COVID-19Phase 1NCT04501796
A Trial of NT-I7 in COVID-19 (SPESELPIS)
A Phase 1 study testing Double-Blind NT-I7 in people with COVID-19, run by NeoImmuneTech at 2 sites in United States.
Trial summary
The main purposes of this study is to determine the following in participants with mild coronavirus disease 2019 (COVID-19): Safety of a single dose of NT-I7 The immunological effects of NT-I7 on peripheral lymphocyte counts in COVID-19 patients. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Double-Blind NT-I7
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Nov 2020to 23 Feb 2023
- Phase
- Phase 1
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals must meet all of the following criteria to be included in the study:
- Laboratory-confirmed SARS-CoV-2 infection as determined by either a documented positive molecular assay/ other commercial or public health assay in any specimen collected < 5 days prior to screening or a documented positive molecular assay ≥ 5 days prior to screening and confirmed by polymerase chain reaction (PCR) at screening.
- Illness of any duration with oxygen saturation > 93% at room air, heart rate ≤ 100 beats per minute at rest, and no evidence of respiratory distress with respiration rate < 20 breaths per minute.
- Able to provide informed consent.
- Aged ≥ 19 and ≤ 75 years.
- Absolute Lymphocyte Count <1,500 lymphocytes/µL.
- Avoid becoming pregnant or impregnate a partner through 90 days after study agent administration. Females must agree to 2 methods of contraception, and males to at least one method of contraception.
- Not participate in any other clinical trial for an investigational therapy through day 30.
Who cannot join
- Moderate to severe hypoxic respiratory failure requiring supplemental oxygen at rest, mechanical ventilation, ECMO, or any other noninvasive ventilation modality.
- CRP >15 mg/L or D-dimer > 0.75 µg/mL.
- Estimated glomerular filtration rate (eGFR) < 40 mL/min/1.73m2, or requiring dialysis.
- AST/ALT > 3-times ULN, or total bilirubin > 1.5 times ULN (except if due to Gilbert's syndrome).
- Pregnancy or breastfeeding.
- Use of systemic corticosteroids or immunomodulant within 4 weeks prior to screening.
Show all 10Show fewer
- Receipt of an investigational agent or investigational use of a licensed agent within 16 weeks prior to screening.
- HIV infection or underlying history of known or unknown primary or acquired immunodeficiency associated with lymphopenia and/or recurrent opportunistic infections.
- Autoimmune disease requiring systemic treatment EXCEPT for vitiligo or endocrine disease (such as diabetes, thyroid disease, and adrenal disease) controlled by replacement therapy.
- Malignancy requiring treatment 1 year prior to screening.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Nih/Niaid
Bethesda, Maryland, 20892
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Phase 1, Single-dose, Dose-escalating Trial of Long-acting Recombinant Human IL-7 (NT-I7) for COVID-19
The main purposes of this study is to determine the following in participants with mild coronavirus disease 2019 (COVID-19):
- Safety of a single dose of NT-I7
- The immunological effects of NT-I7 on peripheral lymphocyte counts in COVID-19 patients.
Read the detailed description
This is a multisite, double-blind, randomized, placebo-controlled, dose-escalating, phase 1 trial of NT-I7 with standard of care (SOC) versus placebo with SOC to evaluate the safety and efficacy of NT-I7 in adults with mild coronavirus disease 2019 (COVID-19). After determination of eligibility and baseline assessment, a single dose of the study agent (NT-I7 or placebo) will be administered after 1:1 randomization, along with SOC. Research blood collection will occur at baseline, days 3, 7, 14, 30, 60 and 90 days after administration. Primary and secondary evaluations will include assessment of adverse events (AEs), absolute lymphocyte count (ALC), and trajectory of other lymphocytes subsets: CD4, CD8, natural killer (NK), B, and mucosal-associated-invariant T (MAIT) cells. The final study visit will be at day 90 after the study agent administration. The investigators hypothesize that NT-I7 is safe for administration and preserves lymphocyte homeostasis in patients with mild COVID-19.
- Conditions
- COVID-19
- Being tested
- Double-Blind NT-I7, Double-Blind Placebo
- Keywords
- NT-I7 (efineptakin alfa, rhIL-7-hyFc), COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double-Blind NT-I7Drug
Also called rhIL-7-hyFc, efineptakin alfa
Administered by intramuscular (IM) injection
Double-Blind PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| NT-I7 | Experimental | NT-I7 will be administered once by IM injection within 24 hours of baseline (day 0). The treatment course pursued in all enrolled participants will be a single dose. Dosing will be staggered with at least 72 hours between each study participant. Receives: Drug: Double-Blind NT-I7 |
| Placebo | Placebo comparator | Placebo will be administered once by IM injection within 24 hours of baseline (day 0). The treatment course pursued in all enrolled participants will be a single dose. Dosing will be staggered with at least 72 hours between each study participant. Receives: Drug: Double-Blind Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety of a single dose of NT-I7 in a dose escalation fashion
Assessment of the number and severity of AEs possibly, probably, or definitely related to study drug evaluated at 7 and 30 days.
Measured: Up to approximately 30 days
Secondary outcomes (1)
Evaluate the immunological effects of NT-I7 cumulatively for all doses on peripheral lymphocyte counts in COVID-19 patients.
