Your browser doesn't support javascript.
Show: 20 | 50 | 100
Results 1 - 19 de 19
Filter
1.
Public Administration ; n/a(n/a), 2022.
Article in English | Wiley | ID: covidwho-1916265

ABSTRACT

COVID-19 represents a turbulent problem: a volatile, uncertain, complex, and ambiguous crisis, in which bounded-rational policymakers may not be able to do everything right, but must do critical things right in order to reduce the death toll. This study conceptualizes these critical things as necessary conditions (NCs) that must be absent to prevent high early mortality from occurring. We articulate a policy-institution-demography framework that includes seven factors as NC candidates for high early COVID-19 mortality. Using necessary condition analysis (NCA), this study pinpoints high levels of a delayed first response, political decentralization, elderly populations and urbanization as four NCs that have inflicted high early COVID-19 mortality across 110 countries. The results highlight the critical role of agility as a key dimension of robust governance solutions?a swift early public-health response as a malleable policy action?in curbing early COVID-19 deaths, particularly for politically decentralized and highly urbanized countries with ageing populations. This article is protected by copyright. All rights reserved.

2.
Chinese Journal of Zoonoses ; 38(1):25-28, 2022.
Article in Chinese | CAB Abstracts | ID: covidwho-1789500

ABSTRACT

This study investigated the temperature sensitivity of severe fever with thrombocytopenia syndrome virus (SFTSV) to provide a basis for SFTSV disinfection and laboratory biosafety protection. We divided SFTSV cell culture supernatants into 250 L PCR vials at 100 L/tube, and placed them in a refrigerator at 4..C, and a metal bath at 25..C, 37..C, 39..C, 56..C, and 70..C. After treatment for predetermined periods of time, the viral titer was determined through indirect immunofluorescence in Vero cells. With increasing temperature, the rate of decline of the viral titer increased. After incubation at 4..C, 25..C, 37..C, and 39..C for 24 h, the titers decreased from 107.25/100 L to 107.00/100 L, 106.75/100 L, 106.50/100 L, and 105.00/100 L, respectively. At the same temperature, with prolonged storage time, the decrease in titer became more pronounced. After SFTSV was placed at 4..C, 25..C, 37..C for 72 h, the viral titer decreased from 107.25/100 L to 106.63/100 L, 106.50/100 L, and 103.38/100 L, respectively. SFTSV lost its infectivity after incubation at 39..C for 72 h. SFTSV was inactivated after exposure to 56..C for 180 min or 70..C for 5 min. We concluded that SFTSV is inactivated after incubation at 70..C for 5 min. However, after 3 days of exposure to 4..C and 25..C, the viral titer did not change significantly. Laboratories and medical staff should focus on personal protection and disinfection of items contaminated by SFTSV.

3.
SSRN; 2022.
Preprint in English | SSRN | ID: ppcovidwho-333130

ABSTRACT

Background: The epidemiological characteristics and transmissibility of Coronavirus Disease 2019 (COVID-19) may undergo changes due to the mutation of Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) strains. The purpose of this study is to compare the differences in the outbreaks of the different strains, with regards to aspects such as epidemiological characteristics, transmissibility, and difficulties in prevention and control. Methods: COVID-19 data from outbreaks of pre-Delta strains, the Delta variant and Omicron variant, were obtained from the Chinese Center for Disease Control and Prevention (CDC). Case data were collected from China’s direct-reporting system, and the data concerning outbreaks were collected by on-site epidemiological investigators and collated by the authors of this paper. Indicators such as the effective reproduction number (Reff), time-dependent reproduction number (Rt), rate of decrease in transmissibility (RDT), and duration from the illness onset date to the diagnosed date (DID) / reported date (DIR) were used to compare differences in transmissibility between pre-Delta strains, Delta variants and Omicron variants. A nonparametric test was used to compare differences in epidemiological characteristics and transmissibility between outbreaks of different strains. P < 0.05 indicated that the difference was statistically significant. Results: Mainland China has maintained a “dynamic zero-out strategy” since the first case was reported, and clusters of outbreaks have occurred intermittently. The strains causing outbreaks in mainland China have gone through three stages: the outbreak of pre-Delta strains, the outbreak of the Delta variant, and outbreaks involving the superposition of Delta and Omicron variant strains. Each outbreak of pre-Delta strains went through two stages: a rising stage and a falling stage;Each outbreak of the Delta variant and Omicron variant went through three stages: a rising stage, a platform stage and a falling stage. The maximum Reff value of Omicron variant outbreaks was highest (median: 6.7;ranged from 5.3 to 8.0) and the differences were statistically significant. The RDT value of outbreaks involving pre-Delta strains was smallest (median: 91.4%;[IQR]: 87.30%-94.27%), and the differences were statistically significant. The DID and DIR of all strains accounted for the most in 0 ~ 2 days, with more than 75%. The range of duration for outbreaks of pre-Delta strains was the largest (median: 20 days, ranging from 1 to 61 days), and the differences were statistically significant. Conclusion: With the evolution of the virus, the transmissibility of the variants has increased. The transmissibility of the Omicron variant is higher than that of both the pre-Delta strains and the Delta variant, and is more difficult to suppress. These findings enable us to get a more clear and precise picture of the transmissibility of the different variants in the real world, in accordance with the findings of previous studies. Reff is more suitable than Rt for assessing the transmissibility of the disease during an epidemic outbreak.

