COVID-19Phase 1NCT04385849

Study of the Safety of Therapeutic Treatment With an Immunomodulatory Agent (N-803) in Adults With COVID-19

A Phase 1 study testing N-803 and Saline in people with COVID-19, run by ImmunityBio, Inc. at 1 site in United States.

Terminated

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

Trial summary

This is a phase 1b, randomized, blinded, placebo-controlled study in adult subjects with COVID-19. This clinical trial is designed to assess the safety and immunostimulatory activity of N-803. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19
What is being tested?: N-803 and Saline
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1 participants
Where: 1 siteUnited States
Study dates: 22 Jul 2020to 25 Jul 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 years old.
Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
Has laboratory-confirmed positive novel coronavirus (SARS-CoV-2) test, as determined by polymerase chain reaction (PCR), or other commercial or public health assay in any specimen < 72 hours prior to enrollment, or meets the criteria to guide the evaluation and testing of patients under investigation (PUI) for COVID-19 (https://emergency.cdc.gov/han/2020/HAN00428.asp).
Has a confirmed NEW score of 0-5.
Has at least one of the following high-risk factors associated with a higher risk of COVID-19 progression:
Age ≥ 60 years.

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Hypertension currently managed by at least 1 antihypertensive medication.
Type 1 or 2 diabetes.
Chronic obstructive pulmonary disease (COPD) diagnosed per medical history.
Adequate respiratory and heart function, evidenced by the following laboratory results:
Respiratory rate (RR) < 20 breaths per minute (bpm).
Heart rate (HR) < 90 beats per minute (bpm).
Arterial oxygen saturation (SaO2) > 93% on room air.
Agrees to the collection of nasopharyngeal (NP) swabs and venous blood per protocol.
Ability to participate in required study visits and participate in adequate follow-up, as required by this protocol.
Agreement to practice effective contraception for female subjects of child-bearing potential and non-sterile males. Female subjects of child-bearing potential must agree to use effective contraception while on study and for at least 1 month after the last dose of N-803. Non-sterile male subjects must agree to use a condom while on study and for up to 1 month after the last dose of N-803. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), oral contraceptives, and abstinence.

Who cannot join

Shortness of breath or hypoxia defined by a ratio of partial pressure of arterial oxygen to the percentage of inspired oxygen (PaO2/FiO2) ≤ 300 mmHg or signs of serious lower airway disease.
Signs or symptoms of acute respiratory distress syndrome (ARDS), systemic inflammatory response syndrome (SIRS)/shock, or cardiac failure; or need for supplemental oxygen.
Inflammatory markers (C-reactive protein [CRP], lactate dehydrogenase [LDH], d-dimer, ferritin, and IL-6) > 1.5 × upper limit of normal (ULN).
Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
Pregnant and nursing women. A negative serum or urine pregnancy test during screening prior to the first dose must be documented before N-803 is administered to a female subject of child-bearing potential.

Trial locations and contacts

1 site in 1 country.

United States1 site

St. Francis
Lynwood, California, 90262

Other trials in United States

About this study

Official title: Phase 1b, Randomized, Blinded, Placebo-controlled Study of the Safety of Therapeutic Treatment With an Immunomodulary Agent (N-803 in Adults With COVID-19

This is a phase 1b, randomized, blinded, placebo-controlled study in adult subjects with COVID-19. This clinical trial is designed to assess the safety and immunostimulatory activity of N-803.

