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

Primary Purpose

COVID-19

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

N-803

Saline

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

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:
1. Age ≥ 60 years.
2. Hypertension currently managed by at least 1 antihypertensive medication.
3. Type 1 or 2 diabetes.
4. Chronic obstructive pulmonary disease (COPD) diagnosed per medical history.
Adequate respiratory and heart function, evidenced by the following laboratory results:
1. Respiratory rate (RR) < 20 breaths per minute (bpm).
2. Heart rate (HR) < 90 beats per minute (bpm).
3. 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.

Exclusion Criteria:

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.

Sites / Locations

St. Francis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Arm

Placebo Arm

Arm Description

N-803 Recombinant human super agonist interleukin-15 (IL-15) complex

Sterile saline solution

Outcomes

Primary Outcome Measures

Preliminary safety and efficacy evaluation of N-803 by adverse event (AE) incidence

AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V5.0

Preliminary safety and efficacy evaluation of N-803 by subject clinical status using a the 7-point ordinal scale.

The 7-point ordinal scale is an assessment of the clinical status and is performed as the first assessment on each study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.

Preliminary safety and efficacy evaluation of N-803

Preliminary safety and efficacy evaluation of N-803 by changes in lymphocyte counts. Incidence of lymphopenia (ie, absolute lymphocyte count [ALC] < 1000/mm3) during COVID-19 infection.

Secondary Outcome Measures

Further evaluate efficacy of N-803 using changes to the National Early Warning Score (NEWS)

National Early Warning Score (NEWS) is based on 7 clinical parameters: respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, and level of consciousness.

Further evaluate the safety of N-803 in hemoglobin

Further evaluate the safety of N-803 using change from baseline in hemoglobin

Further evaluate the safety of N-803 using platelets

Further evaluate the safety of N-803 using change from baseline in platelets

Further evaluate the safety of N-803 using white blood cell count

Further evaluate the safety of N-803 using change from baseline in white blood cell count

Full Information

NCT ID

NCT04385849

First Posted

May 7, 2020

Last Updated

August 23, 2021

Sponsor

ImmunityBio, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04385849

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

July 22, 2020 (Actual)

Primary Completion Date

July 11, 2022 (Anticipated)

Study Completion Date

July 11, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ImmunityBio, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental Arm

Arm Type

Experimental

Arm Description

N-803 Recombinant human super agonist interleukin-15 (IL-15) complex

Arm Title

Placebo Arm

Arm Type

Placebo Comparator

Arm Description

Sterile saline solution

Intervention Type

Biological

Intervention Name(s)

N-803

Intervention Description

Recombinant human super agonist interleukin-15 (IL-15) complex

Intervention Type

Other

Intervention Name(s)

Saline

Intervention Description

Sterile saline solution

Primary Outcome Measure Information:

Title

Preliminary safety and efficacy evaluation of N-803 by adverse event (AE) incidence

Description

AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V5.0

Time Frame

2 weeks

Title

Preliminary safety and efficacy evaluation of N-803 by subject clinical status using a the 7-point ordinal scale.

Description

Time Frame

2 weeks

Title

Preliminary safety and efficacy evaluation of N-803

Description

Preliminary safety and efficacy evaluation of N-803 by changes in lymphocyte counts. Incidence of lymphopenia (ie, absolute lymphocyte count [ALC] < 1000/mm3) during COVID-19 infection.

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Further evaluate efficacy of N-803 using changes to the National Early Warning Score (NEWS)

Description

Time Frame

2 weeks

Title

Further evaluate the safety of N-803 in hemoglobin

Description

Further evaluate the safety of N-803 using change from baseline in hemoglobin

Time Frame

2 weeks

Title

Further evaluate the safety of N-803 using platelets

Description

Further evaluate the safety of N-803 using change from baseline in platelets

Time Frame

2 weeks

Title

Further evaluate the safety of N-803 using white blood cell count

Description

Further evaluate the safety of N-803 using change from baseline in white blood cell count

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria 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. 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. Exclusion Criteria: 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.

Facility Information:

Facility Name

St. Francis

City

Lynwood

State/Province

California

ZIP/Postal Code

90262

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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