Phase 3 – Page 7 – Communicable Diseases Research

Colchicine for community-treated patients with COVID-19 (COLCORONA): a phase 3, randomised, double-blinded, adaptive, placebo-controlled, multicentre trial

Covid-19 (Colcorona)를 가진 지역 사회 치료 환자를위한 콜히친 : 3 단계, 무작위, 이중 맹검, 적응 형, 위약 대조, 다중 센터 시험

Clinical Trial

Published on 2021-08-012022-08-13
Journal: The Lancet. Respiratory Medicine [Category] MERS, SARS, 임상,

A phase 3, open-label, controlled, randomized, multicenter trial evaluating the efficacy and safety of StrataGraft® construct in patients with deep partial-thickness thermal burns

Research article

Published on 2021-08-012022-10-05
Journal: Burns : journal of the International Society for B [Category] 비임상,

[키워드] adverse event assessment BACCbioengineered allogeneic cellularized construct bioengineered allogeneic cellularized construct bovine serum albumin BSAbovine serum albumin Burn burns case report form CIconfidence interval clinical comparable confidence interval CRFcase report form deep partial-thickness DPT DPTdeep partial-thickness Efficacy and safety Endpoint enrolled evaluated Follow-up FTfull-thickness full-thickness GMPGood Manufacturing Practice good manufacturing practice Health Insurance Portability and Accountability Act HIPAAHealth Insurance Portability and Accountability Act HTShypertrophic scarring hypertrophic scarring Identifier intent to treat ITTintent to treat MImultiple imputation mITTmodified intent to treat modified intent to treat Month Multicenter trial multiple imputation objective offer Open-label panel reactive antibody Patient Patient and Observer Scar Assessment Scale patients performed Phase 3 phase 3 study POSASPatient and Observer Scar Assessment Scale PRApanel reactive antibody proportion pruritus Randomized reduce reduction in required Result SAESerious Adverse Event Safety Serious Adverse Event TBSAtotal body surface area TEAEtreatment-emergent adverse event total body total body surface area Treatment treatment-emergent adverse event
[DOI] 10.1016/j.burns.2021.04.021 [Article Type] Research article

A Deferred-Vaccination Design to Assess Durability of COVID-19 Vaccine Effect After the Placebo Group Is Vaccinated

위약 그룹 백신 접종 후 COVID-19 백신 효과의 지속성을 평가하기 위한 지연 백신 접종 설계

Article

Published on 2021-08-012022-09-11
Journal: Annals of internal medicine [Category] SARS, 임상,

Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey

비활성화된 전체 비리온 SARS-CoV-2 백신(CoronaVac)의 효능 및 안전성: 터키에서 이중 맹검, 무작위, 위약 대조, 3상 시험의 중간 결과

Clinical Trial

Published on 2021-07-172022-09-12
Journal: Lancet (London, England) [Category] Fulltext, SARS, 임상, 진단,

[키워드] 1:1 95% CI adverse event adverse events antibody test result bleeding disorders blood product clinical trial Cohort component CoronaVac COVID-19 criteria dose double-blind Efficacy Efficacy and safety enrolled exclusion fatality fatigue follow-up period Frequency health-care humoral hydroxide Immunoglobulin immunosuppressive inactivated individual intention-to-treat intention-to-treat population intramuscularly IQR Local median Negative PCR nine Older outcome Pain participant PCR-confirmed per 1000 person-years per protocol Phase 3 phase 3 trial Placebo placebo-controlled protocol provided randomised Randomly recruited Registered reported safety analysis safety profile SARS-CoV-2 screened second dose shown Steroids symptomatic the placebo group the vaccine therapy Tolerability trials Turkey Vaccine virion virus Volunteer whole-virion SARS-CoV-2 vaccine yielding
[DOI] 10.1016/S0140-6736(21)01429-X PMC 바로가기 [Article Type] Clinical Trial

