Autopsy report · NCT02657356

Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST

“Exposure of these high-risk patients to clinic or in-person visits during the pandemic presented an unacceptable risk to their health”

The sponsor’s own words in the registry.

Life of this trial

• Registered 9 months before it started.
• Ran for about 3 years 7 months before it stopped.
• 202 participants enrolled.
• Results were posted on the registry 3 years after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Biogen

Sponsor type

Industry

Conditions

Connective Tissue Disease-Associated Pulmonary Arterial Hypertension

Interventions

Placebo capsules; Bardoxolone methyl capsules

Participants

202

Sites

106

Countries

Argentina, Australia, Belgium, Brazil, Canada, Czechia, Germany, Israel, Japan, Mexico, Netherlands, Philippines and more

Trials that died the same way

• Impact of the Use of Zinc in the Prevention of Oral Mucositis in Pediatric Patients With Lymphoblastic Acute Leukemia.
  “Health restrictions due to the COVID-19 pandemic” (65% match in meaning)
• Nasal Bridge Pressure Injury Prevention
  “Evolution of the COVID19 pandemic with subsequent spread to all areas of clinical care severely affected the number of potential participants that were able to safely participate in the study.” (64% match in meaning)
• Study Evaluating Subjects With Distal Renal Tubular Acidosis
  “COVID-19 pandemic negatively impacted the ability to enroll patients.” (62% match in meaning)
• Clinical Evaluation Program of DeltaScan (ICU)
  “The pandemic caused a rising tide phenomenon on our primary outcomes 1) Delirium detection (increased by visit reduction \& masked staff) and 2) Admission duration (increased by reorganizations \& quarantines 'impact on being discharged)” (61% match in meaning)
• Treating Stimulant Addiction With Repetitive Transcranial Magnetic Stimulation
  “COVID-19 pandemic adversely affected recruitment.” (59% 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.