Autopsy report · NCT04324021

Efficacy and Safety of Emapalumab and Anakinra in Reducing Hyperinflammation and Respiratory Distress in Patients With COVID-19 Infection.

“Standard of care evolved during the timeframe of the study and had critical impact on recruitment. Early termination was not based on safety reasons but due to the reasons mentoined above. The ongoing patients were completed.”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 7 months before it stopped.
• 16 participants enrolled.
• Results were posted on the registry 1 year 4 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2, Phase 3

Sponsor

Swedish Orphan Biovitrum

Sponsor type

Industry

Conditions

SARS-CoV-2

Interventions

Emapalumab; Anakinra

Participants

16

Sites

12

Countries

Italy, United States

Trials that died the same way

• Ixazomib -Daratumumab Without Dexamethasone (IDara) in Elderly Relapse Refractory Multiple Myeloma
  “Early termination (regarding the follow-up of the patients). The required sample size was reached, and the primary endpoint was met.” (67% match in meaning)
• Stop Exogenous Allergic Alveolitis (EAA) in Childhood
  “After several years of recruitment only 4 patients were included. Study timelines for study completition too long. Decided to terminate trial.” (64% match in meaning)
• Phase 1b/2 Study of U3-1287 in Combination With Trastuzumab Plus Paclitaxel in Newly Diagnosed Metastatic Breast Cancer (MBC)
  “Improved, different standard of care caused business decision to terminate” (64% match in meaning)
• A Dose Escalation Study of L-DOS47 in Recurrent or Metastatic Non-Squamous NSCLC
  “Slow enrolment - standard of care evolved over the duration of the study such that treatment regimen employed in the study was no longer current standard of care for first line resulting in recruitment challenges.” (63% match in meaning)
• Aspirin as a Novel Anti-Inflammatory Modality in the Fontan Patients
  “This study was terminated due to inability to recruit sufficient patients.” (62% 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.