Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3008 | Plasma from a volunteer donor Wiki | 0.58 |
| drug3287 | Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Wiki | 0.26 |
| drug2916 | Placebo Wiki | 0.02 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D007410 | Intestinal Diseases NIH | 0.29 |
| D015212 | Inflammatory Bowel Diseases NIH | 0.19 |
| D040921 | Stress Disorders, Traumatic NIH | 0.10 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002242 | Abnormal intestine morphology HPO | 0.29 |
| HP:0002037 | Inflammation of the large intestine HPO | 0.19 |
Navigate: Correlations HPO
There are 3 clinical trials
To assess the efficacy and safety of Human coronavirus immune plasma (HCIP) to reduce the risk of hospitalization or death, the duration of symptoms and duration of nasopharyngeal or oropharyngeal viral shedding.
Description: Cumulative incidence measured as the proportion of subjects who were hospitalized or who died prior to hospitalization
Measure: Cumulative incidence of hospitalization or death prior to hospitalization Time: Up to day 28Description: Cumulative incidence of treatment-related serious adverse events categorized separately as either severe infusion reactions or Acute Respiratory Distress Syndrome (ARDS) during the study period.
Measure: Cumulative incidence of treatment-related serious adverse events Time: Up to day 28Description: Cumulative incidence measured as the proportion of subjects experiencing a Grade 3 or higher.
Measure: Cumulative incidence of treatment-related grade 3 or higher adverse events Time: Up to day 90Description: Analysis of serum SARS-CoV-2 antibody titers will also primarily be descriptive, comparing the geometric mean titers at day 0, 14, 28 and 90 between the randomized arms and calculating the shift or change in the titer distribution.
Measure: Change in serum SARS-CoV-2 antibody titers Time: Days 0, 14, 28 and 90Description: Compare the rates and duration of SARS-CoV-2 RNA positivity (by RT-PCR) of nasopharyngeal or oropharyngeal fluid between active and control groups at days 0, 14 and 28
Measure: Time to SARS-CoV-2 Polymerase Chain Reaction (PCR) negativity Time: Day 0, 14 and 28Description: Compare the levels of SARS-CoV-2 RNA between active and control groups at days 0, 14 and 28
Measure: Change in level of SARS-CoV-2 RNA Time: Day 0, 14 and 28Description: Comparison of participant self-assessed blood oxygen saturation levels (in percentage oxygen) between treatment arms using pulse oximetry from Day 0 to Day 28.
Measure: Change in oxygen saturation levels Time: Day 0 to Day 28 (where available)Description: Secondary infection will be assessed by measuring the number of individuals that live in the same house as the active arm who became sick by the end of follow-up period.
Measure: Rate of participant-reported secondary infection of housemates Time: Up to day 90Description: Disease severity measured by time (in days) to admission to the ICU or , invasive mechanical ventilation or time to death.
Measure: Time to ICU admission, invasive mechanical ventilation or death in hospital Time: Up to day 90Description: Time (in days) to resolution of COVID-19 symptoms will be based on temperature logs and symptom score sheets.
Measure: Time to resolution of COVID-19 symptoms Time: Up to day 90Description: Assess change in hospitalization rate as measured by number of hospitalizations stratified by age groups <65 and >=65
Measure: Impact of convalescent plasma on outcome as assessed by change in hospitalization rate Time: Day 0 to Day 90Description: Impact of donor antibody titers (high/low) will be assessed by hospitalization rate as measured by number of hospitalizations.
Measure: Impact of donor antibody titers on hospitalizaton rate of convalescent plasma recipients Time: Day 0 to Day 90Description: Impact of donor antibody titers (high/low) will be assessed by antibody levels
Measure: Impact of donor antibody titers on antibody levels of convalescent plasma recipients Time: Day 0 to Day 90Description: Impact of donor antibody titers (high/low) will be assessed by viral positivity rates (number of SARS-CoV-2 positive cases per total cases)
Measure: Impact of donor antibody titers on viral positivity rates of convalescent plasma recipients Time: Day 0 to Day 90Convalescent plasma has been shown to be safe and effective for treatment of several diseases. Preliminary data indicates that it is safe and effective for treatment of COVID. However, data is limited to small studies and case series on severely ill patients. In a preliminary safety study 10 patients with severe COVID-19, defined as requiring supplementary oxygen, having fever and a duration of illness less than 11 days were treated with 200 ml of CP. CP was given as a slow infusion without obvious adverse events. Eight patients had viremia. One patient rapidly cleared the virus and recovered following CP treatment. CP infusion did not appear to clear viremia in 7/8 patients. Five of these were eventually admitted to ICU. Thus CP did not appear to cause acute toxicity but did not seem to be effective at the dose used. Viremia seemed to be a marker of a high risk of disease progression The proposed study thus aims to treat a high risk population identified by having viremia irrespective of but hopefully before they develop pulmonary injury such that they require supplementary oxygen therapy. Moreover the dose of plasma will be increased incrementally with the aim of clearing viremia as our initial study indicates that continued viremia is driving COVID-19.
