A Study to Examine Anktiva for the Treatment of COVID-19. (NCT07123727)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Age ≥ 18 and \< 70 years.
2. 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.
3. Clinical evidence of Long COVID, as confirmed by the Investigator's assessment.
4. 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
5. 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
6. Symptoms must be reported to be at least somewhat bothersome and to have an impact on quality of life and/or everyday functioning AND
7. 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.
8. Not currently hospitalized.
9. Body mass index (BMI) 18 to 50 kilograms/meter squared (kg/m2), inclusive, at the time of screening.
10. In otherwise stable health, as assessed by the Investigator within 28 days prior to screening, based on medical history, physical examination, laboratory findings, and vital signs.
11. For male participants, a. Participants with partners that are 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. 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.
12. 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:

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• Chan Soon-Schiong Institute for Medicine (CSSIFM) — El Segundo, California

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.