Clinical trial NCT04393311: Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients
Official title: A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Safety and Efficacy of Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: COVID-19
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the safety and efficacy of intravenous (IV) infusion of ulinastatin compared to placebo with respect to time to recovery, disease severity, need for ventilator support, and mortality in patients with COVID 19.


Eligibility criteria: Inclusion Criteria:

* Willing and able to provide written informed consent
* Signs and symptoms suggestive of COVID-19 infection
* Laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection ≤7 days before randomization
* Currently hospitalized or in an emergency department with planned hospitalization
* Peripheral capillary oxygen saturation (SpO2) \<93% on room air at Screening

Exclusion Criteria:

* Simultaneous participation in any other clinical study incompatible with this one
* Treatment with an antibody immunotherapy within 4 weeks of Screening
* Requirement for mechanical ventilation or ECMO at Screening
* Hypotension at Screening
* Severe liver injury defined as AST or ALT ≥5x the upper limit of normal
* Severe kidney failure defined as an estimated glomerular filtration rate (eGFR) \<30 mL/min
* Pregnancy or breastfeeding
* \> 120 hours between admission and signing consent

Primary outcomes:
measure: Time to recovery
timeFrame: Up to 29 days
Secondary outcomes:
measure: COVID-19 disease severity scale score on Day 8
timeFrame: Day 8
measure: COVID-19 disease severity scale score on Day 15
timeFrame: Day 15
measure: COVID-19 disease severity scale score on Day 22
timeFrame: Day 22
measure: COVID-19 disease severity scale score on Day 29
timeFrame: Day 29
measure: Incidence of mortality at Day 29
timeFrame: 29 days
measure: Incidence of in-hospital mortality
timeFrame: Up to 29 days
measure: Number of days alive and not on mechanical ventilator or ECMO in the 28 days following first dose
timeFrame: Up to 29 days
measure: Number of patients with resolution of symptoms defined as score of 8 on the 8-point ordinal scale at Day 29
timeFrame: Day 29
measure: Number of patients alive and free of respiratory failure defined as score of 4, 5, 6, 7, or 8 on the 8-point ordinal scale at Day 29
timeFrame: Day 29
measure: Duration of mechanical ventilation
timeFrame: Up to 29 days
measure: Duration of ECMO
timeFrame: Up to 29 days
measure: Duration of noninvasive ventilation
timeFrame: Up to 29 days
measure: Duration of ICU stay
timeFrame: Up to 29 days
measure: Duration of hospital stay
timeFrame: Up to 29 days
measure: Change in oxygen saturation
timeFrame: Between screening and 24 hours after last dose (up to 6 days)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Kevin V Grimes, MD
role: PRINCIPAL_INVESTIGATOR
References: