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Clinical Trials, and HPO
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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1974 | Interleukin-7 Wiki | 0.58 |
| drug819 | CYT107 Wiki | 0.58 |
| drug3969 | Thalidomide Wiki | 0.41 |
Navigate: Correlations HPO
There are 6 clinical trials
Comparison of the effects of CYT107 vs Placebo administered IM at 10µg/kg twice a week for two weeks on immune reconstitution of lymphopenic COVID-19 patients.
Description: A statistically significant increase of the absolute lymphocyte count (ALC) from randomization to day 30 or Hospital Discharge
Measure: Improvement of the absolute lymphocyte count (ALC) of lymphopenic (ALC≤1000/mm3) COVID-19 infected participants out to approximately 30 days following initial Study drug administration or Hospital discharge (HD), whicheve Time: 1 monthDescription: The time to clinical improvement to determine if CYT107 will improve the clinical status of hospitalized COVID-19 patients as measured by clinical improvement score
Measure: To obtain "clinical improvement" as defined by a 2 points improvement in a 7-point ordinal scale for Clinical Assessment, through day 30 or HD. Time: 1 monthDescription: The decrease of SARS-CoV-2 viral load from measurements at baseline and days of treatment dose 4 and dose 5, Day 21 and Day 30 or HD (whichever occurs first)
Measure: determine if CYT107 will lead to a significant decline of SARS-CoV-2 viral load through day 30 or HD Time: one monthDescription: Incidence of secondary infections based on pre-specified criteria as adjudicated by the Secondary Infections Committee (SIC) through Day 45
Measure: To compare the effect of CYT107 versus placebo on the frequency of secondary infections through day 45 Time: 45 daysDescription: Number of days of hospitalization during index hospitalization (defined as time from initial Study drug treatment through HD)
Measure: To compare the effect of CYT107 versus placebo on the length of hospitalization Time: 45 daysDescription: Number of days in ICU during index hospitalization
Measure: To compare the effect of CYT107 versus placebo on the length of stay in ICU Time: 45 daysDescription: Readmissions to ICU through Day 45
Measure: To compare the effect of CYT107 versus placebo on readmissions to ICU Time: 45 daysDescription: Organ support free days (OSFDs) during index hospitalization (This includes ventilator assistance free days.)
Measure: To compare the effect of CYT107 versus placebo on organ support free days Time: 45 daysDescription: Number of readmissions to the hospital through Day 45
Measure: To compare the effect of CYT107 versus placebo on the frequency of re-hospitalization through day 45 Time: 45 daysDescription: All-cause mortality through Day 45
Measure: To assess the impact of CYT107 on all-cause mortality through day 45 Time: 45 daysDescription: Absolute numbers of CD4+ and CD8+ T-cell counts at timepoints indicated on the Schedule of Activities (SoA) through Day 30 or HD
Measure: To determine the effect of CYT107 on CD4+ and CD8+ T cell counts Time: 30 daysDescription: Track and evaluate other known biomarkers of inflammation, Ferritin, from baseline to day 30
Measure: To track and evaluate other known biomarkers of inflammation: Ferritin Time: 30 daysDescription: Track and evaluate other known biomarkers of inflammation, CRP from baseline to day 30
Measure: To track and evaluate other known biomarkers of inflammation: CRP Time: 30 daysDescription: Track and evaluate other known biomarkers of inflammation, D-dimer from baseline to day 30
Measure: To track and evaluate other known biomarkers of inflammation: D-dimer Time: 30 daysDescription: Evaluate improvement of the NEWS2 score value
Measure: Evaluation of physiological status through NEWS2 score Time: 30 daysDescription: Incidence and scoring of all grade 3-4 adverse events through Day 45 (using CTCAE Version 5.0 to assess severity)
Measure: Safety assessment Time: 45 daysBackground: COVID-19 is an acute respiratory syndrome. One symptom of COVID-19 is a reduction in the number of cells called lymphocytes in the blood. Lymphocytes are a type of white blood cell that fights infections. With fewer lymphocytes, the body cannot effectively fight back against SARS CoV-2, the virus that causes COVID-19. Researchers want to better understand how SARS-CoV-2 affects these blood cells. This information may give them ideas for new treatments. Objective: To learn more about how SARS-CoV-2 affects lymphocytes, the immune, and the blood clotting system. Eligibility: Adults age 18 and older who either currently have COVID-19 or have recently recovered from it Design: Participants will give a blood sample. For this, a needle is used to collect blood from an arm vein. For participants who have a central line, blood will be collected through that instead. Participants medical records related to COVID-19 will be reviewed. Participants who have recovered from COVID-19 will be asked to undergo leukapheresis to collect white blood cells. For this, blood is taken from a needle placed in one arm. A machine separates out the white blood cells. The rest of the blood is returned to the participant through a needle placed in the other arm. This takes about 2-3 hours. Recovered participants may have material collected from inside the nostrils and/or rectum. This is done by gently rubbing the area with a sterile cotton swab. Recovered participants may have an echocardiogram to look at their heart. For this, a small probe is held against the chest to get pictures of the heart from different angles. This takes less than 30 minutes. Participation lasts 1-2 days on most cases and may be split in a few visits for recovered patients if leukapheresis and echocardiogram are done. ...
