Ledipasvir plus sofosbuvir in pregnant women with hepatitis C virus infection: a phase 1 pharmacokinetic studyC형 간염 바이러스 감염 임산부에 대한 레디파스비르 + 소포스부비르: 1상 약동학 연구Article Published on 2020-08-132022-09-06 Journal: The Lancet. Microbe [Category] Communicable Disease, [키워드] All participants Alter analysed AUC changes in Child child health clinically concentration–time curve Course development dosing interval during pregnancy effective enrolled Epidemic finding funding genotype 1 geometric geometric mean geometric mean ratio gestation HCV Hepatitis hepatitis C hepatitis C virus Human Human Development Infants Infection Intensive Intervention ledipasvir Magee-Womens Hospital nine Open-label opioid parameter participant participated pharmacokinetic pharmacokinetics Phase 1 phase 1 study Phase 2 Physiological changes Pittsburgh Pregnancy pregnant pregnant women primary analysis Primary outcome reduce Registered Safe screened sofosbuvir sofosbuvir) Transmission treat Trial USA virus was used women [DOI] 10.1016/S2666-5247(20)30062-8 PMC 바로가기 [Article Type] Article
Safety and immunogenicity of a candidate Middle East respiratory syndrome coronavirus viral-vectored vaccine: a dose-escalation, open-label, non-randomised, uncontrolled, phase 1 trial후보 중동 호흡기 증후군 코로나바이러스 바이러스 매개 백신의 안전성 및 면역원성: 용량 증량, 공개, 비무작위, 비통제, 1상 시험Article Published on 2020-07-012022-08-13 Journal: The Lancet. Infectious Diseases [Category] 임상, [키워드] absence adverse event AID All participant All participants antibody Antigen Arabian Peninsula assigned baseline cellular cellular and humoral immunogenicity cellular response ChAdOx1 ChAdOx1 MERS clinical clinical development clinical trial coronavirus Department described dose dose-escalation doses effective elicit ELISA enzyme enzyme-linked immunospot expressing finding FIVE Follow-up follow-up period full-length full-length spike surface glycoprotein funding healthy hepatitis B hepatitis B surface antigen hepatitis C hepatitis C antibodies hepatitis C antibody High-dose high-dose group HIV antibodies humans humoral humoral immunogenicity IgG immunogenicity ImmunoSpot Infection interferon interferon-γ-linked enzyme-linked immunospot intermediate-dose group Intervention Intramuscular injection low-dose Medicine MERS MERS-CoV MERS-CoV spike antigen Middle East Middle East respiratory syndrome Coronavirus Mild mild in severity moderate neutralisation neutralisation assay Neutralising Antibodies nine Occurrence Open-label Oxford participant Phase 1 phase 1 trial pre-vaccination test pre-vaccination tests pregnancy test progression proportion Pseudotyped virus public health Registered Relative risk reported resolved respiratory respiratory syndrome coronavirus response risk Safe Safety Saudi Arabia Serious Adverse Event Serious Adverse Events severe adverse event significant increase significantly higher simian adenovirus-vectored vaccine single dose Support surface antigen Surface glycoprotein T-cell tested Tolerability trials tropical medicine urinary pregnancy test vaccination vectored vaccine Viral viral particle Viral particles virus neutralising assay virus neutralising assays was done women [DOI] 10.1016/S1473-3099(20)30160-2 PMC 바로가기 [Article Type] Article
Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration in COVID-19 (REALIST-COVID-19): A structured summary of a study protocol for a randomised, controlled trialLetter Published on 2020-06-032022-10-29 Journal: Trials [Category] Coronavirus, SARS, [키워드] 1:1 active malignancy acute respiratory distress syndrome Administered administration age approval approved ARDS assessment automated Berlin blinded Cell cell suspension cellular changes in chronic liver disease class clinical Clinical diagnosis Clinical outcome clinical outcomes clinical trial comparator Compliance conducted control group Controlled trial COVID 19 COVID-19 COVID-19 pandemic declined defined described determine diagnosis of COVID-19 dissemination Donor Dose escalation driving Effect Efficacy element eligible Elizabeth enrolled ethics committee EudraCT excluded facilitate failure fixed dose hospital ICU incidence Inclusion increase in index individual information infusion intensive care unit Intervention Invasive mechanical ventilation investigator King’s College London