Latest1 information on COVID-19

I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients

Recruiting

Trial ID: NCT04488081

Age - 18 Years-N/A Gender - All Accepting Healthy Volunteers - No

Purpose

The goal of this project is to rapidly screen promising agents, in the setting of an adaptive platform trial, for treatment of critically ill COVID-19 patients. In this phase 2 platform design, agents will be identified with a signal suggesting a big impact on reducing mortality and the need for, as well as duration, of mechanical ventilation.

Official Title

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

Stanford Investigator(s)

Joseph Levitt, MD, MS
Joseph Levitt, MD, MS

Associate Professor of Medicine (Pulmonary and Critical Care Medicine)

Eligibility


Inclusion Criteria:

A. Male or Female, at least 18 years old.

B. 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.

C. Informed consent provided by the patient or health care proxy.

D. Confirmation of SARS-CoV-2 infection by PCR or Rapid antigen testing for SARS-CoV-2
infection prior to randomization.

Exclusion Criteria:

A. Pregnant or breastfeeding women.

B. 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.

C. Comfort measures only.

D. Acute or chronic liver disease with a Child-Pugh score greater than 11.

E. Resident for more than six months at a skilled nursing facility.

F. Estimated mortality greater than 50% over the next six months from underlying chronic
conditions.

G. Time since requirement for high flow oxygen or ventilation greater than 120 hours (5
days).

H. Anticipated transfer to another hospital which is not a study site within 72 hours.

I. Patients with either end-stage kidney disease or acute kidney injury who are on
dialysis.

J. Co-enrollment in clinical trials of pharmacologic agents requiring an IND.

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Intervention(s):

drug: Remdesivir

drug: Pulmozyme

drug: IC14

drug: Celecoxib Famotidine

drug: Narsoplimab

drug: Aviptadil Acetate

drug: Cyclosporine

Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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