Serologic Status and Toxic Effects of the SARS-CoV-2 BNT162b2 Vaccine in Patients Undergoing Treatment for Cancer

Research

Published on 2021-07-082022-10-30
Journal: JAMA Oncology [Category] COVID-19,

[키워드] 95% CI Administered administration adverse effect adverse event Adverse reaction age antibody production anticancer appear blood cell counts BNT162b2 BNT162b2 vaccine Campus Cancer Chemotherapy Cohort cohort study collected conducted Control controls COVID-19 case COVID-19 infection determine division Effect Efficacy Efficacy and safety electronic medical record enrolled evaluate evaluated exposure finding first dose Future Health care worker healthy healthy individuals high-risk population IgG Importance incidence initiated leukopenia liver enzyme measure men objective occur occurred Odds ratio of BNT162b2 participant Patient patients Patients with cancer Phase 3 Point populations rate ratio reached real-world data receiving reduced Regulatory Relevance reported Result Safe SARS-CoV-2 BNT162b2 SARS-CoV-2 vaccination SARS-CoV-2 vaccine second dose Seroconversion serologic seronegative patients Seronegativity seropositive serum serum sample setting Sociodemographic characteristics status Testing the healthy the patient the SARS-CoV-2 the vaccine therapy toxic Treatment Trial trials vaccination Vaccine vaccine dose was used
[DOI] 10.1001/jamaoncol.2021.2675 PMC 바로가기 [Article Type] Research

Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (TDF) Versus Efavirenz/Emtricitabine/TDF in Treatment-naive Adults With Human Immunodeficiency Virus Type 1 Infection: Week 96 Results of the Randomized, Double-blind, Phase 3 DRIVE-AHEAD Noninferiority Trial

인간 면역 결핍 바이러스 유형 1 감염을 가진 치료-상대 성인의 도라비린/라미부딘/텐 노포 비르 디오 록시 푸마 레이트 (TDF) 대 efavirenz/emtricitabine/tdf : 무작위, 이중 앨범, 상 3 단계 비 제 3 단계 비정기 시험의 96 주 결과.

Major Articles and Commentaries

Published on 2021-07-012022-09-06
Journal: Clinical Infectious Diseases: An Official Publicat [Category] Communicable Disease,

[키워드] 95% confidence interval adverse event analyses antiretroviral ARMS baseline change cholesterol clinical demonstrated doravirine double-blind drug efavirenz Efficacy efficacy end point emtricitabine end point event food fumarate HDL-C HIV-1 Human Human immunodeficiency virus human immunodeficiency virus type 1 Infection inhibitor lamivudine less Lipid lipids lipoprotein cholesterol Low-density lipoprotein Low-Density Lipoprotein cholesterol margin multicenter Neuropsychiatric NNRTI participant Participants phase Phase 3 point of interest profile proportion Randomized Rash Registration Result Safety study drug Support Tablet tenofovir tenofovir disoproxil tenofovir disoproxil fumarate the mean Tolerability Total cholesterol Treatment treatment difference treatment-naive Trial Type Week
[DOI] 10.1093/cid/ciaa822 PMC 바로가기 [Article Type] Major Articles and Commentaries

Operation Warp Speed: implications for global vaccine security

Operation Warp Speed: 글로벌 백신 보안에 미치는 영향

Review

Published on 2021-07-012022-09-11
Journal: The Lancet. Global health [Category] 신약개발, 임상,

Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: interim results from a double-blind, randomised, multicentre, phase 2 trial, and 3-month follow-up of a double-blind, randomised phase 1 trial

비활성화된 SARS-CoV-2 백신, BBV152의 안전성 및 면역원성: 이중 맹검, 무작위, 다기관, 2상 시험 및 이중 맹검, 무작위 1상 시험의 3개월 추적 조사의 중간 결과

Clinical Trial

Published on 2021-07-012022-09-12
Journal: The Lancet. Infectious Diseases [Category] Fulltext, SARS, 임상, 진단,

[키워드] 1:1 95% CI Abstract addition Administered Antigen assigned baseline Bharat block blood draw cell-mediated immune response clinical trial collected defined dose double-blind Efficacy elevated elicited enrolled evaluate first dose Follow-up geometric mean GMT healthy high neutralising antibody Hindi hospital humoral inactivated India intramuscular dose investigators Local material microneutralisation test MNT multicentre neutralisation test neutralising antibody titre nine outcomes participant phase 1 trial Phase 2 study phase 2 trial Phase 3 positive Primary outcome PRNT proportion randomisation randomised Randomly reactogenicity receive Registered remained reported response Safety SARS-CoV-2 SARS-CoV-2 nucleic acid SARS-CoV-2 vaccine screened second dose second vaccination secondary outcome selected Serious Adverse Event seroconversion rate serology test significant difference significantly higher Sponsor T-cell Response Th1 phenotype the vaccine titre Toll-like receptor translation treatment group Trial Vaccine was done were assessed were excluded wild-type
[DOI] 10.1016/S1473-3099(21)00070-0 PMC 바로가기 [Article Type] Clinical Trial

Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine

NVX-CoV2373 Covid-19 백신의 안전성 및 효능

Clinical Trial

Published on 2021-06-302022-09-25
Journal: The New England Journal of Medicine [Category] MERS, SARS, 변종, 신약개발, 임상, 진단,

[키워드] 1:1 95% CI 95% confidence interval acute respiratory syndrome Administered age Alpha Analysis assigned B.1.1.7 B.1.1.7 variant baseline Clinical data conducted coronavirus death dose Efficacy efficacy end point EudraCT full-length spike glycoprotein generally mild healthy Hospitalization illnesses immune response incidence Infection injection intramuscular Matrix-M Mild moderate Novavax NVX-CoV2373 NVX-CoV2373 vaccine observer-blinded Older participant Participants per-protocol Phase 3 Placebo placebo-controlled trial randomization Randomized receive reported Result robust Safe Safety SARS-CoV-2 SARS-COV-2 infection Serious Adverse Event Serologically Severe infection severe SARS-CoV-2 symptom onset the placebo group the vaccine two groups two-dose regimen United Kingdom Vaccine variant variants
[DOI] 10.1056/NEJMoa2107659 PMC 바로가기 [Article Type] Clinical Trial

Potential Therapeutic Targets and Vaccine Development for SARS-CoV-2/COVID-19 Pandemic Management: A Review on the Recent Update

SARS-CoV-2/COVID-19 팬데믹 관리를 위한 잠재적인 치료 목표 및 백신 개발: 최근 업데이트에 대한 검토

Review

Published on 2021-06-302022-09-11
Journal: Frontiers in Immunology [Category] MERS, SARS, 변종, 진단, 치료제,

[키워드] acute respiratory syndrome acute respiratory syndrome coronavirus antibodies antibody Beta cause caused China city clinical trials common cold Coronaviridae family coronavirus disease Coronavirus disease 2019 Coronavirus-2 country CoV COVID-19 develop development disease effort epicenter Health Organization help highly pathogenic Hope Host Inactivated Vaccines Integrative analysis Interaction management Multiple nucleic acid outbreak pandemic peptide peptides Phase 3 phase 3 clinical trials Potential Prophylaxis recent respiratory respiratory symptom respiratory symptoms review Safe SARS-CoV-2 SARS-COV-2 infection SARS-CoV-2 vaccines Severe acute respiratory syndrome severe acute respiratory syndrome Coronavirus severe acute respiratory syndrome coronavirus-2 small molecule small molecule drugs target the Coronaviridae the disease therapeutic Therapeutic approach therapeutic strategy therapeutic targets treat Treatment Vaccine Vaccine development Vaccines virus WHO World Health Organization Wuhan
[DOI] 10.3389/fimmu.2021.658519 PMC 바로가기 [Article Type] Review