A Study to Examine Anktiva for the Treatment of COVID-19.
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorImmunityBio, Inc.
About this trial
This study will examine the safety and effectiveness of Anktiva in treating patients with Long COVID-19 which is defined as persistent symptoms of a COVID-19 infection that remain after the infection is over.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 and < 70 years.
History of at least one SARS-CoV-2 infection, defined as report of a positive nucleic acid amplification test (NAAT) and/or a positive SARS-CoV-2 antigen rapid diagnostic test (RDT). Those with only suspected but unconfirmed infections are not eligible for this study.
Clinical evidence of Long COVID, as confirmed by the Investigator's assessment.
At least 2 symptoms or at least 1 severe symptom as assessed by the study team (see list) that are new or worsened since the time of a SARS-CoV-2 infection, not known to be attributable to another cause upon assessment by the PI. At least 2 symptoms from those listed here must be present: systemic symptoms (eg, fatigue, chills, post-exertional malaise), neurocognitive symptoms (eg, trouble with memory/concentration ("brain fog"), headache, dysautonomia/postural orthostatic tachycardia symptoms, dizziness, unsteadiness, neuropathy, sleep disturbance), cardiopulmonary symptoms (eg, chest pain, palpitations, shortness of breath, cough, fainting spells), musculoskeletal symptoms (eg, muscle aches, joint pain), gastrointestinal symptoms (eg, nausea, diarrhea). Although other symptoms (eg, skin rash, hair loss, trouble with smell/taste, genitourinary symptoms) will be recorded and tracked, at least 2 core symptoms listed above must be present. Note: the 2 symptoms can be from within the same category (for example, brain fog and headache) AND
Disqualifiers
Previously received a SARS-CoV-2 antiviral or monoclonal antibody 30 days prior to planned INT1 or plan to receive such treatment before exiting the study.
Plans to receive any investigational or approved vaccine or booster for SARS-CoV-2 within 14 days prior to plan to receive such treatment before exiting the study.
History of autoimmune disease including, but not limited, to celiac disease, rheumatoid arthritis, psoriasis, and inflammatory bowel diseases.
Myocardial infarction within 90 days of screening; OR
Trial design
Design model
Single group
Treatments tested in this trial
Anktiva
Drug600ug of NAI administered subcutaneously
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: N-803Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of treatment emergent adverse events (TEAEs) through 30 days post final study drug administration.
Time frame
Through 30 days post final study drug administration.2
Incidence of grade 3 or higher TEAEs through 30 days post final study drug administration.
Time frame
Through 30 days post final study drug administration.3
Incidence of serious adverse events (SAEs) through 30 days post final study drug administration.
Time frame
Through 30 days post final study drug administration.4
Incidence of abnormal changes in safety laboratory tests (CBC and CMP).
Time frame
Through the end of the study treatment period (approximately 75 days).Secondary outcomes
1
Percent increase or decrease change in the Absolute lymphocyte count (as measured on CBC) from Screening to End Of Study with various timepoints.
Time frame
Through the end of the study treatment period (approximately 75 days).Other outcomes
1
Percent increase or decrease change in frequency and activation of NK cells and CD8+ T cells as measured by Flow Cytometry from prior to NAI administration to End Of Study.
Time frame
Through the end of the study treatment period (approximately 75 days).2
Immunologic function of NK cells and CD8+ T cells as measured by Flow Cytometry for Peripheral Blood Mononuclear Cell Evaluation and Secretome testing for analyzing cytokines for understanding the body's defenses from prior to NAI administration to EOS.
Time frame
Through the end of the study treatment period (approximately 75 days).Sponsors and contacts
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Source ClinicalTrials.gov