London Mesenchymal stem cells Mesenchymal stromal cells MHRA moderate Mortality MSC MSCs NIHR number objective open label Other outcome pandemic PaO participant Patient patient population patients with ARDS PCR test PF ratio Phase 1 Phase 2 Placebo placebo-controlled protocol protocol amendment Public randomised randomised controlled trial REC receiving recruited recruitment repair reported Research respiratory Resuscitation Sample size secondary Secondary objective Secondary outcomes Serious Adverse Events severe ARDS single intravenous infusion SOFA solution Standard steering committee stratified stromal cell Study protocol Therapeutics therapy trauma Treatment Trial triple blinded Trust umbilical United Kingdom university Venous Thromboembolism Ventilation verbal Volume web-based randomisation system website WHO Withdrawal [DOI] 10.1186/s13063-020-04416-w PMC 바로가기 [Article Type] Letter
Brief Summary of Potential SARS-CoV-2 Prophylactic and Treatment Drugs in the Emergency DepartmentEndemic Infections Published on 2020-05-312022-10-28 Journal: Western Journal of Emergency Medicine [Category] COVID-19, MERS, SARS, [키워드] addition clinical trial death Department discharged drug effective Emergency evaluate expected healthcare hospital initiated Other Patient Phase 1 Potential Prophylactic PROTECT receive recipient SARS-CoV-2 specific treatment supportive care The United States Treatment Vaccine [DOI] 10.5811/westjem.2020.3.47328 PMC 바로가기 [Article Type] Endemic Infections
Potential Rapid Diagnostics, Vaccine and Therapeutics for 2019 Novel Coronavirus (2019-nCoV): A Systematic ReviewReview Published on 2020-02-262022-10-30 Journal: Journal of Clinical Medicine [Category] COVID-19, [키워드] 2019 novel coronavirus 2019-nCoV acute respiratory syndrome Antiviral Asia Beijing carried China clinical trial Cochrane Library Compound condition criteria database diagnostics drug combination effective Efficacy Evidence global health Google search identify in vitro Intervention item Laboratory management MERS-CoV Middle East novel Novel coronavirus outbreak Phase 1 point-of-care testing kit polymerase chain Potential protocol Rapid Reporting Research resource reverse transcription review RT-PCR RT-PCR kit SARS-CoV Serological assay supported tested Therapeutics treatments Vaccine vaccine candidate vaccine trial were used [DOI] 10.3390/jcm9030623 PMC 바로가기 [Article Type] Review
Adeno-associated virus vectored immunoprophylaxis to prevent HIV in healthy adults: a phase 1 randomised controlled trial건강한 성인에서 HIV를 예방하기 위한 아데노 관련 바이러스 매개 면역 예방: 1상 무작위 대조 시험Article Published on 2019-03-152022-09-06 Journal: The Lancet. HIV [Category] Communicable Disease, [키워드] adeno-associated virus adverse event adverse events AIDS alternative analyses anti-drug antibody antibody assigned cassettes Clinical research Cohort Complete Consent detect development dose dose-escalation double-blind eligibility eligible ELISA expression finding Follow-up foundation funding Future gene delivery Gene Expression generally mild genomes groups healthy HIV HIV antibodies HIV infection immunisation induce initiative Intervention Intramuscular injection Melinda Gate Melinda Gates men moderate muscle biopsy neutralisation neutralisation activity neutralising Neutralising Antibodies neutralising antibody Phase 1 Placebo placebo-controlled Prevent provided public health quadricep quadriceps randomised randomised controlled trial Randomly reactogenicity receive Registered Research resolved RT-PCR screened Serious Adverse Event Serious Adverse Events serotype serum sustained T-cell Response T-cell responses Tolerability Trial United State United States Vaccine virus Volunteer volunteers was done were recorded [DOI] 10.1016/S2352-3018(19)30003-7 PMC 바로가기 [Article Type] Article
Safety, Tolerability, and Pharmacokinetics of ARC-520 Injection, an RNA Interference-Based Therapeutic for the Treatment of Chronic Hepatitis B Virus Infection, in Healthy VolunteersClinical Trial Published on 2017-07-012023-06-19 Journal: Clinical pharmacology in drug development [Category] B형 간염, [키워드] hepatitis B pharmacokinetics Pharmacology Phase 1 RNA interference RNAi Safety Tolerability Treatment Viral hepatitis volunteers. [DOI] 10.1002/cpdd.318 PMC 바로가기 [Article Type] Clinical Trial