Phase 2 – Page 10 – Communicable Diseases Research

Safety and efficacy of meplazumab in healthy volunteers and COVID-19 patients: a randomized phase 1 and an exploratory phase 2 trial

건강한 지원자와 COVID-19 환자에 대한 메플라주맙의 안전성 및 효능: 무작위 1상 및 탐색적 2상 시험

Clinical Trial

Published on 2021-05-172022-08-13
Journal: Signal Transduction and Targeted Therapy [Category] Fulltext, SARS, 비임상, 임상, 진단, 치료제,

Scalable modEls of Community rehAbilitation for Individuals Recovering From COVID:19 reLated illnEss: A Longitudinal Service Evaluation Protocol—“SeaCole Cohort Evaluation”

Public Health

Published on 2021-05-132022-10-31
Journal: Frontiers in Public Health [Category] COVID-19, MERS, SARS,

[키워드] accelerate activity Adjusted Life Year anticipated changes in cognitive collected Community Cost effectiveness COVID-19 COVID-19 patient COVID-19 symptom current Digital health dimension discharged Duke effective intervention Effectiveness emotional emotional well-being England exercise experience GAD-7 Health Service healthcare services impairment Independent sector individual International ISRCTN Level longitudinal morbidity NHS outcome outcome measure outcomes pathway Patient Phase 1 Phase 2 PHQ-9 physical primary outcome measure Quality Quality of life recovering from COVID-19 rehabilitation secondary service status Support survivor Survivors Symptom management Treatment Version
[DOI] 10.3389/fpubh.2021.628333 PMC 바로가기 [Article Type] Public Health

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

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

Efficacy and safety of pegylated interferon alfa-2b in moderate COVID-19: A phase II, randomized, controlled, open-label study

중등도 COVID-19에서 페길화된 인터페론 알파-2b의 효능 및 안전성: A상, 무작위, 대조, 공개 라벨 연구

Clinical Trial

Published on 2021-04-012022-09-11
Journal: International Journal of Infectious Diseases [Category] SARS, 임상, 치료제,

Lessons from COVID-19-free Vanuatu: intensive health operations for Phase 1 of repatriation and quarantine, May–July 2020

Covid-19

Published on 2021-03-102022-10-28
Journal: Western Pacific Surveillance and Response Journal [Category] COVID-19, MERS, SARS,

Evaluation of the safety and efficacy of XAV-19 in patients with COVID-19-induced moderate pneumonia: study protocol for a randomized, double-blinded, placebo-controlled phase 2 (2a and 2b) trial

COVID-19 유발 중등도 폐렴 환자에서 XAV-19의 안전성 및 효능 평가: 무작위 배정, 이중 맹검, 위약 대조 2상(2a 및 2b) 시험을 위한 연구 프로토콜

Study Protocol

Published on 2021-03-092022-09-01
Journal: Trials [Category] SARS, 비임상, 임상, 진단,

[키워드] acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 Administered administration anti-SARS-CoV-2 antibodies Anti-viral antibody Antibody Response blunting breath cells clinical benefit clinical benefits Combination convalescent plasma coronavirus COVID-19 COVID-19 patients determine dose double-blinded Drug-drug interactions effective Efficacy EudraCT evaluate Heterologous human cell humanized humans Immunity immunotherapies Immunotherapy indicated infected patient infected patients Infection inhibiting intravenous kidney lack long term moderate Moderate pneumonia neutralizing antibody New not adapted offer pathogenic Patient patients with SARS-CoV-2 performed pharmacodynamic studies pharmacodynamic study Phase 2 Placebo placebo-controlled placebo-controlled study plasma Pneumonia polyclonal polyclonal antibody populations primates pro-inflammatory Prophylaxis raised Randomized Randomized controlled trial recipient recipients Registered Replication respiratory SARS-CoV-2 selected severe acute respiratory syndrome Coronavirus Spike protein spike protein of SARS-CoV-2 Study protocol supplementary material the spike protein Therapeutic approach therapeutic option to define treat Treatment treatment for COVID-19 Trial Trial registration
[DOI] 10.1186/s13063-021-05132-9 PMC 바로가기 [Article Type] Study Protocol

