childbearing potential – Communicable Diseases Research

New Perspectives on Antimicrobial Agents: Molnupiravir and Nirmatrelvir/Ritonavir for Treatment of COVID-19

항균제에 대한 새로운 관점: 코로나19 치료를 위한 몰누피라비르 및 니르마트렐비르/리토나비르

Article

Published on 2022-08-162022-09-11
Journal: Antimicrobial Agents and Chemotherapy [Category] COVID19(2023년), SARS, 변종, 치료제,

Exclusion of Reproductive-Aged Women in COVID-19 Vaccination and Clinical Trials

Research article

Published on 2022-06-012022-10-05
Journal: Women's Health Issues [Category] COVID19(2023년), SARS, 신약개발, 임상,

Safety and immunogenicity of an AS03-adjuvanted SARS-CoV-2 recombinant protein vaccine (CoV2 preS dTM) in healthy adults: interim findings from a phase 2, randomised, dose-finding, multicentre study

건강한 성인에서 AS03 보조제 SARS-CoV-2 재조합 단백질 백신(CoV2 preS dTM)의 안전성 및 면역원성: 2상, 무작위, 용량 찾기, 다기관 연구의 중간 결과

Clinical Trial

Published on 2022-05-012022-09-11
Journal: The Lancet. Infectious Diseases [Category] COVID19(2023년), MERS, SARS, 변종, 임상, 진단,

[키워드] 95% CI abstinence adjuvants Adults adverse event adverse events Adverse reaction Adverse reactions age All participant All participants antibody Antibody titre Antigen AS03 assessments assigned authority baseline booster vaccination candidate vaccine Chemotherapy childbearing potential clinical development Clinical research clinical trial Cohort Contraception COVID-19 vaccine D614G variant development dose effective Endpoint enrolled evaluated expected fixed Frequency geometric mean geometric mean titre GMT GMT ratio GMTs groups healthy High dose High-dose high-dose group Immunocompromised immunogenicity increase in increased risk injection injection site Injections intensity interim results investigator investigators involved Laboratory lactating low dose low-dose medical condition Medical conditions medium medium dose Mild mild to moderate moderate multicentre Neutralising Antibodies neutralising antibody neutralising antibody titre neutralising antibody titres occurred Older Older adults Organ transplant outcome outcome assessor outcome assessors parallel-group participant Participants Phase 2 Phase 3 positive prefusion pregnant primary immunogenicity progression proportion Protein protocol provided pseudovirus neutralisation assay randomised Randomly reactogenicity receive Registered reported Research research and development responses robust Safety safety analysis safety endpoints safety profile Sanofi Pasteur SARS-CoV-2 second dose second vaccination selected Serious Adverse Event Serious Adverse Events serodiagnostic Seven severe COVID-19 Stratification study period supported systemic test result titre titres Treatment treatment group treatment groups Trial USA vaccination Vaccine was done were excluded were measured yes or no
[DOI] 10.1016/S1473-3099(21)00764-7 PMC 바로가기 [Article Type] Clinical Trial

SAVER: sodium valproate for the epigenetic reprogramming of high-risk oral epithelial dysplasia—a phase II randomised control trial study protocol

Saver : 고위험 경구 상피의 후성 재 프로그래밍을위한 나트륨 valproate-2 상 무작위 대조 시험 연구 프로토콜

Study Protocol

Published on 2021-07-052022-09-01
Journal: Trials [Category] SARS, 신약개발, 유전자 메커니즘, 임상, 진단,

[키워드] acceptability adverse effects Blood blood sample Blood samples cancer development Chemoprevention childbearing potential clinical collected Compliance Diagnosis Drug repurposing dysplasia Effect Endpoint Epigenetic Epigenetic reprogramming epithelial European Evidence evidence of excluded feasibility GRADE IIb include lead lesion size malignancy management medication notable observation Open-label oral cancer Oral epithelial dysplasia outcome Patient Perception preliminary evidence Primary outcome protective mechanism provide randomisation randomised randomised controlled trial recruited recruitment reduced risk reduction in regions Registered risk secondary care sodium Sodium valproate Study protocol subsequent supplementary material surgery surgical resection Surveillance targets teratogenic Trial Trial registration Valproate
[DOI] 10.1186/s13063-021-05373-8 PMC 바로가기 [Article Type] Study Protocol

Efficacy and safety of nelfinavir in asymptomatic and mild COVID-19 patients: a structured summary of a study protocol for a multicenter, randomized controlled trial

무증상 및 경증 COVID-19 환자에 대한 nelfinavir의 효능 및 안전성: 다기관, 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약

