Comparison of the effects of CYT107 vs Placebo administered by intra-muscular route (IM) at 10μg/kg twice a week for three 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 10 μg/kg followed, after 72hrs of observation, by 10 μg/kg twice a week for 3 weeks (maximum 7administrations adjusted to patient's length of stay in the hospital) 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. This cohort excludes oncology patients on treatment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
4
IM administration at 10μg/kg twice a week for three weeks and up to 7 administrations according to Hospital length of stay
IM administration of a volume of saline identical to 10μg/kg CYT107, twice a week for three weeks and up to 7 administrations according to Hospital length of stay
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sao Jose
São José, Santa Catarina, Brazil
Upeclin-Unesp
Botucatu, São Paulo, Brazil
Hospital Das Clinicas de Ribeirao Preto
Monte Alegre, São Paulo, Brazil
Change 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: one 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 the 11 points WHO clinical score
Time frame: one month
a significant change 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
frequency of secondary infections through day 45 compared to 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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Universidade Federal de Sao Paolo
São Paulo, São Paulo, Brazil
Hospital Edmundo Vasconcelos
Vila Clementino, São Paulo, Brazil
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 time points 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
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: C reactive protein level (CRP) compared to placebo arm
Level of other known biomarkers of inflammation: CRP compared to placebo arm
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 National Early Warning Score (NEWS2) evaluation compared to Placebo arm
Evaluate chnage of the NEWS2 score value. Score form 0 to 4: NO Risk Score of 7 or more: High risk
Time frame: 30 days