Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1785 | Hydroxychloroquine , Sofosbuvir, daclatasvir Wiki | 1.00 |
| drug3367 | Rilematovir X mg/kg Wiki | 1.00 |
| drug3746 | Standard of care treatment Wiki | 0.71 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D012141 | Respiratory Tract Infections NIH | 0.16 |
| D003141 | Communicable Diseases NIH | 0.07 |
| D007239 | Infection NIH | 0.05 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0011947 | Respiratory tract infection HPO | 0.16 |
Navigate: Correlations HPO
There is one clinical trial.
The purpose of the study is to evaluate the efficacy of rilematovir compared to placebo treatment with respect to the clinical outcome on the RSV Recovery Scale (RRS).
Description: The RRS is an ordinal scale assessing a participant's clinical status.
Measure: Respiratory Syncytial Virus (RSV) Recovery Scale (RRS) Time: Up to Day 8Description: Clinical resolution is defined by free of oxygen supplementation, and free of supplemental feeding, and no medical need for intensive care unit (ICU), and key RSV Signs/Symptoms resolved to absent or mild as per the Pediatric RSV Electronic Severity and Outcome Rating Scale (PRESORS) Clinician Rated Outcome (ClinRO) Signs/Symptoms questionnaire.
Measure: Percentage of Participants with Clinically Resolved RSV Disease as Assessed by ClinRO Sign/Symptoms Questionnaire Time: Up to Day 8Description: Time from first study dose to resolution of key RSV Signs/symptoms (absent or mild) will be assessed based on parent's/caregiver's PRESORS Observer Rated Outcome (ObsRO) signs/symptoms and supplementation free (oxygen and feeding/hydration).
Measure: Time From First Study Dose to Resolution of key RSV Signs/Symptoms Based on ObsRO Time: Up to Day 21Description: Time from discharge to resolution of key RSV Signs/symptoms will be assessed based on PRESORS ObsRO Sign/Symptoms (only including participants who did not reach resolution before first discharge).
Measure: Time From Discharge to Resolution of key RSV Signs/Symptoms based on ObsRO Sign/Symptoms Questionnaire Time: Up to Day 21Description: Time from first dosing to end of oxygen supplementation will be assessed (only including participants who were receiving oxygen supplementation at the time of first dosing).
Measure: Time From First Dosing to end of Oxygen Supplementation Time: Up to Day 35Description: Number of participants with post-baseline RSV-related complications will be assessed.
Measure: Number of Participants with Post-baseline RSV-Related Complications Time: Up to Day 35Description: An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.
Measure: Number of Participants with Adverse Events Time: Up to Day 35Description: Number of participants with abnormalities in Clinical laboratory values (Hematology, Clinical chemistry, and routine urinalysis) will be assessed.
Measure: Number of Participants with Abnormalities in Clinical Laboratory Values Time: Up to Day 35Description: Number of participants with ECG abnormalities will be assessed.
Measure: Number of Participants with Abnormalities in Electrocardiograms (ECG) Time: Up to Day 35Description: Number of participants with vital signs (Temperature, pulse/heart rate, and peripheral capillary oxygen saturation [SpO2]) abnormalities will be assessed.
Measure: Number of Participants with Abnormalities in Vital Signs Time: Up to Day 35Description: Time to resolution of signs/symptoms (absent or mild) of RSV disease as assessed by PRESORS ObsRO signs/symptoms questionnaire.
Measure: Time to Resolution of Signs/symptoms of RSV Disease as Assessed by ObsRO Signs/Symptoms Questionnaire Time: Up to Day 21Description: PRESORS ObsRO Signs/Symptoms Questionnaire Scores will be assessed. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease.
Measure: PRESORS ObsRO Signs/Symptoms Questionnaire Scores Time: Up to Day 21Description: Change from baseline in PRESORS ObsRO Signs/Symptoms questionnaire scores over time will be assessed. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease.
Measure: Change From Baseline in PRESORS ObsRO Signs/Symptoms Questionnaire Scores Over Time Time: Baseline up to Day 21Description: Time to improvement on PRESORS ObsRO GHQ will be assessed. ObsRO GHQ contains questions which are used to record the caregiver's general impression of the child's RSV disease severity, change in RSV disease severity, and overall health status.
Measure: Time to Improvement in ObsRO General Health Questions (GHQ) Time: Up to Day 21Description: Time to resolution of signs/symptoms of RSV disease as assessed by ClinRO signs/symptoms questionnaire will be reported.
Measure: Time to resolution of Signs/Symptoms of RSV Disease as Assessed by ClinRO Signs/Symptoms Questionnaire Time: Up to Day 21Description: PRESORS ClinRO signs/symptoms questionnaire score will be reported. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease.
Measure: PRESORS ClinRO Signs/Symptoms Questionnaire Scores Time: Up to Day 21Description: Change from baseline in PRESORS ClinRO signs/symptoms questionnaire scores over time will be assessed.
