Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation | |
---|---|---|
drug2206 | None - NA Wiki | 1.00 |
drug852 | Control Group Wiki | 1.00 |
Name (Synonyms) | Correlation | |
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D004932 | Esophageal and Gastric Varices NIH | 1.00 |
D003108 | Colonic Diseases NIH | 1.00 |
D005764 | Gastroesophageal Reflux NIH | 1.00 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0002020 | Gastroesophageal reflux HPO | 1.00 |
HP:0002040 | Esophageal varix HPO | 1.00 |
Navigate: Correlations HPO
There is one clinical trial.
This is a prospective, randomized (1:1), double blind study of Convalescent anti-SARS-CoV-2 MBT Plasma (also known as convalescent plasma) plus standard medical treatment (SMT) versus placebo plus SMT in mild or moderate COVID-19 patients who are non-hospitalised. Subjects with confirmed infection by SARS-CoV-2 will receive SMT plus a total of 200-250 mL of convalescent plasma that has been pathogen-inactivated using MBT or placebo. Approximately 474 individuals will be randomized (1:1) with an interim analysis after the first 60 subjects (30 in each arm). The sample size will be re-assessed upon interim analysis. Approximately 135 individuals from selected study sites will be included in the substudy to assess the immune response and the methods of sampling. This is a prospective, randomized (1:1), double blind study of Convalescent anti-SARS-CoV-2 MBT Plasma (also known as convalescent plasma) plus standard medical treatment (SMT) versus placebo plus SMT in mild or moderate COVID-19 patients who are non-hospitalised. Subjects with confirmed infection by SARS-CoV-2 will receive SMT plus a total of 200-250 mL of convalescent plasma that has been pathogen-inactivated using MBT or placebo. Approximately 474 individuals will be randomized (1:1) with an interim analysis after the first 60 subjects (30 in each arm). The sample size will be re-assessed upon interim analysis. Approximately 135 individuals from selected study sites will be included in the substudy to assess the immune response and the methods of sampling. The investigational product will be administered by IV infusion at baseline. Participants will continue their standard medical treatment (SMT) for SARS-CoV-2 infection as prescribed by their regular physician. If applicable, SMT may be modified during the study, depending on personal requirements, the severity and progression of the disease, and need for hospitalization. Subjects' participation (from inclusion/baseline visit to the end-of-study visit) will be up to 60 days.
Description: Assess the therapeutic potential of early administration of convalescent MBT plasma in reducing the rate of hospitalization in non-hospitalised mild or moderate COVID-19 patients.
Measure: Hospitalization rate (safety and efficacy) Time: Day 28Description: Assess the therapeutic potential of early administration of convalescent MBT plasma in reducing SARS-CoV-2 viral load at day 7, measured by quantitative RT-PCR (RT-qPCR) in non-hospitalised mild or moderate COVID-19 patients.
Measure: SARS-CoV-2 viral load (safety and efficacy) Time: Day 7Description: Change in COVID-19 World Health Organization WHO Clinical progression scale score to assess hospitalization rate (i.e. who reach a score ≥4). Minimum to maximum scores below: Score 0 (uninfected) - Uninfected; no viral RNA detected Score 1 (ambulatory mild disease) - Asymptomatic; viral RNA detected Score 2 (ambulatory mild disease) - Symptomatic; independent Score 3 (ambulatory mild disease) - Symptomatic; assistance needed Score 4 (hospitalised: moderate disease) - Hospitalised; no oxygen therapy Score 5 (hospitalised: moderate disease) - Hospitalised; oxygen by mask or nasal prongs Score 6 (hospitalised: severe diseases) - Hospitalised; oxygen by NIV or high flow Score 7 (hospitalised: severe diseases) - Intubation Score 8 (hospitalised: severe diseases) - Mechanical ventilation pO2/FiO2 <150 (SpO2/FiO2 <200) or vasopressors and mechanical ventilation, pO2/FiO2 ≥150 or SpO2/FiO2 ≥200
Measure: COVID-19 WHO Clinical progression scale score (safety and efficacy) Time: Day 60Description: Change in COVID-19 symptoms severity score, assessed with the COVID-19 daily self-score tool (FLU- patient-reported outcome measure (FLU-PRO©) PLUS instrument), certified-Spanish translation. COVID-19 daily self-score tool to assess symptom severity across six body systems: nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic. Data on the presence/absence of symptoms, symptom profiles, and change over time. Items 1-27 are Likert scale questions to score symptom severity (rated 0-4): 0=not at all;4=very much. Items 28-32 are also Likert scale questions (rated 0-4) measuring frequency of specific daily symptoms: 0=never or 0 times;4=always or 4 times. Items 33 and 34 measure the presence/absence of COVID-19 specific symptoms: 0=no;1=yes. Total maximum score of FLU-PRO© PLUS 134
Measure: COVID-19 symptoms severity score (safety and efficacy) Time: Day 14Description: Time to complete resolution of symptoms
Measure: Resolution of symptoms (safety and efficacy) Time: Day 28Description: Death rate
Measure: Death rate (safety and efficacy) Time: Day 60Description: Proportion of patients with adverse events (AE) and proportion of grade ≥4 AE, based on the FDA Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers scale
Measure: Adverse events (AE) (safety and efficacy) Adverse events (AE) Adverse events (AE) Time: Day 28Description: Change in inflammatory prognostic markers (ferritin)
Measure: Ferritin (safety and efficacy) Time: Baseline and Day 7Description: Change in inflammatory prognostic markers (prealbumin)
Measure: Prealbumin (safety and efficacy) Time: Baseline and Day 7Description: Change in inflammatory prognostic markers (Interleukin 6 (IL-6))
Measure: Interleukin 6 (IL-6) (safety and efficacy) Time: Baseline and Day 7Description: Change in inflammatory prognostic markers (D-dimer)
Measure: D-dimer (safety and efficacy) Time: Baseline and Day 7Description: Change in inflammatory prognostic markers (C reactive protein (CRP))
Measure: C reactive protein (CRP) (safety and efficacy) Time: Baseline and Day 7Description: Change in inflammatory prognostic markers (Leukocyte count)
Measure: Leukocyte count (safety and efficacy) Time: Baseline and Day 7Description: Change in inflammatory prognostic markers (Lymphocyte count)
Measure: Lymphocyte count (safety and efficacy) Time: Baseline and Day 7Description: Intergroup comparison of absolute neutralization titers against SARS-CoV-2 in plasma in a subgroup of 135 participants
Measure: Absolute neutralization titers against SARS-CoV-2 in plasma (safety and efficacy) Time: Baseline and Day 7Description: Change in titers of neutralizing antibodies against SARS-CoV-2 in plasma in a subgroup of 135 participants
Measure: Titers of neutralizing antibodies against SARS-CoV-2 in plasma (safety and efficacy) Time: Baseline and Day 60Description: Agreement and SARS-CoV-2 viral load of self-collected middle turbinate (MT) swab and saliva samples compared to nasopharyngeal swabs collected by a healthcare worker in a subgroup of 135 participants Outcome 18: Secondary Outcome Measure:
Measure: SARS-CoV-2 viral load of self-collected middle turbinate (MT) swab and saliva samples compared to nasopharyngeal swabs collected by a healthcare worker (safety and efficacy) Time: Baseline and Day 7Description: Reduction of SARS-CoV-2 viral load in nasopharyngeal swabs at day 28 after start of treatment, as determined by RT-qPCR
Measure: Reduction of SARS-CoV-2 viral load (safety and efficacy) Time: Baseline and Day 28Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 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