Autopsy report · NCT04398290

iNOPulse for COVID-19

“IRB AND FDA REVIEWS DEFERRED”

The sponsor’s own words in the registry.

Life of this trial

• Withdrawn before it enrolled anyone. Its dates are the sponsor's plans, not events that happened.

Vital statistics

Status

Withdrawn

Phase

Phase 2

Sponsor

Roger Alvarez

Sponsor type

University, hospital or other

Conditions

COVID-19; Hypoxemia; Hypoxemic Respiratory Failure

Interventions

Inhaled nitric oxide (iNO); Nitrogen gas; Oxygen gas

Participants

0

Sites

1

Countries

United States

Trials that died the same way

• Open-label, Single-arm, Proof of Concept Study in Subjects with Mild-to-moderate Facial Hyperpigmentation
  “This study had been withdrawn by the sponsor as they are in process to approach FDA with rationale to get agency feedback and share written response on IRB query. Thereafter, they may again approach with new application and FDA written response.” (73% match in meaning)
• Comparing Fetoscopic Surgery Protocols
  “Deferred by IRB.” (68% match in meaning)
• Coronary Artery Study in Pediatric Heart Transplantation
  “never approved by IRB” (68% match in meaning)
• Web System for Engaging Families & Doctors in Continuous Asthma Quality Improvement
  “After IRB review, this study is no longer considered a clinical trial” (67% match in meaning)
• Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Kidney Transplant
  “did not move forward with IRB approval, competing study” (67% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.