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Name (Synonyms) | Correlation | |
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drug2095 | NaCl 0.9% Wiki | 0.58 |
drug3531 | Valsartan (Diovan) Wiki | 0.58 |
drug3486 | Umbilical cord Wharton's jelly-derived human Wiki | 0.58 |
Name (Synonyms) | Correlation | |
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D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.14 |
D055371 | Acute Lung Injury NIH | 0.14 |
D012128 | Respiratory Distress Syndrome, Adult NIH | 0.13 |
Name (Synonyms) | Correlation |
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Navigate: Correlations HPO
There are 3 clinical trials
In this first-in-humans dose escalation study, AZD7442 (AZD8895 + AZD1061) will be evaluated for safety, tolerability, pharmacokinetics, and generation of anti-drug antibodies (ADAs). The study is intended to enable future studies of AZD7442's efficacy in preventing and treating COVID-19.
Description: Safety and tolerability will be evaluated in terms of number of participants with AEs/SAEs, abnormal values of vital signs, safety laboratory parameters, 12 lead safety electrocardiogram, injection site reactions, and physical examination.
Measure: Number of participants with adverse events (AEs) and serious AEs Time: From Day 1 up to last follow-up day (Day 361)Description: Cmax will be assessed after sequential or co-administration (AZD8895 + AZD1061 mixed into a single infusion) of AZD7442 (IV infusion) using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.
Measure: Observed maximum concentration (Cmax) (IV infusion) Time: From Day 1 up to last follow-up day (Day 361)Description: Tmax will be assessed after sequential or co-administration (AZD8895 + AZD1061 mixed into a single infusion) of AZD7442 (IV infusion) using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.
Measure: Time to reach maximum concentration (Tmax) (IV infusion) Time: From Day 1 up to last follow-up day (Day 361)Description: t½λz will be assessed after sequential or co-administration (AZD8895 + AZD1061 mixed into a single infusion) of AZD7442 (IV infusion) using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.
Measure: Terminal elimination half life, estimated as (ln2)/λz (t½λz) (IV infusion) Time: From Day 1 up to last follow-up day (Day 361)Description: AUClast will be assessed after sequential or co-administration (AZD8895 + AZD1061 mixed into a single infusion) of AZD7442 (IV infusion) using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.
Measure: Area under the concentration curve from time zero to the time of last quantifiable concentration (AUClast) (IV infusion) Time: From Day 1 up to last follow-up day (Day 361)Description: AUCinf will be assessed after sequential or co-administration (AZD8895 + AZD1061 mixed into a single infusion) of AZD7442 (IV infusion) using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.
Measure: Area under the concentration time curve from time zero extrapolated to infinity (AUCinf) (IV infusion) Time: From Day 1 up to last follow-up day (Day 361)Description: Vss will be assessed after sequential or co-administration (AZD8895 + AZD1061 mixed into a single infusion) of AZD7442 (IV infusion) using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.
Measure: Volume of distribution at steady state (Vss) (IV infusion) Time: From Day 1 up to last follow-up day (Day 361)Description: Vz will be assessed after sequential or co-administration (AZD8895 + AZD1061 mixed into a single infusion) of AZD7442 (IV infusion) using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.
Measure: Volume of distribution at terminal phase (Vz) (IV infusion) Time: From Day 1 up to last follow-up day (Day 361)Description: CL will be assessed after sequential or co-administration (AZD8895 + AZD1061 mixed into a single infusion) of AZD7442 (IV infusion) using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.
Measure: Systemic clearance (CL) (IV infusion) Time: From Day 1 up to last follow-up day (Day 361)Description: Cmax will be assessed after sequential or co-administration (AZD8895 + AZD1061 mixed into a single infusion) of AZD7442 (IM injection) using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.
Measure: Cmax (IM injection) Time: From Day 1 up to last follow-up day (Day 361)Description: Tmax will be assessed after sequential or co-administration (AZD8895 + AZD1061 mixed into a single infusion) of AZD7442 (IM injection) using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.
Measure: Tmax (IM injection) Time: From Day 1 up to last follow-up day (Day 361)Description: t½λz will be assessed after sequential or co-administration (AZD8895 + AZD1061 mixed into a single infusion) of AZD7442 (IM injection) using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.
Measure: t½λz (IM injection) Time: From Day 1 up to last follow-up day (Day 361)Description: AUClast will be assessed after sequential or co-administration (AZD8895 + AZD1061 mixed into a single infusion) of AZD7442 (IM injection) using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.
