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 accepting patients for this trial.

Lead Sponsor:

University of Minnesota

Collaborator: International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)

Intervention(s):

  • Biological: LY3819253
  • Drug: Placebo
  • Biological: Remdesivir
  • Biological: VIR-7831
  • Biological: BRII-196/BRII-198
  • Biological: AZD7442
  • Drug: MP0420
  • Drug: PF-07304814

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.

   - Women of child-bearing potential who are unwilling to acknowledge the strong advice to
   abstain from sexual intercourse with men or practice appropriate contraception through
   5 weeks of the study (PF-07304814 investigational agent).

   - Pregnant women (PF-07304814 investigational agents).

   - Nursing mothers (PF-07304814 investigational agents).

   - 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.

   - 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 5 weeks of the study (PF-07304814 investigational agent).

   - 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).

   - Participants with moderate to severe hepatic impairment (i.e. Child-Pugh class B or C)
   or acute liver failure (PF-07304814 investigational agent).

   - Participants receiving any medications or substances that are strong inhibitors or
   inducers of cytochrome P450 (CYP) 3A4 (PF-07304814 investigational agent).

   - Patients will be excluded if taking drugs which have a narrow therapeutic window that
   are substrates of CYP3A4, including but not limited to: astemizole, cisapride,
   cyclosporine, dihydroergotamine, ergotamine, pimozide, quinidine, sirolimus,
   tacrolimus, and terfenadine (PF-07304814 investigational agent).

   - Patients with a history of deep vein thrombosis or pulmonary thrombotic embolism
   (Prior to initial futility assessment of PF-07304814 investigational agent).

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
SPECTRUM
6507245282
Recruiting