Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1683 | HLCM051 Wiki | 1.00 |
| drug2935 | Placebo Comparator Wiki | 0.71 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D013577 | Syndrome NIH | 0.09 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.08 |
| D055371 | Acute Lung Injury NIH | 0.08 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There is one clinical trial.
This is a prospective, interventional, multi-centre, phase III, randomized, double blind, placebo-controlled, parallel design trial to evaluate the efficacy, safety and tolerability of favipiravir as adjunct ('add on') to supportive care, in comparison to placebo with supportive care, in the acute treatment of patients who have tested positive for SARS-CoV-2 and presenting with moderate to severe COVID-19. This study will be conducted in two parts; Stage I - Main study and Stage II - Extended Follow up.
Description: This endpoint will be considered to have been met when the patient has attained a score of 4 or lower on the 10-point ordinal scale of clinical status used by WHO in the SOLIDARITY trial (maintaining a blood oxygen saturation of ≥ 95% at rest on room air at sea level) when evaluated over a period of 24 hours.
Measure: Primary Efficacy Endpoint: Time to resolution of hypoxia (Stage I) Time: 1-28 daysDescription: Time (No. of days) from randomization to the earliest time when ALL COVID-19 associated symptoms (fever, chills, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms - specifically diarrhoea and vomiting, shortness of breath or dyspnoea) are scored by the Investigator/trained study personnel as either '0=absent' or 'mild =1' in assessments over a period of 24 hours, when assessed from baseline to Day 28 or discharge from hospital (if discharge happens earlier than Day 28).
Measure: Time to alleviation of symptoms (Stage I) Time: 1-28 days.Description: Percentage of patients with score of either '0=absent' or 'mild =1' over a period of 24 hours, for ALL COVID-19 associated symptoms, by Days 4, 7, 10, 14, 21 and 28 or discharge (if discharge happens earlier than one or more of the above-mentioned timepoints)
Measure: Percentage of patients with score of 0 = absent or mild = 1 (Stage I) Time: 1-28 days.Description: Time to improvement in EACH of the symptoms of fever, chills, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms- specifically diarrhoea and vomiting, shortness of breath or dyspnoea by at least 1 grade over baseline.
Measure: Time to improvement in each of the symptoms (Stage I) Time: 1-28 days.Description: Percentage of patients reporting a clinical relapse of COVID-19 when assessed from day of discharge to 27 days after randomization (Day 28).
Measure: Percentage of patients reporting a 'clinical relapse' (Stage I) Time: 1-28 days.Description: Time (no. of days) to negative conversion of detectable SARS-CoV 2 viral RNA in the RT-PCR assays of respiratory sample, from randomization.
Measure: Time to negative conversion of detectable SARS-CoV 2 (Stage I) Time: 1-28 days.Description: Percentage of patients showing negative conversion of detectable SARS-CoV-2 viral RNA in the RT-PCR assays of respiratory sample on Days 5, 10 and 28 or discharge (if discharge happens earlier than one or more of the above-mentioned timepoints)
Measure: Percentage of patients showing negative conversion of detectable SARS-CoV 2 (Stage I) Time: 1-28 days.Description: Changes over time in patient's clinical status on the 10-point ordinal scale used in the SOLIDARITY trial by WHO
Measure: Changes over time in patient's clinical status on the 10-point ordinal scale of clinical status (Stage I) Time: 1-28 days.Description: Changes over time in patient's clinical status on the 8-point ordinal scale
Measure: Changes over time in patient's clinical status on the 8-point ordinal scale of clinical status (Stage I) Time: 1-28 days.Description: Changes over time in findings on chest X-ray
Measure: Changes over time in findings on chest X-ray (Stage I) Time: 1-28 days.Description: Changes over time in the National Early Warning Score-2 (NEWS-2)
Measure: Changes over time in the National Early Warning Score-2 (Stage I) Time: 1-28 days.Description: Percentage of patients requiring, until Day 28 or discharge from hospital (if discharge happens earlier) Management in intensive care unit High Flow Nasal Oxygen or Non-invasive mechanical ventilation Invasive mechanical ventilation
Measure: Percentage of patients requiring ICU management, high flow nasal oxygen and mechanical ventilation (Stage I) Time: 1-28 days.Description: Time (no. of days) from randomization to: Management in intensive care unit High Flow Nasal Oxygen or Non-invasive mechanical ventilation Invasive mechanical ventilation over an assessment period from randomization until Day 28 or discharge from hospital (if discharge happens earlier)
Measure: Time (no. of days) from randomization to ICU management, high flow nasal oxygen and mechanical ventilation (Stage I) Time: 1-28 days.Description: Duration (no. of days) the patient requires: Management in intensive care unit Oxygen supplementation High Flow Nasal Oxygen Non-invasive mechanical ventilation Invasive mechanical ventilation over an assessment period from randomization until Day 28 or discharge from hospital (if discharge happens earlier)
Measure: Duration (no. of days) the patient requires CU management, high flow nasal oxygen and mechanical ventilation (Stage I) Time: 1-28 days.Description: Percentage of Patients: dying from any cause dying from a COVID-19 associated complication over an assessment period from randomization until Day 28 or discharge from hospital (if discharge happens earlier)
Measure: Percentage of Patients dying (all cause and due to COVID-19) (Stage I) Time: 1-28 daysDescription: Percentage of patients reporting a 'clinical relapse' of COVID-19 when assessed from day of discharge to 59 days after the day of start of study treatment (Day 60). Note: 'Clinical relapse' is defined as either the reappearance or worsening of severity (over the assessment on the day of discharge) of one or more of the above-mentioned COVID-19 associated symptoms, or the appearance of any of these symptoms (due to COVID 19 infection) for the first time after discharge.
Measure: Percentage of 'clinical relapse' (Stage I + Stage II) Time: 1 - 60 daysDescription: Number (and percentage) of patients reporting treatment emergent adverse events (TEAEs) (by MedDRA system organ class and preferred term)
Measure: Incidence of treatment emergent adverse events (Stage I + Stage II) Time: 1 - 60 daysAlphabetical 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