Trial Search Results

ACTIV-3: Therapeutics for Inpatients With COVID-19

This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either a study drug plus current standard of care (SOC), or with placebo plus current SOC.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator: AstraZeneca

Intervention(s):

  • Biological: LY3819253
  • Drug: Placebo
  • Biological: Remdesivir
  • Biological: VIR-7831
  • Biological: BRII-196/BRII-198
  • Biological: AZD7442

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Signed informed consent.

   - Positive test for COVID-19 and progressive disease suggestive of ongoing COVID-19
   infection.

   - Symptoms of COVID-19 for ≤ 12 days.

   - Require admission to hospital for acute medical care (not for purely public health or
   quarantine purposes).

Exclusion Criteria:

   - Patients who have received plasma from a person who recovered from COVID-19 or who
   have received neutralizing monoclonal antibodies at any time prior to hospitalization.

   - Patients not willing to abstain from participation in other COVID-19 treatment trials
   until after Day 5 of the study. Co-enrollment in certain trials that compare
   recommended Standard of Care treatments may be allowed, based on the opinion of the
   study leadership team.

   - Any condition which, in the opinion of the responsible investigator, participation
   would not be in the best interest of the participant or that could prevent, limit, or
   confound the protocol-specified assessments.

   - Patients considered unable to participate in study procedures.

   - Women of child-bearing potential who are not already pregnant at study entry and who
   are unwilling to acknowledge strong advice to abstain from sexual intercourse with men
   or practice appropriate contraception through 18 months of the study.

   - Men who are unwilling to acknowledge the strong advice to abstain from sexual
   intercourse with women of child-bearing potential or to use barrier contraception
   through 18 months of the study.

   - Presence at study enrollment of any of the following:

      1. stroke

      2. meningitis

      3. encephalitis

      4. myelitis

      5. myocardial ischemia

      6. myocarditis

      7. pericarditis

      8. symptomatic congestive heart failure

      9. arterial or deep venous thrombosis or pulmonary embolism

   - Current or imminent requirement for any of the following:

      1. invasive mechanical ventilation

      2. ECMO (extracorporeal membrane oxygenation)

      3. Mechanical circulatory support

      4. vasopressor therapy

      5. commencement of renal replacement therapy at this admission (i.e. not patients on
      chronic renal replacement therapy).

   - Study drug VIR-7831: Pregnant and/or nursing women.

   - Study drug BRII-196/BRII-198: Pregnant and/or nursing women.

   - Study drug VIR-7831: Prior to initial assessment (150 participants enrolled to receive
   VIR-7831, 150 participants enrolled to receive placebo), patients on high-flow oxygen
   or non-invasive ventilation. These patients may be eligible for the study if the
   initial assessment is passed.

   - Study drug BRII-196/BRII-198: Prior to initial assessment (150 participants enrolled
   to receive BRII-196/BRII-198, 150 participants enrolled to receive placebo), patients
   on high-flow oxygen or non-invasive ventilation. These patients may be eligible for
   the study if the initial assessment is passed.

Other investigational drug protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting