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

NCT07108036 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: COVID-4.018-LONG
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Long COVID

Outcome Measures

Primary Outcomes (5)

• Incidence of treatment emergent adverse events (TEAEs) through 30 days post final study drug administration.

  Through 30 days post final study drug administration.

• Incidence of grade 3 or higher TEAEs through 30 days post final study drug administration.

  Through 30 days post final study drug administration.

• Incidence of serious adverse events (SAEs) through 30 days post final study drug administration.

  Through 30 days post final study drug administration.

• Incidence of abnormal changes in safety laboratory tests (CBC and CMP).

  Through the end of the study treatment period (approximately 75 days)

• Clinically important changes in vital signs.

  Through the end of the study treatment period (approximately 75 days)

Secondary Outcomes (5)

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

  Through the study treatment period (approximately 75 days).

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

  45 days following last NAI administration.

• 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.

  Through the study treatment period (approximately 75 days).

• 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.

  Through the study treatment period (approximately 75 days).

• Proportion of participants with reduced SARS-CoV-2 RNA in stool approximately 30 days post NAI administration.

  30 days post NAI administration

Study Arms (1)

N-803

EXPERIMENTAL

All patients will be in this arm.

Drug: N-803 (IL-15 Superagonist)

Interventions

N-803 (IL-15 Superagonist) DRUG

N-803 administered subcutaneously.

N-803

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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, mental health symptoms, 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
• Symptoms must have been present for at least 60 days prior to screening. Symptoms that wax and wane must have been initially present at least 60 days prior to screening AND
• Symptoms must be reported to be at least somewhat bothersome and to have an impact on quality of life and/or everyday functioning AND
• At least 90 days have elapsed since the most recent suspected or confirmed SARS-CoV-2 infection and the time of screening. Note: suspected infections will be determined based upon assessment by the study Investigators.
• Not currently hospitalized.
• Body mass index (BMI) 18 to 50 kilograms/meter squared (kg/m2), inclusive, at the time of screening.
• In otherwise stable health, as assessed by the Investigator within 28 days prior to screening, based on medical history, physical assessment, laboratory findings, and vital signs.
• For male participants,
• a. Participants with partners that are women of childbearing potential (WOCBP) are strongly advised to inform their partners and must agree to use effective contraception from study entry (defined as INT1) through 7 months after the last dose of study intervention. Effective methods of contraception are described in Appendix 2. Participants with pregnant partners must agree to use condoms during vaginal intercourse from study entry (defined as INT1) through 14 days after the last dose of study intervention administration. Participants assigned male sex at birth must agree to refrain from sperm donation from study entry through 14 days after the last dose of study intervention administration.
• For female participants,
• a. A female participant who engages in sexual intercourse with male partners is eligible to participate if she is not pregnant or breastfeeding, and the following conditions applies: i. Is not a WOCBP OR ii. All of the following apply:

You may not qualify if:

• 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.
• Active cardiovascular disease, defined as known prior:
• Myocardial infarction within 90 days of screening; OR
• Coronary artery bypass procedure within 90 days of screening; OR
• Current heart failure with reduced ejection fraction (\<45%); OR
• Current pulmonary arterial hypertension.
• Known stroke within 3 months prior to planned INT1.
• Major surgery within 3 months prior to planned INT1 or planned major surgery during the first 75 days following planned INT1.
• History of unplanned hospitalization for \>24 hours within 28 days prior to Screening.
• Active Hepatitis C (Hep C) infection (defined as Hep C Ab positive or indeterminate with detectable Hep C RNA). Note: Those with cured Hep C (Ab positive or indeterminate but negative Hep C RNA) will remain eligible.
• Laboratory abnormalities including:
• ANC \< 1,500 per mm3
• Platelet count \<100,000 per mm3

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

Study Sites (1)

University of California - San Francisco

San Francisco, California, 94110, United States

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

ALT-803

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Joseph Ward

CONTACT

3236933913; joseph.ward@immunitybio.com

Tamra Madenwald

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 6, 2025
• Study Start: November 14, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)