Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3771 | Standardized crisis management and coping protocol plan toward Coronavirus disease 2019 (COVID-19) Wiki | 1.00 |
| drug3319 | Remdesivir Wiki | 0.19 |
| drug2916 | Placebo Wiki | 0.04 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.04 |
| D018352 | Coronavirus Infections NIH | 0.04 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There is one clinical trial.
This protocol will serve as a platform for assessing treatments for adult patients hospitalized for medical management of COVID-19 without related serious end-organ failure. Trials will involve sites around the world strategically chosen to ensure rapid enrollment. This trial will compare hyperimmune intravenous immunoglobulin (hIVIG) with matched placebo, when added to standard of care (SOC), for preventing further disease progression and mortality related to COVID-19. SOC will include remdesivir unless it is contraindicated for an individual patient.
Description: The primary objective is to compare the clinical status of patients in each group on day 7 of follow-up using the primary ordinal outcome with 7 mutually exclusive categories: 7. Death 6. End-organ failure 5. Life-threatening end-organ dysfunction 4. Serious end-organ dysfunction 3. Moderate end-organ dysfunction 2. Limiting symptoms due to COVID-19 1. No limiting symptoms due to COVID-19 Outcome is reported as the percent of participants in each of 7 categories.
Measure: Ordinal Outcome Scale - Day 7 Time: 7 daysDescription: Outcome reported as the percent of participants who expire for any reason by day 28 post treatment.
Measure: All-cause mortality through Day 28 Time: 28 daysDescription: A secondary outcome is to compare the clinical status of patients in each group on day 3, 5, 14, and 28 of follow-up using the primary ordinal outcome. Outcome is reported as the percent of participants in each of 7 categories.
Measure: Ordinal Outcome Scale Time: 3 days, 5 days, 14 days, and 28 daysDescription: The National Early Warning Score (NEWS) is used to determine the degree of illness of a patient and prompt critical care intervention. The score takes into account respiratory rate, oxygen saturation, use of respiratory support, body temperature, blood pressure, and heart rate. These data are entered into a program to calculate a NEW score. Scores range from -3 to +3 with scores closer to zero representing a lower degree of illness. Scores will be collected at baseline and day 7 and the change in score at these 2 time points will be reported.
Measure: Change in National Early Warning Score (NEWS) Time: 7 daysDescription: Time to worsening is defined as the 3 least favorable categories on the primary ordinal scale. Outcome is reported as the percent of participants in each arm who are characterized as categories 5, 6, and 7 on the primary ordinal scale at 7, 14, and 28 days post treatment.
Measure: Time to Worsening Time: 7 days, 14 days, and 28 daysDescription: Outcome is reported as the percent of participants in each arm who are alive and discharged from the hospital to home or rehabilitation at days 7, 14, and 28 post treatment.
Measure: Discharge Status Time: 7 days, 14 days, and 28 daysDescription: Outcome is reported as the mean number of days alive and outside the hospital from study entry to Day 28 for participants in each arm.
Measure: Days Alive Outside the Hospital Time: 28 daysDescription: A secondary outcome is to compare the clinical status of patients in each group on day 3, 5, 7, 14, and 28 post treatment limited to using the pulmonary elements of the primary ordinal outcome (e.g., requirement for invasive ventilation). Outcome is reported as the percent of participants in each arm who fall into each of the 7 categories of the primary ordinal outcome with regard to their pulmonary dysfunction only.
Measure: Pulmonary-only Components of the Primary Ordinal Outcome Time: 3 days, 5 days, 7 days, 14 days, and 28 daysDescription: A secondary outcome is to compare the clinical status of patients in each group on day 3, 5, 7, 14, and 28 post treatment limited to using the thrombotic conditions (e.g., arterial thrombosis) in the primary ordinal outcome. Outcome is reported as the percent of participants in each arm who fall in each of the 7 categories of the primary ordinal outcome with regard to thrombotic conditions only.
Measure: Thrombotic Components of the Primary Ordinal Outcome Time: 3 days, 5 days, 7 days, 14 days, and 28 daysDescription: Time to recovery is defined as the 2 most favorable categories on the primary ordinal scale. Outcome is reported as the percent of participants in each arm who are characterized as categories 1 or 2 at 7, 14, and 28 days post treatment.
Measure: Time to recovery Time: 7 days, 14 days, and 28 daysDescription: Clinical organ dysfunction is defined by new onset of any one or more of the following. Outcome is reported as the percent of participants in each arm who meet any 1 of the following criteria by day 28 post treatment. A) Respiratory dysfunction B) Cardiac and vascular dysfunction C) Renal dysfunction D) Hepatic dysfunction E) Neurological dysfunction F) Haematological dysfunction G) Serious infection
Measure: Clinical Organ Dysfunction Time: 28 daysDescription: Outcome is reported as the percent of participants in each arm who experience a new grade 3 or 4 event, a serious adverse event (SAE), or death through day 7 (primary safety endpoint) post treatment.
Measure: Safety and Tolerability - Adverse Events Time: 7 daysDescription: Outcome is reported as the percent of participants in each arm for who had any grade of reaction during the infusion or within 2 hours afterwards, for whom the infusion is interrupted prior to completion, or for whom the infusion is stopped prior to completion.
Measure: Safety and Tolerability - Infusion Reactions, Interruptions, or Cessation Time: approximately 2 hoursDescription: Outcome is reported as the percent of participants in each arm who experience a serious adverse event (SAE) or death through day 28 post treatment.
Measure: Safety and Tolerability - Serious Adverse Events Time: 28 daysDescription: Outcome is reported as the percent of participants in each arm who experience an adverse event (AE) of any grade present (new or continuing) on days 1, 3, 7, and 28 post treatment.
Measure: Safety and Tolerability - Prevalence of Adverse Events Time: 1 day, 3 days, 7 days, and 28 daysDescription: Outcome reported as the change in anti-SARS-CoV-2 IgG antibody level in blood from baseline to 1, 3, 7, and 28 days post treatment. Outcome is reported in units of antibody titer.
Measure: Change in Neutralizing Antibody Level Time: 1 day, 3 days, 7 days, and 28 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