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COVID-19Phase 2ILIAD-7-BRANCT04927169

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

A Phase 2 study testing Interleukin-7 in people with COVID-19 and Lymphocytopenia, run by Revimmune at 6 sites in Brazil.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 25 to 80 years
Conditions the study is for
COVID-19, Lymphocytopenia
What is being tested?
Interleukin-7
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4 participants
Where
6 sitesBrazil
Study dates
1 Mar 2021to 30 Mar 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Brazil6 sites

  • Upeclin-Unesp

    Botucatu, São Paulo, 18618

  • Hospital Das Clinicas de Ribeirao Preto

    Monte Alegre, São Paulo, 14051

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035

  • Hospital Sao Jose

    São José, Santa Catarina, 88103

  • Universidade Federal de Sao Paolo

    São Paulo, São Paulo, 04021

  • Hospital Edmundo Vasconcelos

    Vila Clementino, São Paulo, 04038

Other trials in Brazil

About this study

Official title: Recombinant Human InterLeukin-7 (CYT107) to Improve Clinical Outcomes in Lymphopenic PAtients With COVID-19 Infection - "ILIAD 7 Trial" Brazil Cohort

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

Read the detailed description

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

Being tested
Interleukin-7, PLACEBO
Medical subject headings
COVID-19, Lymphopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interleukin-7Drug

    Also called CYT107

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

  • PLACEBODrug

    Also called SALINE

    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

Study groups in NCT04927169
Study groupRoleWhat they receive
CYT107ExperimentalIM administration of CYT107 / Interleukin-7
Receives: Drug: Interleukin-7
PLACEBOPlacebo comparatorIM administration of Saline at the same volume
Receives: Drug: PLACEBO

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: one month

Secondary outcomes (14)

  1. 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

    Measured: one month

  2. 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)

    Measured: one month

  3. 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

    Measured: 45 days

  4. 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)

    Measured: 45 days

  5. Length of stay in ICU compared to placebo arm

    Number of days in ICU during index hospitalization

    Measured: 45 days

  6. number of readmissions to ICU compared to placebo arm

    Readmissions to ICU through Day 45

    Measured: 45 days

  7. organ support free days compared to placebo arm

    Organ support free days (OSFDs) during index hospitalization (This includes ventilator assistance free days)

    Measured: 45 days

  8. Frequency of re-hospitalization through day 45 compared to placebo arm

    Number of readmissions to the hospital through Day 45

    Measured: 45 days

  9. All-cause mortality through day 45 compared to placebo arm

    All-cause mortality through Day 45

    Measured: 45 days

  10. 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

    Measured: 30 days

  11. 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

    Measured: 30 days

  12. 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

    Measured: 30 days

  13. 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

    Measured: 30 days

  14. 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

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2021
  2. Study start1 Mar 2021
  3. Primary completion31 Dec 2021
  4. Study completion30 Mar 2022

Why it stopped: POOR ACCRUAL

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized controlled of treatment vs placebo
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04927169
Sponsor's protocol ID
ILIAD-7 BRAZIL
Acronym
ILIAD-7-BRA
Status last verified
Apr 2024
First submitted
14 Jun 2021
Last updated
12 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Publication

Publications

  • 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.

    PubMed 32171076

  • 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.

    PubMed 32031570

  • 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.

    PubMed 29515037

  • 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.

    PubMed 18946659

  • 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.

    PubMed 39903535

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Interleukin-7 in people with COVID-19 and Lymphocytopenia, run by Revimmune at 6 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: POOR ACCRUAL). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: one month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04927169, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.

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