CovidResearchTrials by Shray Alag


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Report for D008231: Lymphopenia NIH

(Synonyms: Lymphopenia)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)


Name (Synonyms) Correlation
drug1230 Interleukin-7 Wiki 0.63
drug506 CYT107 Wiki 0.63
drug1860 Placebos Wiki 0.11
drug1822 Placebo Wiki 0.08

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D014777 Virus Diseases NIH 0.05

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0001888 Lymphopenia HPO 1.00

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)

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 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

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 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

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 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

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 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