Serious Adverse Events – Page 13 – Communicable Diseases Research

Corticosteroid therapy for COVID-19: A systematic review and meta-analysis of randomized controlled trials

COVID-19에 대한 코르티코스테로이드 요법: 무작위 대조 시험의 체계적인 검토 및 메타 분석

Meta-Analysis

Published on 2021-05-212022-09-11
Journal: Medicine [Category] SARS, 임상,

Efficacy of the NVX-CoV2373 Covid-19 Vaccine Against the B.1.351 Variant

B.1.351 변이체에 대한 NVX-CoV2373 Covid-19 백신의 효능

Clinical Trial

Published on 2021-05-202022-08-13
Journal: The New England Journal of Medicine [Category] Fulltext, SARS, 변종, 임상, 진단,

[키워드] 1:1 95% CI 95% confidence interval acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 Administered Against B.1.351 B.1.351 variant baseline baseline serostatus both groups coronavirus COVID-19 pandemic dosed doses Efficacy healthy HIV-negative Human immunodeficiency virus immunodeficiency virus in both groups laboratory-confirmed Matrix-M1 adjuvant Mild mild to moderate moderate multicenter not differ NVX-CoV2373 NVX-CoV2373 nanoparticle vaccine NVX-CoV2373 vaccine observer observer-blinded pandemic participant Participants Placebo placebo recipients placebo-controlled trial PLWH Preliminary local primary endpoint primary endpoints Randomized receive Recombinant spike protein respiratory Result SARS-CoV-2 SARS-CoV-2 variant SARS-CoV-2 variants second dose sequenced Serious Adverse Event Serious Adverse Events seronegative participant seropositive serostatus severe acute respiratory syndrome Coronavirus South Africa Spike protein symptomatic COVID-19 systemic reactogenicity uninfected participants Vaccine Vaccine development vaccine efficacy variant variants with HIV
[DOI] 10.1056/NEJMoa2103055 PMC 바로가기 [Article Type] Clinical Trial

Reconvalescent plasma/camostat mesylate in early SARS-CoV-2 Q-PCR positive high-risk individuals (RES-Q-HR): a structured summary of a study protocol for a randomized controlled trial

초기 SARS-CoV-2 Q-PCR 양성 고위험 개인(RES-Q-HR)의 회복기 혈장/카모스타트 메실레이트: 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약

Letter

Published on 2021-05-172022-08-31
Journal: Trials [Category] SARS, 임상, 치료기술, 치료제,

[키워드] accommodation acts Administered administration Adult patients Adverse adverse events alcohol Alcohol Abuse ALT anti-SARS-CoV-2 antibodies anti-SARS-CoV-2 antibody anticancer Antiviral antiviral therapy appearance approved AST blinded Blinding BMI body weight Bone marrow Breastfeeding CAD camostat Camostat mesylate Capsule Care Caregivers Cell Child chronic Chronic kidney disease chronic obstructive pulmonary disease chronic obstructive pulmonary disease (COPD) cirrhosis CKD clinical clinical condition Compliance Concomitant concurrent conducted control group Controlled trial convalescent plasma COPD Coronary artery Coronary artery disease cough COVID-19 COVID-19 pneumonia criteria cumulative defined diabetes Diabetes Mellitus diagnosed diagnosis of SARS-CoV-2 diarrhea disease Disease progression disease stage disorder dissemination double-blind Duration early disease Early phase of SARS-CoV-2 infection Efficacy element enrolled Enrollment enrolment EudraCT evaluate evening event evidence of Exanthema excluded exclusion criteria fatigue Fever fibrosis Germany GFR half-live headache high risk higher risk Hospitalization Hospitalized host cell hypersensitivity IgA deficiency immunization Inclusion inclusion criteria increased risk independent individual Infection infection with SARS-CoV-2 Influenza influenza A Informed consent inhibitor institution intervention arm intervention arms Kidney disease less Life expectancy likelihood Liver cirrhosis Local local Ethics Committee Mask mesylate moderate mother multicenter nasal nasal cannula Neutralizing number objective Obstructive obstructive pulmonary disease Older Ordinal Scale organ outcome outcomes oxygen oxygen demand Pancreatitis parallel group participant Participants passive immunization Patient patients hospitalized PCR Placebo plasma Plasma transfusion Pneumonia positive pregnant women Presence Prevent prevent disease progression primary endpoint progression protocol pulmonary disease pulmonary fibrosis Q-PCR randomization Randomized Randomized controlled trial receive recruitment reduce Regulatory reported risk factor safety monitoring committee Sample size SARS-CoV-2 SARS-COV-2 infection SARS-CoV-2 PCR screening visit Serine serine protease TMPRSS2 Serious Adverse Event Serious Adverse Events severe COVID-19 Shortness of breath SOC sore throat Stage Standard Standard of care stratified Stress Study protocol supplementary material Symptom symptom duration Symptoms tertiary care center tested the cell titers TMPRSS2 transfusion reaction Treatment treatment arm Trial Trial registration Tumor typical symptom typical symptoms ULN virus website WHO with COVID-19 women working hypothesis written Informed Consent
[DOI] 10.1186/s13063-021-05181-0 PMC 바로가기 [Article Type] Letter

