Health TrialsbyHealthPanel

A Study to Assess Anktiva in Patients With Long Covid-19.

ConditionLong COVID
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorImmunityBio, Inc.

About this trial

This study will test the safety and tolerability of Anktiva in patients with Long Covid. Eligible patients will receive up to 2 doses of Anktiva and have follow-up exams and tests.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 and < 70 years.

Enrolled or willing to enroll and complete at least 1 visit in the UCSF Long-term Impact of Infection with Novel Coronavirus study. Any adult who has been infected with SARS-CoV-2 or has ever received or is eligible to receive a SARS-CoV-2 vaccination, and who is able to provide written informed consent, is eligible to participate in LIINC.

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). Written proof of the test will be requested but is not required as long as the participant attests to the positive test. 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.

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 planned INT1 or before FU2.5 following planned INT1.

History of autoimmune disease including, but not limited to, celiac disease, rheumatoid arthritis, psoriasis, and inflammatory bowel disease.

Myocardial infarction within 90 days of screening; OR

Trial design

Design model

Single group

Treatments tested in this trial

  • N-803 (IL-15 Superagonist)

    Drug

    N-803 administered subcutaneously.

Treatment groups

20 Participants
are divided into 1 treatment group
Group 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

Change in the ALC from Screening, INT1, FU1.3, INT2, FU2.3, FU2.4, FU2.5, and EOS.

Time frame
Through the study treatment period (approximately 75 days).
2

Change in patient-reported outcomes (PROs) PROMIS-29 score from Baseline to FU2.5 (45 days following last NAI administration).

Time frame
45 days following last NAI administration.
3

Change in other assessments (eg, EuroQoL Quality of Life) from baseline, intervention 2, FU2.3 (2 weeks after last NAI administration), FU2.5, and EOS.

Time frame
Through the study treatment period (approximately 75 days).
4

Proportion of participants with no detection of SARS-CoV-2 plasma remnants (ie viral detection by reverse transcriptase-polymerase chain reaction [RTPCR]) compared to baseline at FU2.5 and EOS.

Time frame
Through the study treatment period (approximately 75 days).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ImmunityBio, Inc.

Lead sponsor

Source ClinicalTrials.gov
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