Description: To characterize lymphopenia and immunologic phenotypes and inflammatory responses including inflammasome responses and coagulopathy in patients with COVID-19.
Measure: Evaluation of lymphocyte subsets in patients with COVID-19 at various stages of disease, including recovery. Time: Throughout the studyDescription: 1. Correlation of lymphopenia, immunologic phenotypes, and inflammatory responses with clinical outcomes. 2. Characterization of complement activation in patients with COVID-19. 3. Evaluation of activationinduced cell death and activated T cell autonomous death through measurement of intracellular reactive oxygen species in monocyte, natural killer (NK), and T cell subsets in peripheral blood and correlation with double stranded (ds)-DNA damage ( >=-H2AX), FAS/FasL, BCL-2, caspase-1 activation, and activation-induced proliferation. 4. Evaluation of homing receptors to lymphoid, skin, and mucosal surfaces on B and T cells and correlate with ACE2, bradykinin, and homing chemokine levels.
Measure: Evaluation of inflammatory pathways that may contribute to COVID-19 disease pathogenesis. Time: Throughout the studyComparison of the effects of CYT107 vs Placebo administered IM at 10μg/ kg twice a week for two weeks on immune reconstitution of lymphopenic COVID-19 patients.
Description: A statistically significant increase of the absolute lymphocyte count (ALC) from randomization to day 30 or Hospital Discharge
Measure: Improvement of the absolute lymphocyte count (ALC) of lymphopenic (ALC≤1000/mm3) COVID-19 infected participants out to approximately 30 days following initial Study drug administration or Hospital discharge (HD), whichever occurs first Time: 1 monthDescription: The time to clinical improvement to determine if CYT107 will improve the clinical status of hospitalized COVID-19 patients as measured by clinical improvement score
Measure: "clinical improvement" as defined by a 2 points improvement in a 7-point ordinal scale for Clinical Assessment, through day 30 or HD. Time: 1 monthDescription: The decrease of SARS-CoV-2 viral load from measurements at baseline and days of treatment dose 4 and dose 5, Day 21 and Day 30 or HD (whichever occurs first)
Measure: a significant decline of SARS-CoV-2 viral load through day 30 or HD Time: 1 month or HD (whichever occurs first)Description: Incidence of secondary infections based on pre-specified criteria as adjudicated by the Secondary Infections Committee (SIC) through Day 45
Measure: frequency of secondary infections through day 45 compared tp placebo arm Time: 45 daysDescription: Number of days of hospitalization during index hospitalization (defined as time from initial Study drug treatment through HD)
Measure: length of hospitalization compared to placebo arm Time: 45 daysDescription: Number of days in ICU during index hospitalization
Measure: length of stay in ICU compared to placebo arm Time: 45 daysDescription: Readmissions to ICU through Day 45
Measure: number of readmissions to ICU compared to placebo arm Time: 45 daysDescription: Organ support free days (OSFDs) during index hospitalization (This includes ventilator assistance free days)
Measure: organ support free days compared to placebo arm Time: 45 daysDescription: Number of readmissions to the hospital through Day 45
Measure: Frequency of re-hospitalization through day 45 compared to placebo arm Time: 45 daysDescription: All-cause mortality through Day 45
Measure: All-cause mortality through day 45 compared to placebo arm Time: 45 daysDescription: Absolute numbers of CD4+ and CD8+ T-cell counts at timepoints indicated on the Schedule of Activities (SoA) through Day 30 or HD
Measure: CD4+ and CD8+ T cell counts compared to placebo arm Time: 30 daysDescription: Track and evaluate other known biomarkers of inflammation, Ferritin, from baseline to day 30
Measure: level of other known biomarkers of inflammation: Ferritin compared to placebo arm Time: 30 daysDescription: Track and evaluate other known biomarkers of inflammation, CRP from baseline to day 30
Measure: Level of other known biomarkers of inflammation: CRP compared to placebo arm Time: 30 daysDescription: Track and evaluate other known biomarkers of inflammation, D-dimer from baseline to day 30
