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Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite

NCT04401527 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-09-16

No results posted yet for this study

Summary

This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of intravenous Sodium Nitrite Injection for treatment of patients infected with COVID-19 who develop lung injury and require mechanical ventilation.

Conditions

  • COVID-19
  • Acute Respiratory Distress Syndrome
  • Acute Respiratory Failure

Interventions

DRUG

Sodium Nitrite

Continuous intravenous infusion of Sodium Nitrite Injection

DRUG

Normal Saline

Continuous intravenous infusion of Normal Saline

Sponsors & Collaborators

  • Hope Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Hope Pharmaceuticals Medical Director · Hope Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-22
Primary Completion
2020-08-15
Completion
2020-08-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04401527 on ClinicalTrials.gov