LY3819253 (LY-CoV555) for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
Condition: COVID-19
MeSH terms: COVID-19
Intervention: LY3819253; Placebo; Remdesivir
Intervention description: LY3819253 is a neutralizing immunoglobulin G (IgG)-1 monoclonal antibody (mAb) to the receptor binding domain (RBD) of the S protein of SARS-CoV-2; Commercially available 0.9% sodium chloride solution; Antiviral agent
Intervention MeSH terms: Remdesivir; Bamlanivimab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 314.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; COVID 19; Coronaviridae Infections; Coronavirus Infections; RNA Virus Infections; Virus Diseases; Nidovirales Infections; SARS-CoV-2; SARS Coronavirus; ACTIV-3; ACTIV3; TICO

Summary:

      This study looks at the safety and effectiveness of LY3819253 in treating COVID-19 in people
      who have been hospitalized with the infection. Participants in the study will be treated with
      either LY3819253 plus current standard of care (SOC), or with placebo plus current SOC. This
      is ACTIV-3/TICO Treatment Trial H1.
    

Eligibility criteria:

        Inclusion Criteria: Refer to the master protocol (NCT04501978)

        Exclusion Criteria: Refer to the master protocol (NCT04501978)

        Additional Criteria:

        Non-pregnant female participants who are of reproductive potential and male participants
        who are able to father a child must abstain from male/female sexual intercourse or agree to
        use two forms of effective contraception, where at least one form is highly effective (less
        than 1% failure rate), for the entirety of the study and for 90 days after investigational
        agent is administered. Highly effective methods of contraception (less than 1% failure
        rate) include, but are not limited to:

          -  combination oral contraceptives

          -  implanted contraceptives

          -  intrauterine devices

        Effective methods of contraception include, but are not limited to:

          -  diaphragms and cervical caps with spermicide

          -  cervical sponges

          -  condoms with spermicide

        NOTE:

          -  Use of male and female condoms as a double barrier method is not considered acceptable
             due to the high failure rate when these barrier methods are combined.

          -  Barrier protection methods without concomitant use of a spermicide are not an
             effective or acceptable method of contraception.

          -  Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods),
             and withdrawal are not acceptable methods of contraception. Participants not of
             reproductive potential are eligible without requiring the use of a contraceptive
             method. Participant-reported history is acceptable documentation of surgical
             sterilization and menopause. Participants with pregnant partners should use condoms
             during vaginal intercourse through 90 days after investigational agent administration.
             Participants should refrain from sperm donation through 90 days after investigational
             agent administration. NOTE: Reproductive potential is defined as patients who have
             reached menarche, who have not been post-menopausal for at least 12 consecutive months
             with follicle-stimulating hormone (FSH) ≥ 40 IU/ml or 24 consecutive months if an FSH
             is not available, who have not undergone surgical sterilization, who do not have other
             clinical condition that could induce amenorrhea, who are not taking medications such
             as oral contraceptives, hormones, gonadotropin releasing hormone, antiestrogens,
             selective estrogen receptor modulators (SERMs) or chemotherapy that could induce
             amenorrhea. Individuals with permanent infertility due to an alternate medical cause
             (e.g. Mullerian agenesis, androgen insensitivity), investigator discretion should be
             applied.