COVID-19Phase 2ILIAD-7-UKNCT04379076
InterLeukin-7 (CYT107) to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection UK Cohort
A Phase 2 study testing Interleukin-7 in people with COVID-19 and Lymphocytopenia, run by Revimmune at 13 sites in United Kingdom.
Trial summary
Comparison of the effects of CYT107 vs Placebo administered IM at 10µg/kg twice a week for two 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 13 sitesUnited Kingdom
- Study dates
- 14 May 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 one absolute lymphocyte count (ALC) ≤ 1000 cells/mm3, collected at baseline or no more than 72h before baseline
- Hospitalized patients with moderate to severe hypoxemia requiring oxygen therapy at >2L 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
- Private insurance or government support (through NHS or other)
Who cannot join
- Pregnancy or breast feeding;
- Refusal or inability to practice contraception regardless of the gender of the patient;
- 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.
Show all 16Show fewer
- Active tuberculosis, uncontrolled active HBV or HCV infection, HIV with positive viral load.
- Patients whose respiratory condition is showing significant deterioration as indicated by:
- requirement for a persistent and sustained increase in inspired oxygen concentrations of 20% or more over the past 24 hours to maintain SpO2 at greater than or equal to 88% (this 20 % limit does not apply to O2 delivered by nasal canula)
- or need for invasive mechanical ventilation
- Patients with chronic kidney dialysis
- 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 with a SOFA score ≥ 9 at baseline
- Patients with a BMI > 40
- Patients with baseline Rockwood Clinical Frailty Scale ≥ 6.(assessed as patient or proxy 4-week recall of chronic health and frailty status prior to COVID infection)
- Patients under guardianship
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United Kingdom13 sites
Sandwell Birmingham Hospital
Birmingham, B18 7QH
Sandwell Birmingham Hospital
Birmingham
Bradford Institute for Health Research
Bradford, BD9 6RJ
ST JAMES's UNIVERSITY HOSPITAL
Leeds, LS9 7TF
Medway Maritime Hospital
London, ME7 5NY
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RS
King'S College Hospital
London, SE5 9RS
Wythenshawe Hospital/ Manchester Royal Infirmary
Manchester, M23 9LT
North Manchester General Hospital
Manchester, M8 5RB
Royal Victoria Infirmary and Freeman Hospital
Newcastle, NE1 4LP
Royal Preston Hospital
Preston
Sunderland Royal Hospital
Sunderland
Watford General Hospital
Watford, WD18 0HB
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 in UK
Comparison of the effects of CYT107 vs Placebo administered IM at 10µg/kg twice a week for two 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 3 μg/kg followed, after 48hrs of observation, by 10 μg/kg twice a week for 2 weeks or (b) Intramuscular (IM) placebo (normal saline) at the same frequency. An interim safety review will take place after the first 12 patients. If the CYT107 is well tolerated, the test dose (3 μg/kg) will cease and that initial dose will become the same as the rest of the doses (10 μg/kg). So, the remaining patients will be randomized to receive 5 administrations of (a) CYT107 at 10 μg/kg every 3 to 4 days for 2 weeks 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
- Conditions
- COVID-19, Lymphocytopenia
- Being tested
- Interleukin-7, Placebos
- 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
Intramuscular (IM) administration of CYT107 at 3 μg/kg followed, after 48hrs of observation, by 10 μg/kg twice a week for 2 weeks or
PlacebosDrug
Also called Saline
Intramuscular (IM) placebo (normal saline) at the same frequency
| Study group | Role | What they receive |
|---|---|---|
| CYT107 | Experimental | Intra-muscular administration of CYT107 twice a week for a total of 5 administrations Receives: Drug: Interleukin-7 |
| Saline | Placebo comparator | Intramuscular (IM) administration of saline at the same volume and same time for a total of 5 administrations Receives: Drug: Placebos |
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), whicheve
A statistically significant increase of the absolute lymphocyte count (ALC) from randomization to day 30 or Hospital Discharge
Measured: 1 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 WHO score
Measured: 1 month
determine if CYT107 will lead to 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
To compare the effect of CYT107 versus placebo on the frequency of secondary infections through day 45
Incidence of secondary infections based on pre-specified criteria as adjudicated by the Secondary Infections Committee (SIC) through Day 45
Measured: 45 days
To compare the effect of CYT107 versus placebo on the length of hospitalization
Number of days of hospitalization during index hospitalization (defined as time from initial Study drug treatment through HD)
Measured: 45 days
To compare the effect of CYT107 versus placebo on the length of stay in ICU
Number of days in ICU during index hospitalization
Measured: 45 days
To compare the effect of CYT107 versus placebo on readmissions to ICU
Readmissions to ICU through Day 45
Measured: 45 days
To compare the effect of CYT107 versus placebo on organ support free days
Organ support free days (OSFDs) during index hospitalization (This includes ventilator assistance free days.)