4.
Circulation ; 145(18): 1398-1411, 2022 05 03.
Article in English | MEDLINE | ID: covidwho-1779500

ABSTRACT

BACKGROUND: SARS-CoV-2, the causal agent of COVID-19, enters human cells using the ACE2 (angiotensin-converting enzyme 2) protein as a receptor. ACE2 is thus key to the infection and treatment of the coronavirus. ACE2 is highly expressed in the heart and respiratory and gastrointestinal tracts, playing important regulatory roles in the cardiovascular and other biological systems. However, the genetic basis of the ACE2 protein levels is not well understood. METHODS: We have conducted the largest genome-wide association meta-analysis of plasma ACE2 levels in >28 000 individuals of the SCALLOP Consortium (Systematic and Combined Analysis of Olink Proteins). We summarize the cross-sectional epidemiological correlates of circulating ACE2. Using the summary statistics-based high-definition likelihood method, we estimate relevant genetic correlations with cardiometabolic phenotypes, COVID-19, and other human complex traits and diseases. We perform causal inference of soluble ACE2 on vascular disease outcomes and COVID-19 severity using mendelian randomization. We also perform in silico functional analysis by integrating with other types of omics data. RESULTS: We identified 10 loci, including 8 novel, capturing 30% of the heritability of the protein. We detected that plasma ACE2 was genetically correlated with vascular diseases, severe COVID-19, and a wide range of human complex diseases and medications. An X-chromosome cis-protein quantitative trait loci-based mendelian randomization analysis suggested a causal effect of elevated ACE2 levels on COVID-19 severity (odds ratio, 1.63 [95% CI, 1.10-2.42]; P=0.01), hospitalization (odds ratio, 1.52 [95% CI, 1.05-2.21]; P=0.03), and infection (odds ratio, 1.60 [95% CI, 1.08-2.37]; P=0.02). Tissue- and cell type-specific transcriptomic and epigenomic analysis revealed that the ACE2 regulatory variants were enriched for DNA methylation sites in blood immune cells. CONCLUSIONS: Human plasma ACE2 shares a genetic basis with cardiovascular disease, COVID-19, and other related diseases. The genetic architecture of the ACE2 protein is mapped, providing a useful resource for further biological and clinical studies on this coronavirus receptor.


Subject(s)
Angiotensin-Converting Enzyme 2 , COVID-19 , Angiotensin-Converting Enzyme 2/genetics , COVID-19/genetics , Cross-Sectional Studies , Genome-Wide Association Study , Humans , Receptors, Coronavirus , SARS-CoV-2
5.
J Healthc Eng ; 2022: 5020154, 2022.
Article in English | MEDLINE | ID: covidwho-1691218

ABSTRACT

Hospital logistics staff comprise a crucial, albeit easily overlooked, group in the prevention and control of hospital nosocomial infections, especially during the COVID-19 pandemic. From the perspective of hospital safety improvement, this paper describes the current situation and challenges in the prevention and control of nosocomial infections among hospital logistics staff. We also provide the following suggestions to improve nosocomial infections: (1) updating the learning system of nosocomial infections, (2) reinforcing the training of infections prevention, (3) properly arranging manpower and resources, and (4) improving the supervision and management system.


