Trial intelligence / Profile preview

IMMUNEPOTENT-CRP in Outpatients with Mild to Moderate COVID-19

NCT06676709Phase 2

Key facts

Status
Completed
Start
Apr 2021
Primary completion
Feb 2022
Countries
1
Sponsor
Universidad Autónoma de Nuevo León
Modality
Peptides, Recombinant Proteins and Enzymes
Conditions
coronavirus disease 2019 (COVID-19)
01

Overview

Phase 2, randomised, double-blind trial in coronavirus disease 2019 (COVID-19) comparing I-CRP group with Placebo control (2 arms). Primary endpoint: Cytokine and Chemokine Serum Levels Evaluation at Day 14. Started Apr 2021; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • I-CRP group

    IMMUNEPOTENT-CRP (I-CRP) 5 U/vial.

  • Placebo control

    Placebo (corn starch extract).

03

Who it enrols

Adult outpatients with mild to moderate COVID-19 and confirmed SARS-CoV-2 infection. Excludes patients with immunosuppression, autoimmune disease, history of malignancy, or those receiving chemotherapy.

04

Endpoints

Primary

  • Cytokine and Chemokine Serum Levels Evaluation

Secondary

  • Lactate Dehydrogenase Levels

  • High-Sensitivity C-Reactive Protein Levels

  • Ferritin Levels

  • D-Dimer Levels

  • Lymphocyte Subpopulations

  • SARS-CoV-2 Infection Status Evaluation

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