Clinical Trial to Evaluate CERC-002 in Adults With COVID-19 Pneumonia and Acute Lung Injury
Condition: COVID-19 Pneumonia; Acute Lung Injury; ARDS
MeSH terms: COVID-19; Pneumonia; Lung Injury; Acute Lung Injury; Wounds and Injuries
Intervention: CERC-002; Placebo
Intervention description: Administered once subcutaneously at 16 mg/kg dose up to a maximum dose of 1200 mg.; Administered once subcutaneously
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double-blind (Participant, Investigator)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study is a prospective, randomized, placebo-controlled, double-blind phase 2 clinical
      study of the efficacy and safety of CERC-002, a potent inhibitor of LIGHT (Lymphotoxin-like,
      exhibits Inducible expression, and competes with Herpes Virus Glycoprotein D for Herpesvirus
      Entry Mediator, a receptor expressed by T lymphocytes), for the treatment of patients with
      2019 novel coronavirus disease (COVID-19) pneumonia who have mild to moderate Acute
      Respiratory Distress Syndrome (ARDS).

      LIGHT is a cytokine in the tumor necrosis factor super family (TNFSF14) which drives
      inflammation and induces many other cytokines including IL-1, IL-6 and GM-CSF. LIGHT levels
      have been shown to be elevated in COVID-19 infected patients and inhibiting LIGHT is
      hypothesized to ameliorate the cytokine storm which has shown to be a major factor in
      progression of ARDS.

      The study will assess the efficacy and safety of CERC-002 in patients with severe COVID-19
      over a 28 day period as single dose on top of standard of care.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject/legally authorized representative (LAR) is able to understand and provide
             written informed consent, and assent (as applicable) to participate in this study.

          2. Subject is ≥18 years of age at the time of informed consent and assent (as
             applicable).

          3. Subject is male or non-pregnant, non-lactating female, who if of childbearing
             potential agrees to comply with any applicable contraceptive requirements if.
             discharged from the hospital prior to completing the study.

          4. Subject has a diagnosis of COVID-19 infection through an approved testing method.

          5. Subject has been hospitalized due to clinical diagnosis of pneumonia with acute lung
             injury defined as diffuse bilateral radiographic infiltrates with partial pressure of
             arterial oxygen/percentage of inspired oxygen (PaO2/FiO2) >100 and <300.

          6. Subject's oxygen saturation at rest in ambient air <93%

        Exclusion Criteria:

          1. Subject is intubated.

          2. Subject is currently taking immunomodulators or anti-rejection drugs.

          3. Subject has been administered an immunomodulating biologic drug within 60 days of
             baseline.

          4. Subject is in septic shock defined as persistent hypotension requiring vasopressors to
             maintain mean arterial pressure (MAP) of 65 mm Hg or higher and a serum lactate level
             greater than 2 mmol/L (18 mg/dL) despite adequate volume resuscitation.

          5. Subject has received any live attenuated vaccine, such as varicella-zoster, oral
             polio, or rubella, within 3 months prior to the baseline visit.