Autopsy report · NCT04343248

Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post-Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses in Elderly Residents of Long-Term Care Facilities (LTCF)

“Study recruitment was halted prematurely as widespread vaccination of the study population made completion infeasible.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 month before it started.
• Ran for about 9 months before it stopped.
• 190 participants enrolled.
• Results were posted on the registry 3 years 5 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Romark Laboratories L.C.

Sponsor type

Industry

Conditions

COVID-19; Viral Respiratory Illnesses

Interventions

Nitazoxanide; Placebo; Vitamin Super B-Complex

Participants

190

Sites

4

Countries

United States

Trials that died the same way

• High Cut Off Dialysis in Systemic Inflammatory Response Syndrome Patients After Cardiac Surgery
  “Study halted prematurely, prior to enrollment of first patient, due to recruiting problems.” (77% match in meaning)
• Platelet Reactivity With Fentanyl, Morphine, or no Narcotic
  “The study was halted prematurely due to difficulties in recruiting a sufficient number of participants. Despite efforts to enroll eligible individuals, the recruitment goals were not met, making it infeasible to continue the study as planned.” (76% match in meaning)
• BELIEVE Study: Nesiritide and Post Myocardial Infarction Left Ventricular Modeling
  “recruitment of subjects was halted prematurely. recruiting subjects halted prematurely” (76% match in meaning)
• The Effect of Buprenorphine Continuation for Patients With Opioid Use Disorder
  “This study was halted prior to accumulating the full number of participants due to difficulty in recruiting study subjects.” (76% match in meaning)
• Omission of Surgery in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti-HER2-based Neoadjuvant Therapy
  “The study was prematurely halted primarily due to low patient accrual. Despite efforts to optimize recruitment, the enrollment rate remained insufficient to meet the predefined targets, and continuation was deemed unfeasible” (75% 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.