Subject(s)
COVID-19 , Cross Infection , Cross Infection/epidemiology , Cross Infection/prevention & control , Hospitals , Humans , Infection Control , Pandemics/prevention & control , SARS-CoV-2
6.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-321366

ABSTRACT

Background: Treatment of severe Corona Virus Disease 2019 (COVID-19) is challenging. We performed a phase 2 trial to assess the efficacy and safety of human umbilical cord-mesenchymal stem cells (UC‑MSCs) to treat patients with severe COVID-19 with lung damage, based on our phase 1 data.Methods: In this randomised, double-blind, and placebo-controlled trial, we recruited 101 eligible patients with severe COVID-19 with lung damage aged between 18–74 years from two hospitals. Enrolled patients were randomly assigned at a 2:1 ratio to receive either UC-MSCs (4 × 107 cells per infusion) or placebo on day 0, 3, and 6. We excluded patients with malignant tumours, shock, or other organ failure. The primary endpoint was an altered proportion of whole lung lesion areas from baseline to day 28, measured by chest computed tomography. Other imaging outcomes, 6-minute walk test, maximum vital capacity, diffusing capacity, plasma biomarkers, and adverse events were recorded and analysed. Primary analysis was done in the modified intention-to-treat (mITT) population and safety analysis was done in all patients who started their assigned treatment. Findings: From March 5, 2020, to March 28, 2020, 100 patients were finally enrolled and received either UC-MSCs (n = 65) or placebo (n = 35). During follow-up, the patients receiving UC-MSCs exhibited a trend of numerical improvement in whole lung lesions from baseline to day 28 compared with the placebo cases. UC-MSCs administration significantly reduced the proportions of consolidation lesions from baseline to day 28 in the treated patients compared with the placebo subjects. The 6-minute walk test showed an increased distance in patients treated with UC-MSCs. Notably, UC-MSCs delivery was well tolerated, with no serious adverse events.Interpretation: UC-MSCs treatment is a safe and potentially effective therapeutic approach for patients with severe COVID‑19. The trial suggests that UC-MSCs administration might benefit patients with COVID-19 with lung damage at the convalescent stage as well as the progression stage.Trial Registration: This trial is registered with ClinicalTrials.gov, number NCT04288102.Funding Statement: This trial was supported by The National Key R&D Program of China (2020YFC0841900, 2020YFC0844000, 2020YFC08860900);The Innovation Groups of the National Natural Science Foundation of China (81721002);The National Science and Technology Major Project (2017YFA0105703).Declaration of Interests: All authors declare no competing interests.Ethics Approval Statement: Ethical approval was obtained from the institutional review boards of each participating hospital. Written informed consent was obtained from all the enrolled patients or their legal representatives if they were unable to provide consent.

7.
Ann Vasc Surg ; 79: 114-121, 2022 Feb.
Article in English | MEDLINE | ID: covidwho-1458689

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) has become a global pandemic which may compromise the management of vascular emergencies. An uncompromised treatment for ruptured abdominal aortic aneurysm (rAAA) during such a health crisis represents a challenge. This study aimed to demonstrate the treatment outcomes of rAAA and the perioperative prevention of cross-infection under the COVID-19 pandemic. METHODS: In cases of rAAA during the pandemic, a perioperative workflow was applied to expedite coronavirus testing and avoid pre-operative delay, combined with a strategy for preventing cross-infection. Data of rAAA treated in 11 vascular centers between January-March 2020 collected retrospectively were compared to the corresponding period in 2018 and 2019. RESULTS: Eight, 12, and 14 rAAA patients were treated in 11 centers in January-March 2018, 2019, and 2020, respectively. An increased portion were treated at local hospitals with a comparable outcome compared with large centers in Guangzhou. With EVAR-first strategy, 85.7% patients with rAAA in 2020 underwent endovascular repair, similar to that in 2018 and 2019. The surgical outcomes during the pandemic were not inferior to that in 2018 and 2019. The average length of ICU stay was 1.8 ± 3.4 days in 2020, tending to be shorter than that in 2018 and 2019, whereas the length of hospital stay was similar among 3 years. The in-hospital mortality of 2018, 2019, and 2020 was 37.5%, 25.0%, and 14.3%, respectively. Three patients undergoing emergent surgeries were suspected of COVID-19, though turned out to be negative after surgery. CONCLUSIONS: Our experience for emergency management of rAAA and infection prevention for healthcare providers is effective in optimizing emergent surgical outcomes during the COVID-19 pandemic.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Aortic Rupture/surgery , COVID-19/prevention & control , Cross Infection/prevention & control , Infection Control , Vascular Surgical Procedures , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnosis , Aortic Rupture/diagnosis , COVID-19/diagnosis , COVID-19/transmission , COVID-19/virology , COVID-19 Testing , China , Cross Infection/diagnosis , Cross Infection/transmission , Cross Infection/virology , Emergencies , Female , Humans , Male , Middle Aged , Patient Safety , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome , Vascular Surgical Procedures/adverse effects , Workflow
8.
Respir Med ; 186: 106516, 2021 09.
Article in English | MEDLINE | ID: covidwho-1275693

