RecruitingPhase 2

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

United States20 participantsStarted 2025-11-14

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. Is a WOCBP and is using a contraceptive method that is effective as described in Appendix 1 from -21 days from study entry (defined as INT1), during the study intervention period, and for at least 7 months after the last study intervention administration. She must also agree not to donate her eggs (ova, oocytes) for the purpose of reproduction from study entry (defined as INT1), during the study intervention period, and for at least 7 months after the last study intervention administration.
✓. A WOCBP must have a negative urine pregnancy test within 24 hours prior to all doses of study intervention. If a urine pregnancy test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test must be negative.

Exclusion criteria

✕. 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.
✕. ANC \< 1,500 per mm3
✕. Platelet count \<100,000 per mm3
✕. Baseline AST or ALT \> 1.5 × ULN
✕. Hemoglobin \< 9 d/dL

What they're measuring

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

Timeframe: Through 30 days post final study drug administration.

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

Timeframe: Through 30 days post final study drug administration.

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

Timeframe: Through 30 days post final study drug administration.

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

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

Clinically important changes in vital signs.

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

Trial details

NCT IDNCT07108036

SponsorImmunityBio, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10

Contact for this trial

Kayleigh Russell

424.539.2412 Kayleigh.Russell@ImmunityBio.com

View on ClinicalTrials.gov More Long COVID trials

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. Is a WOCBP and is using a contraceptive method that is effective as described in Appendix 1 from -21 days from study entry (defined as INT1), during the study intervention period, and for at least 7 months after the last study intervention administration. She must also agree not to donate her eggs (ova, oocytes) for the purpose of reproduction from study entry (defined as INT1), during the study intervention period, and for at least 7 months after the last study intervention administration.
✓. A WOCBP must have a negative urine pregnancy test within 24 hours prior to all doses of study intervention. If a urine pregnancy test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test must be negative.

Exclusion criteria

✕. 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.
✕. ANC \< 1,500 per mm3
✕. Platelet count \<100,000 per mm3
✕. Baseline AST or ALT \> 1.5 × ULN
✕. Hemoglobin \< 9 d/dL