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  • HP:0001888: Lymphopenia
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    HP:0001888: Lymphopenia

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (7)


    Name (Synonyms) Correlation
    drug667 CYT107 Wiki 0.53
    drug1652 Interleukin-7 Wiki 0.53
    drug827 Complete blood picture, bone marrow aspiration cytology Wiki 0.38
    Name (Synonyms) Correlation
    drug3239 T memory cells and NK cells Wiki 0.38
    drug2687 Questionnaire Administration Wiki 0.11
    drug2532 Placebos Wiki 0.09
    drug2448 Placebo Wiki 0.05

    Correlated MeSH Terms (5)


    Name (Synonyms) Correlation
    D008231 Lymphopenia NIH 1.00
    D014777 Virus Diseases NIH 0.04
    D011014 Pneumonia NIH 0.02
    Name (Synonyms) Correlation
    D045169 Severe Acute Respiratory Syndrome NIH 0.02
    D018352 Coronavirus Infections NIH 0.01

    Correlated HPO Terms (1)


    Name (Synonyms) Correlation
    HP:0002090 Pneumonia HPO 0.02

    Clinical Trials

    Navigate: Correlations   HPO

    There are 7 clinical trials


    1 A Multicenter, Randomized, Double-blinded Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) for Immune Restoration of Hospitalized Lymphopenic Patients With Coronavirus COVID-19 Infection in UK

    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.

    NCT04379076
    Conditions
    1. COVID-19
    2. Lymphocytopenia
    Interventions
    1. Drug: Interleukin-7
    2. Drug: Placebos
    MeSH:Lymphopenia
    HPO:Lymphopenia

    Primary Outcomes

    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 month

    Secondary Outcomes

    Description: 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 month

    Description: 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 month

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: Readmissions to ICU through Day 45

    Measure: To compare the effect of CYT107 versus placebo on readmissions to ICU

    Time: 45 days

    Description: 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 days

    Description: 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 days

    Description: All-cause mortality through Day 45

    Measure: To assess the impact of CYT107 on all-cause mortality through day 45

    Time: 45 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: Evaluate improvement of the NEWS2 score value

    Measure: Evaluation of physiological status through NEWS2 score

    Time: 30 days

    Other Outcomes

    Description: 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 days
    2 COVID-19 Associated Lymphopenia Pathogenesis Study in Blood (CALYPSO)

    Background: 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. ...

    NCT04401436
    Conditions
    1. Corona Virus Disease 2019
    MeSH:Virus Diseases Lymphopenia
    HPO:Lymphopenia

    Primary Outcomes

    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 study

    Secondary Outcomes

    Description: 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 study
    3 Study of the Etiology of Lymphopenia in Covid19 Viral Infection

    Study of the cause of lymphopenia in Covid19 viral infection will be done in 3 cohorts. First cohort will be patients asymptomatic or with mild symptoms. Second cohort will be patients with severe illness and admitted to ICU. Third cohort will be patients critically ill and on artificial ventilation.

    NCT04404608
    Conditions
    1. Lymphopenia
    Interventions
    1. Diagnostic Test: Complete blood picture, bone marrow aspiration cytology
    MeSH:Lymphopenia
    HPO:Lymphopenia

    Primary Outcomes

    Description: Follow up

    Measure: Death or recovery

    Time: Up to 24 weeks
    4 A Multicenter, Randomized, Double-blinded Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) for Immune Restoration of Hospitalized Lymphopenic Patients With Coronavirus COVID-19 Infection in France and Belgium

    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.

    NCT04407689
    Conditions
    1. COVID-19
    2. Lymphocytopenia
    Interventions
    1. Drug: Interleukin-7
    2. Drug: Placebo
    MeSH:Lymphopenia
    HPO:Lymphopenia

    Primary Outcomes

    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 month

    Secondary Outcomes

    Description: 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 month

    Description: 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 days

    Description: 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 days

    Description: Number of days in ICU during index hospitalization

    Measure: length of stay in ICU compared to placebo arm

    Time: 45 days

    Description: Readmissions to ICU through Day 45

    Measure: number of readmissions to ICU compared to placebo arm

    Time: 45 days

    Description: 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 days

    Description: Number of readmissions to the hospital through Day 45

    Measure: Frequency of re-hospitalization through day 45 compared to placebo arm

    Time: 45 days

    Description: All-cause mortality through Day 45

    Measure: All-cause mortality through day 45 compared to placebo arm

    Time: 45 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Other Outcomes

    Description: 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 days
    5 A Multicenter, Randomized, Double-blinded Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) for Immune Restoration of Hospitalized Lymphopenic Patients With Coronavirus COVID-19 Infection. US Oncology Cohort

    Comparison 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

    NCT04426201
    Conditions
    1. COVID-19
    2. Lymphocytopenia
    Interventions
    1. Drug: CYT107
    2. Drug: Placebo
    MeSH:Lymphopenia
    HPO:Lymphopenia

    Primary Outcomes

    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 month

    Secondary Outcomes

    Description: 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 month

    Description: 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 days

    Description: 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 days

    Description: Number of days in ICU during index hospitalization

    Measure: length of stay in ICU compared to placebo arm

    Time: 45 days

    Description: Readmissions to ICU through Day 45

    Measure: number of readmissions to ICU compared to placebo arm

    Time: 45 days

    Description: 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 days

    Description: Number of readmissions to the hospital through Day 45

    Measure: Frequency of re-hospitalization through day 45 compared to placebo arm

    Time: 45 days

    Description: All-cause mortality through Day 45

    Measure: All-cause mortality through day 45 compared to placebo arm

    Time: 45 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Other Outcomes

    Description: 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 days
    6 A Multicenter, Randomized, Double-blinded Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) for Immune Restoration of Hospitalized Lymphopenic Patients With Coronavirus COVID-19 Infection. US Infectious Cohort

    Comparison 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

    NCT04442178
    Conditions
    1. COVID-19
    2. Lymphocytopenia
    Interventions
    1. Drug: CYT107
    2. Drug: Placebo
    MeSH:Lymphopenia
    HPO:Lymphopenia

    Primary Outcomes

    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 month

    Secondary Outcomes

    Description: 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 month

    Description: 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 month

    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 days

    Description: 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 days

    Description: Number of days in ICU during index hospitalization

    Measure: Length of stay in ICU compared to placebo arm

    Time: 45 days

    Description: Readmissions to ICU through Day 45

    Measure: number of readmissions to ICU compared to placebo arm

    Time: 45 days

    Description: 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 days

    Description: Number of readmissions to the hospital through Day 45

    Measure: Frequency of re-hospitalization through day 45 compared to placebo arm

    Time: 45 days

    Description: All-cause mortality through Day 45

    Measure: All-cause mortality through day 45 compared to placebo arm

    Time: 45 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Other Outcomes

    Description: 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 days
    7 A Phase I/II Dose-escalation Multi Center Study to Evaluate the Safety of Infusion of NatuRal KillEr celLs or MEmory T Cells as Adoptive Therapy in coronaviruS pnEumonia and/or Lymphopenia

    This 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.

    NCT04578210
    Conditions
    1. Corona Virus Infection
    Interventions
    1. Biological: T memory cells and NK cells
    MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Lymphopenia
    HPO:Lymphopenia Pneumonia

    Primary Outcomes

    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 months

    HPO Nodes


    Reports

    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.

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