Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial60세 이상의 건강한 성인을 대상으로 한 불활성화 SARS-CoV-2 백신(CoronaVac)의 안전성, 내약성 및 면역원성: 무작위, 이중 맹검, 위약 대조, 1/2상 임상 시험Randomized Controlled Trial Published on 2021-06-012022-09-11 Journal: The Lancet. Infectious Diseases [Category] MERS, SARS, 임상, 진단, 치료기술, [키워드] Adults Adverse reaction Adverse reactions age All participants Aluminium aluminium hydroxide antibody Antibody Response Antibody titre assigned baseline Beijing block Block randomisation China Chinese clinical trial CoronaVac COVID-19 COVID-19 vaccine Cutoff defined detectable development dose dose-escalation double-blind eight Endpoint enrolled groups healthy hydroxide immunogenicity inactivated injection injection site pain intervention group Intramuscular injection investigators Laboratory live SARS-CoV-2 Mild moderate morbidity morbidity and mortality Neutralising Antibodies neutralising antibody neutralising antibody titres occurred Older Older adults participant Participants Phase 1 Phase 2 phase 3 trial Placebo placebo group placebo-controlled positive primary immunogenicity Program random assignment randomised Randomly receive Registered reported research and development Safe Safety safety population SARS-CoV-2 SARS-CoV-2 vaccine Science second dose Serious Adverse Events Seroconversion seroconversion rate seronegative seropositive Seven severity technology the disease the placebo group titre Tolerability treatment allocation trial protocol vaccination Vaccine virus [DOI] 10.1016/S1473-3099(20)30987-7 PMC 바로가기 [Article Type] Randomized Controlled Trial
Vitamin D supplementation for the treatment of COVID-19: a living systematic reviewCOVID-19 치료를 위한 비타민 D 보충: 살아있는 체계적인 검토Article Published on 2021-05-242022-09-11 Journal: The Cochrane database of systematic reviews [Category] 임상, [키워드] 95% CI 95% confidence interval acute respiratory syndrome addressed Administered adverse event adverse events age all-cause mortality approach Arm Asymptomatic Asymptomatic disease baseline benefit Blood level blood levels calcifediol certainty certainty of evidence cholecalciferol clinical clinical status Cochrane COVID-19 Study Register comparability Consistency control group control groups coronavirus disease coronavirus diseases COVID-19 COVID-19 symptoms daily dose Data collection death decrease described determine died disease disease severity dose effective Effectiveness Effects Ethnicity event Evidence excluded Gender Health Organization heterogeneity High dose higher risk hospital discharge hypercalcaemia identify include indicate individual individuals inflammatory markers information Invasive mechanical ventilation investigated life maintain MERS methodological methodology Middle East Middle East respiratory syndrome Mild Mild disease moderate moderate or severe disease moderate to severe Mortality multiple dose multiple doses nine oral calcifediol oral cholecalciferol outcome outcomes participant Participants people with COVID-19 Placebo placebo group placebo treatment Population progression Quality Quality of life randomisation randomised controlled trial Randomised controlled trials RCT RCTs recording reported required risk of bia risk ratio Safe Safety searched Selection selective Serious Adverse Event Serious Adverse Events Severe acute respiratory syndrome severe disease Standard of care subject syndrome systematic review the placebo group the WHO treated Treatment treatment for COVID-19 treatment of COVID-19 viral clearance Vitamin D vitamin D serum Vitamin D status Vitamin D supplementation vomiting Web of Science WHO World Health Organization [DOI] 10.1002/14651858.CD015043 PMC 바로가기 [Article Type] Article
The Efficacy of Antioxidant Oral Supplements on the Progression of COVID-19 in Non-Critically Ill Patients: A Randomized Controlled TrialArticle Published on 2021-05-192022-10-28 Journal: The Cochrane database of systematic reviews [Category] COVID-19, [키워드] alkaline phosphatase antioxidant antioxidants biochemical C-reactive protein clinical evidence clinical parameter clinical trial Controlled COVID-19 cytokine production Cytokine storm Disease progression double-blinded ferritin Final functional groups help hospitalized COVID-19 patient IL-6 Ill IMPROVE improvement Infection Inflammatory cytokine interleukin-6 investigated leukocyte Lymphocyte count MCP-1 monocyte Neutrophil-to-lymphocyte ratio non-critically ill non-critically ill patients oral outcome parameter parameters Patient patients with SARS-CoV-2 Protein Randomized reduced risk significantly significantly lower the cytokine storm the placebo group TNF-α tumor necrosis factor-α were measured [DOI] 10.3390/antiox10050804 PMC 바로가기 [Article Type] Article
MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 studyArticle Published on 2021-05-102022-10-04 Journal: Nature Medicine [Category] 임상, [키워드] 1:1 3,4-methylenedioxymethamphetamine Adverse adverse event alcohol baseline childhood clinical evaluation clinical trial Comorbidity decrease Depression disability disorder double-blind Drug development DSM-5 effective Efficacy and safety event functional impairment inactive individual induce MDMA medication nine participant Patient Phase 3 phase 3 study Phase III trials Placebo placebo-controlled placebo-controlled trial Post-traumatic stress disorder Psychiatric PTSD public health QT prolongation Randomized receive Result robust Safe scale SDS secondary endpoint significantly Stress substance use disorders Symptoms the placebo group the primary endpoint therapy those with comorbidities total score trauma Treatment were assessed [DOI] 10.1038/s41591-021-01336-3 PMC 바로가기 [Article Type] Article
Ivermectin in combination with doxycycline for treating COVID-19 symptoms: a randomized trialRandomized Controlled Trial Published on 2021-05-012022-10-05 Journal: The Journal of international medical research [Category] SARS, 임상, [키워드] 95% confidence interval age assigned blinded clinical recovery Combination COVID-19 COVID-19 infection COVID-19 negative COVID-19 symptom disease Disease progression doxycycline Dryad enrolled evaluated Follow-up groups hazard ratio Infection Ivermectin less Median recovery time men Mild-to-moderate outcome Patient patients Placebo placebo group placebo-controlled trial polymerase chain positive Primary outcome proportion Randomized randomized trial Randomly Recovery time reduced remained Repository reverse transcription reverse transcription polymerase chain reaction RT-PCR screened secondary significantly lower the placebo group treated treating COVID-19 Treatment treatment group with COVID-19 [DOI] 10.1177/03000605211013550 PMC 바로가기 [Article Type] Randomized Controlled Trial
Sarilumab in patients admitted to hospital with severe or critical COVID-19: a randomised, double-blind, placebo-controlled, phase 3 trial중증 또는 치명적인 COVID-19로 병원에 입원한 환자의 Sarilumab: 무작위 배정, 이중 맹검, 위약 대조, 3상 시험Clinical Trial Published on 2021-05-012022-09-12 Journal: The Lancet. Respiratory Medicine [Category] Fulltext, SARS, 임상, 진단, [키워드] adverse event assessments assigned block Brazil Canada Care Clinical improvement Course COVID-19 COVID-19 severity Critical Critical disease death double-blind Efficacy EudraCT Face mask FIVE France Germany greater hazard ratio hospital immunomodulatory therapy inhibitor intensive care interleukin-6 receptor Intervention intravenous investigator Italy Japan Laboratory laboratory-confirmed SARS-CoV-2 infection mechanical ventilation median time modified intention-to-treat nasal nine no significant difference outcome outcome assessors oxygen supplementation Patient phase 3 trial Placebo placebo-controlled Pneumonia primary endpoint Proinflammatory cytokine proportion randomised Randomly receive receiving Regeneron Pharmaceuticals Registered remained required requiring supplemental oxygen Russia Safety Sanofi sarilumab screened secondary endpoint Seven Spain suggested supplemental oxygen Support survival the placebo group treatment-emergent adverse event Trial WHO with COVID-19 [DOI] 10.1016/S2213-2600(21)00099-0 PMC 바로가기 [Article Type] Clinical Trial
Insulin fast-dissolving film for intranasal delivery via olfactory region, a promising approach for the treatment of anosmia in COVID-19 patients: Design, in-vitro characterization and clinical evaluationResearch article Published on 2021-05-012022-10-05 Journal: International journal of pharmaceutics [Category] SARS, 치료법, [키워드] alcohol Anosmia approach Characteristics clinical clinical evaluation clinical study conducted COVID-19 COVID-19 infection disintegration Fast-dissolving film Fourier transform In-vitro insulin Interaction intervention group intranasal investigated methyl cellulose olfactory Patient patients physical placebo group polymers selected significant difference significant differences significant increase the placebo group Treatment Variation were used [DOI] 10.1016/j.ijpharm.2021.120600 [Article Type] Research article
