COVID-19 Clinical Trial
— ILIAD-7-BRAOfficial title:
Recombinant Human InterLeukin-7 (CYT107) to Improve Clinical Outcomes in Lymphopenic PAtients With COVID-19 Infection - "ILIAD 7 Trial" Brazil Cohort
Verified date | April 2024 |
Source | Revimmune |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Terminated |
Enrollment | 4 |
Est. completion date | March 30, 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. 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 2. Men and women aged = 25 - 80 (included) years of age 3. Hospitalized patients with two absolute lymphocyte count (ALC) = 1000 cells/mm3, at two time points at least 24 hours apart, following HOSPITALIZATION: 4. 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 5. Confirmed infection with COVID-19 by any acceptable test available / utilized at each site 6. Willingness and ability to practice contraception regardless of the gender of the patient during 5 months after last drug exposure 7. Private insurance or government / institution financial support (through CMS or other) Exclusion Criteria: 1. Pregnancy or breast feeding 2. ALT and/or AST > 5 x ULN 3. Known, active auto-immune disease; 4. Ongoing cancer treatment with chemotherapy / immunotherapy or any cancer therapy within last 3 months and/or ongoing 5. Patients with past history of Solid Organ transplant 6. Active tuberculosis, uncontrolled active HBV or HCV infection, HIV with positive viral load 7. Hospitalized patients with refractory hypoxia, defined as inability to maintain saturation >85% with maximal available therapy for >6 hours 8. 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 9. Patients with baseline Rockwood Clinical Frailty Scale = 6 at Hospital admission 10. 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) 11. Patients under guardianship |
Country | Name | City | State |
---|---|---|---|
Brazil | Upeclin-Unesp | Botucatu | SAO Paolo |
Brazil | Hospital Das Clinicas de Ribeirao Preto | Monte Alegre | SAO Paolo |
Brazil | Hospital de Clinicas de Porto Alegre | Porto Alegre | RIO Grande DO SUL |
Brazil | Hospital Sao Jose | São José | Santa Catarina |
Brazil | Universidade Federal de Sao Paolo | São Paulo | SAO Paolo |
Brazil | Hospital Edmundo Vasconcelos | Vila Clementino | SAO Paolo |
Lead Sponsor | Collaborator |
---|---|
Revimmune | C.R.O. ReSolution Latin America S.A. |
Brazil,
Francois B, Jeannet R, Daix T, Walton AH, Shotwell MS, Unsinger J, Monneret G, Rimmele T, Blood T, Morre M, Gregoire A, Mayo GA, Blood J, Durum SK, Sherwood ER, Hotchkiss RS. Interleukin-7 restores lymphocytes in septic shock: the IRIS-7 randomized clinic — View Citation
Venet F, Chung CS, Kherouf H, Geeraert A, Malcus C, Poitevin F, Bohe J, Lepape A, Ayala A, Monneret G. Increased circulating regulatory T cells (CD4(+)CD25 (+)CD127 (-)) contribute to lymphocyte anergy in septic shock patients. Intensive Care Med. 2009 Ap — View Citation
Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):106 — View Citation
Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety assessment through incidence and scoring of grade 3-4 adverse events | Incidence and scoring of all grade 3-4 adverse events through Day 45 (using CTCAE Version 5.0) to assess safety | 45 days | |
Primary | 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 | one month | |
Secondary | 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 | one month | |
Secondary | 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) | one month | |
Secondary | 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 | 45 days | |
Secondary | 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) | 45 days | |
Secondary | Length of stay in ICU compared to placebo arm | Number of days in ICU during index hospitalization | 45 days | |
Secondary | number of readmissions to ICU compared to placebo arm | Readmissions to ICU through Day 45 | 45 days | |
Secondary | organ support free days compared to placebo arm | Organ support free days (OSFDs) during index hospitalization (This includes ventilator assistance free days) | 45 days | |
Secondary | Frequency of re-hospitalization through day 45 compared to placebo arm | Number of readmissions to the hospital through Day 45 | 45 days | |
Secondary | All-cause mortality through day 45 compared to placebo arm | All-cause mortality through Day 45 | 45 days | |
Secondary | 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 | 30 days | |
Secondary | 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 | 30 days | |
Secondary | 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 | 30 days | |
Secondary | 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 | 30 days | |
Secondary | 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 | 30 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT06065033 -
Exercise Interventions in Post-acute Sequelae of Covid-19
|
N/A | |
Completed |
NCT06267534 -
Mindfulness-based Mobile Applications Program
|
N/A | |
Completed |
NCT05047601 -
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection
|
Phase 2/Phase 3 | |
Recruiting |
NCT05323760 -
Functional Capacity in Patients Post Mild COVID-19
|
N/A | |
Recruiting |
NCT04481633 -
Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection
|
N/A | |
Completed |
NCT04537949 -
A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
|
Phase 1/Phase 2 | |
Completed |
NCT04612972 -
Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru
|
Phase 3 | |
Recruiting |
NCT05494424 -
Cognitive Rehabilitation in Post-COVID-19 Condition
|
N/A | |
Active, not recruiting |
NCT06039449 -
A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2
|
Phase 3 | |
Enrolling by invitation |
NCT05589376 -
You and Me Healthy
|
||
Completed |
NCT05158816 -
Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
|
||
Recruiting |
NCT04341506 -
Non-contact ECG Sensor System for COVID19
|
||
Completed |
NCT04384445 -
Zofin (Organicell Flow) for Patients With COVID-19
|
Phase 1/Phase 2 | |
Completed |
NCT04512079 -
FREEDOM COVID-19 Anticoagulation Strategy
|
Phase 4 | |
Completed |
NCT05975060 -
A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT05542862 -
Booster Study of SpikoGen COVID-19 Vaccine
|
Phase 3 | |
Withdrawn |
NCT05621967 -
Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
|
N/A | |
Terminated |
NCT05487040 -
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
|
Phase 1 | |
Terminated |
NCT04498273 -
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
|
Phase 3 | |
Active, not recruiting |
NCT06033560 -
The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure
|