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Cytokine
CYT107 for Coronavirus (ILIAD-7-BRA Trial)
Phase 2
Waitlist Available
Led By Reinaldo SALOMAO, MD
Research Sponsored by Revimmune
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one month
Summary
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
Eligible Conditions
- Coronavirus
- Lymphocytopenia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Body Weight Changes
Secondary study objectives
All-cause mortality through day 45 compared to placebo arm
CD8-Positive T-Lymphocytes
Frequency of re-hospitalization through day 45 compared to placebo arm
+11 moreOther study objectives
Safety assessment through incidence and scoring of grade 3-4 adverse events
Side effects data
From 2018 Phase 2 trial • 27 Patients • NCT0264080744%
Injection site reaction
33%
Hepatic cytolysis
33%
High alkaline phosphatase
22%
Gastrointestinal bleed
22%
Anemia
22%
High potassium
22%
Persisting Fever
22%
Vomiting
22%
Acute hypoxic event
22%
Deep Vein Thrombosis
22%
High sodium
22%
Supra ventricular tachycardia
22%
Ascites
22%
Renal failure
22%
Ileus
22%
Low phosphate
11%
Tracheobronchitis
11%
Mediastinitis
11%
Cutaneous rash
11%
Confusion
11%
Weaning failure
11%
Hypoglycemia
11%
Lung Abscess
11%
Papilledema
11%
Tamponade
11%
Relapse of endocarditis
11%
Oesophago-bronchial fistula
11%
Ischemic stroke
11%
Bile leak
11%
ischemic colitis
11%
Diarrhea
11%
Yeast infection
11%
Skin erosion
11%
Low Calcium
11%
DRESS
11%
Acute respiratory failure
11%
Pleural effusion
11%
Dyspepsia
11%
Dysphagia
11%
Depression
11%
Intra-abdominal collections
11%
Ischemic Colitis
11%
Recurrent septic shock
11%
Epistaxis
11%
Oral herpes
11%
Urinary infection
11%
Necrotizing fingers
11%
Cholestatis
11%
Acute renal failure
11%
Ventricular tachycardia
11%
Hypercapnic coma
11%
Endocarditis
11%
Hemorrhagic gastric ulcer
11%
Ileopsoas hematoma
11%
Pressure ulcer
100%
80%
60%
40%
20%
0%
Study treatment Arm
CYT107 High Frequency
CYT107 Low Frequency
Control
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CYT107Experimental Treatment1 Intervention
IM administration of CYT107 / Interleukin-7
Group II: PLACEBOPlacebo Group1 Intervention
IM administration of Saline at the same volume
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Interleukin-7
2016
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
C.R.O. ReSolution Latin America S.A.UNKNOWN
RevimmuneLead Sponsor
10 Previous Clinical Trials
207 Total Patients Enrolled
ReSolution Latin America S.A.UNKNOWN
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