NCT04442178

Brief Summary

Comparison of the effects of CYT107 vs Placebo administered IM at 10μg/kg twice a week for three weeks on immune reconstitution of lymphopenic COVID-19 patients

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_2 covid19

Timeline
Completed

Started Sep 2020

Longer than P75 for phase_2 covid19

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 15, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

April 8, 2022

Status Verified

March 1, 2022

Enrollment Period

1.5 years

First QC Date

June 19, 2020

Last Update Submit

March 30, 2022

Conditions

COVID-19Lymphocytopenia

Outcome Measures

Primary Outcomes (1)

  • Improvement 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 decline 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

  • +9 more secondary outcomes

Other Outcomes (1)

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

    45 days

Study Arms (2)

CYT107 Treatment

EXPERIMENTAL

Intramuscular (IM) administration of CYT107 twice a week for 3 weeks

Drug: CYT107

Placebo

PLACEBO COMPARATOR

Intramuscular (IM) administration of Saline twice a week for 3 weeks

Drug: Placebo

Interventions

CYT107DRUG

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: Interleukin-7
CYT107 Treatment
PlaceboDRUG

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: Saline
Placebo

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 month 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Florida College of Medicine

Gainesville, Florida, 32608, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Rutgers Health

New Brunswick, New Jersey, 08901, United States

Location

Stony Brook Medicine

Stony Brook, New York, 11794, United States

Location

Cleveland Clinic Lerner College of Medicine

Cleveland, Ohio, 44195, United States

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: 32171076RESULT

  • 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: 32031570RESULT

  • 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: 29515037RESULT

  • Venet F, Foray AP, Villars-Mechin A, Malcus C, Poitevin-Later F, Lepape A, Monneret G. IL-7 restores lymphocyte functions in septic patients. J Immunol. 2012 Nov 15;189(10):5073-81. doi: 10.4049/jimmunol.1202062. Epub 2012 Oct 10.

    PMID: 23053510RESULT

  • 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: 39903535DERIVED

MeSH Terms

Conditions

COVID-19Lymphopenia

Interventions

Interleukin-7Sodium Chloride

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte DisordersImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Richard Hotchkiss, MD PhD

    Washington University School of Medicine

    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 placeb
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled of treatment vs placebo
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2020

First Posted

June 22, 2020

Study Start

September 15, 2020

Primary Completion

March 30, 2022

Study Completion

March 30, 2022

Last Updated

April 8, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Publication

Locations

US(5)