Letter

Published on 2021-04-282022-09-10
Journal: Trials [Category] SARS, 임상, 치료기술,

[키워드] 1:1 Administered administration adverse event adverse events age all-cause mortality ALT Analysis anticipated Antigen antiviral efficacy AST Asymptomatic asymptomatic patients blinded blinded outcome assessment Blinding blood glucose body temperature both group both groups capture caused childbearing potential clearance clinical Clinical efficacy clinical examinations Clinical symptoms clinical trial clinical trials comparator Patients condition Consent contraceptive method Controlled clinical trial cough COVID-19 creatinine creatinine clearance dataset Day defervescence diabete diabetes diarrhea discretion dissemination distribution drug element enrolled enrolment evaluate event exclusion criteria exploratory Factor female patient Fever Frequency Glucose group hazard ratio Hemophiliac Hemorrhagic history HIV infection hospital hypersensitivity incidence incidence rate Inclusion inclusion and exclusion criteria inclusion criteria Infection Informed consent initial investigator investigator-initiated investigators Japan Japanese LAMP limit log-rank test male Mild mild COVID-19 patient Mild disease mixed-effects model multicenter Nasopharyngeal swab Negative conversion Negative PCR nelfinavir null hypothesis number objective Open-label outcome oxygen Oxygen administration p value parallel group parameter participant Patient patients with asymptomatic PCR PCR test Pneumonia power Pregnancy primary endpoint Primary outcome principal investigator Probability probability distribution protocol random randomization Randomized Randomized controlled trial Registered registry reported required respiratory tract rifampicin room air safety endpoint Saliva saliva samples Sample size SARS-CoV-2 SARS-CoV-2 vaccination secondary efficacy endpoint serious complication serum creatinine severity specimen Standard status study period Study protocol supplementary material survival survival function Symptom symptomatic symptomatic COVID-19 Symptomatic treatment the log-rank test Three times daily Treatment treatment for HIV treatment period Trial Trial registration two-sided Unsuitable Viral viral dynamics Viral load virus was determined website Withdrawal withdrawal of consent
[DOI] 10.1186/s13063-021-05282-w PMC 바로가기 [Article Type] Letter

Appropriateness for SARS-CoV-2 vaccination for otolaryngologist and head and neck surgeons in case of pregnancy, breastfeeding, or childbearing potential: Yo-IFOS and CEORL-HNS joint clinical consensus statement

Miscellaneous

Published on 2021-04-152022-10-31
Journal: European archives of oto-rhino-laryngology : offic [Category] COVID-19, MERS, SARS,

Multi-arm Trial of Inflammatory Signal Inhibitors (MATIS) for hospitalised patients with mild or moderate COVID-19 pneumonia: a structured summary of a study protocol for a randomised controlled trial

경증 또는 중등도의 COVID-19 폐렴으로 입원한 환자를 위한 염증 신호 억제제(MATIS)의 다군 시험: 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약

Letter

Published on 2021-04-122022-09-10
Journal: Trials [Category] 임상,

[키워드] 24 hours accounted Administered age agreement All participants Allergic reactions approved baseline blind blinded Blinding block Breastfeeding Caregivers cell proliferation childbearing potential clinical clinical outcomes clinically suspected college comparator completion Compliance Concomitant medication Contraception Controlled trial coronavirus COVID-19 COVID-19 disease COVID-19 pneumonia CPAP CRP Data monitoring committee Day death defined Desaturation determine diagnosed disease disease severity dissemination dose drug ECMO effective Efficacy element English enrolment exclusion experimental arm experimental intervention facemask FOS fostamatinib generate GRADE grade 3 Graft graft-versus-host-disease hepatic dysfunction hospital Hospital admission Hospital stay hospitalisation hospitalised patient Hospitalised patients Immune thrombocytopenia Imperial College Healthcare NHS Trust incidence information Informed consent inhibitor Inpatient Inpatients Intervention invasive Invasive mechanical ventilation invasive ventilation investigational agent investigator JAK1 JAK2 janus kinase Kinase inhibitor kinases Laboratory male participants MATIS Mild minimum moderate Moderate COVID-19 moderate to severe Modification multi-arm myelofibrosis nasal oxygen NHS Non-invasive non-invasive ventilation number objective Obstructive obstructive sleep apnoea opinion Ordinal Scale outcome oxygen Pairwise comparison pandemic parallel-group participant Patient Pneumonia polycythaemia vera principal investigator product progression promise proportion protocol random randomisation randomised randomised controlled trial receiving recruit recruited reduce reduce mortality reducing renal impairment renal replacement therapy replacement therapy required Requirement ruxolitinib Sample size sample size calculation Sample size calculations SARS-CoV2 infection scale Secondary objectives selective sequence severe allergic reaction Severe COVID-19 pneumonia severity severity of COVID-19 sexual intercourse signal sleep apnoea Sperm sperm donation spleen Splenomegaly Stage stage 2 Standard Standard of care statistical analysis status Stratification study drug Study protocol supplementary material Symptom systemic inflammation the WHO therapy thrombocytopenia translation Treatment Trial Trial registration Trust tyrosine tyrosine kinase inhibitor Venous Thromboembolism verbal website WHO with COVID-19
[DOI] 10.1186/s13063-021-05190-z PMC 바로가기 [Article Type] Letter

