Recombinant Human InterLeukin-7 (CYT107) to Improve Clinical Outcomes in Lymphopenic PAtients With COVID-19 Infection - "ILIAD 7 Trial" Brazil Cohort
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 6
- 主要终点
- 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
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Unblinded Pharmacist will prepare blinded syringes of colorless drug or placebo
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 two absolute lymphocyte count (ALC) ≤ 1000 cells/mm3, at two time points at least 24 hours apart, following HOSPITALIZATION:
- •Hospitalized patients with moderate to severe hypoxemia requiring oxygen therapy at >4L 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
- •Willingness and ability to practice contraception regardless of the gender of the patient during 5 months after last drug exposure
- •Private insurance or government / institution financial support (through CMS or other)
排除标准
- •Pregnancy or breast feeding
- •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
- •Hospitalized patients with refractory hypoxia, defined as inability to maintain saturation >85% with maximal available therapy for >6 hours
- •Patients receiving any agent with immune suppressive effects, other than steroids at dosages less than 300 mg/day equivalent hydrocortisone and/or anti-IL-6R treatments like Tocilizumab or Sarilumab or anti-IL-1 treatment like Anakinra which should preferably be minimized
- •Patients with baseline Rockwood Clinical Frailty Scale ≥ 6 at Hospital admission
- •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 under guardianship
研究组 & 干预措施
CYT107
IM administration of CYT107 / Interleukin-7
干预措施: Interleukin-7 (Drug)
PLACEBO
IM administration of Saline at the same volume
干预措施: PLACEBO (Drug)
结局指标
主要结局
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
时间窗: one month
A statistically significant increase of the absolute lymphocyte count (ALC) from randomization to day 30 or Hospital Discharge
次要结局
- To obtain "clinical improvement" as defined by an improvement in a 11-points WHO score for Clinical Assessment, through day 30 or HD.(one month)
- a significant change of SARS-CoV-2 viral load through day 30 or HD(one month)
- frequency of secondary infections through day 45 compared to placebo arm(45 days)
- length of hospitalization compared to placebo arm(45 days)
- All-cause mortality through day 45 compared to placebo arm(45 days)
- level of other known biomarkers of inflammation: Ferritin compared to placebo(30 days)
- Length of stay in ICU compared to placebo arm(45 days)
- number of readmissions to ICU compared to placebo arm(45 days)
- organ support free days compared to placebo arm(45 days)
- Level of other known biomarkers of inflammation: C reactive protein level (CRP) compared to placebo arm(30 days)
- Level of other known biomarkers of inflammation: D-dimer compared to placebo arm(30 days)
- Physiological status through National Early Warning Score (NEWS2) evaluation compared to Placebo arm(30 days)
- Frequency of re-hospitalization through day 45 compared to placebo arm(45 days)
- CD4+ and CD8+ T cell counts compared to placebo arm(30 days)