Assessment of Length and Readability of Informed Consent Documents for COVID-19 Vaccine TrialsCOVID-19 백신 시험에 대한 사전 동의 문서의 길이 및 가독성 평가Research Published on 2021-04-282022-09-10 Journal: JAMA Network Open [Category] MERS, SARS, 임상, [키워드] Accessibility Analysis analyzed assessment average CLARITY clinical trials collected complex complexity conducted Consent COVID-19 COVID-19 vaccine COVID-19 vaccine trial COVID-19 vaccine trials document effective enrolled examined exceeded explain finding Formal GRADE ideal Importance IMPROVE Informed Informed consent Length Level measure minute not difficult objective outcome participant Participants placebo group Point Quality improvement randomized clinical trial randomized clinical trials Readability reading receive reduce Relevance Research Research Ethics Result Safe score scored secondary Secondary outcomes setting the placebo group the vaccine Trial trials Vaccine [DOI] 10.1001/jamanetworkopen.2021.10843 PMC 바로가기 [Article Type] Research
Efficacy of the TMPRSS2 inhibitor camostat mesilate in patients hospitalized with Covid-19-a double-blind randomized controlled trial.Research article Published on 2021-04-222022-10-05 Journal: EClinicalMedicine [Category] 임상, [키워드] 30-Day mortality 7-point ordinal scale 95% confidence interval acute respiratory syndrome Admission adverse event assigned baseline camostat mesilate cell entry Clinical improvement conducted coronavirus coronavirus disease discharge double-blind EudraCT evaluated finding Frequency hazard ratio Hospitalization ICU admission in viral Infection interquartile range investigator-initiated IQR Mortality Multicenter trial not affect Oropharyngeal Other outcome participant Patient patients hospitalized Placebo placebo-controlled Primary outcome progression protease protocol Randomized Randomized controlled trial randomized trials Randomly receive SARS-CoV-2 SARS-COV-2 infection serine 2 the placebo group TMPRSS2 TMPRSS2 inhibitor Treatment two groups Viral load [DOI] 10.1016/j.eclinm.2021.100849 [Article Type] Research article
Effect of Early Treatment With Hydroxychloroquine or Lopinavir and Ritonavir on Risk of Hospitalization Among Patients With COVID-19 The TOGETHER Randomized Clinical Trial하이드록시클로로퀸 또는 로피나비르 및 리토나비르를 사용한 조기 치료가 COVID-19 환자의 입원 위험에 미치는 영향 The TOGETHER 무작위 임상 시험Randomized Controlled Trial Published on 2021-04-222022-08-13 Journal: JAMA Network Open [Category] MERS, 임상, 진단, 치료제, [키워드] Administered adverse events age all-cause hospitalization Analysis analyzed assigned benefit Brazil clinical clinical outcomes clinical trial ClinicalTrials.gov Identifier: NCT04403100 conducted country Course COVID-19 COVID-19 pandemic COVID-19 treatment guideline COVID-19 treatment guidelines Cox proportional hazard Cox proportional hazards model data safety monitoring board death determine diagnosed early symptomatic COVID-19 Effect effective Efficacy enrolled Enrollment expedient clinical trial expedient clinical trials fatality finding followed by futility group hazard ratio high-risk patient High-risk patients Hospitalization Hydroxychloroquine hydroxychloroquine group Importance Interim analyses interim analysis Intervention intervention group large-scale outpatient clinical trials Loading dose Lopinavir Lopinavir-ritonavir measure monitoring board no significant difference no significant differences not significantly different objective Odds ratio Outpatient outpatients pandemic participant Participants Patient patients patients hospitalized patients treated Placebo placebo group Point Prevent Primary outcome Primary outcomes proportion proportional hazards model randomization Randomized randomized clinical trial Randomly recorded reduce reducing Registration Relevance Repurposed drug Repurposed drugs respiratory respiratory symptom respiratory symptoms Result Ritonavir Sample size SARS-COV-2 infection secondary outcome self-identified as mixed-race setting statistical analysis symptom resolution symptomatic adult symptomatic adults the median the placebo group Treatment Trial Viral viral clearance was performed with COVID-19 women [DOI] 10.1001/jamanetworkopen.2021.6468 PMC 바로가기 [Article Type] Randomized Controlled Trial