Effect of human umbilical cord-derived mesenchymal stem cells on lung damage in severe COVID-19 patients: a randomized, double-blind, placebo-controlled phase 2 trial

중증 COVID-19 환자의 폐 손상에 대한 인간 탯줄 유래 중간엽 줄기세포의 효과: 무작위, 이중 맹검, 위약 대조 2상 시험

Clinical Trial

Published on 2021-02-102022-08-13
Journal: Signal Transduction and Targeted Therapy [Category] Fulltext, MERS, 바이오마커, 임상, 치료제,

[키워드] 6-minute walk test 6-MWT 95% CI administration adverse event adverse events analyzed assigned baseline Cell China coronavirus disease Coronavirus disease 2019 COVID-19 COVID-19 patient COVID-19 patients diffusing diffusing capacity double-blind Effect effective Efficacy and safety evaluate incidence infusion long-term pulmonary disability lung lung damage lung lesion median MSCs Other outcomes patients treated performed Phase 1 Phase 2 phase 2 trial phase 3 trial Placebo placebo-controlled placebo-controlled trial primary endpoint Program proportion proportions pulmonary disability Randomized Randomly receive recruited reduced reducing mortality required Safe severe coronavirus disease severe COVID-19 severe COVID-19 patient severe COVID-19 patients significantly solid component stem cell stem cells the median Therapeutic approach treat Treatment two groups UC-MSC UC-MSCs umbilical vital capacity Volume were recorded
[DOI] 10.1038/s41392-021-00488-5 PMC 바로가기 [Article Type] Clinical Trial

A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine

Clinical Trial

Published on 2021-02-092023-06-16
Journal: Vaccine [Category] MERS, SARS,

Direct antivirals working against the novel coronavirus: azithromycin (DAWn-AZITHRO), a randomized, multicenter, open-label, adaptive, proof-of-concept clinical trial of new antivirals working against SARS-CoV-2—azithromycin trial

신종 코로나바이러스에 대항하는 직접 항바이러스제: 아지스로마이신(DAWn-AZITHRO), 무작위, 다기관, 공개 라벨, 적응형, SARS-CoV-2에 대해 작용하는 새로운 항바이러스제의 개념 증명 임상 시험 - 아지스로마이신 시험

Study Protocol

Published on 2021-02-092022-09-10
Journal: Trials [Category] MERS, 임상, 치료제,

[키워드] 7-category ordinal scale adaptive Admission amplify antibiotic Antiviral Antiviral effect Azithromycin Belgium blunt Bronchoalveolar lavage Care chance chest CT scan clinical Clinical improvement clinical trial coronavirus SARS-CoV-2 Course COVID COVID-19 COVID-19 disease cytokine cytokine signaling decrease defined diagnosed with COVID-19 Diagnosis Direct discharge disease disease course drug Efficacy eligible EudraCT feature health regulations Hospitalized hospitalized patient hospitalized patients Hydroxychloroquine hyperinflammatory state immunomodulatory properties implicated in vitro include Inclusion Intervention life Local Macrolide medical need multicenter name Nasopharyngeal swab National Novel coronavirus novel coronavirus SARS-CoV-2 Open-label Ordinal Scale pathway Pathways Patient patients patients with COVID-19 PCR Phase 2 Primary outcome proof-of-concept clinical trial radiological Randomized Randomized controlled trial receive recruit SARS-CoV-2 severe COVID-19 disease shown Standard Standard of care study inclusion supplementary material Support sustained symptomatic the disease the WHO treatment effect treatment effects treatment group treatment strategy Trial Viral viral replication widespread with COVID-19
[DOI] 10.1186/s13063-021-05033-x PMC 바로가기 [Article Type] Study Protocol