DUR-928 in Subjects With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-21

Study Completion Date

2021-03-04

Brief Summary

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Evaluate safety and efficacy of DUR-928 in treatment of acute organ failure in subjects infected with SARS-CoV-2

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Detailed Description

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Conditions

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SARS-CoV-2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3:1 randomization DUR-928:placebo

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DUR-928

Group Type EXPERIMENTAL

DUR-928

Intervention Type DRUG

IV infusion

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

IV infusion

Interventions

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DUR-928

IV infusion

Intervention Type DRUG

Placebo

IV infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Hospitalized with moderate, severe, or early critical COVID-19 illness diagnosed by RT- PCR
* Acute liver injury (including acute on chronic liver disease) or acute kidney injury or moderate COVID-19 pneumonia

Exclusion Criteria

* Critical COVID-19 illness (MAP \< 60 mm Hg, on mechanical ventilator for ≥ 5 days)
* On maintenance hemodialysis or peritoneal dialysis
* Child Pugh C cirrhosis
* Hepatorenal syndrome
* Ascites and/or hepatic encephalopathy
* History of end stage renal disease or CKD with eGFR \< 15 mL/min/1.73m2
* Women who are pregnant or breast feeding
* Receipt of other concomitant experimental therapies

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No