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

Summary

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.

Conditions

• COVID-19

Interventions

DRUG

Remdesivir

Participants who receive remdesivir as part of their standard of care will be administered remdesivir by IV for up to ten days. Remdesivir 200mg loading dose on day 1, followed by 100mg IV once daily maintenance doses for 4 or 9 days.

DRUG

Imatinib Mesylate

Subjects will be administered 800 mg on Day 1 orally, in divided doses of 400 mg administered twice per day. 400 mg daily will be administered orally for the following 9 days or until discharge, whichever is sooner.

DRUG

Dexamethasone

6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.

DRUG

Cenicriviroc

Oral, loading 300 mg qAM followed by 150 mg qPM, 12 hours apart on day 1, then 150 mg BID for total of 14 to 28 days depending on date of hospital discharge.

DRUG

Icatibant

Subcutaneous, a safety run-in for the first 10 subjects was conducted using a regimen of 30 mg q8h × 3 days. All subsequent subjects received drug at 30 mg q8h x 6 days.

DRUG

Apremilast

oral, 30 mg bid × 14 days.

BIOLOGICAL

dornase alfa

For Non-intubated subjects: 2.5 mg BID until hospital discharge, improvement to room air (or baseline oxygen use prior to illness) for 24 hours, or total of 14 days of study drug, whichever comes first. For intubated subjects: 5.0 mg BID in 10 mL normal saline until extubation or 14 days, whichever comes first. If intubated for less than 14 days, extubated subjects received 2.5 mg BID for a total Dornase treatment of 14 days, or until hospital discharge, whichever comes first.

DRUG

Celecoxib

Oral: 400 mg BID for 7 days.

DRUG

Famotidine

Oral: High dose 80 mg QID for 7 days followed by 40 mg BID for a course of 14 days.

BIOLOGICAL

IC14

intravenous, 4 mg/kg on day 1, followed by 2 mg/kg on days 2, 3, 4

DRUG

Aviptadil

Inhalation via nebulizer, 100 µg three times (TID) daily for a maximum of 14 days

BIOLOGICAL

narsoplimab

Dosed at 4 mg/kg, given as a 30-minute intravenous infusion (up to a maximum of 370 mg per infusion) twice weekly for a total of four weeks (i.e. 9 doses) or until hospital discharge whichever comes first.

DRUG

Cyproheptadine

4 mg tablet, with dosing regimen of 8 mg every 8 hours daily for ten (10) days. If the patient weighs less than 48 kg, the regimen is 6 mg every 8 hours daily for ten (10) days. If the participant was discharged before completion of this dosing regimen the drug was not continued.

DRUG

Cyclosporine

Modified CsA at an oral dose of 5mg/kg per day administered in two divided doses daily for 5-days.

Sponsors & Collaborators

• University of California, San Francisco

  collaborator OTHER

• Emory University

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• University of Southern California

  collaborator OTHER

• Yale University

  collaborator OTHER

• Wake Forest University Health Sciences

  collaborator OTHER

• Long Beach Memorial Medical Center

  collaborator OTHER

• Georgetown University

  collaborator OTHER

• University of California, Davis

  collaborator OTHER

• Main Line Health

  collaborator OTHER

• DHR Health Institute for Research and Development

  collaborator OTHER

• University of California, Irvine

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• West Virginia University

  collaborator OTHER

• University of Miami

  collaborator OTHER

• University Hospitals Cleveland Medical Center

  collaborator OTHER

• M.D. Anderson Cancer Center

  collaborator OTHER

• QuantumLeap Healthcare Collaborative

  lead OTHER

Principal Investigators

• Derek W Russell, MD · University of Alabama at Birmingham Heersink School of Medicine

• Kathleen D Liu, MD · University of California, San Francisco

• Laura Esserman, MD · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-31

Primary Completion

2028-07-31

Completion

2030-07-31

FDA Drug

Yes

Countries

• United States

Study Locations