Measure: Level of other known biomarkers of inflammation: D-dimer compared to placebo arm Time: 30 daysDescription: Evaluate improvement of the NEWS2 score value. Score form 0 to 4: NO Risk Score of 7 or more: High risk
Measure: Physiological status through NEWS2 evaluation compared to Placebo arm Time: 30 daysDescription: Incidence and scoring of all grade 3-4 adverse events through Day 45 (using CTCAE Version 5.0 to assess severity)
Measure: Safety assessment through incidence and scoring of grade 3-4 adverse events Time: 45 daysComparison of the effects of CYT107 vs Placebo administered IM at 10μg/kg twice a week for three weeks on immune reconstitution of lymphopenic COVID-19 patients
Description: A statistically significant increase of the absolute lymphocyte count (ALC) from randomization to day 30 or HospitalDischarge
Measure: Improvement of the absolute lymphocyte count (ALC) of lymphopenic (ALC≤1000/mm3) COVID-19 infected participants out to approximately 30 days following initial Study drug administration or Hospital discharge (HD), whichever occurs first Time: one monthDescription: The time to clinical improvement to determine if CYT107 will improve the clinical status of hospitalized COVID-19 patients as measured by clinical improvement score
Measure: "clinical improvement" as defined by a 2 points improvement in a 7-point ordinal scale for Clinical Assessment, through day 30 or HD. Time: one monthDescription: The decrease of SARS-CoV-2 viral load from measurements at baseline and days of treatment dose 4 and dose 5, Day 21 and Day 30 or HD (whichever occurs first)
Measure: a significant decline of SARS-CoV-2 viral load through day 30 or HD Time: 1 month or HD (whichever occurs first)Description: Incidence of secondary infections based on pre-specified criteria as adjudicated by the Secondary Infections Committee (SIC) through Day 45
Measure: frequency of secondary infections through day 45 compared to placebo arm Time: 45 daysDescription: Number of days of hospitalization during index hospitalization (defined as time from initial Study drug treatment through HD)
Measure: length of hospitalization compared to placebo arm Time: 45 daysDescription: Number of days in ICU during index hospitalization
Measure: length of stay in ICU compared to placebo arm Time: 45 daysDescription: Readmissions to ICU through Day 45
Measure: number of readmissions to ICU compared to placebo arm Time: 45 daysDescription: Organ support free days (OSFDs) during index hospitalization (This includes ventilator assistance free days)
Measure: organ support free days compared to placebo arm Time: 45 daysDescription: Number of readmissions to the hospital through Day 45
Measure: Frequency of re-hospitalization through day 45 compared to placebo arm Time: 45 daysDescription: All-cause mortality through Day 45
Measure: All-cause mortality through day 45 compared to placebo arm Time: 45 daysDescription: Absolute numbers of CD4+ and CD8+ T-cell counts at time points indicated on the Schedule of Activities (SoA) through Day 30 or HD
Measure: CD4+ and CD8+ T cell counts compared to placebo arm Time: 30 daysDescription: Track and evaluate other known biomarkers of inflammation, Ferritin, from baseline to day 30
Measure: level of other known biomarkers of inflammation: Ferritin compared to placebo arm Time: 30 daysDescription: Track and evaluate other known biomarkers of inflammation, CRP from baseline to day 30
Measure: Level of other known biomarkers of inflammation: CRP compared to placebo arm Time: 30 daysDescription: Track and evaluate other known biomarkers of inflammation, D-dimer from baseline to day 30
Measure: Level of other known biomarkers of inflammation: D-dimer compared to placebo arm Time: 30 daysDescription: Evaluate improvement of the NEWS2 score value. Score form 0 to 4: NO Risk Score of 7 or more: High risk
Measure: Physiological status through NEWS2 evaluation compared to Placebo arm Time: 30 daysDescription: Incidence and scoring of all grade 3-4 adverse events through Day 45 (using CTCAE Version 5.0) to assess safety
Measure: Safety assessment through incidence and scoring of grade 3-4 adverse events Time: 45 daysComparison of the effects of CYT107 vs Placebo administered IM at 10μg/kg twice a week for three weeks on immune reconstitution of lymphopenic COVID-19 patients