Early antiviral treatment in outpatients with COVID-19 (FLARE): a structured summary of a study protocol for a randomised controlled trial

COVID-19(FLARE) 외래 환자의 조기 항바이러스 치료: 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약

Letter

Published on 2021-03-082022-09-01
Journal: Trials [Category] SARS, 임상, 진단, 치료기술, 치료제,

[키워드] 24 hours 48 hour 48 hours absence admitted to ICU aetiology age ALT Analysis Anosmia anticipated antiviral therapy Antiviral treatment antivirals Appendix Arm arrhythmia AST Asthma Asymptomatic Autoimmune blinded to treatment Blinding blood sample BMI Breastfeeding childbearing potential Cholangitis chronic chronic hepatitis Chronic kidney disease chronic liver disease chronic respiratory disease cirrhosis clinical condition collected combination therapy Comorbidity concealed Concomitant concomitant medications conducted COPD coryza cough COVID-19 COVID-19 disease COVID-19 vaccine criteria current Date Day decrease defined Deleterious detectable diabetes died disease dissemination dose double-blind Duration early treatment effective EGFR element enrolled enrolment Ethnicity examined exclusion criteria factorial design Favipiravir female female participant Fever followed by Free Gender headache heart disease Hepatitis hepatotoxicity HIV infection hospital hospitalisation hypersensitivity hypertension in viral include inclusion criteria ingredient investigator investigators Ischaemic heart disease Kidney disease liver Liver disease London Lopinavir Lopinavir/ritonavir malaise male participant male participants measure medication Mutation myalgia Myocardial infarction no symptom non-hospitalised not limited number obesity objective observational studies observational study oral outcome Outpatient outpatients participant Participants partner percentage pharmacokinetic phase IIa Placebo placebo-controlled placebo-controlled trial positive presence or absence Primary outcome Proportion of participant Protease inhibitor protocol randomised randomised controlled trial Rate Registered Registration respiratory Respiratory disease risk Ritonavir Safety Saliva saliva samples Sample size SARS-CoV-2 secondary Secondary outcomes Shortness of breath smoker smoking smoking status Stage status steatohepatitis Stool Study protocol supplementary material Symptom symptom onset symptomatic tested therapy Toxicity Treatment treatment allocation Trial trial medication Trial registration undetectable United Kingdom upper respiratory tract vaccine trial valvular valvular heart disease Viral Viral load website with COVID-19
[DOI] 10.1186/s13063-021-05139-2 PMC 바로가기 [Article Type] Letter

Double-blind, randomized, controlled, trial to assess the efficacy of allogenic mesenchymal stromal cells in patients with acute respiratory distress syndrome due to COVID-19 (COVID-AT): A structured summary of a study protocol for a randomised controlled trial

COVID-19(COVID-AT)로 인한 급성 호흡 곤란 증후군 환자에서 동종 간엽 기질 세포의 효능을 평가하기 위한 이중 맹검, 무작위, 대조 시험: 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약

Letter

Published on 2021-01-062022-09-10
Journal: Trials [Category] MERS, 바이오마커, 임상, 치료제,

[키워드] 1:1 24 hours 7-point ordinal scale acute respiratory distress acute respiratory distress syndrome Administered administration Admission Adult patient Adult patients Adverse Adverse drug reactions AEs age All trial participants all-cause mortality allergy Allogeneic ARDS assessment assigned baseline Biomarker blinded Blinding C-reactive protein carcinoma carcinoma in situ carried cellular chain change childbearing potential Chloroquine Clinical practice clinical status clinical trial coagulation test coagulation tests conducted Control control arm Course COVID COVID-19 CRF criteria CT scan cumulative incidence current Cytokines D-dimer Day death described determined by Diagnosis disease dissemination double-blind drug Duration ECMO Efficacy Efficacy and safety element eligible End endpoints enrolment EudraCT evaluate evaluate the effect event exclusion criteria Extracorporeal extracorporeal membrane oxygenation failure ferritin fibrosis FiO2 form GRADE grade 3 greater Haemodialysis handling hemofiltration history hospital Hospitalization hydroxy ICU ICU admission IMPROVE include inclusion criteria Informed consent intravenous Intravenous administration intravenous dose intubation Invasive mechanical ventilation invasive ventilation investigational medicinal product involved laboratory confirmation laboratory-confirmed SARS-CoV-2 infection lactation LDH less Level Local Lopinavir Lopinavir/ritonavir lung disorder lymphocyte marker Mechanical mechanical ventilation Medicine Medicines Mesenchymal stromal cells moderate to severe Mortality MSC negative pregnancy test neoplasm neutrophil neutrophil counts Non-invasive number objective occur off-label opinion Ordinal Scale organ oropharyngeal swab oropharyngeal swabs Other outcome oxygen oxygen saturation Oxygen therapy PaO2 PaO2/FiO2 ratio parameters participant Patient PCR percentage Placebo polymerase chain reaction Pregnancy primary endpoint product Production profile progression protocol Pulmonary embolism pulmonary fibrosis Pulmonary function tests randomised randomised controlled trial randomization Randomized Randomly Rapid antigen tests reaction receive recruitment Registered Remdesivir report respiratory Respiratory distress syndrome Resuscitation Ritonavir SAEs Sample size SARS-COV-2 infection secondary Secondary endpoints Sequential Organ Failure Assessment Serious Adverse Events SOFA Spain specificity specimen Sponsor Standard of care status stromal cell stromal cells Study protocol subpopulations supplemental oxygen supplementary material syndrome the cell the disease the patient the primary endpoint the WHO time Tocilizumab Tolerability Treatment treatment arm treatment for COVID-19 treatment group Treatment protocol Trial trial participant Trial registration unit website women worldwide pandemic written consent
[DOI] 10.1186/s13063-020-04964-1 PMC 바로가기 [Article Type] Letter

Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19: A structured summary of a study protocol for a randomised controlled trial

Letter

Published on 2020-10-282022-10-29
Journal: Trials [Category] Coronavirus, MERS, SARS,

[키워드] 1:1 24 hour Ability absence accompany activity Administered administration Admission adverse events Affect age alkaline phosphatase allergy ALT alternative hypothesis ambient Analysis ANC Anti-inflammatory anticipated antipyretics antivirals Arm ARMS assumed AST Baltimore baseline benefit blinded block block randomization Blood breastfeeding women Bronchoalveolar lavage calculated Care Cellulose center Chest chest X-ray childbearing potential clinical clinical condition Clinical course clinical impact Clinical improvement Clinical outcome clinical status clinical trial collected competing Compliance concealed Concentration Concomitant conditions conducted congestive heart failure Contraception Control control arm Conventional Corticosteroids COVID-19 COVID-19 disease COVID-19 infection COVID-19 pandemic criteria criterion Critical CT scan current Day Declaration of Helsinki decrease defined detect direct bilirubin disease disorder dissemination dose double-blind drug Drug administration drug-drug interaction drugs Duration ECMO Efficacy Efficacy and safety element eligible endosomal pH Enrollment ethnic group evaluate Evidence exclusion expected exploratory endpoint extracorporeal membrane oxygenation Face mask FDA Fisher Good group handling harmonization hematologic histocompatibility complex Hospitalization Hospitalized hospitalized patient Hydroxychloroquine Hypothesis ICU IL-6 levels Imatinib immunomodulatory immunomodulatory drugs IND information Informed consent inhibitory activity intensive care intensive care unit intention to treat interfere International Conference invasive Invasive mechanical ventilation investigational agent investigator ITT Laboratory Last limit limitation liver Local lysosomal sequestration magnitude matching placebo mechanical ventilation men and women MHC mononuclear cell Mortality nasal nasopharyngeal Nasopharyngeal swab neutrophil count New new oxygen use non-invasive ventilation non-rebreather mask not blinded null hypothesis number objective off-label off-label use Oropharyngeal outcome outcomes oxygen Oxygenation P450 packaged PaO participant Participants Patient patients patients with ARDS patients with COVID-19 PBMCs performed Pharmacist Pharmacy phase 3 study Placebo placebo-controlled Pneumonia positive COVID-19 Practice primary analysis primary endpoint principal progression proportion protocol Psychiatric Radiographic random number generator randomised controlled trial randomization Randomized Randomized controlled trial receive receiving recruitment Regulatory renal dysfunction renal replacement therapy replication of SARS-CoV-2 required requiring supplemental oxygen Respiratory illness respiratory tract risk RT-PCR Safety Sample size sarilumab SARS-CoV SARS-CoV-2 secondary endpoint Seizure Serious Adverse Events service severe disease severity significance level Site Society stability Standard of care status stratified study drug study enrollment study outcomes Study protocol subject submitted supplemental oxygen Support Suspension symptomatic Tablet temperature Test the patient the primary endpoint time TKI TKI-induced attenuation of vascular leak TKI-induced prevention and treatment lung inflammation Tocilizumab transcriptomics Treatment treatment allocation treatment arm treatments for COVID-19 Trial two-sided tyrosine kinase inhibitor uncontrolled university unstable angina vasopressors ventilator ventilator free days viral ABL-1 signalling website with COVID-19
[DOI] 10.1186/s13063-020-04819-9 PMC 바로가기 [Article Type] Letter