Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation | |
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drug2959 | SCTA01 Placebo Wiki | 0.58 |
drug83 | AK119 Wiki | 0.58 |
drug3430 | Tocilizumab Wiki | 0.09 |
Name (Synonyms) | Correlation | |
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D018352 | Coronavirus Infections NIH | 0.06 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.02 |
Name (Synonyms) | Correlation |
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Navigate: Correlations HPO
There are 3 clinical trials
The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics of SCTA01(anti-SARS-CoV-2 monoclonal antibody) in Healthy Chinese Subjects.
Description: DLT will be assessed by DAIDS v2.1. The measurements include clinical symptoms and abnormal vital signs, abnormal laboratory tests (complete blood cell count, serum chemistry, routine urinalysis, coagulation function, etc.) and 12-lead ECGs
Measure: Dose-limiting toxicity(DLT) Time: 7 daysDescription: MTD will be assessed by DAIDS v2.1. The measurements include clinical symptoms and abnormal vital signs, abnormal laboratory tests (complete blood cell count, serum chemistry, routine urinalysis, coagulation function, etc.) and 12-lead ECGs.
Measure: Maximal Tolerable Dose(MTD) Time: 12 weeksDescription: Area under the curve from the time of dosing to the last measurable concentration time t (AUC0-t)
Measure: AUC0-t Time: 12 weeksDescription: Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞)
Measure: AUC0-∞ Time: 12 weeksDescription: Elimination Phase Half-life(t1/2)
Measure: t1/2 Time: 12 weeksDescription: Time to the Maximum Concentration(Tmax)
Measure: Tmax Time: 12 weeksDescription: Positive rate of anti-SCT A01 antibody
Measure: Anti-drug antibody(ADA) Time: 12 weeksDescription: Adverse events as assessed by DAIDS v2.1, including clinical symptoms and abnormal vital signs, abnormal laboratory tests (complete blood cell count, serum chemistry, routine urinalysis, coagulation function, etc.) and 12-lead ECGs
Measure: Adverse events Time: 12 weeksThe study is a multicenter, adaptive, randomized, double-blinded and placebo-controlled Phase II/III trial, and will be conducted globally. The study is comprised of two parts: dose selection (Phase II) and pivotal treatment effect (Phase III).
Description: As assessed by time to clinical improvement (TTCI)
Measure: The clinical efficacy of SCTA01 (Phase II and III) Time: Day 29Description: Cumulative incidence of serious adverse events in both Phase II and III
Measure: Cumulative incidence of SAEs(Phase II, III) Time: 3 MonthsDescription: Change from baseline in viral shedding as measured by RT-qPCR in NP swab samples
Measure: Change from baseline in viral shedding as measured by RT-qPCR(Phase II and III) Time: Day 120Description: AUC0-t through Day 120
Measure: area under the curve (AUC0-t)(Phase II) Time: Day 120Description: AUC0-∞ through Day 120
Measure: AUC0-∞(Phase II) Time: Day 120Description: t1/2 through Day 120
Measure: Half-life time (t1/2)(Phase II) Time: Day 120Description: Cmax through Day 120
Measure: Maximum concentration (Cmax)(Phase II) Time: Day 120Description: Tmax through Day 120
Measure: Peak time (Tmax)(Phase II) Time: Day 120Description: CL through Day 120
Measure: Clearance (CL)(Phase II) Time: Day 120Description: Vd through Day 120
Measure: Apparent volume of distribution (Vd)(Phase II) Time: Day 120Description: λz through Day 120
Measure: Elimination rate constant (λz)(Phase II) Time: Day 120Description: ADA against SCTA01 at baseline and Day 120
Measure: Immunogenicity as measured by anti-drug antibodies (ADA) (Phase II, III) Time: Day 120This is an adaptive, randomized, double-blinded, placebo-controlled, Phase II/III study conducted to evaluate the effect of SCTA01 on participant survival and clinical efficacy in participants with severe COVID-19 admitted to high dependence or ICUs. The study duration of subject participation will be up to: 120 days Participants will receive a single intravenous (IV) infusion of SCTA01 at Treatment day 1. Follow up visits will be up to 120 days or early withdrawal visit.
Description: The mortality rates in placebo and treatment groups regardless of the cause of death.
Measure: All-cause mortality rate at D29 Time: Day 29Description: The mortality rates in placebo and treatment groups regardless of the cause of death.
Measure: All-cause mortality rate at Day 60 Time: Day 60Description: The number of days from randomization to discontinue MV support
Measure: Time to discontinue mechanical ventilation (MV) at Day 29 Time: Baseline through Day 29Description: The number of days from baseline to two categories decreases on World Health Organization (WHO) 10-Point Ordinal Scale at Day 29.
Measure: Time to improvement of two categories on WHO 10-Point Ordinal Scale from baseline at Day 29 Time: Baseline through Day 29Description: The number of days from randomization to discontinue supplemental oxygen support
Measure: Time to discontinue supplemental oxygen at Day 29 Time: Baseline through Day 29Description: The number of days from randomization to subject's discharge from hospital.
Measure: Time to hospital free at Day 29 Time: Baseline through Day 29Description: Change from baseline in viral shedding
Measure: Change from baseline in viral shedding as measured by quantitative reverse transcription polymerase chain reaction (RT-qPCR) Time: Baseline through Day 29Description: SAEs collected from Day 1 to Day 120
Measure: SAE Time: Day 1 through Day 120Description: ADA will be tested at Day 29 and Day120 after SCTA01/placebo administration
Measure: Anti-drug antibody (ADA) Time: Day 29, Day 120Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on January 01, 2021.
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