Covid 19 Research using Clinical Trials (Home Page)
Report for D008231: Lymphopenia NIH
(Synonyms: Lymphopenia)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
There are 5 clinical trials
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 COVID-19 Lymphocytopenia Drug: Interleukin-7 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)
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 monthSecondary 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 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 daysOther 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 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. ...
NCT04401436 Corona Virus Disease 2019 MeSH:Lymphopenia Virus Diseases
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 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
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 studySecondary 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 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.
NCT04407689 COVID-19 Lymphocytopenia Drug: Interleukin-7 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
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. US Oncology Cohort
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 monthSecondary 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 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 daysOther 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 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
NCT04426201 COVID-19 Lymphocytopenia Drug: CYT107 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
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 Infectious Cohort
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 monthSecondary 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 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 daysOther 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 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
NCT04442178 COVID-19 Lymphocytopenia Drug: CYT107 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
HPO Nodes
HP:0001888: Lymphopenia
Genes 132
DOCK8 SMARCAL1 ICOS NHEJ1 RAG1 PIK3R1 G6PC3 ELANE PSMB9 WIPF1 IL2RG SRP54 SGPL1 NFKB1 TERT CORO1A STAT1 RAG2 WAS EPG5 IKZF1 PTEN CASP10 EXTL3 FOXN1 UNC119 MS4A1 GATA2 FOXN1 RASGRP1 RAG1 STAT4 CD81 SAMD9 ATM WAS TTC37 SKIV2L ATM CDCA7 TRNT1 CHD7 FOXN1 RAG1 TTI2 DNMT3B CD19 LEP ADAMTS3 ZBTB24 JAK3 PGM3 TNFRSF13B RAG1 STK4 CD3E CTLA4 IRAK1 ICOS CD8A TNFRSF13C TCIRG1 IL7R SEMA3E RFXAP XRCC4 SMARCAL1 MSN RMRP LEPR CTPS1 MYSM1 RAG2 HELLS TINF2 FASLG CD3G SP110 PIK3CD RFXANK CXCR4 FAS ACP5 TERC PTPRC ZAP70 CCBE1 NFKB2 DCLRE1C PSMB4 GFI1 CIITA MTHFD1 TNFSF12 AK2 TPP2 MAGT1 RAG2 TCN2 TFR2 CR2 IL2RA MYC LCK DNMT3B BCL11B DOCK2 CD3D EXTL3 TCF3 NBN NFKB2 ADA IL7R TNFSF12 IGHM TNFAIP3 SPP1 FAS WIPF1 PNP PTEN PRKCD RFX5 PRKCD FAT4 STAT1 ADA CD247 PGM3 IL2RG GFI1 Protein Mutations 0
SNP 0
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 monthSecondary 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 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 daysOther 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