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Phosphodiesterase 4 Inhibitor

Various Treatments for Critically Ill COVID-19 Patients (I-SPY_COVID Trial)

Phase 2

Recruiting

Led By Laura Esserman, MD

Research Sponsored by QuantumLeap Healthcare Collaborative

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 days

Awards & highlights

Approved for 20 Other Conditions

No Placebo-Only Group

Summary

This trial is looking for treatments that could help COVID-19 patients who are critically ill and need mechanical ventilation.

Who is the study for?

Adults hospitalized with severe COVID-19 needing high oxygen or on ventilators can join. They must have confirmed SARS-CoV-2 infection and give consent. Excluded are those with serious liver disease, long-term nursing home residents, pregnant/breastfeeding women, late-stage kidney disease patients on dialysis, certain heart conditions, or expected to transfer out within 72 hours.

What is being tested?

The trial is testing multiple drugs like Remdesivir and Dexamethasone in critically ill COVID-19 patients using an adaptive platform design to quickly find treatments that reduce death rates and the need for mechanical ventilation.

What are the potential side effects?

Potential side effects from the drugs may include liver issues, weakened immune response leading to infections, allergic reactions similar to past allergies noted in medical records, heart complications especially if there's a history of heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Health care utilization

Improvement in disease severity

Mortality

+1 more

Awards & Highlights

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

13Treatment groups

Experimental Treatment

Active Control

Group I: Narsoplimab + Standard of Care (CLOSED)Experimental Treatment3 Interventions

Subjects administered standard of care + 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.

Group II: Imatinib + Standard of Care (CLOSED)Experimental Treatment3 Interventions

Subjects will be administered standard of care + 800 mg imatinib 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.

Group III: Imatinib (PENDING ACTIVATION)Experimental Treatment1 Intervention

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.

Group IV: Icatibant + Standard of Care (CLOSED)Experimental Treatment3 Interventions

Subjects administered standard of care + icatibant subcutaneously, 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.

Group V: IC14 + Standard of Care (CLOSED)Experimental Treatment3 Interventions

Subjects administered standard of care + IC14 intravenously , 4 mg/kg on day 1, followed by 2 mg/kg on days 2, 3, 4

Group VI: Dornase + Standard of Care (CLOSED)Experimental Treatment3 Interventions

For Non-intubated subjects: Subjects administered standard of care + dornase, 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: Subjects administered standard of care + dornase, 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.

Group VII: Cyproheptadine + Standard of Care (CLOSED)Experimental Treatment3 Interventions

Subjects administered standard of care + cyproheptadine via 4 mg tablet, with dosing regimen of 8 mg every 8 hours daily for ten (10) days.

Group VIII: Cyclosporine + Standard of Care (CLOSED)Experimental Treatment3 Interventions

Subjects administered standard of care + modified cyclosporine at an oral dose of 5mg/kg per day administered in two divided doses daily for 5-days.

Group IX: Cenicriviroc + Standard of Care (CLOSED)Experimental Treatment3 Interventions

Subjects administered standard of care + cenicriviroc orally , 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.

Group X: Celecoxib/famotidine + Standard of Care (CLOSED)Experimental Treatment4 Interventions

Subjects administered standard of care + celecoxib/famotidine orally . Celecoxib, oral: 400 mg BID for 7 days. Famotidine, oral: High dose 80 mg QID for 7 days followed by 40 mg BID for a course of 14 days.

Group XI: Aviptadil + Standard of Care (CLOSED)Experimental Treatment3 Interventions

Subjects administered standard of care + aviptadil (inhalation via nebulizer), 100 µg three times (TID) daily for a maximum of 14 days

Group XII: Apremilast + Standard of Care (CLOSED)Experimental Treatment3 Interventions

Subjects administered standard of care + apremilast orally , 30 mg bid × 14 days.

Group XIII: Control/Backbone - Remdesivir and Dexamethasone (CLOSED)Active Control2 Interventions

Participants randomized to the backbone control will be given standard of care (supportive care for ARDS, including remdesivir and, if needed, lung protective ventilation). Because dexamethasone was shown to have benefit in at least one large randomized clinical trial, patients in the backbone control arm should receive dexamethasone for a total of 10 days during the hospitalization or until or hospital discharge. Remdesivir (intravenous): 200-mg loading dose on day 1, followed by a daily maintenance dose of 100-mg on days 2 through 10. Dexamethasone (intravenous): 6 mg intravenous or oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyproheptadine

2011

Completed Phase 4

~330

Cenicriviroc

2013

Completed Phase 2

~400