Phase 3 – Page 4 – Communicable Diseases Research

Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients

입원하지 않은 환자의 코로나19 경구 치료용 몰누피라비르

Clinical Trial

Published on 2022-02-102022-09-11
Journal: The New England Journal of Medicine [Category] COVID19(2023년), SARS, 신약개발, 임상, 진단, 치료제,

Hyperimmune immunoglobulin for hospitalised patients with COVID-19 (ITAC): a double-blind, placebo-controlled, phase 3, randomised trial

입원한 COVID-19 환자를 위한 과면역 면역글로불린(ITAC): 이중 맹검, 위약 대조, 3상, 무작위 시험

Clinical Trial

Published on 2022-02-052022-09-11
Journal: Lancet (London, England) [Category] Fulltext, MERS, 임상, 진단, 치료제,

[키워드] 1:1 95% CI addition adjusted Administered adverse events Analysis Anti-spike antibody assigned baseline carried clinical care clinical trials Complication COVID-19 death donors double-blind duration of symptoms Efficacy Efficacy and safety eligibility criteria end-organ Endpoint enrolled Evidence evidence of Factors finding greater Group allocation heterogeneity hospitalised hospitalised patient Hospitalised patients hyperimmune Immunoglobulin Immunotherapy Infection infusion Interaction International Intravenous immunoglobulin investigators mass mITT mITT analysis modified intention-to-treat Neutralising Antibodies neutralising antibody Organ failure outbreak outcome participant Passive Patient Phase 3 Placebo placebo group placebo-controlled placebo-controlled trial positive Primary outcome randomisation randomised randomised clinical trial Randomised trial Randomly ranged reaction receive Registered Remdesivir Research risk Saline SARS-CoV-2 serious infections significantly Standard of care stratified subgroup subgroups Symptom symptomatic therapy to define Treatment treatment of COVID-19 Trial trial participant trial participants Volume was measured were used with COVID-19
[DOI] 10.1016/S0140-6736(22)00101-5 PMC 바로가기 [Article Type] Clinical Trial

Use of remdesivir in patients with COVID-19: a systematic review and meta-analysis

COVID-19 환자의 렘데시비르 사용: 체계적인 검토 및 메타 분석

Meta-Analysis

Published on 2022-02-022022-09-11
Journal: Revista da Sociedade Brasileira de Medicina Tropic [Category] COVID19(2023년), SARS, 치료제,

[키워드] 95% CI adverse event adverse events Clinical improvement clinical trials clinically control group control groups controls COVID-19 COVID-19 patient eligibility criteria English Evidence extracorporeal membrane oxygenation had no mechanical ventilation membrane Meta-analysis moderate moderate to severe Mortality no significant difference no significant differences Observational cohort study outcomes Oxygenation pacientes com COVID-19 pacientes hospitalizado Patient patients hospitalized patients with moderate Phase 3 question randomizado randomized clinical trial RCT RCTs receiving Remdesivir retrieved risk risk difference selected severe COVID-19 shown statistically significant difference systematic review treat Treatment
[DOI] 10.36416/1806-3756/e20210393 PMC 바로가기 [Article Type] Meta-Analysis

Remdesivir plus standard of care versus standard of care alone for the treatment of patients admitted to hospital with COVID-19 (DisCoVeRy): a phase 3, randomised, controlled, open-label trial

COVID-19(DisCoVeRy)로 입원한 환자의 치료를 위한 렘데시비르 + 표준 치료 대 표준 치료 단독: 3상, 무작위, 대조, 공개 시험

Clinical Trial

Published on 2022-02-012022-09-11
Journal: The Lancet. Infectious Diseases [Category] Fulltext, MERS, 임상, 치료법, 치료제,