ABSTRACT

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is transmitted through respiratory droplets, aerosols and close contact. Cross infections occur because viruses spread rapidly among humans. Nineteen percent (19%) of the infected patients developed severe pneumonia and acute respiratory distress syndrome (ARDS). Hypoxemia usually occurs and patients may require oxygen therapy or mechanical ventilation (MV) support. In this article, recently published clinical experience and observational studies were reviewed. Corresponding respiratory therapy regarding different stages of infection is proposed. Infection control principles and respiratory strategies including oxygen therapy, non-invasive respiratory support (NIRS), intubation evaluation, equipment preparation, ventilator settings, special maneuvers comprise of the prone position (PP), recruitment maneuver (RM), extracorporeal membrane oxygenation (ECMO), weaning and extubation are summarized. Respiratory equipment and device disinfection recommendations are worked up. We expect this review article could be used as a reference by healthcare workers in patient care while minimizing the risk of environmental contamination.


Subject(s)
COVID-19/prevention & control , COVID-19/therapy , Critical Care/methods , Critical Illness , Extracorporeal Membrane Oxygenation/methods , Infection Control/methods , Oxygen Inhalation Therapy/methods , Respiration, Artificial/methods , SARS-CoV-2/pathogenicity , COVID-19/complications , COVID-19/transmission , Cannula , Cross Infection/prevention & control , Cross Infection/transmission , Cross Infection/virology , Humans , Hypoxia/etiology , Hypoxia/therapy , Pneumonia, Viral/etiology , Pneumonia, Viral/therapy , Respiratory Distress Syndrome/etiology , Respiratory Distress Syndrome/therapy
9.
Intelligent Medicine ; 2021.
Article in English | ScienceDirect | ID: covidwho-1253040

ABSTRACT

In recent years, noncontact crewless operations have become prominent in the field of environmental disinfection. Robots that automatically disinfect the air and surfaces of hospital environments can help reduce the human resources spent on environmental cleaning and disinfection and minimize the risk of occupational exposure for staff. These robots also facilitate informatized management of environmental disinfection, reduce costs, and increase the efficiency of disinfection efforts.

10.
Signal Transduct Target Ther ; 6(1): 58, 2021 02 10.
Article in English | MEDLINE | ID: covidwho-1078577

ABSTRACT

Treatment of severe Coronavirus Disease 2019 (COVID-19) is challenging. We performed a phase 2 trial to assess the efficacy and safety of human umbilical cord-mesenchymal stem cells (UC-MSCs) to treat severe COVID-19 patients with lung damage, based on our phase 1 data. In this randomized, double-blind, and placebo-controlled trial, we recruited 101 severe COVID-19 patients with lung damage. They were randomly assigned at a 2:1 ratio to receive either UC-MSCs (4 × 107 cells per infusion) or placebo on day 0, 3, and 6. The primary endpoint was an altered proportion of whole lung lesion volumes from baseline to day 28. Other imaging outcomes, 6-minute walk test (6-MWT), maximum vital capacity, diffusing capacity, and adverse events were recorded and analyzed. In all, 100 COVID-19 patients were finally received either UC-MSCs (n = 65) or placebo (n = 35). UC-MSCs administration exerted numerical improvement in whole lung lesion volume from baseline to day 28 compared with the placebo (the median difference was -13.31%, 95% CI -29.14%, 2.13%, P = 0.080). UC-MSCs significantly reduced the proportions of solid component lesion volume compared with the placebo (median difference: -15.45%; 95% CI -30.82%, -0.39%; P = 0.043). The 6-MWT showed an increased distance in patients treated with UC-MSCs (difference: 27.00 m; 95% CI 0.00, 57.00; P = 0.057). The incidence of adverse events was similar in the two groups. These results suggest that UC-MSCs treatment is a safe and potentially effective therapeutic approach for COVID-19 patients with lung damage. A phase 3 trial is required to evaluate effects on reducing mortality and preventing long-term pulmonary disability. (Funded by The National Key R&D Program of China and others. ClinicalTrials.gov number, NCT04288102.


