Evaluating the efficacy and safety of a novel prophylactic nasal spray in the prevention of SARS-CoV-2 infection: A multi-centre, double blind, placebo-controlled, randomised trialRandomized Controlled Trial Published on 2022-10-012022-10-04 Journal: Journal of Clinical Virology [Category] COVID19(2023년), SARS, 임상, [키워드] absence Administered analysed Anti-spike clinical clinical symptom clinical trial co-morbidity Community Course COVID-19 COVID-19 pandemic double blind Effect Efficacy and safety eligibility criteria evaluate Evaluating healthcare Immunoglobulin Infection nasal offer participant Placebo placebo-controlled placebo-controlled trial positive primary end point Prophylactic Prophylaxis random randomised Randomised trial Randomized reduced Result Safe SARS-CoV-2 SARS-COV-2 infection SARS-CoV-2. significantly subject tested the primary endpoint the spike protein Treatment vaccination [DOI] 10.1016/j.jcv.2022.105248 PMC 바로가기 [Article Type] Randomized Controlled Trial
Randomized clinical trial of BCG vaccine in patients with convalescent COVID-19: Clinical evolution, adverse events, and humoral immune responseArticle Published on 2022-10-012022-11-15 Journal: Journal of internal medicine [Category] 진단, [키워드] acute respiratory syndrome Adults adverse effect adverse event adverse events Ageusia angiotensin-converting enzyme 2 Anosmia Bacillus BCG center clinical clinical evolution clinical trial convalescence convalescent coronavirus coronavirus disease COVID-19 cross-protection double-blind evaluated Evolution expected Follow-up humoral humoral immune response IgG Immunoglobulin immunomodulation induce lesions Local modulation multicenter N protein neutralization neutralize NNT offer Other outcome Outpatient Patient Placebo placebo-controlled placebos prevented Primary outcome proportion Randomized receptor recipient Safe Safety. SARS-CoV-2 serum Seven severely ill patient significantly higher South America statistically significant systemic adverse effects treat university Vaccine viral disease virus [DOI] 10.1111/joim.13523 PMC 바로가기
Inhaled aviptadil for the possible treatment of COVID-19 in patients at high risk for ARDS: study protocol for a randomized, placebo-controlled, and multicenter trialArticle Published on 2022-09-202022-11-16 Journal: Trials [Category] SARS, 변종, [키워드] acute lung injury acute respiratory distress addition adverse effects antibody applied ARDS Aviptadil baseline Clinical improvement clinical status Concentration conducted COVID-19 COVID-19 in patient COVID-19 patient defined double-blinded Efficacy and safety Europe exclusion criteria FIVE hemodynamic instability high risk homeostasis hospital discharge Hospitalization immunomodulating IMPROVE indicate Inhaled intensive care intestinal intravenously lung lung tissue management mechanical ventilation metabolism Mortality multicenter Multicenter trial pandemic Pathways Patient patients hospitalized peptide placebo-controlled Prevent primary endpoint pro-inflammatory Prognosis Protein Public Hospital Randomized randomized trial Randomly reduction Regulation respiratory complication Risk factors SARS-CoV-2 severe disease course shown standard care stratified Study protocol suggested syndrome the SARS-CoV-2 therapeutic agent Therapies therapy Treatment unique vaccination Vaccine variants of SARS-CoV-2 Vasoactive VIP VIP. with COVID-19 World Health Organization [DOI] 10.1186/s13063-022-06723-w PMC 바로가기
A study protocol for a double-blind randomised placebo-controlled trial evaluating the efficacy of carrageenan nasal and throat spray for COVID-19 prophylaxis-ICE-COVIDArticle Published on 2022-09-152022-11-16 Journal: Trials [Category] SARS, 변종, [키워드] 1:1 applied carrageenan clinical trial COVID-19 COVID-19 infection COVID-19. demonstrated double-blind double-blinded Effect effective Efficacy expressed General population host cell surface host cells in vitro activity include Infection infections initial viral load iota-carrageenan kappa-carrageenan nasal Non-COVID-19 nose and throat occur outcome participant penetrate Placebo placebo-controlled placebo-controlled clinical trial placebo-controlled trial polysaccharide positive PCR Prophylactic Prophylaxis purified questionnaire randomised receptors reduce Research risk SARS-CoV-2 secondary Seroconversion severity severity of COVID-19 shown Sodium chloride Study protocol subsequent Swab Symptom symptom onset thought treatment arm Trial upper respiratory tract utility vaccination Vaccine variant viral entry virus [DOI] 10.1186/s13063-022-06685-z PMC 바로가기
Anti-C5a antibody (vilobelimab) therapy for critically ill, invasively mechanically ventilated patients with COVID-19 (PANAMO): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trialArticle Published on 2022-09-072022-10-06 Journal: The Lancet. Respiratory Medicine [Category] COVID19(2023년), SARS, 진단, [키워드] 1:1 95% CI Acute kidney injury acute respiratory distress addition all-cause mortality all-cause mortality rate Analysis antibody assigned Belgium Block randomisation Brazil C5a Critically ill defined determine died dose double-blind eligible excluded France Germany hazard ratio hospital hospital discharge IMPROVE intravenously intubation invasive Invasive mechanical ventilation ITT analysis Kaplan-Meier analysis matching placebo mechanically ventilated patient monoclonal antibody Mortality multicentre Netherlands Older one patient outcome PaO participant Patient patient population phase 2 trial phase 3 trial Placebo placebo-controlled Pneumonia primary analysis Primary outcome random assignment randomised Randomly receive receiving reduced Registered reported Research Russia Safe Safety analysis safety analysis SARS-COV-2 infection Septic shock shown significant decrease significantly South Africa Standard of care survival TEAE the placebo group therapy Treatment treatment-emergent adverse event variant vilobelimab viral infections was performed with COVID-19 [DOI] 10.1016/S2213-2600(22)00297-1 PMC 바로가기 [Article Type] Article
A Randomized Double-Blinded Placebo Controlled Trial of Clazakizumab for the Treatment of COVID-19 Pneumonia With Hyperinflammation고염증을 동반한 COVID-19 폐렴의 치료를 위한 Clazakizumab의 무작위 이중 맹검 위약 대조 시험Clinical Trial Published on 2022-09-012022-09-12 Journal: Critical Care Medicine [Category] COVID19(2023년), MERS, SARS, 임상, 진단, [키워드] 1:1 accompanied added Bayesian benefit board changes Clazakizumab Clinical outcome clinical status Controlled COVID-19 COVID-19 disease Critical cumulative double-blinded dropped enrolled Frequency greater High-dose hospitalized patient hyperinflammation ICU ICU admission inhibitor Inpatient interleukin-6 intubation Logistic low-dose measurement monitoring Odds ratio outcome Patient patients patients hospitalized Placebo placebo-controlled Poisson regression model Primary outcome Randomized receiving recommendations risk Safety seamless secondary secondary outcome severe COVID-19 disease significantly suggested survival Trial Ventilation ventilator-free survival were used with COVID-19 [DOI] 10.1097/CCM.0000000000005591 PMC 바로가기 [Article Type] Clinical Trial
Debulking different Corona (SARS-CoV-2 delta, omicron, OC43) and Influenza (H1N1, H3N2) virus strains by plant viral trap proteins in chewing gums to decrease infection and transmissionArticle Published on 2022-09-012022-11-15 Journal: Biomaterials [Category] COVID19(2023년), SARS, 신종인플루엔자, 치료기술, [키워드] Chewing clinical trial Corona Debulking decrease dose-dependent double-blinded evaluate expressed H1N1 H3N2 HCoV-OC43 IND Infection Influenza investigated linear magnitude N-antigen nasal nasopharyngeal OC43 overlapping Particle phase placebo-controlled plant cells Protein purified reduced reduction Saliva SARS-CoV-2 delta significantly Spike protein strain Transmission transmission of SARS-CoV-2 Viral load virus virus load virus strain [DOI] 10.1016/j.biomaterials.2022.121671 PMC 바로가기
Efficacy and safety of camostat mesylate in early COVID-19 disease in an ambulatory setting: a randomized placebo-controlled phase II trialClinical Trial Published on 2022-09-012022-10-04 Journal: International Journal of Infectious Diseases [Category] COVID19(2023년), SARS, 임상, 치료제, [키워드] 95% confidence interval adverse event analysis antiviral drug assigned asymptomatic patient camostat Camostat mesylate Clinical improvement conducted Confirmed COVID-19 infection COVID-19 COVID-19 disease Cox regression cycle threshold distribution early phase effective Efficacy Efficacy and safety Frequency hazard ratio nasopharyngeal viral load Neutralizing antibodies Neutralizing antibody titer participant performed Placebo placebo group placebo-controlled protocol Randomized Randomized controlled trial Randomly receive Safety Safety. SARS-CoV-2 symptomatic treat Treatment Trial two groups [DOI] 10.1016/j.ijid.2022.06.054 PMC 바로가기 [Article Type] Clinical Trial
Safety and immunogenicity of SpikoGen®, an Advax-CpG55.2-adjuvanted SARS-CoV-2 spike protein vaccine: a phase 2 randomized placebo-controlled trial in both seropositive and seronegative populationsArticle Published on 2022-09-012022-11-15 Journal: Clinical microbiology and infection : the official [Category] COVID19(2023년), SARS, 진단, [키워드] Advax-CpG adverse event antibody Cellular immune response composed conducted COVID-19 COVID-19 vaccine dose double-blind fatigue geometric mean concentration humoral incidence injection site pain Mild outcome participant phase Phase 2 phase 2 trial Placebo placebo-controlled Population primary immunogenicity Protein Randomized randomized placebo-controlled trial receive Safety safety profile SARS-CoV-2 SARS-CoV-2 spike protein second dose Serious Adverse Event Seroconversion seroconversion rate seronegative seropositive SpikoGen subunit subunit protein vaccine. the placebo group vaccination Vaccine Volunteer were recorded [DOI] 10.1016/j.cmi.2022.04.004 PMC 바로가기
Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adultsResearch article Published on 2022-09-012022-10-05 Journal: Vaccine [Category] 임상, 진단, 치료기술, [키워드] 95 % CI adverse event Adverse events of special interest analyses analysis Analysis baseline Brighton Collaboration Coalition for Epidemic Preparedness Innovations collaboration Combined COVID-19 COVID-19 vaccination COVID-19 vaccine COVID-19 vaccine trials COVID-19 vaccines datasets evaluate exhibited higher risk Moderna Moderna COVID-19 vaccine mRNA-1273 mRNA mRNA COVID-19 vaccine mRNA vaccine mRNA vaccines NCT04368728 NCT04470427 outcomes Pfizer Pfizer-BioNTech COVID-19 vaccine BNT162b2 Placebo placebo-controlled randomized clinical trial randomized trial reported Result risk Safety Platform for Emergency vACcines SARS-CoV-2 secondary Serious Adverse Event Serious Adverse Events serious COVID-19 stratified the vaccine Trial Vaccines World Health Organization [DOI] 10.1016/j.vaccine.2022.08.036 [Article Type] Research article