Efficacy and safety of umbilical cord mesenchymal stem cells for the treatment of patients with COVID-19

Research article

Published on 2021-05-112022-10-05
Journal: Clinics [Category] SARS, 바이오마커, 치료법,

[키워드] acute respiratory syndrome allergic reaction baseline Biomarker Cell changes in Clinicians Computerized tomography control group coronavirus coronavirus disease COVID-19 Decreased demonstrated drug Effect effective Efficacy evaluated healthy hematology tests IgM Immunoglobulin Inflammatory intravenous infusion large cohort lung mesenchymal stem cell Mesenchymal stem cells MSC MSC therapy MSC-treated MSCs Occurrence outbreak oxygenation index patients with COVID-19 pilot study public health pulmonary inflammation Randomized controlled trial reducing restored Serious Adverse Events significant changes in significantly stem cell Stem cell therapy therapeutic potential therapy tissue treated Treatment umbilical
[DOI] 10.6061/clinics/2021/e2604 [Article Type] Research article

Convalescent plasma for adults with acute COVID-19 respiratory illness (CONCOR-1): study protocol for an international, multicentre, randomized, open-label trial

급성 COVID-19 호흡기 질환이 있는 성인을 위한 회복기 혈장(CONCOR-1): 국제, 다기관, 무작위 배정, 공개 시험을 위한 연구 프로토콜

Study Protocol

Published on 2021-05-042022-09-01
Journal: Trials [Category] SARS, 임상, 진단, 치료기술, 치료제,

[키워드] acute COVID-19 acute respiratory syndrome Analysis anti-SARS-CoV-2 antibodies antibodies antibody titres baseline Blood Group CCP Community community acquired community acquired pneumonia CONCOR-1 convalescent plasma coronavirus COVID-19 COVID-19 infection criteria death detect detectable anti-SARS-CoV-2 antibodies detectable anti-SARS-CoV-2 antibody determine Donor donors Ebola Ebola virus Efficacy and safety estimation Evidence exclusion criteria Exploratory analyses global pandemic hospital include inclusion criteria independent Infection Influenza information intensive care interim analysis International Intubated intubation Middle East Middle East respiratory syndrome multicentre NCT04348656 Neutralization assay neutralization assays Non-intubated Novel coronavirus Open-label outcome oxygen Patient patients with SARS-CoV-2 plasma Pneumonia Primary outcome quantified randomization Randomized Randomized controlled trial randomized trial reaction receive receiving recruitment reduce reduction in Relative risk respiratory respiratory complication Respiratory complications Respiratory illness respiratory symptom respiratory symptoms responsible risk risk reduction Sample size SARS-CoV-2 SARS-CoV-2 antibody titre SARS-CoV-2 antibody titres SARS-COV-2 infection SARS-CoV-2 viral load secondary Secondary outcomes Serious Adverse Events Serologically Severe acute respiratory syndrome Standard of care Study protocol supplemental oxygen Support syndrome threshold thresholds titre transfusion reactions Trial two-sided Ventilator-free days Viral viral disease Viral diseases Viral load with COVID-19
[DOI] 10.1186/s13063-021-05235-3 PMC 바로가기 [Article Type] Study Protocol

Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial

비활성화된 SARS-CoV-2 백신 BBV152의 안전성 및 면역원성: 이중 맹검, 무작위, 1상 시험

Clinical Trial

Published on 2021-05-012022-09-11
Journal: The Lancet. Infectious Diseases [Category] Fulltext, SARS, 임상, 진단, 치료기술,