Description: A statistically significant increase of the absolute lymphocyte count (ALC) from randomization to day 30 or Hospital Discharge
Measure: Improvement of the absolute lymphocyte count (ALC) of lymphopenic (ALC≤1000/mm3) COVID-19 infected participants out to approximately 30 days following initial Study drug administration or Hospital discharge (HD), whichever occurs first Time: one monthDescription: The time to clinical improvement to determine if CYT107 will improve the clinical status of hospitalized COVID-19 patients as measured by clinical improvement score
Measure: "clinical improvement" as defined by a 2 points improvement in a 7-point ordinal scale for Clinical Assessment, through day 30 or HD. Time: one monthDescription: The decrease of SARS-CoV-2 viral load from measurements at baseline and days of treatment dose 4 and dose 5, Day 21 and Day 30 or HD (whichever occurs first)
Measure: a significant decline of SARS-CoV-2 viral load through day 30 or HD Time: one monthDescription: Incidence of secondary infections based on pre-specified criteria as adjudicated by the Secondary Infections Committee (SIC) through Day 45
Measure: frequency of secondary infections through day 45 compared to placebo arm Time: 45 daysDescription: Number of days of hospitalization during index hospitalization (defined as time from initial Study drug treatment through HD)
Measure: length of hospitalization compared to placebo arm Time: 45 daysDescription: Number of days in ICU during index hospitalization
Measure: Length of stay in ICU compared to placebo arm Time: 45 daysDescription: Readmissions to ICU through Day 45
Measure: number of readmissions to ICU compared to placebo arm Time: 45 daysDescription: Organ support free days (OSFDs) during index hospitalization (This includes ventilator assistance free days)
Measure: organ support free days compared to placebo arm Time: 45 daysDescription: Number of readmissions to the hospital through Day 45
Measure: Frequency of re-hospitalization through day 45 compared to placebo arm Time: 45 daysDescription: All-cause mortality through Day 45
Measure: All-cause mortality through day 45 compared to placebo arm Time: 45 daysDescription: Absolute numbers of CD4+ and CD8+ T-cell counts at time points indicated on the Schedule of Activities (SoA)through Day 30 or HD
Measure: CD4+ and CD8+ T cell counts compared to placebo arm Time: 30 daysDescription: Track and evaluate other known biomarkers of inflammation, Ferritin, from baseline to day 30
Measure: level of other known biomarkers of inflammation: Ferritin compared to placebo a Time: 30 daysDescription: Level of other known biomarkers of inflammation: CRP compared to placebo arm
Measure: Level of other known biomarkers of inflammation: CRP compared to placebo arm Time: 30 daysDescription: Track and evaluate other known biomarkers of inflammation, D-dimer from baseline to day 30
Measure: Level of other known biomarkers of inflammation: D-dimer compared to placebo arm Time: 30 daysDescription: Evaluate improvement of the NEWS2 score value. Score form 0 to 4: NO Risk Score of 7 or more: High risk
Measure: Physiological status through NEWS2 evaluation compared to Placebo arm Time: 30 daysDescription: Incidence and scoring of all grade 3-4 adverse events through Day 45 (using CTCAE Version 5.0) to assess safety
Measure: Safety assessment through incidence and scoring of grade 3-4 adverse events Time: 45 daysThis is a phase I/II clinical trial using adoptive cell therapy with NK cells or memory T cells in patients affected by COVID-19. Severe cases with COVID-19 present a dysregulated immune system with T cell lymphopenia, specially NK cells and memory T cells, and a hyper-inflammatory state. This clinical trial proposes the use of cell therapy for the treatment of patients with worse prognosis due to SARS-CoV-2 infection (those with pneumonia and/or lymphopenia). This is an innovative and a non-pharmacological intervention.
Description: Any grade 3 or higher toxicity with an attribution of definitely or probably related to the infusion of the cells and any lower grade toxicity that increases to a grade 3 or higher as a direct result of the cell infusion.
Measure: Occurrence of DLTs in all patients during the study treatment, until 21 days after cell infusion and the MTD Time: 3 monthsAlphabetical 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