CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 80 enrolled
Drug / intervention
IMMUNEPOTENT-CRP (I-CRP) +1 morebiological
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/NCT06676709
NCT06676709Phase 2Completed

Effect of IMMUNEPOTENT-CRP, a Bovine Dialyzable Leukocyte Extract, on Serum Pro-Inflammatory Cytokines in Outpatients with Mild to Moderate COVID-19: a Randomized, Double-Blind, Placebo-Controlled Study

Universidad Autonoma de Nuevo Leon·interventional·Posted Nov 6, 2024·Updated Nov 8, 2024

In Brief

A Phase 2 clinical trial evaluating IMMUNEPOTENT-CRP (I-CRP) and Placebo Comparator for COVID-19 and SARS-CoV2 Infection. Completed, enrolled 80 participants across 2 sites.

Detailed Summary

In this study, the effects of IMMUNEPOTENT-CRP (I-CRP), a dialyzable leukocyte extract (DLE) derived from bovine spleen cells, on the levels of key inflammatory cytokines in outpatients with COVID-19 were examined. I-CRP has been previously studied for its ability to regulate the immune system in other conditions, such as cancer and sepsis. Based on its potential to reduce harmful inflammation, the study aimed to determine if similar benefits could be observed in COVID-19 outpatients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMexico

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedNov 6, 2024
Enrollment StartApr 20, 2021
Primary CompletionFeb 3, 2022
Study CompletionMar 5, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 1.7 years ago

Interventions

IMMUNEPOTENT-CRP (I-CRP)biological

IMMUNEPOTENT-CRP (I-CRP), a bovine dialyzable leukocyte extract (DLE) obtained from disrupted spleen cells, is a mixture of low-molecular-weight peptides (\<12 kDa) that exhibit non-specific immunomodulatory properties.

Placebo Comparatorbiological

The placebo was prepared from a lyophilized corn starch extract and was provided in an identical appearance and presentation to IMMUNEPOTENT-CRP (I-CRP).