Measured: 45 days
To compare the effect of CYT107 versus placebo on the frequency of re-hospitalization through day 45
Number of readmissions to the hospital through Day 45
Measured: 45 days
To assess the impact of CYT107 on all-cause mortality through day 45
All-cause mortality through Day 45
Measured: 45 days
To determine the effect of CYT107 on CD4+ and CD8+ T cell counts
Absolute numbers of CD4+ and CD8+ T-cell counts at timepoints indicated on the Schedule of Activities (SoA) through Day 30 or HD
Measured: 30 days
To track and evaluate other known biomarkers of inflammation: Ferritin
Track and evaluate other known biomarkers of inflammation, Ferritin, from baseline to day 30
Measured: 30 days
To track and evaluate other known biomarkers of inflammation: CRP
Track and evaluate other known biomarkers of inflammation, CRP from baseline to day 30
Measured: 30 days
To track and evaluate other known biomarkers of inflammation: D-dimer
Track and evaluate other known biomarkers of inflammation, D-dimer from baseline to day 30
Measured: 30 days
Evaluation of physiological status through NEWS2 score
Evaluate improvement of the NEWS2 score value
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 posted7 May 2020
- Study start14 May 2020
- Primary completion28 Feb 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 (7)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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revimmune
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amarex Clinical Research
- Responsible party
- Sponsor
- Investigators
- Manu Shankar-Hari, MD PhD, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379076
- Sponsor's protocol ID
- CLI107 COVID UK (ILIAD-7-UK)
- Acronym
- ILIAD-7-UK
- Status last verified
- Mar 2022
- First submitted
- 5 May 2020
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: publication
Publications
Manzanilla-Sevilla R, Gonzalez-Iniguez R, Casanova-Alvarez N, Martinez-Alcala F. Tubal sterilization and ovarian perfusion: selective arteriography in vivo and in vitro. Int J Gynaecol Obstet. 1978-1979;16(2):137-43. doi: 10.1002/j.1879-3479.1978.tb00414.x.
PubMed 32109Zhou 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 29515037Hotchkiss RS, Monneret G, Payen D. Immunosuppression in sepsis: a novel understanding of the disorder and a new therapeutic approach. Lancet Infect Dis. 2013 Mar;13(3):260-8. doi: 10.1016/S1473-3099(13)70001-X.
