InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection (Brazil Cohort)

NCT04927169 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: ILIAD-7 BRAZIL
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 6

Brief 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

Conditions

COVID-19; Lymphocytopenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• 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

• Length of stay in ICU compared to placebo arm

  45 days

Other Outcomes (1)

• Safety assessment through incidence and scoring of grade 3-4 adverse events

  45 days

Study Arms (2)

CYT107

EXPERIMENTAL

IM administration of CYT107 / Interleukin-7

Drug: Interleukin-7

PLACEBO

PLACEBO COMPARATOR

IM administration of Saline at the same volume

Drug: PLACEBO

Interventions

Interleukin-7 DRUG

IM administration at 10μg/kg twice a week for three weeks and up to 7 administrations according to Hospital length of stay

Also known as: CYT107

CYT107

PLACEBO DRUG

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

Also known as: SALINE

PLACEBO

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Revimmune: lead
• Resolution Latin America: collaborator

Study Sites (6)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035, Brazil

Location

Hospital Sao Jose

São José, Santa Catarina, 88103, Brazil

Location

Upeclin-Unesp

Botucatu, São Paulo, 18618, Brazil

Location

Hospital Das Clinicas de Ribeirao Preto

Monte Alegre, São Paulo, 14051, Brazil

Location

Universidade Federal de Sao Paolo

São Paulo, São Paulo, 04021, Brazil

Location

Hospital Edmundo Vasconcelos

Vila Clementino, São Paulo, 04038, Brazil

Location

Related Publications (5)

• 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 study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.

  PMID: 32171076 RESULT

• 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):1061-1069. doi: 10.1001/jama.2020.1585.

  PMID: 32031570 RESULT

• 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 clinical trial. JCI Insight. 2018 Mar 8;3(5):e98960. doi: 10.1172/jci.insight.98960.

  PMID: 29515037 RESULT

• 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 Apr;35(4):678-86. doi: 10.1007/s00134-008-1337-8. Epub 2008 Oct 23.

  PMID: 18946659 RESULT

• Shankar-Hari M, Francois B, Remy KE, Gutierrez C, Pastores S, Daix T, Jeannet R, Blood J, Walton AH, Salomao R, Auzinger G, Striker D, Martin RS, Anand NJ, Bosanquet J, Blood T, Brakenridge S, Moldawer LL, Vachharajani V, Yee C, Dal-Pizzol F, Morre M, Berbille F, van den Brink M, Hotchkiss R. A randomized, double-blind, placebo-controlled trial of IL-7 in critically ill patients with COVID-19. JCI Insight. 2025 Feb 4;10(6):e189150. doi: 10.1172/jci.insight.189150.

  PMID: 39903535 DERIVED

MeSH Terms

Conditions

COVID-19; Lymphopenia

Interventions

Interleukin-7; Sodium Chloride

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Reinaldo SALOMAO, MD

  Escola Paulista de Medicina Universidade Federal de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Unblinded Pharmacist will prepare blinded syringes of colorless drug or placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized controlled of treatment vs placebo

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 15, 2021
• Study Start: March 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: March 30, 2022
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (6)