|drug1010||Completion of survey after peak of pandemic Wiki||0.41|
|drug2628||Norovirus Bivalent (GI.1 / GII.4) Vaccine（low） Wiki||0.41|
|drug1009||Completion of pre-pandemic survey Wiki||0.41|
|drug2627||Norovirus Bivalent (GI.1 / GII.4) Vaccine（high） Wiki||0.41|
|drug1008||Completion of post telemedicine encounter survey Wiki||0.41|
|drug4302||Wharton's jelly derived Mesenchymal stem cells. Wiki||0.41|
|drug4063||Trans Sodium Crocetinate Wiki||0.41|
|drug2629||Norovirus Bivalent (GI.1 / GII.4) Vaccine（middle） Wiki||0.41|
|drug4642||pathogen reduced SARS-CoV-2 convalescent plasma Wiki||0.41|
|drug263||Aluminum adjuvant Wiki||0.41|
|drug2072||Ketotifen 1 MG Wiki||0.41|
|drug1824||Hydroxychloroquine, lopinavir/ritonavir or azithromycin and placebo (standard therapy) Wiki||0.41|
|D017250||Caliciviridae Infections NIH||0.29|
|D001943||Breast Neoplasms NIH||0.17|
There are 6 clinical trials
This trial investigates whether clazakizumab (an anti-interleukin (IL)-6 monoclonal antibody (mAb)) may be beneficial for the treatment of CABMR in recipients of a kidney transplant by inhibiting the production of Donor Specific Antibodies (DSA) and re-shaping T cell alloimmune responses.
Description: The aim of this study is to follow enrolled participants until 221 occurrences of all-cause allograft loss, defined as return to dialysis, allograft nephrectomy, re-transplantation, eGFR <15 mL/min/1.73 m2 or death from any cause have been observed. The analysis will be a stratified log rank test of the effect of treatment on all-cause composite allograft loss, with stratification factors of dichotomized baseline eGFR (25-45 mL/min/1.73 m2 versus >45-65 mL/min/1.73 m2), baseline proteinuria, treatment for early (within 6 months of transplant) ABMR rejection episodes (yes/no), and treatment for late (greater than 6 months post transplant) ABMR rejection episodes (yes/no). Surviving subjects without allograft loss will be censored at the time of their last assessment.Measure: Incidence of all cause composite allograft loss Time: Five years
A total of 450 subjects were enrolled, divided into four age groups, including 18-59 years, 6-17 years, 3-5 years, and 6-35 months. There are three types of the test vaccine component in each age group. A total of 30 people in each dose group were vaccinated with the test vaccine or placebo 1 or placebo 2, respectively, in a ratio of 3: 1: 1. The 18-59-year-old, 6-17-year-old, and 3-5-year-old age groups were vaccinated 2 times at a time interval of 28 days. The 6-35 month age group is divided into two groups, Group 1 is inoculated with 2 doses interval of 28 days each, and Group 2 is inoculated with 3 doses interval of 28 days.
Description: Active AE: Local and systemic adverse reactions occurring within 0-7 days after each dose of vaccinationMeasure: All active AEs within 0-7 days after each dose Time: 7 days
Description: Adverse events other than active AE include solicitation adverse events reported in addition to the specified solicitation time windowMeasure: All non-active collection AEs within 0-28（30） days after each dose Time: 28（30） days
This proposal addresses the problem of preventing the very high mortality and morbidity associated with the development of Cytokine Storm Syndrome (CSS) associated respiratory failure in Covid-19 infection.
Description: Percentage of subjects discharged from hospital without the need for intubation and mechanical ventilationMeasure: Percentage of patients discharged from the hospital alive and without the need for mechanical ventilation. Time: Variable up to Day 28
Description: 25% change (decrease) in noted baseline elevations of serum ferritin, LDH, CRP, and d-dimer.Measure: Percentage of subjects with 25% change (decrease) in cytokine storm markers at 48 hours Time: 48 hours
Description: Supplemental oxygen requirement to maintain oxygen saturation >90% stable or decreased without escalation of respiratory support measures (addition of CPAP, initiation of mechanical ventilation)Measure: Percentage of subjects without increase in oxygen requirement and no increase in oxygen delivery/respiratory support measures after 48 hours. Time: Day 2 (48 hours)-Day 10 (240 hours)
Description: Time from initial dosing of IP to achievement of ≥93% oxygen saturation on room air for 24 hoursMeasure: Average time in days to achieve sustained ≥93% oxygen saturation without oxygen/respiratory support Time: 0-10 days
Description: Normalization or ≥ 75% improvement by Day 10 (120 hours) in each of the following laboratory CSS attributes elevated beyond the normal range at randomization: ferritin, fibrinogen, AST, ALT, leucopenia, thrombocytopenia, d-dimer, CRP, triglycerides, sCD25.Measure: Percentage of subjects with resolution of laboratory markers of Cytokine Storm syndrome Time: Day 10
Description: No increased prevalence of bacterial or fungal or viral infection through the time of hospital discharge until Day 28.Measure: Percentage of subjects who develop bacterial or fungal or non-Covid-19 viral infection Time: Day 0-28
Description: No failure to develop neutralizing antibody to Covid-19 measured at Day 28.Measure: Percentage of subjects who develop neutralizing antibody to Covid-19 Time: Day 28
COVID-19 is highly infectious and transmission of the virus is thought to be similar to that of influenza which can be transferred through droplets released when a person coughs, sneezes or talks. Studies have shown that nasal rinsing and mouth washes may be an important way to deliver treatments that could reduce the amount of a virus that is present in the nose and mouth. This also could mean that there is less virus available to pass on to others. We want to see if the use of nose rinses and mouth washes using Povidone-Iodine will reduce the the amount of virus in the nose and throat of people who have tested positive for COVID-19 disease and also reduce the spread of infection within their household.
