligible. Two investigators independently extracted data and assessed risk of bias. A quality effects model was used for the meta-analyses. Subgroup analysis and meta-regression identified sources of heterogeneity. For hospitalized patients, studies were ordered by overall disease severity of each population and this order was used as the modifier variable in meta-regression. Overall, 86 studies (n = 91,621) contributed data to the meta-analyses. Severe disease was strongly associated with fever, cough, dyspnea, pneumonia, any computed tomography findings, any ground glass opacity, lymphocytopenia, elevated C-reactive protein, elevated alanine aminotransferase, elevated aspartate aminotransferase, older age and male sex. These variables typically increased in prevalence by 30-73% from mild/early disease through to moderate/severe disease. Among hospitalized patients, 30-78% of heterogeneity was explained by severity of disease. Elevated white blood cell count was strongly associated with more severe disease among moderate/severe hospitalized patients. Elevated lymphocytes, low platelets, interleukin-6, erythrocyte sedimentation rate and D-dimers showed potential associations, while fatigue, gastrointestinal symptoms, consolidation and septal thickening showed non-linear association patterns. Headache and sore throat were associated with the presence of disease, but not with more severe disease. In COVID-19, more severe disease is strongly associated with several clinical, laboratory and radiological characteristics. Symptoms and other variables in early/mild disease appear non-specific and highly heterogeneous. Clinical Trial Registration: PROSPERO CRD42020170623.


Subject(s)
Betacoronavirus , Coronavirus Infections/epidemiology , Pandemics , Pneumonia, Viral/epidemiology , Adult , Aged , Biomarkers , Blood Cell Count , Blood Proteins/analysis , Blood Sedimentation , Combined Modality Therapy , Coronavirus Infections/blood , Coronavirus Infections/diagnostic imaging , Coronavirus Infections/therapy , Female , Hospitalization , Humans , Lung/diagnostic imaging , Male , Middle Aged , Pneumonia, Viral/blood , Pneumonia, Viral/diagnostic imaging , Pneumonia, Viral/therapy , Pregnancy , Pregnancy Complications, Infectious/epidemiology , Prevalence , Randomized Controlled Trials as Topic , Symptom Assessment
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