Conditions: COVID-19
Being tested: N-803, Saline
Medical subject headings: COVID-19

What participants receive

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

N-803Biological
Recombinant human super agonist interleukin-15 (IL-15) complex
SalineOther
Sterile saline solution

Study groups in NCT04385849
Study group	Role	What they receive
Experimental Arm	Experimental	N-803 Recombinant human super agonist interleukin-15 (IL-15) complex Receives: Biological: N-803
Placebo Arm	Placebo comparator	Sterile saline solution Receives: Other: Saline

What is being measured

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

Number of Participants With Adverse Events
AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Measured: 3 days

Timeline

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

22 Jul 202025 Jul 2020

First posted13 May 2020
Study start22 Jul 2020
Primary completion25 Jul 2020
Study completion25 Jul 2020

Why it stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by ImmunityBio, Inc.The sponsor's other registered studies.
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: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04385849
Sponsor's protocol ID: QUILT-COVID-19
Status last verified: Aug 2021
First submitted: 7 May 2020
Last updated: 5 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1b, Randomized, Blinded, Placebo-controlled Study of the Safety of Therapeutic Treatment With an Immunomodulary Agent (N-803 in Adults With COVID-19
ClinicalTrials.gov ID: NCT04385849
Acronym / sponsor ID: QUILT-COVID-19
Conditions: COVID-19
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.
Enrolment: 1 participants (actual)
Lead sponsor: ImmunityBio, Inc.Industry (pharma, biotech, devices)
Study start: 22 Jul 2020 (actual)
Primary completion: 25 Jul 2020 (actual)
Study completion: 25 Jul 2020 (actual)
First posted: 13 May 2020 (actual)
Results: Posted 5 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a phase 1b, randomized, blinded, placebo-controlled study in adult subjects with COVID-19. This clinical trial is designed to assess the safety and immunostimulatory activity of N-803.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Experimental Arm	Experimental	Biological: N-803N-803 Recombinant human super agonist interleukin-15 (IL-15) complex
Placebo Arm	Placebo comparator	Other: SalineSterile saline solution

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Age ≥ 18 years old.
Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
Has laboratory-confirmed positive novel coronavirus (SARS-CoV-2) test, as determined by polymerase chain reaction (PCR), or other commercial or public health assay in any specimen < 72 hours prior to enrollment, or meets the criteria to guide the evaluation and testing of patients under investigation (PUI) for COVID-19 (https://emergency.cdc.gov/han/2020/HAN00428.asp).
Has a confirmed NEW score of 0-5.
Has at least one of the following high-risk factors associated with a higher risk of COVID-19 progression:

Key exclusion criteria (5 listed)

Shortness of breath or hypoxia defined by a ratio of partial pressure of arterial oxygen to the percentage of inspired oxygen (PaO2/FiO2) ≤ 300 mmHg or signs of serious lower airway disease.
Signs or symptoms of acute respiratory distress syndrome (ARDS), systemic inflammatory response syndrome (SIRS)/shock, or cardiac failure; or need for supplemental oxygen.
Inflammatory markers (C-reactive protein [CRP], lactate dehydrogenase [LDH], d-dimer, ferritin, and IL-6) > 1.5 × upper limit of normal (ULN).
Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
Pregnant and nursing women. A negative serum or urine pregnancy test during screening prior to the first dose must be documented before N-803 is administered to a female subject of child-bearing potential.

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
N-803Recombinant human super agonist interleukin-15 (IL-15) complex	Biological	Experimental Arm
SalineSterile saline solution	Other	Placebo Arm

Primary outcome

Number of Participants With Adverse Events
Time frame: 3 days
AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V5.0

Results and safety

Results posted to the registry on 5 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental Arm	1	0
Placebo Arm	0	0

Primary outcome: Number of Participants With Adverse Events

Time frame: 3 days. Count of participants. Unit: Participants

Measure	Experimental Arm n = 1	Placebo Arm n = 0
Value	1	0

Population analysed: All randomized subjects

Adverse events

Time frame: The planned follow up time was 29 days post dose, but the one participant enrolled was lost to follow up 3 days post dose.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental Arm	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Placebo Arm	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): The study is terminated early due to low enrollment. Effect of the study drug on efficacy was not analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing N-803 and Saline in people with COVID-19, run by ImmunityBio, Inc. at 1 site 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 16 inclusion and 5 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 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 5 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Adverse Events (time frame: 3 days). 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 NCT04385849.

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 5 Sep 2024.