Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trialCOVID-19(TICO)로 입원한 성인을 위한 두 가지 중화 단일클론항체 치료제인 소트로비맙과 BRII-196과 BRII-198의 효능 및 안전성: 무작위 대조 시험Randomized Controlled Trial Published on 2022-05-012022-09-12 Journal: The Lancet. Infectious Diseases [Category] COVID19(2023년), SARS, 임상, 진단, [키워드] addition adjusted adjusted odds ratio Administered analyses Analysis assigned Biotechnology Clinical outcome clinical recovery clinical trial Complication complications of COVID-19 COVID-19 COVID-19 symptom death defined Denmark died discharge double-blind Efficacy Efficacy and safety eligible enrolled enrolment female hospital hospitalised Inpatient Interim intravenously laboratory-confirmed SARS-CoV-2 infection male matching placebo median age modified intention-to-treat monoclonal antibody neutralising operation Organ failure outcome participant Patient Placebo placebo group placebo-controlled Poland Primary outcome randomisation randomised randomised controlled trial Randomly recruited Registered Serious Adverse Events significantly higher single dose speed Standard of care stratified study drug sustained Switzerland the placebo group Therapeutics Therapies therapy Treatment Trial USA were assessed with COVID-19 [DOI] 10.1016/S1473-3099(21)00751-9 PMC 바로가기 [Article Type] Randomized Controlled Trial
Immunogenicity and safety of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine in people living with and without HIV-1 infection: a randomised, controlled, phase 2A/2B trialHIV-1 감염 여부에 관계없이 살고 있는 사람들을 대상으로 한 SARS-CoV-2 재조합 스파이크 단백질 나노입자 백신의 면역원성과 안전성: 무작위, 대조, 2A/2B상 시험Clinical Trial Published on 2022-05-012022-09-12 Journal: The Lancet. HIV [Category] COVID19(2023년), MERS, SARS, 임상, 진단, [키워드] 1:1 amplification angiotensin-converting enzyme 2 anti-Spike IgG antibody Antiretroviral therapy article assigned baseline clinical Coalition Cohort COVID-19 COVID-19 vaccine death dosage Efficacy and safety ELISA endpoints enrolled enrolment evaluated first vaccination geometric mean titre GMT GMTs HIV-1 HIV-1 viral HIV-negative humoral immune response immunogenicity increased risk individual injection interim analysis intervention group Intramuscular injection less Local Matrix-M Melinda Gate multicentre neutralising antibody titres Novavax NVX-CoV2373 NVX-CoV2373 vaccine observer-blinded occurred PACTR202009726132275 participant Participants paucity of data Placebo placebo-controlled provided randomised Randomly reactive receive Recombinant spike protein Registered registry remained reported safety analysis SARS-CoV-2 SARS-CoV-2 nucleic acid SCR SCRs second vaccination Serious Adverse Event Serious Adverse Events seroconversion rate serostatus South Africa stratified study group Support systemic adverse event the placebo group the vaccine Trial vaccination Vaccine vaccine immunogenicity Volume was used were assessed [DOI] 10.1016/S2352-3018(22)00041-8 PMC 바로가기 [Article Type] Clinical Trial
Bacillus Calmette-Guérin vaccine to reduce healthcare worker absenteeism in COVID-19 pandemic, a randomized controlled trial ☆Original Article Published on 2022-04-282022-10-04 Journal: Clinical microbiology and infection : the official [Category] COVID19(2023년), MERS, SARS, 임상, [키워드] 1:1 95% CI 95% confidence interval acute respiratory symptom adjusted hazard ratio adjusted relative risk Bacillus BCG BCG vaccination COVID-19 COVID-19 pandemic COVID-19 patient cumulative incidence did not reduce duration of follow-up Endpoint enrolled Fever first episode HCW health care workers healthcare worker hospital Immunity increase interquartile range investigated median medication nine non-specific objective occurred Participants Placebo primary endpoint Randomized Randomized controlled trial reduce Registered reported respiratory infection Result secondary Serious Adverse Event the placebo group trained immunity Unplanned Vaccine [DOI] 10.1016/j.cmi.2022.04.009 PMC 바로가기 [Article Type] Original Article
Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19코비드-19를 가진 고위험, 입원하지 않은 성인을 위한 경구 NirmatrelvirClinical Trial Published on 2022-04-142022-09-11 Journal: The New England Journal of Medicine [Category] COVID19(2023년), SARS, 신약개발, 임상, 진단, 치료제, [키워드] 1:1 95% CI 95% confidence interval acute respiratory syndrome acute respiratory syndrome coronavirus adjusted Administered adverse event adverse events Analysis assigned conducted Controlled trial coronavirus coronavirus disease Coronavirus disease 2019 death deaths diarrhea double-blind drug dysgeusia enhancer evaluated Final final analysis high risk Hospitalization in vitro incidence inhibitor initiated interim analysis log M pro mean difference milliliter modified intention-to treat modified intention-to-treat Nirmatrelvir occurred onset of symptoms oral Patient patients patients treated Pfizer pharmacokinetic Placebo placebo group progression protease randomization randomized, controlled trial receive Relative risk risk risk reduction Ritonavir Serious Adverse Events severe acute respiratory syndrome Coronavirus severe coronavirus disease severe COVID-19 symptom onset symptomatic symptomatic COVID-19 the placebo group Treatment treatment period two group two groups Viral load [DOI] 10.1056/NEJMoa2118542 PMC 바로가기 [Article Type] Clinical Trial
A randomized, double-blind, placebo-controlled trial of intravenous alpha-1 antitrypsin for ARDS secondary to COVID-19Clinical Trial Published on 2022-04-082022-10-05 Journal: Med (New York, N.Y.) [Category] 바이오마커, 임상, [키워드] accelerated acute respiratory distress acute respiratory distress syndrome addition alpha-1 antitrypsin Anti-inflammatory ARDS biochemically changes in circulating Clinical outcome clinical trial Concentration coronavirus COVID-19 Cytokines develop double-blind EudraCT feasible febrile Grifols groups IL-10 IL-1β IL-6 IL-8 Inflammation interleukin-6 intravenous moderate Mortality multicenter Necrosis patients patients receiving placebo patients with COVID-19 phase 3 trial Placebo placebo-controlled trial plasma primary endpoint pro-inflammatory progression Randomized randomized control trial randomized control trial. receive receptor reduce Safe Secondary endpoints severe ARDS severe coronavirus disease Support syndrome the placebo group therapeutic Tolerability Treatment treatment group Trial ventilator ventilator-free day was increased were assessed [DOI] 10.1016/j.medj.2022.03.001 PMC 바로가기 [Article Type] Clinical Trial
Efficacy, safety, and immunogenicity of the DNA SARS-CoV-2 vaccine (ZyCoV-D): the interim efficacy results of a phase 3, randomised, double-blind, placebo-controlled study in IndiaClinical Trial Published on 2022-04-022022-10-05 Journal: Lancet (London, England) [Category] COVID19(2023년), SARS, 임상, [키워드] 1:1 95% CI Administered adverse event Analysis assessment assigned baseline Biotechnology clinical clinical trial comorbid conditions conducted COVID-19 criteria Cutoff death Department DNA dose double-blind Efficacy efficacy analysis eligible enrolled Government of India Gujarat identify immunogenic India individual injection interim analysis investigators multicentre Occurrence Older outcome assessor participant per-protocol population Phase 3 phase 3 trial Placebo placebo group placebo-controlled placebo-controlled study Primary outcome randomisation randomised Randomly receive Registered registry reported Safe safety population SARS-CoV-2 SARS-CoV-2 vaccine screened symptomatic the placebo group Tolerability Treatment treatment group Trial Vaccine was done was used [DOI] 10.1016/S0140-6736(22)00151-9 PMC 바로가기 [Article Type] Clinical Trial
Efficacy of favipiravir in adults with mild COVID-19: a randomized, double-blind, multicentre, placebo-controlled clinical trialRandomized Controlled Trial Published on 2022-04-012022-10-04 Journal: Clinical microbiology and infection : the official [Category] 신약개발, 임상, [키워드] 1:1 28-day mortality 95% CI acute respiratory syndrome Admissions adverse events assigned clinical clinical recovery clinical trial coronavirus coronavirus disease COVID-19 did not reduce double-blind double-blinded enrolment evaluate Favipiravir hazard ratio Hospital admission Hospitalization intensive care interim analysis interquartile range male matching placebo median age median time Mild mild case mild COVID-19 mild COVID-19 patient monitoring board multicentre negative RT-PCR no difference Non-severe SARS-CoV-2 Non-severe SARS-CoV-2. participant Patient PCR test PCR-confirmed Placebo placebo-controlled clinical trial placebo-controlled trial Primary outcome Randomized receive recruited reduce reducing SARS-CoV-2 Saudi Arabia secondary outcome Seven severe adverse events symptom resolution the placebo group therapy Treatment treatment group Trial two group viral clearance [DOI] 10.1016/j.cmi.2021.12.026 PMC 바로가기 [Article Type] Randomized Controlled Trial