Subject(s)
COVID-19/therapy , Mesenchymal Stem Cell Transplantation , Mesenchymal Stem Cells , SARS-CoV-2 , Umbilical Cord , Aged , Allografts , COVID-19/mortality , COVID-19/physiopathology , Double-Blind Method , Female , Humans , Male , Middle Aged , Treatment Outcome
11.
Preprint in English | medRxiv | ID: ppmedrxiv-20241265

ABSTRACT

BackgroundTravel-related dissemination of SARS-CoV-2 continues to contribute to the global pandemic. A novel SARS-CoV-2 lineage (B.1.177) reportedly arose in Spain in the summer of 2020, with subsequent spread across Europe linked to travel by infected individuals. Surveillance and monitoring through the use of whole genome sequencing (WGS) offers insights into the global and local movement of pathogens such as SARS-CoV-2 and can detect introductions of novel variants. MethodsWe analyzed the genomes of SARS-CoV-2 sequenced for surveillance purposes from specimens received by Public Health Ontario (Sept 6 - Oct 10, 2020), collected from individuals in eastern Ontario. Taxonomic lineages were identified using pangolin (v2.08) and phylogenetic analysis incorporated publicly available genomes covering the same time period as the study sample. Epidemiological data collected from laboratory requisitions and standard reportable disease case investigation was integrated into the analysis. ResultsGenomic surveillance identified a COVID-19 case with SARS-CoV-2 lineage B.1.177 from an individual in eastern Ontario in late September, 2020. The individual had recently returned from Europe. Genomic analysis with publicly available data indicate the most closely related genomes to this specimen were from Southern Europe. Genomic surveillance did not identify further cases with this lineage. ConclusionsGenomic surveillance allowed for early detection of a novel SARS-CoV-2 lineage in Ontario which was deemed to be travel related. This type of genomic-based surveillance is a key tool to measure the effectiveness of public health measures such as mandatory self-isolation for returned travellers, aimed at preventing onward transmission of newly introduced lineages of SARS-CoV-2.

12.
Drug Des Devel Ther ; 14: 5097-5108, 2020.
Article in English | MEDLINE | ID: covidwho-948000

ABSTRACT

OBJECTIVE: This study aims to comprehensively evaluate the characteristics of clinical drug trials to facilitate the collection of evidence for COVID-19 drug treatments. METHODS: A retrospective analysis of 910 trials retrieved on August 7, 2020. RESULTS: A total of 910 registered clinical trials with at least one drug intervention were evaluated. The number of registrations (32.4%, 295) from the United States accounted for nearly one-third of the total and far exceeded that of other countries individually. Furthermore, the peak number of trials were registered in April (34.3%, 312). Over half of the trials (51.2%, 466) are in the recruitment phase, and only 4.2% (38) of the trials have been completed. The median (interquartile range) estimated enrollment is 127 (59, 365). In 39% (355) of trials, the estimated enrollment is less than 100 participants. A total of 94.5% (790) of the trials use randomization in the allocation, 82.7% (753) use a parallel intervention mode, and 52.2% (475) use masking. A total of 287 drug names have been standardized and mapped. "Hydroxychloroquine" is the leading drug among the registered trials (7.47%, 68). Among the main countries contributing to investigations on "hydroxychloroquine", the United States ranks first with 36.76% (25) of the trials. CONCLUSION: The designs of COVID-19 clinical drug trials have greatly improved in terms of the implementation of randomization and, particularly, blinding methods. In terms of drug reuse, the number of drug types has greatly increased, and hundreds of drugs have been used for efficacy screening. The emergence of large-sample registration trials is expected to address the uncertainty regarding the current clinical efficacy of some drugs.


Subject(s)
COVID-19/drug therapy , Clinical Trials as Topic/statistics & numerical data , Adolescent , Adult , Aged , Aged, 80 and over , Antiviral Agents/therapeutic use , Child , Child, Preschool , Drug Repositioning , Female , Humans , Hydroxychloroquine/therapeutic use , Infant , Male , Middle Aged , Pandemics , Research Design , Young Adult
13.
China Tropical Medicine ; 20(9):853-856, 2020.
Article in Chinese | GIM | ID: covidwho-890728

ABSTRACT

Objective: To explore the transmission characteristics of the typical clusters of coronavirus diseases 2019 (COVID-19) in Xi'an, so as to provide scientific basis for optimizing the control strategy of COVID-19.

