COVID-19Phase 2ILIAD-7-US-INCT04442178
InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection ( ILIAD-7-US-I )
A Phase 2 study testing CYT107 in people with COVID-19 and Lymphocytopenia, run by Revimmune at 5 sites in United States.
Trial 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 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?
- CYT107
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Sep 2020to 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 month 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
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cleveland Clinic Lerner College of Medicine
Cleveland, Ohio, 44195
University of Florida College of Medicine
Gainesville, Florida, 32608
Rutgers Health
New Brunswick, New Jersey, 08901
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Stony Brook Medicine
Stony Brook, New York, 11794
About this study
Official title: A Multicenter, Randomized, Double-blinded Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) for Immune Restoration of Hospitalized Lymphopenic Patients With Coronavirus COVID-19 Infection. US Infectious Cohort
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
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
- Conditions
- COVID-19, Lymphocytopenia
- Being tested
- CYT107, 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.
CYT107Drug
Also called Interleukin-7
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 at 10μg/kg twice a week for three weeks and up to 7 administrations according to Hospital length of stay
| Study group | Role | What they receive |
|---|---|---|
| CYT107 Treatment | Experimental | Intramuscular (IM) administration of CYT107 twice a week for 3 weeks Receives: Drug: CYT107 |
| Placebo | Placebo comparator | Intramuscular (IM) administration of Saline twice a week for 3 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
to determine if CYT107 will improve the clinical status of hospitalized COVID-19 patients as measured by 11 steps WHO clinical improvement score
Measured: one month
a significant decline 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
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
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
Length of stay in ICU compared to placebo arm
Number of days in ICU during index hospitalization
Measured: 45 days
number of readmissions to ICU compared to placebo arm
Readmissions to ICU through Day 45
Measured: 45 days
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
Frequency of re-hospitalization through day 45 compared to placebo arm
Number of readmissions to the hospital through Day 45
Measured: 45 days
All-cause mortality through day 45 compared to placebo arm
All-cause mortality through Day 45
Measured: 45 days
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
level of other known biomarkers of inflammation: Ferritin compared to placebo a
Track and evaluate other known biomarkers of inflammation, Ferritin, from baseline to day 30
Measured: 30 days
Level of other known biomarkers of inflammation: CRP compared to placebo arm
Level of other known biomarkers of inflammation: CRP compared to placebo arm
Measured: 30 days
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
Physiological status through NEWS2 evaluation compared to Placebo arm
Evaluate improvement 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.
- First posted22 Jun 2020
- Study start15 Sep 2020
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Why it stopped: POOR ACCRUAL
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revimmune
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Washington University School of Medicine, Amarex Clinical Research
- Responsible party
- Sponsor
- Investigators
- Richard Hotchkiss, MD PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442178
- Sponsor's protocol ID
- ILIAD-7 COVID US INFECTIOUS
- Acronym
- ILIAD-7-US-I
- Status last verified
- Mar 2022
- First submitted
- 19 Jun 2020
- Last updated
- 8 Apr 2022
- 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 32171076Wang 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 32031570Francois 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 29515037Venet 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.
PubMed 23053510Shankar-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
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blinded Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) for Immune Restoration of Hospitalized Lymphopenic Patients With Coronavirus COVID-19 Infection. US Infectious Cohort
- ClinicalTrials.gov ID
- NCT04442178
- Acronym / sponsor ID
- ILIAD-7-US-I / ILIAD-7 COVID US INFECTIOUS
- Conditions
- COVID-19, Lymphocytopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: POOR ACCRUAL
- Enrolment
- 26 participants (actual)
- Lead sponsor
- RevimmuneIndustry (pharma, biotech, devices)
- Collaborators
- Washington University School of Medicine, Amarex Clinical Research
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled of treatment vs placebo
| Arm | Type | Receives |
|---|---|---|
| CYT107 Treatment | Experimental | Drug: CYT107Intramuscular (IM) administration of CYT107 twice a week for 3 weeks |
| Placebo | Placebo comparator | Drug: PlaceboIntramuscular (IM) administration of Saline twice a week for 3 weeks |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYT107Also: Interleukin-7IM administration at 10μg/kg twice a week for three weeks and up to 7 administrations according to Hospital length of stay | Drug | CYT107 Treatment |
| PlaceboAlso: SalineIM administration at 10μg/kg twice a week for three weeks and up to 7 administrations according to Hospital length of stay | Drug | Placebo |
Primary outcome
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
Time frame: one month
A statistically significant increase of the absolute lymphocyte count (ALC) from randomization to day 30 or Hospital Discharge
14 secondary outcomes
To obtain "clinical improvement" as defined by an improvement in a 11-points WHO score for Clinical Assessment, through day 30 or HD.
Time frame: one month
a significant decline of SARS-CoV-2 viral load through day 30 or HD
Time frame: one month
frequency of secondary infections through day 45 compared to placebo arm
Time frame: 45 days
length of hospitalization compared to placebo arm
Time frame: 45 days
Length of stay in ICU compared to placebo arm
Time frame: 45 days
number of readmissions to ICU compared to placebo arm
Time frame: 45 days
organ support free days compared to placebo arm
Time frame: 45 days
Frequency of re-hospitalization through day 45 compared to placebo arm
Time frame: 45 days
All-cause mortality through day 45 compared to placebo arm
Time frame: 45 days
CD4+ and CD8+ T cell counts compared to placebo arm
Time frame: 30 days
level of other known biomarkers of inflammation: Ferritin compared to placebo a
Time frame: 30 days
Level of other known biomarkers of inflammation: CRP compared to placebo arm
Time frame: 30 days
Level of other known biomarkers of inflammation: D-dimer compared to placebo arm
Time frame: 30 days
Physiological status through NEWS2 evaluation compared to Placebo arm
Time frame: 30 days
Results and safety
The study was stopped early (reason given: POOR ACCRUAL). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Results publication: PubMed 32171076Zhou 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.
- Results publication: PubMed 32031570Wang 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.
- Results publication: PubMed 29515037Francois 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.
- Results publication: PubMed 23053510Venet 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.
- Derived from this study: PubMed 39903535Shankar-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.
- Individual participant dataSharing planned: No. Publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Hotchkiss, MD PhD principal investigator
Washington University School of Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CYT107 in people with COVID-19 and Lymphocytopenia, run by Revimmune at 5 sites in United States.
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 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
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 (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 NCT04442178, 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 8 Apr 2022.