Achieving viral CLEARance in immunocompromised participants with long-term persistence of SARS-CoV-2 - an open-label randomized trial

You may be able to join if

• 1. Male or female participants ≥18 years of age.
• 2. Participants under an ongoing immunosuppression or a previous immunosuppression with an ongoing effect, defined by ≥ 1 of the following criteria: a. CAR-T-cell therapy or a hematologic stem cell transplant recipient within 2 years of treatment, with ongoing immunosuppressive therapy or residual immunodeficiency due to incomplete regeneration b. Moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott- Aldrich syndrome) c. Use of at least 1 of the following immunosuppressive medications:  Recent treatment with corticosteroids equivalent to prednisone ≥20 mg daily for at least 14 consecutive days, all of which must have been within the last 30 days prior to screening OR current treatment with ≥20 mg daily that must have been administered for at least 14 consecutive days at the time of screening.  Active treatment causing significant immunosuppression, including alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents, TNF blockers, or other highly immunosuppressive drugs such as biologics.  Previous or ongoing immunosuppressive treatment(s) resulting in residual immunodeficiency (e.g. hypogammaglobulinemia following anti-CD20 directed therapies). d. HIV infection with CD4+ cell count <200 mm3 from known medical history within the past 6 months of screening.
• 3. Documented SARS-CoV-2 persistence of at least 28 days in the pre-screening phase, defined as a sequence of laboratory-confirmed positive PCR results (defined as a PCR test with a cycle threshold (Ct) value of ≤30) from a nose swab or another respiratory material, that fulfils both of the following conditions: 1.) Duration: the total time elapsed between the first positive result (index test) and the second positive result confirming persistence (persistence test) is at least 28 days (additional tests may be performed between these two timepoints) and 2.) Continuity: all consecutive positive PCR tests following the persistence test, including the test confirming eligibility at screening (qualifying test), must be performed at intervals of no more than 21 days.
• 4. Willing and able to provide written informed consent.
• 5. Ability to understand the nature of the trial and the trial related procedures and to comply with them.
• 6. All female participants who are not pregnant at study entry, and who in the opinion of the investigator, are biologically capable of having children must agree to use a highly effective method of contraception consistently and correctly for at least 28 days after study completion. The following methods are considered highly effective: a. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral intravaginal or transdermal). b. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable). c. Intrauterine device (IUD). d. Intrauterine hormone-releasing system (IUS). e. Bilateral tubal occlusion. f. Vasectomized partner. g. Sexual abstinence.