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Phase COVID-II

I-SPY COVID TRIAL: An Adaptive Platform Trial to Reduce Mortality and Ventilator Requirements for Critically Ill Patients

  • Study HIC#:2000028816
  • Last Updated:07/15/2021

Identify agents that will result in substantial improvements to the clinical condition of participants with COVID-19.

  • Age18 years and older
  • GenderBoth
  • Start Date10/08/2020
  • End Date07/24/2022

Trial Purpose and Description

Identify agents that will result in substantial improvements to the clinical condition of participants with COVID-19.

Eligibility Criteria

Inclusion Criteria:

  • Male or Female, at least 18 years old.
  • Admitted to the hospital and placed on high flow oxygen (greater than 6L by nasal cannula or mask delivery system) or intubated for the treatment of (established or presumed) COVID-19.
  • Informed consent provided by the patient or health care proxy.
  • Confirmation of SARS-CoV-2 infection by PCR prior to randomization.

Exclusion Criteria:

  • Pregnant or breastfeeding women.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent based on review of the medical record and patient history.
  • Comfort measures only.
  • Acute or chronic liver disease with a Child-Pugh score greater than 11.
  • Resident for more than six months at a skilled nursing facility.
  • Estimated mortality greater than 50% over the next six months from underlying chronic conditions.
  • Time since requirement for high flow oxygen or ventilation greater than 72 hours.
  • Anticipated transfer to another hospital which is not a study site within 72 hours.

Sub-Investigator

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