Effect of early treatment with polyvalent immunoglobulin on acute respiratory distress syndrome associated with SARS-CoV-2 infections (ICAR trial): study protocol for a randomized controlled trialSARS-CoV-2 감염과 관련된 급성 호흡 곤란 증후군에 대한 다가 면역글로불린의 조기 치료 효과(ICAR 시험): 무작위 대조 시험을 위한 연구 프로토콜Study Protocol Published on 2021-02-282022-09-01 Journal: Trials [Category] MERS, 임상, 진단, [키워드] 1:1 90% power activities activity acute respiratory distress acute respiratory distress syndrome administration adverse event Alpha ARDS assessment chloride coronavirus coronavirus disease Coronavirus disease 2019 COVID-19 daily living defined died double-blind early treatment Effect effect size Efficacy and safety EudraCT evaluate evaluate the effect failure France functional GRADE grade 3 Hospital stay Hospitalized ICU Immunoglobulin immunomodulatory increase in intensive care intensive care unit Intravenous immunoglobulin IVIG Lung injury mechanical ventilation morbidity mortality rate multicenter Occurrence Organ failure outcome parallel group participant Patient pharmacological treatment placebo group Polyvalent immunoglobulin Primary outcome Randomized Randomized controlled trial receive reduction in respiratory distress SARS-CoV-2 SARS-COV-2 infection Secondary objective Secondary objectives sequential design Sodium chloride SOFA Study protocol subject survival survival rate syndrome the placebo group treatment group Trial Trial registration ventilator-free day Ventilator-free days Volume were infected with COVID-19 [DOI] 10.1186/s13063-021-05118-7 PMC 바로가기 [Article Type] Study Protocol
Proxalutamide Significantly Accelerates Viral Clearance and Reduces Time to Clinical Remission in Patients with Mild to Moderate COVID-19: Results from a Randomized, Double-Blinded, Placebo-Controlled TrialInfectious Disease Published on 2021-02-222022-10-31 Journal: Cureus [Category] COVID-19, [키워드] accelerated acute respiratory syndrome affected AGA Androgen receptor androgenetic alopecia anti-androgen therapy average clinical coronavirus COVID-19 Day defined dependent on double-blinded drugs expressed female female subject inhibitor less men Mild moderate Moderate COVID-19 Modification Patient patients treated Placebo positive proxalutamide Randomized receptor recruited reduced regulated Remission reported Result SARS-CoV-2 SARS-COV-2 infection SARS-CoV-2 test severe coronavirus disease significantly subject subjects the placebo group time TMPRSS2 transmembrane transmembrane protease serine 2 treated Treatment Type II pneumocyte viral clearance viral spike protein [DOI] 10.7759/cureus.13492 PMC 바로가기 [Article Type] Infectious Disease
Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in RussiarAd26 및 rAd5 벡터 기반 이종 프라임-부스트 COVID-19 백신의 안전성 및 효능: 러시아의 무작위 대조 3상 시험 중간 분석Clinical Trial Published on 2021-02-202022-09-12 Journal: Lancet (London, England) [Category] Fulltext, MERS, 임상, 진단, [키워드] 95% CI Administered adverse event age Analysis assigned available data case report form Cellular immune response city clinical trials COVID-19 database death Department Direct dose double-blind Efficacy Efficacy and safety enrolment events excluded first dose full-length SARS-CoV-2 Gam-COVID-Vac glycoprotein Heterologous heterologous prime-boost hospital humoral IgG and IgM independent Infectious disease interim analysis intramuscularly Investment large cohort MOST participant Participants PCR-confirmed COVID-19 phase 3 trial Placebo placebo-controlled Primary outcome primary outcome analysis proportion protocol randomised randomised controlled Randomly receive receiving recombinant adenovirus Registered reported Russia Safety safety profile SARS-CoV-2 PCR second dose Serious Adverse Event Stratification the placebo group the vaccine Trial vaccination Vaccine vector were assessed [DOI] 10.1016/S0140-6736(21)00234-8 PMC 바로가기 [Article Type] Clinical Trial
