Status:
TERMINATED
Study of the Safety of Therapeutic Treatment With an Immunomodulatory Agent (N-803) in Adults With COVID-19
Lead Sponsor:
ImmunityBio, Inc.
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2020
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04385849
Start Date
July 22 2020
End Date
July 25 2020
Last Update
September 5 2024
Active Locations (1)
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1
St. Francis
Lynwood, California, United States, 90262