Measure: AUClast (IM injection) Time: From Day 1 up to last follow-up day (Day 361)Description: AUCinf will be assessed after sequential or co-administration (AZD8895 + AZD1061 mixed into a single infusion) of AZD7442 (IM injection) using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.
Measure: AUCinf (IM injection) Time: From Day 1 up to last follow-up day (Day 361)Description: CL/F will be assessed after sequential or co-administration (AZD8895 + AZD1061 mixed into a single infusion) of AZD7442 (IM injection) using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.
Measure: Extravascular systemic clearance (CL/F) (IM injection) Time: From Day 1 up to last follow-up day (Day 361)Description: F will be assessed after sequential or co-administration (AZD8895 + AZD1061 mixed into a single infusion) of AZD7442 (IM injection) using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.
Measure: Bioavailability (F) (IM injection) Time: From Day 1 up to last follow-up day (Day 361)Description: Vz/F will be assessed after sequential or co-administration (AZD8895 + AZD1061 mixed into a single infusion) of AZD7442 (IM injection) using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.
Measure: Extravascular terminal-phase volume of distribution (Vz/F) (IM injection) Time: From Day 1 up to last follow-up day (Day 361)Description: The incidence of ADAs to AZD7442 in serum will be summarised by number and percentage of participants who are ADA positive. The ADA titer will be listed by participant at different time points.
Measure: Number and percentage of participants who are ADA positive Time: From Day 1 up to last follow-up day (Day 361)This study will assess the safety and efficacy of a single dose of AZD7442(× 2 IM injections) compared to placebo for the prevention of COVID-19.
Description: To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19 through Day 183
Measure: The incidence of the first case of SARS CoV-2 RT PCR positive symptomatic illness Time: Day 183Description: To assess the safety and tolerability of a single IM dose of AZD7442 compared to placebo
Measure: AEs, SAEs, MAAEs, and AESIs through 365 days post dose of IMP Time: 1 yearDescription: To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19 through Day 366
Measure: The incidence of the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurring after dosing with IMP through Day 366 Time: 1 yearDescription: To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of SARS-CoV-2 infection
Measure: The incidence of participants who have a post-treatment response (negative at baseline to positive at any time post-baseline) for SARS-CoV-2 nucleocapsid antibodies Time: 1 yearDescription: To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of severe or critical symptomatic COVID-19
Measure: The incidence of SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring after dosing with IMP Time: 1 yearDescription: To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19-related Emergency Department visits
Measure: The incidence of COVID-19-related Emergency Department visits occurring after dosing with IMP Time: 1 yearDescription: To assess the pharmacokinetics of AZD7442 administered as a single dose of 300 mg IM
Measure: Serum AZD7442 concentrations, PK parameters if data permit. Time: 1 yearDescription: To evaluate ADA responses to AZD7442 in serum
Measure: Incidence of ADA to AZD7442 in serum. Time: 1 yearThis study will assess the efficacy of AZD7442 for the post-exposure prophylaxis of COVID-19 in Adults.
Description: To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19
Measure: The incidence of the first case of SARS CoV-2 RT PCR positive symptomatic illness Time: Day 183Description: To assess the safety and tolerability of a single IM dose of AZD7442 compared to placebo
Measure: AEs, SAEs, MAAEs, and AESIs through 365 days post dose of IMP Time: 1 yearDescription: To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of severe or critical symptomatic COVID-19
Measure: The incidence of SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring after dosing with IMP Time: Day 183Description: To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of SARS-CoV-2 infection
Measure: The incidence of participants who have a post-treatment response (negative at baseline to positive at any time post-baseline) for SARSCoV- 2 nucleocapsid antibodies Time: 1 yearDescription: To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19-related death
Measure: The incidence of COVID-19-related death occurring after dosing with IMP Time: 1 yearDescription: To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of all-cause mortality
Measure: The incidence of all-cause mortality occurring after dosing with IMP Time: 1 yearDescription: To assess the pharmacokinetics of AZD7442 administered as a single dose of 300 mg IM
Measure: Serum AZD7442 concentrations, PK parameters if data permit. Time: 1 yearDescription: To evaluate ADA responses to AZD7442 in serum
Measure: Incidence of ADA to AZD7442 in serum Time: 1 yearAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 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.
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