CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 100 enrolled
Drug / intervention
Salovum +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03339505
NCT03339505Phase 3Completed
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Salovum (Antisecretory Factor) in Patients With Severe Traumatic Brain Injury

Peter Siesjö·interventional·Posted Nov 13, 2017·Updated Oct 12, 2022

In Brief

A Phase 3 clinical trial evaluating Salovum and Placebo for Brain Trauma. Completed, enrolled 100 participants across 1 site.

Detailed Summary

The present trial intends to assess whether Salovum®, an egg powder enriched for antisecretory factor given to patients with severe traumatic brain injury will improve outcome compared to a control group given placebo egg powder. 100 patients with GCS\<9 will be enrolled and randomised to active or placebo treatment during maximum 5 days. Salovum® or placebo will be administered orally by nasogastric feeding tubes. Primary endpoint will be overall 30 data mortality. Secondary endpoints will be intracranial pressure and treatment intensity level.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Trauma
CountriesSouth Africa
CollaboratorsUniversity of Stellenbosch

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedNov 13, 2017
Enrollment StartSep 17, 2017
Primary CompletionOct 10, 2022
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 8.6 years ago

Interventions

Salovumdietary

Dietary supplement with high concentration of anti-secretory factor

Placebodietary

Placebo for Salovum