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

NCT ID: NCT04385849

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-22
• Study Completion Date: 2020-07-25

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental Arm

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

Group Type: EXPERIMENTAL

N-803

Intervention Type: BIOLOGICAL

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

Placebo Arm

Sterile saline solution

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: OTHER

Sterile saline solution

Interventions

N-803

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

Intervention Type: BIOLOGICAL

Saline

Sterile saline solution

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ImmunityBio, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

St. Francis

Lynwood, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

QUILT-COVID-19

Identifier Type: -

Identifier Source: org_study_id