Description: viral load as measured by real time polymerase chain reaction (PCR)Measure: Change in viral load in the oral and nasopharyngeal cavity Time: Day 0, 2, 3, 7, 14
Description: Visual analogue score 1-5 per symptom via a smartphone appMeasure: Symptom severity in primary participants and co-residents Time: Days 0 to 14
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SAB Biotherapeutics has developed SAB-185, an Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (transchromosomic [Tc] bovine-derived), as a potential therapeutic to treat COVID-19. This study will evaluate the safety, immunogenicity, and pharmacokinetics of SAB-185 in healthy participants.
Description: Incidence and severity of other adverse events and severe adverse events (SAE)Measure: Number of Participants Having Adverse Events Time: 29 Days
Description: transfusion-related adverse eventsMeasure: Number of Participants Having Transfusion-Related Adverse Events Time: 29 Days
Description: Incidence and severity of adverse events and SAEs from Screening through Study Day 90Measure: Number of Participants Having Adverse Events Time: 90 Days
Description: SARS-CoV-2 binding (ELISA) and neutralizing (PRNT80) antibody titers from Screening through Study Day 90Measure: Pharmacokinetics from screening to day 90 Time: 90 Days
This study will assess the safety and efficacy of TSC as a treatment for participants who are infected with SARS-CoV-2 (COVID-19).
Description: Lead-in phase: Serious adverse events and DLTs, defined as any study drug related grade 3 or 4 adverse event during the treatment period, with the exception of pulmonary events in the CTCAE that are known complications of SARS-CoV-2 infection: ARDS, Cough, Dyspnea, Hypoxia, Pneumonitis, Pulmonary Edema, Respiratory Failure, or Respiratory, Thoracic and Mediastinal disorders - Other.Measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) Time: 5 days
Description: Randomized phase: Time to achieve (and maintain through Day 28) a World Health Organization (WHO) ordinal COVID-19 severity scale score of 1, 2 or 3 with a minimum 1-point improvement from baseline. The scale assesses clinical status and the range is 0-9, as follows: 0. Uninfected - No clinical or virological evidence of infection Ambulatory - No limitation of activities Ambulatory - Limitation of activities Hospitalized, Mild Disease - Hospitalized, no oxygen therapy Hospitalized, Mild Disease - Oxygen by mask or nasal prongs Hospitalized Severe Disease - Non-invasive ventilation or high-low oxygen Hospitalized Severe Disease - Intubation and mechanical ventilation Hospitalized Severe Disease - Ventilation + additional organ support (pressors, Renal Replacement Therapy (RRT), Extracorporeal Membrane Oxygenation (ECMO) Dead - DeathMeasure: Time to recovery through Day 28 Time: 28 days
Description: Proportion of subjects with WHO ordinal severity scale score of 6 or 7 at any time through Day 28Measure: WHO Ordinal Severity Scale Time: 28 days
Description: Time to an improvement of one category (i.e., a 1-point improvement) from baselineMeasure: WHO Ordinal Severity Scale - Time to Improvement Time: 28 days
Description: Change from baseline in WHO scale score at days 2, 4, 7, 10, 14 and 28, as a categorical improvement or worsening Mean change in WHO ordinal severity scale score from baseline through days 2, 4, 7, 10, 14 and 28Measure: WHO Ordinal Severity Scale - Change from Baseline Time: 28 days
Description: • The time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first The NEWS score determines the degree of illness of a patient and prompts critical care intervention. The following physiological parameters are assessed on a scale of 0 to 3, with a higher score indicating a more critical condition: Respiration rate Oxygen saturation (SpO2) Air or oxygen Systolic blood pressure Pulse rate Level of consciousness or new confusion TemperatureMeasure: National Early Warning Score (NEWS) Time: 28 days
Description: Change from baseline through days 2, 4, 7, 10, 14 and 28 in NEWSMeasure: National Early Warning Score (NEWS) - Change from Baseline Time: 28 days
Description: Ventilator free days in the first 28 days (to day 29).Measure: Mechanical Ventilation Time: 28 days
Description: Incidence and duration of new mechanical ventilation use during the trialMeasure: Mechanical Ventilation - Duration Time: 28 days
Description: Hospital length of stay by Day 29 ICU length of stay by Day 29Measure: Hospitalization Time: 28 days
Description: Oxygenation free days in the first 28 days from start of therapy Days on extracorporeal membrane oxygenation (ECMO)Measure: Oxygenation Time: 28 days
Description: Incidence and duration of new oxygen use during the trialMeasure: Oxygenation - New Oxygen Use Time: 28 days
Description: Proportion on mechanical ventilation, ECMO, noninvasive ventilation and high-flow nasal cannula oxygen delivery and return to room air or baseline oxygen requirementMeasure: Oxygenation - Advanced Therapies Time: 28 days
Description: Time to return to room air or baseline oxygen requirementMeasure: Oxygenation - Time to Return to Baseline Time: 28 days
Description: Blood oxygenation by recorded continuous pulse oximetry (SpO2:FiO2 ratio)Measure: Oxygenation - Pulse Oximetry Time: 28 days
Description: Blood oxygenation by serial arterial blood gas measurements collected prior to the first dose of TSC and at 1 minute, 10 minutes, 30 minutes, 1.5 hours, 3 hours and 6 hours post TSC administration by calculated PaO2:FiO2 ratiosMeasure: Oxygenation - ABG Measurements Time: 28 days
Description: 15-day mortality 28-day mortality All-cause mortality at day 29 In hospital mortality Mortality at Day 60Measure: Mortality Time: Up to 60 days
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports