Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Navigate: Correlations HPO
There is one clinical trial.
This is an open-label, interventional exploratory study to evaluate the safety and efficacy of 5-ALA-Phosphate + SFC in subjects with acute moderate or severe respiratory illness secondary to infection with SARS-CoV-2 virus (COVID-19) involving 40 subjects. The primary objective is to evaluate the safety of 4-week oral administration of 5-ALAPhosphate + SFC. This study is expected to last for 4 weeks and will include follow-up until day 28 in the hospital or in an outpatient setting if the subjects are discharged earlier.
Description: To describe the incidence of treatment-emergent Adverse Events (TEAEs) of CTC Grades III and IV within four weeks following base line dose.
Measure: The incidence of treatment emergent Adverse Events (safety and tolerability) of 5-ALA-Phospate + SFC in patients with acute moderate or severe respiratory illness secondary to infection with SARS-CoV-2 virus (COVID-19). Time: 28 daysDescription: To describe patient's condition in Moderate and Severe group using average, median, minimum and maximum in COVID-19 Modified Ordinal Scale for Clinical Improvement score.
Measure: Sum COVID-19 Modified Ordinal Scale for Clinical Improvement maximum daily score over 28 days of dosing for Moderate group and for Severe group Time: 28 daysDescription: To describe patient´s condition in Moderate and Severe Group using rate of change in COVID-19 Modified Ordinal Scale for Clinical Improvement score.
Measure: Rate of change in COVID-19 Modified Ordinal Scale for Clinical Improvement maximum daily score over 28 days of dosing for individual subjects in Moderate group and in Severe group Time: 28 daysDescription: To describe patient´s condition in Moderate and Severe Group using patient and subgroup profile of COVID-19 Modified Ordinal Scale for Clinical Improvement score vs. days hospitalized.
Measure: Patient and subgroup profile of COVID-19 Modified Ordinal Scale for Clinical Improvement score vs. days hospitalized Time: 28 daysDescription: To describe time until death from any cause
Measure: Overall survival Time: day 14 and day 28Description: To describe patient´s blood oxygenation
Measure: Results of investigator´s assessment of patient´s oxygen therapy Time: 28 daysDescription: To describe mechanical ventilation settings course during study.
Measure: Results of mechanical ventilation settings Time: 28 daysDescription: To describe duration of patient´s ventilation
Measure: Results of duration of ventilation Time: from date of enrolment until the extubation or until last 5-ALA- Phosphate -SFC administration on day 28Description: To describe patient´s specific symptoms course during study.
Measure: The time to resolution of patient´s symptoms Time: 28 daysDescription: To describe patient´s oxygen saturation course during study.
Measure: Results of patient´s oxygen saturation (respiratory parameters) Time: 28 daysDescription: To describe duration of hospitalization in the patient groups.
Measure: Length of hospitalization Time: From date of enrolment until last 5-ALA- Phosphate -SFC administration at day 28Description: To describe duration of residence in ICU in the patient groups.
Measure: The total time in ICU Time: From date of enrolment until last 5-ALA- Phosphate -SFC administration at day 28Description: To describe patient´s (q)SOFA score course during study.
Measure: Results of investigator´s assessment of patient´s condition using (q)SOFA score Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe patient´s coagulation function course during study which by evaluating the PT value.
Measure: Results of patient´s PT parameter Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe patient´s coagulation function course during study which by evaluating the D-Dimer value.
Measure: Results of patient´s D-Dimer parameter Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe patient´s coagulation function course during study which by evaluating the PTT value.
Measure: Results of patient´s PTT parameter Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe patient's SARS-CoV-2 viral load course during study.
Measure: Results of patient´s SARS-CoV-2 viral load status (efficacy) Time: day 7, 14 and 28Description: To describe infection parameter course of each patient during study by evaluating the Procalcitonin value.
