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
Drug: Interleukin-7
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
Other Name: CYT107
Drug: Placebos
Intramuscular (IM) placebo (normal saline) at the same frequency
Other Name: Saline
Inclusion Criteria:
- A written, signed informed consent, or emergency oral consent, by the patient or the
patient's legally authorized representative, and the anticipated ability for
participant to be re-consented in the future for ongoing Study participation
- Men and women aged ≥ 25 - 80 (included) years of age
- Hospitalized patients with one absolute lymphocyte count (ALC) ≤ 1000 cells/mm3,
collected at baseline or no more than 72h before baseline
- Hospitalized patients with moderate to severe hypoxemia requiring oxygen therapy at
>2L per minute nasal cannula or greater to keep saturations >90%, non-invasive
positive pressure ventilation (e.g., BIPAP), or patients intubated/ventilated for
respiratory failure
- Confirmed infection with COVID-19 by any acceptable test available/utilized at each
site
- Private insurance or government support (through NHS or other)
Exclusion Criteria:
- Pregnancy or breast feeding;
- Refusal or inability to practice contraception regardless of the gender of the
patient;
- ALT and/or AST > 5 x ULN
- Known, active auto-immune disease;
- Ongoing cancer treatment with chemotherapy / immunotherapy or any cancer therapy
within last 3 months and/or ongoing;
- Patients with past history of Solid Organ transplant.
- Active tuberculosis, uncontrolled active HBV or HCV infection, HIV with positive viral
load.
- Patients whose respiratory condition is showing significant deterioration as indicated
by:
- requirement for a persistent and sustained increase in inspired oxygen concentrations
of 20% or more over the past 24 hours to maintain SpO2 at greater than or equal to 88%
(this 20 % limit does not apply to O2 delivered by nasal canula)
- or need for invasive mechanical ventilation
- Patients with chronic kidney dialysis
- Patients showing an increase of the NEWS2 score by more than 6 points during the
screening / baseline period (48 to 72 hrs prior to first administration)
- Patients with a SOFA score ≥ 9 at baseline
- Patients with a BMI > 40
- Patients with baseline Rockwood Clinical Frailty Scale ≥ 6.(assessed as patient or
proxy 4-week recall of chronic health and frailty status prior to COVID infection)
- Patients under guardianship
Sandwell Birmingham Hospital
Birmingham, United Kingdom
Sandwell Birmingham Hospital
Birmingham, United Kingdom
Bradford Institute for Health Research
Bradford, United Kingdom
ST JAMES's UNIVERSITY HOSPITAL
Leeds, United Kingdom
Medway Maritime Hospital
London, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
King'S College Hospital
London, United Kingdom
Wythenshawe Hospital/ Manchester Royal Infirmary
Manchester, United Kingdom
North Manchester General Hospital
Manchester, United Kingdom
Royal Victoria Infirmary and Freeman Hospital
Newcastle, United Kingdom
Royal Preston Hospital
Preston, United Kingdom
Sunderland Royal Hospital
Sunderland, United Kingdom
Watford General Hospital
Watford, United Kingdom
Manu Shankar-Hari, MD PhD, Principal Investigator
Guy's and St Thomas' NHS Foundation Trust