Inflawell ® improves neutrophil-to-lymphocyte ratio and shortens hospitalization in patients with moderate COVID-19, in a randomized double-blind placebo-controlled clinical trialInflawell®은 무작위 이중 맹검 위약 대조 임상 시험에서 중등도 COVID-19 환자의 호중구 대 림프구 비율을 개선하고 입원 기간을 단축합니다.Randomized Controlled Trial Published on 2022-04-012022-09-11 Journal: Inflammopharmacology [Category] COVID19(2023년), SARS, 임상, 치료기술, [키워드] activated activities addition administration Anti-inflammatory Anti-viral drugs average baseline Boswellia boswellic acids clinical clinical symptom Clinical symptoms clinical trial completion conducted cough COVID-19 COVID-19 symptom COVID-19 symptoms CRP Cytokines Disease progression double-blind duration of hospitalization dysfunction Dyspnea dysregulated immune response enrolled evaluated Fewer patients Gustatory headache help Hospital stay Hospitalization hospitalized patient IMPROVE increase in Inflammation Inflawell® syrup Intervention investigated LDH lymphocyte Lymphocytes marker Moderate COVID-19 moderate COVID-19 patients myalgia neutrophil Neutrophil-to-lymphocyte ratio Neutrophils NLR NLR. olfactory olfactory and gustatory dysfunction oxygen oxygen saturation Patient patients with moderate PCR-positive Placebo placebo group placebo-controlled placebo-controlled clinical trial Prevent prevent disease progression pro-inflammatory cytokines public health Randomized reduce Registered significant decrease significant increase significantly shorter Standard of care statistically significant Symptom syrup the placebo group the WHO therapeutic potential TNF Treatment Trial unique Vaccine [DOI] 10.1007/s10787-022-00928-w PMC 바로가기 [Article Type] Randomized Controlled Trial
Efficacy and safety of baricitinib plus standard of care for the treatment of critically ill hospitalised adults with COVID-19 on invasive mechanical ventilation or extracorporeal membrane oxygenation: an exploratory, randomised, placebo-controlled trialClinical Trial Published on 2022-04-012022-10-04 Journal: The Lancet. Respiratory Medicine [Category] COVID19(2023년), SARS, 임상, 치료법, [키워드] 1:1 A significant reduction all-cause mortality assigned Baricitinib baseline Blood clots Brazil cardiovascular event Care Cohort Combination company conducted Corticosteroids Critically ill death died double-blind duration of hospitalisation Efficacy efficacy analysis Efficacy and safety Endpoint enrolled evaluate event exploratory extracorporeal membrane oxygenation hazard ratio hospital hospitalised hospitalised patient infections inhibitor intention-to-treat population Invasive mechanical ventilation investigator Janus kinase laboratory-confirmed SARS-CoV-2 infection less Lilly membrane Mortality not differ participant Participants Patient Phase 3 phase 3 trial Placebo placebo-controlled trial placebo-treated participant prevented randomised Randomly receiving reduced reduction Registered risk reduction safety analysis safety population SARS-COV-2 infection selective severely ill patient shown significantly significantly shorter Standard Standard of care Study design study group study population systemic corticosteroid the placebo group Time to recovery Treatment treatment group treatment groups Trial USA ventilator-free day Ventilator-free days was done with COVID-19 [DOI] 10.1016/S2213-2600(22)00006-6 PMC 바로가기 [Article Type] Clinical Trial
Effect of Androgen Suppression on Clinical Outcomes in Hospitalized Men With COVID-19: The HITCH Randomized Clinical TrialRandomized Controlled Trial Published on 2022-04-012022-10-04 Journal: JAMA Network Open [Category] COVID19(2023년), SARS, 임상, [키워드] adverse event Affair age all-cause mortality analyzed androgen antiandrogen Antibiotics Asthma baseline cardiovascular disease Care Cell chronic obstructive chronic respiratory clinical Clinical improvement Clinical outcome common Comorbidity convalescent plasma COVID-19 COVID-19 severity Department determine Dexamethasone diabete disease severity disorder double-blind Effect Efficacy end point End points enrolled Hemodialysis hospital Hospitalization Hospitalized hypertension IMPROVE Inpatient interim analysis intravenous fluids Invasive mechanical ventilation mechanical ventilation median men Mortality no difference no significant difference outcome Patient patients patients randomized Peritoneal dialysis Placebo placebo group placebo-controlled primary end point protease randomization Randomized randomized clinical trial reduce expression Remdesivir requiring supplemental oxygen saline placebo SARS-CoV-2 entry secondary Serious Adverse Event severity of COVID-19 Standard standard care stratified subcutaneous dose supplemental oxygen suppression temperature the placebo group therapy TMPRSS2 Trial usual care vasopressor support veteran with COVID-19 [DOI] 10.1001/jamanetworkopen.2022.7852 PMC 바로가기 [Article Type] Randomized Controlled Trial