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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04385849
• Other study ID #: QUILT-COVID-19
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 22, 2020
• Est. completion date: July 11, 2022

Study information

• Verified date: August 2021
• Source: ImmunityBio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1
• Est. completion date: July 11, 2022
• Est. primary completion date: July 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. Age = 18 years old.

2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.

3. 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).

4. Has a confirmed NEW score of 0-5.

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.

6. 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.

7. Agrees to the collection of nasopharyngeal (NP) swabs and venous blood per protocol.

8. Ability to participate in required study visits and participate in adequate follow-up, as required by this protocol.

9. 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:

1. 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.

2. Signs or symptoms of acute respiratory distress syndrome (ARDS), systemic inflammatory response syndrome (SIRS)/shock, or cardiac failure; or need for supplemental oxygen.

3. Inflammatory markers (C-reactive protein [CRP], lactate dehydrogenase [LDH], d-dimer, ferritin, and IL-6) > 1.5 × upper limit of normal (ULN).

4. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.

5. 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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Other:
• Saline
Sterile saline solution

Locations

Country	Name	City	State
United States	St. Francis	Lynwood	California

Sponsors (1)

Lead Sponsor	Collaborator
ImmunityBio, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 weeks
Primary	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.	2 weeks
Primary	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.	2 weeks
Secondary	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.	2 weeks
Secondary	Further evaluate the safety of N-803 in hemoglobin	Further evaluate the safety of N-803 using change from baseline in hemoglobin	2 weeks
Secondary	Further evaluate the safety of N-803 using platelets	Further evaluate the safety of N-803 using change from baseline in platelets	2 weeks
Secondary	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	2 weeks