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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| drug3922 | Telehealth Wiki | 0.71 |
| drug2916 | Placebo Wiki | 0.04 |
| Name (Synonyms) | Correlation |
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Navigate: Correlations HPO
There is one clinical trial.
The primary objectives of this study is to evaluate the safety and tolerability of V590 versus placebo and to assess the immunogenicity of V590 on Day 28. The primary hypothesis is that at least one well-tolerated dose of V590 increases the geometric mean titers (GMTs) of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike serum neutralizing antibody, as measured by plaque reduction neutralization test (PRNT), compared to placebo.
Description: An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs (redness, swelling, and tenderness/pain) will be assessed.
Measure: Percentage of Participants with at Least 1 Solicited Injection Site Adverse Event Time: Up to 5 days post-vaccinationDescription: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs (muscle pain, joint pain, headache, tiredness, fatigue, rash, nausea, joint swelling, oral lesions, and sweating more than usual) will be assessed.
Measure: Percentage of Participants with at Least 1 Solicited Systemic Adverse Event Time: Up to 28 days post-vaccinationDescription: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Unsolicited AEs will be assessed.
Measure: Percentage of Participants with at Least 1 Unsolicited Adverse Event Time: Up to 28 days post-vaccinationDescription: A medically attended adverse event (MAAE) is an AE in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency room visit, office visit, or an urgent care visit with any medical personnel for any reason. Any MAAE will be assessed.
Measure: Percentage of Participants with at Least 1 Medically Attended Adverse Event Time: Up to 180 days post-vaccinationDescription: A serious adverse event is "life threatening," requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity and is a congenital anomaly/birth defect. Any SAE will be assessed.
Measure: Percentage of Participants with at Least 1 Serious Adverse Event Time: Up to 365 days post-vaccinationDescription: Serum samples will be collected and the presence of serum neutralization antibodies (SNAs) will be assessed using plaque reduction neutralization test (PRNT).
Measure: Geometric Mean Titers for Serum Neutralizing Antibodies as Measured by Plaque Reduction Neutralization Test (Panels A - H) Time: Day 28 post-vaccinationDescription: Serum samples will be collected and the presence of SNAs will be assessed using PRNT.
Measure: Geometric Mean Titers for SNAs as Measured by PRNT (Panels A-H) Time: Days 7, 14, 90, 180, 270, and 365 post-vaccinationDescription: Serum samples will be collected and the total anti-spike IgG antibodies will be assessed using enzyme-linked immunosorbent assay (ELISA).
Measure: Geometric Mean Concentration of Total Anti-SARS-CoV-2 Spike SNAs as Measured by Enzyme-Linked Immunosorbent Assay (Panels A-H) Time: Days 7, 14, 28, 90, 180, 270, and 365 post-vaccinationDescription: The percentage of participants with viremia detected by reverse transcription polymerase chain reaction (RT-PCR) of blood specimens will be assessed.
Measure: Percentage of Participants with Vaccine Viremia as Measured by Reverse Transcription-Polymerase Chain Reaction Time: Days 1, 2, 3, 4, 5, 6, 7, 14 and 28 post-vaccinationDescription: The percentage of participants with viral shedding detected by RT-PCR in urine or saliva specimens will be assessed.
Measure: Percentage of Participants with Vaccine Shedding in Saliva or Urine as Measured by RT-PCR Time: Days 1, 2, 3, 4, 5, 6, 7, 14, and 28 post-vaccinationDescription: The percentage of participants with vaccine shedding in stool as measured by RT-PCR will be assessed. Total of 2 stool samples collected if produced: one sample on Days 2 to 4; one sample on Days 5 to 7.
Measure: Percentage of Participants with Vaccine Shedding in Stool as Measured by RT-PCR Time: Days 2-4, 5-7 post-vaccinationAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
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