[키워드] Abstract activities activity acute respiratory distress acute respiratory distress syndrome adaptive Administered Adult patient Adult patients Analysis antiviral efficacy assigned Bacterial infection Belgium block Breastfeeding Chronic kidney disease clinical clinical benefit Clinical efficacy clinical evidence Clinical research clinical status Combination Commission computer-generated conducted control group Controlled trial COVID-19 criteria death development discharged distribution elevated elevated liver enzymes eligible enrolled Europe European evaluate evidence of exclusion criteria extracorporeal membrane oxygenation followed by France French group Health care hepatorenal syndrome high flow oxygen devices hospital hospitalised Hydroxychloroquine Inclusion indication Innovation intention-to-treat population interferon interferon beta Interferon beta-1a intravenous intravenous infusion Invasive mechanical ventilation investigators Kidney disease laboratory-confirmed SARS-CoV-2 infection limitation liver enzymes Lopinavir Lopinavir-ritonavir Luxembourg material Ministry of Health modified intention-to-treat multicentre no significant difference non-invasive ventilation not significant Occurrence Odds ratio once daily one health Open-label Ordinal Scale oxygen oxygen supplementation oxygen support participant Patient Phase 3 Pneumonia Portugal Pregnancy Primary outcome random assignment randomisation randomised Randomly receive Regional Registered Remdesivir required requiring supplemental oxygen respiratory distress ribavirin Ritonavir Safety SARS-CoV-2 SARS-COV-2 infection Secondary outcomes Serious Adverse Event Serious Adverse Events seven-point ordinal scale Severity of disease Sponsor Standard of care stratified supplemental oxygen Support symptomatic syndrome the WHO translation Treatment treatment group treatment groups Trial Tumor union ventilator were excluded WHO ordinal scale with COVID-19
[DOI] 10.1016/S1473-3099(21)00485-0 PMC 바로가기 [Article Type] Clinical Trial

The Landscape of COVID-19 Research in the United States: a Cross-sectional Study of Randomized Trials Registered on ClinicalTrials.Gov

미국의 COVID-19 연구 환경: ClinicalTrials.Gov에 등록된 무작위 시험의 횡단면 연구

Article

Published on 2022-01-012022-09-11
Journal: Journal of General Internal Medicine [Category] SARS, 임상, 치료기술,

[키워드] antiviral medication Antiviral medications antivirals capita Characteristics Chloroquine chloroquine/hydroxychloroquine clinical endpoint clinical trial clinical trials Composite conducted Controlled trial COVID-19 cross-sectional cross-sectional study deaths Descriptive statistics detect diagnosed with COVID-19 distribution effective evaluate excluded followed by Geographic distribution greater highest highlighting Hydroxychloroquine identify immunomodulator Intervention IQR landscape less lowest measure monoclonal antibodies monoclonal antibody Mortality National ongoing trials pandemic participant pathogen people with COVID-19 Phase 3 power Prevent Primary outcome Randomized Randomized controlled trial Randomized controlled trials randomized trial randomized trials reduction in mortality Registered Relative risk resulting risk reduction Sample size SARS-CoV-2 setting severity single trial single-center small molecule Statistical power the median the United State Treatment treatments for COVID-19 Trial trials United States Vaccine Variability Ventilation
[DOI] 10.1007/s11606-021-07167-9 PMC 바로가기 [Article Type] Article

Achievements of the COVID-19 Turkey Platform in vaccine and drug development with an approach of “co-creation and succeeding together”

“공동 창조와 성공”의 접근 방식으로 백신 및 약물 개발에서 Covid-19 칠면조 플랫폼의 업적

Review

Published on 2021-12-172022-08-31
Journal: Turkish Journal of Medical Sciences [Category] SARS, 신약개발,

Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico

Clinical Trial

Published on 2021-12-152022-10-04
Journal: The New England Journal of Medicine [Category] COVID19(2023년), MERS, SARS, 변종, 비임상, 임상,

