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Clinical Assessment of Oral Lactoferrin as a Safe Antiviral and Immunoregulatory in Treating COVID-19 Disease

NCT04412395 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 516

Last updated 2021-11-15

No results posted yet for this study

Summary

The aim of the study is to clinically use bovine Lf as a safe antiviral adjuvant for treatment and to assess the potential in reducing mortality and morbidity rates in COVID-19 patients. The study was approved by the ethical committee of the Egyptian Center for Research and Regenerative Medicine in 11-5-2020.

Conditions

  • Corona Virus Infection
  • Middle East Respiratory Syndrome (MERS)
  • Acute Respiratory Distress Syndrome
  • Coronavirus Infection
  • COVID-19
  • SARS-CoV 2

Interventions

DIETARY_SUPPLEMENT

Lactoferrin (Apolactoferrin)

Apolactoferrin is an iron-free Lactoferrin (with very low iron saturation). Lactoferrin (Lf) is a natural glycoprotein that is found predominantly in milk. Lf represents a known component of the innate immune system present in neutrophil-specific granules and broadly distributed within the body fluids and exocrine secretions.

DRUG

Placebo of excipient(s) will be administered

Placebo of the equivalent excipient will be administered to placebo group

Sponsors & Collaborators

  • Egyptian Military Medical Services

    collaborator OTHER_GOV

  • National Research Centre, Egypt

    lead OTHER

Principal Investigators

  • Rehab Hegazy, PhD · National Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2022-08-01
Completion
2022-12-30

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04412395 on ClinicalTrials.gov