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 took place after the first 12 patients. Since the CYT107 was well tolerated, the test dose (3 μg/kg) ceased and the initial dose became 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
34
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
Intramuscular (IM) placebo (normal saline) at the same frequency
University Hospital of Limoges
Limoges, France
Hôpital Edouard Herriot
Lyon, France
hopital Edouard Herriot
Lyon, France
Chr Orleans La Source
Orléans, France
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
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 11 steps WHO clinical improvement score
Time frame: 1 month
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: 1 month or HD (whichever occurs first)
frequency of secondary infections through day 45 compared tp placebo arm
Incidence of secondary infections based on pre-specified criteria as adjudicated by the Secondary Infections Committee (SIC) through Day 45
Time frame: 45 days
length of hospitalization compared to placebo arm
Number of days of hospitalization during index hospitalization (defined as time from initial Study drug treatment through HD)
Time frame: 45 days
length of stay in ICU compared to placebo arm
Number of days in ICU during index hospitalization
Time frame: 45 days
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hopital COCHIN
Paris, France
Chru Tours
Tours, France
number of readmissions to ICU compared to placebo arm
Readmissions to ICU through Day 45
Time frame: 45 days
organ support free days compared to placebo arm
Organ support free days (OSFDs) during index hospitalization (This includes ventilator assistance free days)
Time frame: 45 days
Frequency of re-hospitalization through day 45 compared to placebo arm
Number of readmissions to the hospital through Day 45
Time frame: 45 days
All-cause mortality through day 45 compared to placebo arm
All-cause mortality through Day 45
Time frame: 45 days
CD4+ and CD8+ T cell counts compared to placebo arm
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
level of other known biomarkers of inflammation: Ferritin compared to placebo arm
Track and evaluate other known biomarkers of inflammation, Ferritin, from baseline to day 30
Time frame: 30 days
Level of other known biomarkers of inflammation: CRP compared to placebo arm
Track and evaluate other known biomarkers of inflammation, CRP from baseline to day 30
Time frame: 30 days
Level of other known biomarkers of inflammation: D-dimer compared to placebo arm
Track and evaluate other known biomarkers of inflammation, D-dimer from baseline to day 30
Time frame: 30 days
Physiological status through NEWS2 evaluation compared to Placebo arm
Evaluate improvement of the NEWS2 score value. Score form 0 to 4: NO Risk Score of 7 or more: High risk
Time frame: 30 days