Measure: Change From Baseline in ClinRO Signs/Symptoms Questionnaire Scores Time: Baseline up to Day 21Description: Percentage of participants with clinically resolved RSV disease based on PRESORS ClinRO signs/symptoms will be assessed.
Measure: Percentage of Participants with Clinically Resolved RSV Disease Based on ClinRO Signs/symptoms Time: Day 2 to 8Description: Change from baseline in ClinRO GHQ score over time will be assessed. ClinRO GHQ contains questions which are used to record the caregiver's general impression of the child's RSV disease severity, change in RSV disease severity, and overall health status.
Measure: Change from Baseline in ClinRO GHQ Score Over Time Time: Baseline up to Day 21Description: Time to hospital discharge from start of dosing will be assessed.
Measure: Time to Hospital Discharge From Start of Dosing Time: Up to Day 35Description: Time to readiness of participants for hospital discharge (as evaluated by the investigator) will be assessed.
Measure: Time to Readiness for Hospital Discharge Time: Up to Day 35Description: Percentage of participants requiring ICU stay will be assessed.
Measure: Percentage of Participants Requiring Intensive Care Unit (ICU) Stay Time: Up to Day 35Description: Duration of requiring ICU stay will be assessed.
Measure: Duration of Requiring ICU Stay Time: Up to Day 35Description: Percentage of participants requiring re-hospitalization for respiratory/other reasons will be assessed.
Measure: Percentage of Participants Requiring Re-hospitalization for Respiratory/other Reasons Time: Up to Day 35Description: Time to end of oxygen supplementation will be assessed.
Measure: Time to end of Oxygen Supplementation Time: Up to Day 35Description: Percentage of participants requiring oxygen supplementation will be assessed.
Measure: Percentage of Participants Requiring Oxygen Supplementation Time: Up to Day 35Description: Duration of oxygen supplementation will be assessed.
Measure: Duration of Oxygen Supplementation Time: Up to Day 35Description: Time to end of supplemental feeding/hydration will be assessed.
Measure: Time to end of Supplemental Feeding/hydration Time: Up to Day 35Description: Percentage of participants requiring hydration and/or feeding by IV administration or nasogastric tube will be assessed.
Measure: Percentage of Participants Requiring Hydration and/or Feeding by Intravenous (IV) Administration or Nasogastric Tube Time: Up to Day 35Description: Duration of supplemental feeding/hydration will be assessed.
Measure: Duration of Supplemental Feeding/hydration Time: Up to Day 35Description: Time to end of supplemental oxygen and/or feeding/hydration will be assessed.
Measure: Time to end of Supplemental Oxygen and/or Feeding/hydration Time: Up to Day 35Description: Number of participants with medical care encounters and treatments (including physician or emergency room visits, tests and procedures, and medications, surgeries and other procedures) will be reported.
Measure: Number of Participants with Medical Encounters and Treatments Time: Up to Day 35Description: Number of participants with antibiotic treatment episodes will be assessed.
Measure: Number of Participants with Antibiotic Treatment Episodes Time: Up to Day 35Description: Number of participants with systemic or inhaled corticosteroids and bronchodilators use will be assessed.
Measure: Number of Participants with Systemic or Inhaled Corticosteroids and Bronchodilators use Time: Up to Day 35Description: RSV viral load area under the RSV viral load-time curve [AUC] will be assessed by quantitative real-time reverse transcription-polymerase chain reaction (qRT-PCR) assay of nasal swabs.
Measure: RSV Viral Load Area Under the RSV Viral Load-time Curve [AUC]) From Immediately Prior to First Dose of Study Intervention (Baseline) Through Day 3, Day 5, and Day 8 Time: Baseline, Day 3, 5 and Day 8Description: RSV viral load over time will be assessed by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Measure: RSV Viral Load Over Time Time: From Baseline to Day 21Description: Change From baseline in RSV viral load over time will be assessed by qRT-PCR assay in the mid-turbinate nasal swabs specimens.
Measure: Change From Baseline in RSV Viral Load Over Time Time: Baseline to Day 21Description: Percentage of participants with undetectable RSV viral load will be assessed.
Measure: Percentage of Participants with Undetectable RSV Viral Load Time: Up to Day 21Description: Number of participants with post-baseline changes in the RSV F-gene compared with baseline sequences will be assessed.
Measure: Number of Participants with Post-baseline Changes in the RSV F-gene Compared with Baseline Sequences Time: Up to Day 21Description: Plasma concentration of rilematovir will be assessed.
Measure: Plasma Concentration of Rilematovir Time: Post-dose (Day 1) and pre-dose (Day 2)Description: Acceptability and palatability of the rilematovir formulation will be assessed through a questionnaire completed by parent(s)/caregiver(s).
Measure: Acceptability and Palatability of the Rilematovir Formulation as Assessed by Parent(s)/Caregiver(s) Time: Day 8Alphabetical 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