|drug2128||NHANES smell and taste tests Wiki||1.00|
|D000857||Olfaction Disorders NIH||0.24|
|D014777||Virus Diseases NIH||0.11|
There is one clinical trial.
This is an open-Label, randomized study to assess safety, pharmacokinetics, and efficacy of BAT2020 in Hospitalized Patients Infected With COVID-19. This study is composed of two Parts: single ascending dose (Part 1) and multiple ascending dose escalation or treatment period with a double-blind, placebo-controlled design (Part 2). Part 1. Single ascending dose (SAD) SAD: The patients will receive a single IV infusion of BAT2020 on day 1, and will be followed for up to 28 days. Safety, efficacy and PK information will be collected during this period. A total of 24 subjects, 3 cohorts of 8 subjects each, will be enrolled in this study. Screening for the study will begin 3 days prior to the actual dosing. Treatment cohorts are planned as following: Cohort 1: BAT2020 1 mg/kg (n=6) + Placebo (n=2) Cohort 2: BAT2020 3 mg/kg (n=6) + Placebo (n=2) Cohort 3: BAT2020 10 mg/kg (n=6) + Placebo (n=2) After a cohort completes the study on Day 28, data on safety and tolerability for each cohort will be evaluated by the Safety Monitoring Committee (SMC). Administration of the next higher dose to a new dosing cohort will be permitted only if adequate safety and tolerability have been demonstrated. If encouraging clinical benefit is observed at a certain dose level, the study may proceed to a to Part 2 based on emerging data. Part 2. Treatment Period (double-blind, Placebo-controlled study) The SMC will review safety, PK, PD, and efficacy data of each cohort prior to Part 2. Part 2 is a double-blind, placebo-controlled, multi-center, Phase 2-like study in hospitalized adult patients with laboratory confirmed SARS-CoV-2 infection. A total of 100~150 patients will be enrolled a 2-arm (1:1 randomization of BAT2020 vs. standard supportive care) or a 3-arm (1:1:1 two dosing regimens of BAT2020 vs. standard supportive care) trial with 50 patients in each arm (the sample size and statistical analysis may be amended based on emerging data from Part 1). An independent data and safety monitoring board (DSMB) will actively monitor interim data to allow early stopping for futility, efficacy, or safety. Patients will be assessed daily while hospitalized. Discharged patients will be asked to attend study visits at Days 15 and 28. All subjects will undergo a series of efficacy, safety, and laboratory assessments.
Description: SAE, TEAEs, mortality, those resulting in treatment discontinuation, and changes from baseline in safety laboratory assessmentsMeasure: Incidence of adverse events (AEs) Time: Day 28
Description: The ordinal scale is as follows: Death; Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activities.Measure: Percentage of patients reporting each severity rating on an 8-point ordinal scale Time: Day 15
Description: This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). Maximum=20, Minimun=0, the higher the worse.Measure: Change in National Early Warning Score (NEWS) from baseline Time: Days 7, 14, 21, 28
Description: Defined as SPO2≤ 94% on room air or PaO2/FiO2< 300mmHg and requirement for supplemental oxygen or more advanced ventilator supportMeasure: Frequency of respiratory progression Time: Day 1 through Day 28
Description: Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating.Measure: Cumulative incidence of Grade 3 and 4 adverse events (AEs) Time: Day 1 through Day 28
Description: The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.Measure: Time to discharge or to a National Early Warning Score (NEWS) of = 2 and maintained for 24 hours, whichever occurs first Time: Day 1 through Day 28
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