[키워드] 95% CI Administered adverse event Adverse reactions alum assigned baseline Bharat block Block randomisation CD4 CD8 Cell-mediated responses control group control vaccine COVID-19 doses double-blind Effect Efficacy eligible ELISPOT enrolled evaluated event fatigue Fever first dose groups headache healthy hospital immune responses immunogenicity inactivated India individual injection site pain intramuscular dose investigator investigators Local Mild mitigate moderate multicentre nausea neutralisation nine nucleic acid outcome participant Participants Phase 1 phase 1 trial Phase 2 platform Pneumonitis positive Primary outcomes randomisation randomised Randomly receive Registered reported response Safety SARS-CoV-2 nucleic acid SARS-CoV-2 vaccine screened secondary secondary outcome selected Serious Adverse Event Serious Adverse Events Seroconversion seroconversion rates serology test serology tests Seven staining study duration subset systemic adverse reaction systemic adverse reactions systemic reactogenicity T-cell Response T-cell responses the vaccine tolerable Toll-like receptor treatment group Trial trials vaccination Vaccine Viral vomiting was done were excluded wild-type virus
[DOI] 10.1016/S1473-3099(20)30942-7 PMC 바로가기 [Article Type] Clinical Trial

Major Update: Remdesivir for Adults With COVID-19 : A Living Systematic Review and Meta-analysis for the American College of Physicians Practice Points

주요 업데이트: COVID-19 성인을 위한 Remdesivir : American College of Physicians Practice Points를 위한 살아있는 체계적인 검토 및 메타 분석

Meta-Analysis

Published on 2021-05-012022-09-11
Journal: Annals of internal medicine [Category] Fulltext, SARS, 치료제,

[키워드] assessment baseline benefit Bia clinically college controlled trials coronavirus disease Coronavirus disease 2019 Course COVID-19 decrease Department development disease severity Effect Evidence Final GRADE greater hospital Hospitalized IMPROVE include increase in Major mechanical ventilation Meta-analysis moderate Mortality New outcomes Patient patients with COVID-19 physician Point Practice proportion Randomized controlled trial RCT RCTs receiving reduce reduce mortality reduction in reduction in mortality Remdesivir review risk risk ratio Serious Adverse Event Serious Adverse Events severity Time to recovery Treatment Ventilation veteran were used with COVID-19
[DOI] 10.7326/M20-8148 PMC 바로가기 [Article Type] Meta-Analysis

Tocilizumab plus standard care versus standard care in patients in India with moderate to severe COVID-19-associated cytokine release syndrome (COVINTOC): an open-label, multicentre, randomised, controlled, phase 3 trial

인도에서 중등도에서 중증의 COVID-19 관련 사이토카인 방출 증후군(COVINTOC) 환자에 대한 토실리주맙과 표준 치료 대 표준 치료: 공개, 다기관, 무작위 배정, 대조, 3상 시험

Clinical Trial

Published on 2021-05-012022-09-12
Journal: The Lancet. Respiratory Medicine [Category] Fulltext, SARS, 임상, 진단,

[키워드] 1:1 Action acute respiratory distress adverse event adverse events analyses anti-IL-6 receptor antibody assigned baseline Block randomisation Cipla clinical country COVID-19 COVID-19 progression Cytokine release syndrome death decrease discharge education effective eight Evidence FIVE Follow-up grade 3 hospital India intensive care investigated mechanical ventilation medication Ministry of Health moderate modified intention-to-treat multicentre occurred one patient Open-label participant Patient patients died phase 3 trial positive SARS-CoV-2 PCR post-hoc Prevent primary endpoint progression Racial randomised randomised controlled trial Randomly randomly assigned patients receive recruited reduced Registered registry reported Roche routine Safety Serious Adverse Events Seven severe COVID-19 shown standard care standard care group supported syndrome the primary endpoint Tocilizumab Treatment Trial with COVID-19
[DOI] 10.1016/S2213-2600(21)00081-3 PMC 바로가기 [Article Type] Clinical Trial

The therapeutic effect and safety of the drugs for COVID-19: A systematic review and meta-analysis