A Randomized Trial of Convalescent Plasma in Covid-19 Severe PneumoniaCovid-19 중증 폐렴에서 회복기 혈장의 무작위 시험Randomized Controlled Trial Published on 2021-02-182022-09-12 Journal: The New England Journal of Medicine [Category] MERS, SARS, 임상, 진단, [키워드] 95% CI 95% confidence interval Administered Adverse assigned Clinical outcome clinical status convalescent plasma convalescent plasma group COVID-19 pneumonia criterion death distribution Enrollment event Follow-up Hospitalized Hypoxemia improve clinical outcomes infused interquartile range Intervention median time median titer Mortality no significant difference Observational data Odds ratio onset of symptom overall mortality Patient patients treated Placebo plasma Primary outcome randomized, controlled trials Randomly receive reported risk SARS-CoV-2 antibody Serious Adverse Event severity significant difference the patient the placebo group Total Trial two groups [DOI] 10.1056/NEJMoa2031304 PMC 바로가기 [Article Type] Randomized Controlled Trial
Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19: A Randomized Clinical Trial경증에서 중등도의 COVID-19 환자의 바이러스 부하에 대한 밤라니비맙 단독 요법 또는 에테세비맙 병용 요법의 효과: 무작위 임상 시험Clinical Trial Published on 2021-02-162022-09-25 Journal: JAMA [Category] MERS, 임상, 진단, 치료법, 치료제, [키워드] 95% CI acute respiratory syndrome age ambulatory patient Analysis antibody bamlanivimab baseline clinical clinical benefit Clinical outcome clinical trial combination therapy combination treatment comparison coronavirus Coronavirus disease 2019 COVID-19 death determine Effect Efficacy End points enrolled etesevimab evaluated evaluation period events Final Hospitalization hypersensitivity reaction Immediate in viral load log measure Mild moderate Moderate COVID-19 monotherapy NCT04427501 neutralizing antibody no significant difference occurred outcome Patient patients with COVID-19 phase 2/3 trial Placebo positive Potential treatment primary end point proportion Randomized receive reduction reported SARS-CoV-2 SARS-COV-2 infection SARS-CoV-2 viral load secondary outcome measure secondary outcome measures Spread statistically significant statistically significant reduction Symptoms tested the placebo group Treatment treatment group Viral load women [DOI] 10.1001/jama.2021.0202 PMC 바로가기 [Article Type] Clinical Trial
Beneficial effects of colchicine for moderate to severe COVID-19: a randomised, double-blinded, placebo-controlled clinical trial중등도에서 중증 COVID-19에 대한 콜히친의 유익한 효과: 무작위, 이중 맹검, 위약 대조 임상 시험Randomized Controlled Trial Published on 2021-02-042022-08-13 Journal: RMD Open [Category] MERS, 임상, [키워드] 1:1 addition Admission Colchicine colchicine group COVID-19 death death rate diarrhoea died double-blinded drug Effect evaluate groups hospitalisation intensive care IQR log moderate moderate to severe Mortality objective outcome assessment outcomes oxygen Oxygen therapy Patient Placebo placebo group placebo-controlled clinical trial primary endpoint primary endpoints randomised reduced regimen registration number Result Safe severe COVID-19 standard treatment supplemental oxygen Supplemental oxygen therapy the placebo group Treatment Two patient two patients [DOI] 10.1136/rmdopen-2020-001455 PMC 바로가기 [Article Type] Randomized Controlled Trial
Early Antiandrogen Therapy With Dutasteride Reduces Viral Shedding, Inflammatory Responses, and Time-to-Remission in Males With COVID-19: A Randomized, Double-Blind, Placebo-Controlled Interventional Trial (EAT-DUTA AndroCoV Trial – Biochemical)Endocrinology/Diabetes/Metabolism Published on 2021-02-012022-10-31 Journal: Cureus [Category] COVID-19, [키워드] 24 hour acute respiratory syndrome AGA Analysis androgen Anosmia antagonist antiandrogen Azithromycin benefit biochemical C-reactive protein cell entry clinical recovery clinics conducted coronavirus COVID-19 COVID-19 disease severity D-dimer Day demonstrated determine disease dutasteride erythrocyte sedimentation rate ESR fatigue FIVE Inflammatory marker inhibitor Lactate LDH male median Mild mild COVID-19 symptom moderate nitazoxanide oxygen saturation participant Placebo positive protease receptor recruitment reduce reduced Regulation Result SARS-CoV-2 serine 2 Seven severe coronavirus disease shedding Standard therapy subject subsequent Symptoms the placebo group therapy transmembrane treated Treatment treatment for COVID-19 troponin level viral shedding were given [DOI] 10.7759/cureus.13047 PMC 바로가기 [Article Type] Endocrinology/Diabetes/Metabolism
Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled, phase 2 trialSARS-CoV-2 감염 치료를 위한 흡입 분무 인터페론 베타-1a(SNG001)의 안전성 및 효능: 무작위 배정, 이중 맹검, 위약 대조, 2상 시험Clinical Trial Published on 2021-02-012022-09-11 Journal: The Lancet. Respiratory Medicine [Category] 임상, 치료제, [키워드] 1:1 activities acute respiratory syndrome acute respiratory syndrome coronavirus adverse event adverse events Analysis assigned clinical clinical condition Clinical improvement clinical trials coronavirus COVID-19 symptoms death dose double-blind during treatment Efficacy Efficacy and safety FIVE greater hazard ratio headache hospital identify improvement Infection inhalation Inhaled Inpatient Inpatients intention-to-treat population interferon Interferon beta-1a MIU Multiple nine no infection Odds ratio Older Ordinal Scale oxygen oxygen supplementation Patient Phase 2 phase 2 trial Placebo placebo group placebo-controlled point-of-care positive RT-PCR Primary outcome randomised Randomly receive receiving Registered reported required respiratory Safety SARS-CoV-2 SARS-COV-2 infection scale Seven severe acute respiratory syndrome Coronavirus severe acute respiratory syndrome coronavirus 2 statistical study drug substantial risk Symptoms the placebo group the WHO those receiving placebo Treatment treatment-emergent adverse event Trial trials WHO ordinal scale with COVID-19 [DOI] 10.1016/S2213-2600(20)30511-7 PMC 바로가기 [Article Type] Clinical Trial
Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial18~59세의 건강한 성인을 대상으로 한 비활성화된 SARS-CoV-2 백신의 안전성, 내약성 및 면역원성: 무작위 배정, 이중 맹검, 위약 대조, 1/2상 임상 시험Clinical Trial Published on 2021-02-012022-09-12 Journal: The Lancet. Infectious Diseases [Category] MERS, SARS, 임상, 진단, [키워드] 1:1 acute respiratory syndrome Adverse reaction allergic assigned axillary temperature Beijing Block randomisation Cell chamber China Chinese clinical trial Cohort cohorts Community Corning CoronaVac coronavirus COVID-19 COVID-19 pandemic development diluent dose dose-escalating manner double-blind Efficacy Endpoint enrolled FIVE healthy High-dose hydroxide immunogenic inactivated Inactivated vaccine incidence Infection injection investigated investigators Jiangsu Laboratory live SARS-CoV-2 low dose low-dose morbidity and mortality neutralising antibody nine outcome participant per-protocol population phase 1 trial phase 2 trial Phase 3 trials Placebo placebo-controlled produced Program randomisation randomised Randomly receive recruited Registered Safety safety population SARS-CoV-2 SARS-CoV-2 vaccine Science separated Seroconversion seroconversion rate Seven Sinovac Life Sciences study drug suggested Taking technology the placebo group Tolerability treatment allocation Trial vaccination vaccination schedule Vaccine was done were excluded were given [DOI] 10.1016/S1473-3099(20)30843-4 PMC 바로가기 [Article Type] Clinical Trial
A five-day course of ivermectin for the treatment of COVID-19 may reduce the duration of illnessRandomized Controlled Trial Published on 2021-02-012022-10-05 Journal: International Journal of Infectious Diseases [Category] SARS, 임상, 치료법, [키워드] acute respiratory syndrome anti-parasitic assigned Bangladesh clearance clinical Combination comparable conducted control group coronavirus cough Course COVID-19 determine double-blind doxycycline drug duration of illness effective event Fever food hospitalized patient in vitro inhibit Ivermectin ivermectin treatment Mild Patient Placebo placebo-controlled trial preliminary findings Randomized recorded reduce Replication Safe SARS-CoV-2 SARS-CoV-2 patients single dose sore throat Symptom the placebo group three groups Treatment Trial viral clearance [DOI] 10.1016/j.ijid.2020.11.191 PMC 바로가기 [Article Type] Randomized Controlled Trial