PubMed 23427891Venet 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 7 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 in UK
- ClinicalTrials.gov ID
- NCT04379076
- Acronym / sponsor ID
- ILIAD-7-UK / CLI107 COVID UK (ILIAD-7-UK)
- Conditions
- COVID-19, Lymphocytopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: POOR ACCRUAL
- Enrolment
- 35 participants (actual)
- Lead sponsor
- RevimmuneIndustry (pharma, biotech, devices)
- Collaborators
- Amarex Clinical Research
- Study start
- 14 May 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 7 May 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 two 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 3 μg/kg followed, after 48hrs of observation, by 10 μg/kg twice a week for 2 weeks or (b) Intramuscular (IM) placebo (normal saline) at the same frequency. An interim safety review will take place after the first 12 patients. If the CYT107 is well tolerated, the test dose (3 μg/kg) will cease and that initial dose will become the same as the rest of the doses (10 μg/kg). So, the remaining patients will be randomized to receive 5 administrations of (a) CYT107 at 10 μg/kg every 3 to 4 days for 2 weeks 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
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 | Experimental | Drug: Interleukin-7Intra-muscular administration of CYT107 twice a week for a total of 5 administrations |
| Saline | Placebo comparator | Drug: PlacebosIntramuscular (IM) administration of saline at the same volume and same time for a total of 5 administrations |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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 one absolute lymphocyte count (ALC) ≤ 1000 cells/mm3, collected at baseline or no more than 72h before baseline
- Hospitalized patients with moderate to severe hypoxemia requiring oxygen therapy at >2L 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 (16 listed)
- Pregnancy or breast feeding;
- Refusal or inability to practice contraception regardless of the gender of the patient;
- 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;
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 |
|---|---|---|
| Interleukin-7Also: CYT107Intramuscular (IM) administration of CYT107 at 3 μg/kg followed, after 48hrs of observation, by 10 μg/kg twice a week for 2 weeks or | Drug | CYT107 |
| PlacebosAlso: SalineIntramuscular (IM) placebo (normal saline) at the same frequency | Drug | Saline |
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), whicheve
Time frame: 1 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: 1 month
determine if CYT107 will lead to a significant decline of SARS-CoV-2 viral load through day 30 or HD
Time frame: one month
To compare the effect of CYT107 versus placebo on the frequency of secondary infections through day 45
Time frame: 45 days
To compare the effect of CYT107 versus placebo on the length of hospitalization
Time frame: 45 days
To compare the effect of CYT107 versus placebo on the length of stay in ICU
Time frame: 45 days
To compare the effect of CYT107 versus placebo on readmissions to ICU
Time frame: 45 days
To compare the effect of CYT107 versus placebo on organ support free days
Time frame: 45 days
To compare the effect of CYT107 versus placebo on the frequency of re-hospitalization through day 45
Time frame: 45 days
To assess the impact of CYT107 on all-cause mortality through day 45
Time frame: 45 days
To determine the effect of CYT107 on CD4+ and CD8+ T cell counts
Time frame: 30 days
To track and evaluate other known biomarkers of inflammation: Ferritin
Time frame: 30 days
To track and evaluate other known biomarkers of inflammation: CRP
Time frame: 30 days
To track and evaluate other known biomarkers of inflammation: D-dimer
Time frame: 30 days
Evaluation of physiological status through NEWS2 score
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 7 Apr 2022.
- Background: PubMed 32109Manzanilla-Sevilla R, Gonzalez-Iniguez R, Casanova-Alvarez N, Martinez-Alcala F. Tubal sterilization and ovarian perfusion: selective arteriography in vivo and in vitro. Int J Gynaecol Obstet. 1978-1979;16(2):137-43. doi: 10.1002/j.1879-3479.1978.tb00414.x.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: PubMed 23427891Hotchkiss RS, Monneret G, Payen D. Immunosuppression in sepsis: a novel understanding of the disorder and a new therapeutic approach. Lancet Infect Dis. 2013 Mar;13(3):260-8. doi: 10.1016/S1473-3099(13)70001-X.
- Background: 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
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Manu Shankar-Hari, MD PhD principal investigator
Guy's and St Thomas' NHS Foundation Trust
13 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 Interleukin-7 in people with COVID-19 and Lymphocytopenia, run by Revimmune at 13 sites in United Kingdom.
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 6 inclusion and 16 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 7 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 13 sites in United Kingdom. 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), whicheve (time frame: 1 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 NCT04379076, which also lists 7 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 7 Apr 2022.