Assessment of the trajectory of ALC, CD4, CD8, NK, B, and MAIT cells measured at days 7, 14 and 30 after administration of NT-I7 or placebo compared to baseline values.
Measured: Up to approximately 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start27 Nov 2020
- Primary completion21 Jul 2021
- Study completion23 Feb 2023
Why it stopped: Study was halted due to lack of patient population resulting in slow enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeoImmuneTech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501796
- Sponsor's protocol ID
- NIT-116 (SPESELPIS)
- Status last verified
- Jul 2023
- First submitted
- 27 Jul 2020
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Phase 1, Single-dose, Dose-escalating Trial of Long-acting Recombinant Human IL-7 (NT-I7) for COVID-19
- ClinicalTrials.gov ID
- NCT04501796
- Acronym / sponsor ID
- NIT-116 (SPESELPIS)
- Conditions
- COVID-19
- Keywords
- NT-I7 (efineptakin alfa, rhIL-7-hyFc), COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was halted due to lack of patient population resulting in slow enrollment.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- NeoImmuneTechIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), University of Nebraska
- Study start
- 27 Nov 2020 (actual)
- Primary completion
- 21 Jul 2021 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 6 Aug 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.
The main purposes of this study is to determine the following in participants with mild coronavirus disease 2019 (COVID-19):
- Safety of a single dose of NT-I7
- The immunological effects of NT-I7 on peripheral lymphocyte counts in COVID-19 patients.
Detailed description
This is a multisite, double-blind, randomized, placebo-controlled, dose-escalating, phase 1 trial of NT-I7 with standard of care (SOC) versus placebo with SOC to evaluate the safety and efficacy of NT-I7 in adults with mild coronavirus disease 2019 (COVID-19). After determination of eligibility and baseline assessment, a single dose of the study agent (NT-I7 or placebo) will be administered after 1:1 randomization, along with SOC. Research blood collection will occur at baseline, days 3, 7, 14, 30, 60 and 90 days after administration. Primary and secondary evaluations will include assessment of adverse events (AEs), absolute lymphocyte count (ALC), and trajectory of other lymphocytes subsets: CD4, CD8, natural killer (NK), B, and mucosal-associated-invariant T (MAIT) cells. The final study visit will be at day 90 after the study agent administration. The investigators hypothesize that NT-I7 is safe for administration and preserves lymphocyte homeostasis in patients with mild COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NT-I7 | Experimental | Drug: Double-Blind NT-I7NT-I7 will be administered once by IM injection within 24 hours of baseline (day 0). The treatment course pursued in all enrolled participants will be a single dose. Dosing will be staggered with at least 72 hours between each study participant. |
| Placebo | Placebo comparator | Drug: Double-Blind PlaceboPlacebo will be administered once by IM injection within 24 hours of baseline (day 0). The treatment course pursued in all enrolled participants will be a single dose. Dosing will be staggered with at least 72 hours between each study participant. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Individuals must meet all of the following criteria to be included in the study:
- Laboratory-confirmed SARS-CoV-2 infection as determined by either a documented positive molecular assay/ other commercial or public health assay in any specimen collected < 5 days prior to screening or a documented positive molecular assay ≥ 5 days prior to screening and confirmed by polymerase chain reaction (PCR) at screening.
- Illness of any duration with oxygen saturation > 93% at room air, heart rate ≤ 100 beats per minute at rest, and no evidence of respiratory distress with respiration rate < 20 breaths per minute.
- Able to provide informed consent.
- Aged ≥ 19 and ≤ 75 years.
Key exclusion criteria (10 listed)
- Moderate to severe hypoxic respiratory failure requiring supplemental oxygen at rest, mechanical ventilation, ECMO, or any other noninvasive ventilation modality.
- CRP >15 mg/L or D-dimer > 0.75 µg/mL.
- Estimated glomerular filtration rate (eGFR) < 40 mL/min/1.73m2, or requiring dialysis.
- AST/ALT > 3-times ULN, or total bilirubin > 1.5 times ULN (except if due to Gilbert's syndrome).
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| Double-Blind NT-I7Also: rhIL-7-hyFc, efineptakin alfaAdministered by intramuscular (IM) injection | Drug | NT-I7 |
| Double-Blind PlaceboPlacebo | Drug | Placebo |
Primary outcome
Evaluate the safety of a single dose of NT-I7 in a dose escalation fashion
Time frame: Up to approximately 30 days
Assessment of the number and severity of AEs possibly, probably, or definitely related to study drug evaluated at 7 and 30 days.
1 secondary outcome
Evaluate the immunological effects of NT-I7 cumulatively for all doses on peripheral lymphocyte counts in COVID-19 patients.
Time frame: Up to approximately 30 days
Results and safety
The study was stopped early (reason given: Study was halted due to lack of patient population resulting in slow enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Double-Blind NT-I7 in people with COVID-19, run by NeoImmuneTech at 2 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 8 inclusion and 10 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 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: Study was halted due to lack of patient population resulting in slow enrollment.). 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?
Evaluate the safety of a single dose of NT-I7 in a dose escalation fashion (time frame: Up to approximately 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2023.