Measure: Results of patient´s Procalcitonin level. Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe infection parameter course of each patient during study by evaluating the IL-6 value.
Measure: Results of patient´s IL-6 level Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe infection parameter course of each patient during study by evaluating the Serum ferritin value.
Measure: Results of patient´s Serum Ferritin level Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe infection parameter course of each patient during study by evaluating the C-Reactive protein (CRP) value.
Measure: Results of patient´s C-Reactive protein (CRP) level Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe infection parameter course of each patient during study by evaluating the T helper cells (CD4/CD8) value.
Measure: Results of patient´s T helper cells (CD4/CD8) level. Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe infection parameter course of each patient during study by evaluating the Bilirubin value.
Measure: Results of patient´s Bilirubin level. Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe laboratory assessments course during study by evaluating Leucocytes value
Measure: Results on patient´s Leucocytes Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe laboratory assessments course during study by evaluating Neutrophils value
Measure: Results on patient´s Neutrophils Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe laboratory assessments course during study by evaluating Lymphocyte value
Measure: Results on patient´s Lymphocyte Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe laboratory assessments course during study by evaluating Platelets value
Measure: Results on patient´s Platelets Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe laboratory assessments course during study by evaluating Hemoglobin value
Measure: Results on patient´s Hemoglobin Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe laboratory assessments course during study by evaluating Albumin value
Measure: Results on patient´s Albumin Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe laboratory assessments course during study by evaluating AST value
Measure: Results on patient´s AST Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe laboratory assessments course during study by evaluating ALT value
Measure: Results on patient´s ALT Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe laboratory assessments course during study by evaluating Total bilirubin value
Measure: Results on patient´s Total bilirubin Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe laboratory assessments course during study by evaluating Blood urea nitrogen value
Measure: Results on patient´s Blood urea nitrogen Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe laboratory assessments course during study by evaluating Serum creatinine value
Measure: Results on patient´s Serum creatinine Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe laboratory assessments course during study by evaluating Creatinine kinase value
Measure: Results on patient´s Creatinine kinase Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe laboratory assessments course during study by evaluating LDH value
Measure: Results on patient´s LDH Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe laboratory assessments course during study by evaluating Myoglobin glucose value
Measure: Results on patient´s Myoglobin glucose Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe laboratory assessments course during study by evaluating aPTT value
Measure: Results on patient´s aPTT Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe laboratory assessments course during study by evaluating urinalysis (urine test strip)
Measure: Results on patient´s urine Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe laboratory assessments course during study by evaluating hepatic function
Measure: Results on hepatic function Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe laboratory assessments course during study by evaluating renal function
Measure: Results on patient´s renal function Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe laboratory assessments course during study by evaluating iron parameters
Measure: Results on patient´s iron parameters Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe patient´s conditions course during study using physical examination which include General Appearance, ENT, Respiratory, Cardiovascular, Musculoskeletal, Skin and Neurological.
Measure: Results on patient´s physical examination Time: day 0, 2, 3, 5, 7, 10, 14, 21, 28Description: To describe patient's Co-infections course during study.
Measure: Results on patient´s Co-infections Time: 28 daysDescription: To describe patient´s care level course during study.
Measure: Results on patient´s Care Level Time: 28 daysDescription: To describe patient´s vital signs course during study by evaluating Mean arterial pressure(MAP)
Measure: Results on patient´s Mean arterial pressure(MAP) Time: 28 daysDescription: To describe patient´s vital signs course during study by evaluating heart rate (HR)
Measure: Results on patient´s heart rate (HR) Time: 28 daysDescription: To describe patient´s vital signs course during study by evaluating respiratory rate (RR)
Measure: Results on patient´s respiratory rate (RR) Time: 28 daysDescription: To describe patient´s 12-lead ECG result course during study.
Measure: Results on patient´s 12-lead ECG Time: day 0, 7, 14 and 28Description: To describe patient´s organ damage status during the study
Measure: Organ damage Time: 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