[키워드] 95% CI 95% confidence interval acute respiratory syndrome age Alpha assigned B.1.1.7 caused Clinical efficacy conducted coronavirus coronavirus disease determine disease dose effective Efficacy Efficacy and safety evaluate first dose Genome Infection median age Mild moderate MOST North America Novavax NVX-CoV2373 NVX-CoV2373 recipient observer-blinded occurred over participant Phase 3 Placebo placebo recipient placebo recipients placebo-controlled trial randomization Randomized Randomly receive recipient Recombinant spike protein Result Safe Safety SARS-CoV-2 second dose sequenced Severe case shown South Africa Strains tested the United State Trial United Kingdom Vaccine vaccine efficacy variant variants of concern viral genome yielding
[DOI] 10.1056/NEJMoa2116185 PMC 바로가기 [Article Type] Clinical Trial

Calibration of two validated SARS-CoV-2 pseudovirus neutralization assays for COVID-19 vaccine evaluation

COVID-19 백신 평가를위한 두 개의 검증 된 SARS-COV-2 슈도 바이러스 중화 분석의 교정

Comparative Study

Published on 2021-12-142022-09-01
Journal: Scientific Reports [Category] SARS, 바이오마커, 변종, 임상, 진단, 치료기술,

Efficacy, safety, and lot-to-lot immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152): interim results of a randomised, double-blind, controlled, phase 3 trial

Clinical Trial

Published on 2021-12-112022-10-05
Journal: Lancet (London, England) [Category] Fulltext, MERS, 임상,

[키워드] 1:1 95% CI absence Administered Adults adverse event age Analysis anaphylaxis assigned Bharat chronic conditions clinical Clinical efficacy clinical trial clinically clinics computer-generated Council COVID-19 COVID-19 infection Cutoff deaths dependent on distribution dose double-blind Efficacy evaluate Follow-up groups healthy hospital immunocompromising condition immunological immunosuppressive inactivated India interim analysis intramuscular dose investigators laboratory-confirmed median medical condition multicentre Nurse occurred Occurrence outcome outcomes participant Participants per-protocol population Phase 3 phase 3 trial Placebo placebo group placebo recipients placebo-controlled Primary outcome proportion raised randomisation randomised Randomly reactogenicity receive recipient recruited Registered registry reported Research safety population SARS-CoV-2 vaccine second dose Serious Adverse Event seronegative participant severity significant difference Sponsor stratified study population symptomatic symptomatic COVID-19 disease the vaccine therapy Toll-like receptor Treatment treatment group Trial Vaccine virion
[DOI] 10.1016/S0140-6736(21)02000-6 PMC 바로가기 [Article Type] Clinical Trial

Remdesivir for Severe Coronavirus Disease 2019 (COVID-19) Versus a Cohort Receiving Standard of Care

중증 코로나바이러스 감염증 2019(COVID-19)에 대한 렘데시비르 대 치료 표준을 받는 코호트

Clinical Trial

Published on 2021-12-062022-09-11
Journal: Clinical Infectious Diseases: An Official Publicat [Category] SARS, 임상, 치료제,

[키워드] 95% CI 95% confidence interval acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 adjusted odds ratio Analysis Antiviral antiviral agent Antiviral treatment clinical Clinical outcome clinical outcomes clinical status Comparative analysis coronavirus coronavirus disease Coronavirus disease 2019 Course COVID-19 criteria death dichotomized died Efficacy greater Hospitalized inclusion criteria Infection Mortality multivariable logistic regression Open-label open-label trial Ordinal Scale oxygen oxygen saturation Patient Phase 3 primary endpoint Probability proportion pulmonary infiltrates Randomized receiving reduced Remdesivir required retrospective cohort retrospective cohort study room air SARS-CoV-2 secondary endpoint severe acute respiratory syndrome Coronavirus severe coronavirus disease severe COVID-19 significantly Standard Standard of care Standard-of-care supplemental oxygen treated Treatment Trial was used Weighting
[DOI] 10.1093/cid/ciaa1041 PMC 바로가기 [Article Type] Clinical Trial