14.
SSRN; 2020.
Preprint | SSRN | ID: ppcovidwho-741

ABSTRACT

Objective: On the premise of ensuring the sensitivity and specificity of nucleic acid detection, explore the choice and number of gene targets on the nucleic ac

15.
Chin. Trad. Herbal Drugs ; 11(51): 2967-2976, 20200612.
Article in Chinese | WHO COVID, ELSEVIER | ID: covidwho-682204

ABSTRACT

Objective: To explore the network regulation mechanism of Tanreqing Capsule (TRQC) on the treatment of coronavirus disease 2019 (COVID-19). Methods: Potential targets of the 19 major constituents in TRQC were predicted by the Swiss Target Prediction server and TCMSP database. Gene ontology (GO) function enrichment and pathway analysis of the targets were analyzed by Omicsbean analytic system and String 10 database. Finally, Cytoscape 3.6.1 software was used to construct the network pharmacology map. Results: A total of 19 compounds affected 68 pathways such as IL-17 signaling pathway, T cell receptor signaling pathway, arachidonic acid metabolism, cAMP signaling pathway, PI3K-Akt signaling pathway, influenza A, etc, by acting on 163 related targets, which associated with anti-inflammation, immune regulation, antipyresis, eliminating phlegm, relieving cough and asthma, analgesia, antibacterial and antiviral, and sedation. The network of "compound-target-pathway-pharmacological action-efficacy" was also constructed. Conclusion: The major constituents in TRQC, including scutellarin, baicalin, oroxylin-7-O-glucuronide, chrysin-7-O-glucuronide, forsythin, forsythiaside E, forsythiaside D, chlorogenic acid, caffeic acid, isochlorogenic acid A, ursodeoxycholic acid and chenodeoxycholic acid, may interfere with efficacy-related biological processes associated with antipyresis, eliminating phlegm and removing toxin by acting on key protein like TNF, EGFR, NOS3, PTGS2, IL2, GABBR1, MAPK14, ADRB2, REN, VCAM1, ACHE, PTPRC, etc.

16.
Curr Med Res Opin ; 36(7): 1131-1135, 2020 07.
Article in English | MEDLINE | ID: covidwho-305917

ABSTRACT

Objective: The aim of this study was to provide recommendations for improving the design of subsequent studies through analysis of the registered coronavirus disease 2019 (COVID-19) clinical trials.Methods: A retrospective analysis of 189 trial retrievals achieved on 20 February 2020.Results: A total of 189 trials are included in the study. There were 69.3% interventional studies, 21.7% observational studies, 5.3% diagnostic tests and 3.7% other studies. The following statistics are provided only for the interventional studies. Severity of disease: 5.3% light and common type, 17.6% severe and critically ill and 59.6% with no restricted classification. Medication use: 51.1% Western medicine, 32.1% Chinese medicine, 10.7% blood related product and 6.1% non-drug therapy. The median and inner quantile range of the sample sizes included in these studies: 104 (IQR: 60, 200). Primary outcome type most used: 45.8% with clinical characteristics and 21.4% with virological. Study design characteristics: 71% of all studies were randomized, 5% of all studies were blinded, 18% of all studies were multicenter and 76% of all studies were single center.Conclusion: Although many COVID-19 studies include randomization in their design, the lack of additional double-blind and placebo-controlled elements in their designs result in a less robust evaluation of intervention safety and efficacy. Furthermore, similar or repeated research and small sample studies that have less promise in gains of new information have possibly led to a shortage of recruitable patients and become a barrier to the completion of large multicenter clinical trial studies.