COVID-19 치료제의 치료 효과 및 안전성: 체계적인 검토 및 메타 분석

Meta-Analysis

Published on 2021-04-232022-09-11
Journal: Medicine [Category] SARS, 치료제,

[키워드] 95% CI ACEi ACEi/ARB addition antiviral medicine caused Chloroquine chloroquine/hydroxychloroquine Clinical improvement Clinical symptoms clinical trial Cochrane Library conducted control group coronavirus disease Coronavirus disease 2019 COVID-19 COVID-19 patients COVID-19 treatment discharge rate drug effective drug effective drugs Efficiency eligible end point evaluate had no Hydroxychloroquine indicated involved measure medication Meta-analysis Mortality no significant effect Patient reduce mortality Region Serious Adverse Event Serious Adverse Events significant effect Spread systematic review therapeutic effect Treatment Trial whole body
[DOI] 10.1097/MD.0000000000025532 PMC 바로가기 [Article Type] Meta-Analysis

A randomised, double-blind, placebo-controlled, pilot trial of intravenous plasma purified alpha-1 antitrypsin for SARS-CoV-2-induced Acute Respiratory Distress Syndrome: a structured summary of a study protocol for a randomised, controlled trial

SARS-CoV-2 유발 급성 호흡곤란 증후군에 대한 정맥내 혈장 정제 알파-1 항트립신의 무작위 이중 맹검 위약 대조 파일럿 시험: 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약

Letter

Published on 2021-04-192022-09-10
Journal: Trials [Category] 임상,

[키워드] 24 hours active malignancy acute kidney Acute kidney injury acute respiratory distress syndrome addition Administered administration adverse event adverse events AEs age Alpha alpha-1 antitrypsin Amendment Anti-viral Antibiotics anticipated antitrypsin antivirals approval approved ARDS ARMS authority bacterial pneumonia baseline Berlin criteria blinded to treatment Blinding BMI body weight Cancer changes in Child-Pugh score chloride Chronic kidney disease chronic liver disease circulating class clinical Clinical outcome clinical trial Combination commenced Committee comparator Complete conducted Consent Controlled trial correction COVID-19 Culture cytokine level cytokine levels Data collection defined determine Diagnosis diagnosis of ARDS dialysis dissemination DNAR double-blind Echocardiogram Effect Effectiveness elapsed element ELISA enrolled EudraCT excluded exclusion exclusion criteria facilitate Follow-up followed by for inclusion group Health Products regulatory Authority hospital Hospital admission hypertension ICU IgA deficiency IL-10 IL-1β IL-6 IL-8 incidence inclusion criteria individual information intensive care unit intensive care units interim analysis interleukin interleukin-10 interleukin-1β interleukin-6 interleukin-8 interpreter Intervention intravenous intravenous infusion intravenously invasive investigational medicinal product investigator Ireland Kidney disease Laboratory laboratory-confirmed life Local maintain major trauma malignancy mandatory marker mechanical ventilation Microscopy moderate moderate to severe Mortality Non-invasive non-invasive mechanical ventilation non-invasive ventilation number objective occur Organ failure outcome outcome measure PaO participant Patient patient recruitment patients with moderate PCR-confirmed Phase 2 physician Placebo placebo-controlled plasma plasma analysis plasma concentration plasma concentrations pregnant preparation product protocol provided Pulmonary embolism pulmonary hypertension purified Radiographic randomisation randomisation list randomised randomised controlled trial rationale readmission REC receiving receptor recruited recruitment reduce Regulatory removal renal renal replacement therapy replacement therapy reported required Research Research Ethics Research Ethics Committee research nurse research nurses respiratory respiratory distress Respiratory distress syndrome resulting Resuscitation SAE SAEs Sample size SARS-CoV-2 secondary secondary bacterial pneumonia Secondary objective Secondary objectives Secondary outcomes secretion Sequential Organ Failure Assessment Serious Adverse Event Serious Adverse Events severe ARDS Shock single dose skin cancer Sodium chloride SOFA Standard statistician stratified study participation Study protocol subject submitted supplementary material Support sustained TNF TNF-α Tolerability trauma Treatment treatment allocation Trial trial protocol Trial registration vasopressors ventilator verbal Version Volume website WHO Withdrawal writing
[DOI] 10.1186/s13063-021-05254-0 PMC 바로가기 [Article Type] Letter