Description: Progression to non-invasive or invasive ventilation or a sustained requirement of 15L of supplementary oxygen therapy in patients that are not eligible for intensive care treatment.
Measure: Number and proportion of patients with progression to ventilation or sustained requirement of supplementary oxygen therapy Time: Measured in the first 28 days after inclusion.Description: Adverse reactions and serious adverse reactions. The safety of the intervention will be assessed with regard to AEs, baseline medical conditions, and findings from the physical examination and laboratory tests. Possible adverse events will be elicited using a modification and Swedish translation (appendix 6) of Common Terminology Criteria for Adverse Events v5.0 and they will be continuously reported to the sponsor. Adverse events related to convalescent plasma therapy shall be followed to assess reversibility.
Measure: Adverse events Time: The reporting period for AEs starts at inclusion and ends at the final follow-up visit 2 months after inclusion.Description: Measured as doses of convalescent plasma administered (1-7 infusions, 200ml).
Measure: Dose of plasma needed to clear viremia Time: 28 daysDescription: SARS-CoV-2 RNA detection by PCR in blood or serum. Blood samples for immunological analyses and serology will be taken daily until discharge, on day 28, and at 6 months.
Measure: Clearance of viremia Time: 6 months.Description: Time to resolution of fever and symptoms. Breathing rate, peripheral oxygen saturation (measured with pulse oximetry after 20 minutes of rest), oxygen use, pulse, blood pressure, body temperature and mental state will be monitored 3 times/day while hospitalized.
Measure: Fever and symptoms Time: Until discharged from the hospital, up to 2 monthsDescription: Time to normalization of inflammatory parameters. Blood samples for inflammatory parameters will be taken daily until normalized or discharged from the hospital.
Measure: Inflammatory parameters Time: Until discharged from the hospital, up to 2 monthsDescription: Characterization of the antibody response to SARS-CoV-2. Blood samples for immunological analyses and serology will be taken daily until discharge, on day 28, and at 6 months.
Measure: Antibody response to SARS-CoV-2 Time: 6 monthsThere is currently no effective treatment for COVID-19 except best supportive care. The aim is assess the safety, tolerability and efficacy of convalescent plasma for treatment of patients with varying degrees of COVID-19 illness. Convalescent plasma has been shown to be safe and effective for treatment of several diseases. Preliminary data indicates that it is safe and effective for treatment of COVID-19. However, data is limited to small studies and case series on severely ill patients. The proposed study assesses the safety and efficacy earlier in the course of illness, in slightly less severe patients with the possibility of detecting less severe adverse events and the potential for early treatment to hinder the development of severe disease. Plasma is collected from consenting donors who have recovered from SARS-CoV-2.
Description: Decrease in progression to requiring non-invasive or invasive ventilation
Measure: Disease progression Time: 28 daysDescription: Adverse reactions and serious adverse reactions. The safety of the intervention will be assessed with regard to AEs, baseline medical conditions, and findings from the physical examination and laboratory tests. Possible adverse events will be elicited using a modification and Swedish translation (appendix 6) of Common Terminology Criteria for Adverse Events v5.0 and they will be continuously reported to the sponsor. Adverse events related to convalescent plasma therapy shall be followed to assess reversibility.
Measure: Adverse events (AE) Time: The reporting period for AEs starts at inclusion and ends at the final follow-up visit 2 months after inclusion.Description: Measured daily until discharged from the hospital.
Measure: Time ro resolution of fever and symptoms Time: Until discharged from the hospital, up to 2 monthsDescription: SARS-CoV-2 RNA detection by polymerase chain reaction (PCR) in blood or serum. Blood samples for immunological analyses and serology will be taken daily until discharge, on day 28, and at 6 months.
Measure: Clearance of viraemia Time: Evaluated daily until discharge, at day 28, and last measurement taken at 6 months of follow-up after inclusion.Description: Time to normalization of inflammatory parameters. The markers that will be monitored are the following: C-reactive protein (CRP), white blood cell count (WBC), haemoglobin (Hb), Pro-calcitonin, and Creatine Kinase. Blood samples for these markers will be taken daily until normalized or discharged from hospital.
Measure: Inflammatory parameters Time: Until discharged from the hospital, up to 2 monthsDescription: Change in the antibody response to SARS-CoV-2 as measured in serum. Blood samples for immunological analyses and serology will be taken daily until discharge, on day 28, and at 6 months.
Measure: Antibody response to SARS-CoV-2 Time: Evaluated daily until discharge, at day 28, and last measurement taken at 6 months of follow-up after inclusion.Alphabetical 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