Subject(s)
Betacoronavirus , Clinical Trials as Topic/organization & administration , Coronavirus Infections/therapy , Pneumonia, Viral/therapy , Research Design , COVID-19 , Humans , Pandemics , SARS-CoV-2
17.
Ther Innov Regul Sci ; 54(5): 1236-1255, 2020 09.
Article in English | MEDLINE | ID: covidwho-276254

ABSTRACT

Two phase-III, double-blind, randomized clinical trials of remdesivir plus SOC (standard of care) versus placebo plus SOC have been conducted in Wuhan hospitals by Chinese investigators during the urgent COVID-19 epidemic [ClincalTrials.gov NCT04257656 and NCT04252664]. These trials have been highly anticipated worldwide. We expect investigators of the trials will soon report the clinical and laboratory findings from the medical perspective. This manuscript provides documentary style information on the process of monitoring key data and making recommendations to the sponsor and investigators based on analytical insights when dealing with the emergent situation from the statistical viewpoint. Having monitored data sequentially from 237 patients, we comment on the strength and weakness of the study design and suggest the treatment effect of remdesivir on severe COVID-19 cases. Our experience with using the Dynamic Data Monitoring (DDM) tool has demonstrated its efficiency and reliability in supporting DSMB's instantaneous review of essential data during the emergent situation. DDM, when used properly by disciplined statisticians, has shown its capability of exploring the trial data flexibly and, in the meantime, protecting the trial's scientific integrity.


Subject(s)
Adenosine Monophosphate/analogs & derivatives , Alanine/analogs & derivatives , Antiviral Agents/therapeutic use , Betacoronavirus/drug effects , Clinical Trials, Phase III as Topic , Coronavirus Infections/drug therapy , Data Accuracy , Pneumonia, Viral/drug therapy , Randomized Controlled Trials as Topic , Research Design , Adenosine Monophosphate/adverse effects , Adenosine Monophosphate/therapeutic use , Alanine/adverse effects , Alanine/therapeutic use , Antiviral Agents/adverse effects , Betacoronavirus/pathogenicity , COVID-19 , China , Clinical Trials Data Monitoring Committees , Coronavirus Infections/diagnosis , Coronavirus Infections/virology , Host Microbial Interactions , Humans , Pandemics , Pneumonia, Viral/diagnosis , Pneumonia, Viral/virology , SARS-CoV-2 , Time Factors , Treatment Outcome
18.
Engineering (Beijing) ; 6(10): 1147-1152, 2020 Oct.
Article in English | MEDLINE | ID: covidwho-9250

ABSTRACT

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

19.
Chinese Journal of Emergency Medicine ; (12): E016-E016, 2020.
Article in Chinese | WPRIM (Western Pacific), WPRIM (Western Pacific) | ID: covidwho-6220

ABSTRACT

Objective@#To investigate the role of epidemiological history in the screening of Corona Virus Disease 2019 (COVID-19) in fever clinic, to improve the efficiency in fever clinic and reduce the incidence of cross infection.@*Methods@#This is a retrospective study. Patients who were admitted to the fever clinic in West China Hospital of Sichuan University from January 23th, 2020 to February 11th, 2020 included the study. According to epidemiological history, the patients were divided into epidemiological history group (the experimental group) and no epidemiological history group (the control group). The two groups of patients were admitted and treated separately. The clinical data, NEWS score, etiology results, viral pneumonia showed on CT, time of visit, COVID-19 patient ratio, and admission composition ratio were compared between the two groups. The measurement data were presented as the mean ± standard deviation (SD), and the numeration data were expressed as ratio or constituent ratio. The measurement data of normal distribution between the two groups were compared by independent sample t test. The measurement data of skewed distribution are expressed by the median (interquartile range), and the comparison between the two groups is tested by non-parameter. The differences between enumeration data were assessed by chi-square test. A P<0.05 was considered statistically significant.@*Results@#A total of 2423 patients were included, including 927 patients in the experimental group and 1296 patients in the control group. There were no significant differences in gender, NEWS score and clinical symptoms between the two groups (P> 0.05). The age (35.00 ± 12.80 vs 38.13 ± 15.57 years) , the proportion of fever patients (28.80% vs 32.75%) and waiting time (31.72 vs 58.08 min) of the experimental group were lower than the control group, the difference was statistically significant (P <0.05). The CT examination ratio (37.54% vs 20.39%), viral pneumonia ratio showed on CT (9.77% vs 2.95%), ratio of examined COVID-19 nucleic acid test (85.44% vs 56.75%), and the admission ratio (16.72% vs 9.63%) of the experimental group were higher than the control group, and the differences were statistically significant (P <0.05); There was no significant difference in the positive rates of influenza virus and rhinovirus between the two groups (P> 0.05).@*Conclusion@#It is necessary to adjust the management mode of fever clinic during the Corona Virus Disease 2019, and to manage the patients according to the epidemiological history which can improve the screening efficiency and reduce the risk of cross infection.

SELECTION OF CITATIONS
SEARCH DETAIL