A Phase 2 interventional study of Interleukin-7 and Placebos in COVID-19 and Lymphocytopenia, sponsored by Revimmune. Terminated at 13 sites in United Kingdom. Open to participants aged 25 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-04-07.
Sponsored by Revimmune · Phase 2, Interventional, and Treatment
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.
Approximately forty-eight (48) participants will be randomized 1:1 to receive (a) Intramuscular (IM) administration of CYT107 at 3 μg/kg followed, after 48hrs of observation, by 10 μg/kg twice a week for 2 weeks or (b) Intramuscular (IM) placebo (normal saline) at the same frequency. An interim safety review will take place after the first 12 patients. If the CYT107 is well tolerated, the test dose (3 μg/kg) will cease and that initial dose will become the same as the rest of the doses (10 μg/kg). So, the remaining patients will be randomized to receive 5 administrations of (a) CYT107 at 10 μg/kg every 3 to 4 days for 2 weeks or (b) Intramuscular (IM) placebo (normal saline) at the same frequency.
The aim of the study is to test the ability of CYT107 to produce an immune reconstitution of these patients and observe possible association with a clinical improvement
7,641 studies on the registry are indexed under COVID-19; 487 are open to participants now.
This study's enrollment of 35 is below the median of 100 across 4,100 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Revimmune is the lead sponsor of 8 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intra-muscular administration of CYT107 twice a week for a total of 5 administrations
Drug: Interleukin-7
Intramuscular (IM) administration of saline at the same volume and same time for a total of 5 administrations
Drug: Placebos
Intramuscular (IM) administration of CYT107 at 3 μg/kg followed, after 48hrs of observation, by 10 μg/kg twice a week for 2 weeks or
Also known as: CYT107
Intramuscular (IM) placebo (normal saline) at the same frequency
Also known as: Saline
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
A statistically significant increase of the absolute lymphocyte count (ALC) from randomization to day 30 or Hospital Discharge
Time frame: 1 month
To obtain "clinical improvement" as defined by an improvement in a 11-points WHO score for Clinical Assessment, through day 30 or HD.
to determine if CYT107 will improve the clinical status of hospitalized COVID-19 patients as measured by WHO score
Time frame: 1 month
determine if CYT107 will lead to a significant decline of SARS-CoV-2 viral load through day 30 or HD
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)
Time frame: one month
To compare the effect of CYT107 versus placebo on the frequency of secondary infections through day 45
Incidence of secondary infections based on pre-specified criteria as adjudicated by the Secondary Infections Committee (SIC) through Day 45
Time frame: 45 days
To compare the effect of CYT107 versus placebo on the length of hospitalization
Number of days of hospitalization during index hospitalization (defined as time from initial Study drug treatment through HD)
Time frame: 45 days
To compare the effect of CYT107 versus placebo on the length of stay in ICU
Number of days in ICU during index hospitalization
Time frame: 45 days
To compare the effect of CYT107 versus placebo on readmissions to ICU
Readmissions to ICU through Day 45
Time frame: 45 days
To compare the effect of CYT107 versus placebo on organ support free days
Organ support free days (OSFDs) during index hospitalization (This includes ventilator assistance free days.)
Time frame: 45 days
To compare the effect of CYT107 versus placebo on the frequency of re-hospitalization through day 45
Number of readmissions to the hospital through Day 45
Time frame: 45 days
To assess the impact of CYT107 on all-cause mortality through day 45
All-cause mortality through Day 45
Time frame: 45 days
To determine the effect of CYT107 on CD4+ and CD8+ T cell counts
Absolute numbers of CD4+ and CD8+ T-cell counts at timepoints indicated on the Schedule of Activities (SoA) through Day 30 or HD
Time frame: 30 days
To track and evaluate other known biomarkers of inflammation: Ferritin
Track and evaluate other known biomarkers of inflammation, Ferritin, from baseline to day 30
Time frame: 30 days
To track and evaluate other known biomarkers of inflammation: CRP
Track and evaluate other known biomarkers of inflammation, CRP from baseline to day 30
Time frame: 30 days
To track and evaluate other known biomarkers of inflammation: D-dimer
Track and evaluate other known biomarkers of inflammation, D-dimer from baseline to day 30
Time frame: 30 days
Evaluation of physiological status through NEWS2 score
Evaluate improvement of the NEWS2 score value
Time frame: 30 days
Safety assessment
Incidence and scoring of all grade 3-4 adverse events through Day 45 (using CTCAE Version 5.0 to assess severity)
Time frame: 45 days
Plan to share: No — publication
This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Revimmune