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

November 12, 2021 updated by: Rehab Ragab Hegazy, National Research Centre, Egypt

Clinical Assessment of Oral Lactoferrin as a Safe Antiviral and Immunoregulatory Therapy in Patients Diagnosed With COVID-19 Disease

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The World Health Organization (WHO) declared the coronavirus (SARS-CoV-2, COVID-19) outbreak a Public Health Emergency of International Concern with a pandemic spread. The situation is rapidly evolving, which raises the approach of reproposing already approved drugs to meet the emerging challenge and to save time and money. Lactoferrin (Lf) is a natural glycoprotein that broadly distributed within the body fluids and found predominantly in milk. It represents a known component of the innate immune system. The antiviral activity of Lf has been reported against many viruses, including SARS-CoV-1, through blocking the viral receptors on the host cells preventing them from entry and replication. Markedly, data reveals that Lf interacts with Heparan Sulfate Proteoglycans (HSPGs) and Angiotensin Converting Enzyme 2 (ACE2) receptors that are reported as SARS-CoV-2-binding sites to enter the host cell, suggesting a potential significance of Lf as an antiviral against SARS-CoV-2. Moreover, the immunoregulatory effects of Lf can protect against the cytokine-storm and thrombotic complications that result from the COVID-19-induced over-stimulated inflammatory response and exaggerated immune reactions. In addition, Lf can decrease the free iron toxicity caused by the virus as it has a strong iron chelating ability. Lf is a safe approved food supplement that is available in the markets for enhancement of immunity and for treatment of anemia. The aim of this study is to perform a randomized, double-blind, placebo-controlled, two arms, clinical trial to assess oral enteric-coated tablet of bovine apolactoferrin (the low iron-content form of Lf) as a safe antiviral and immunoregulatory therapy in patients diagnosed with COVID-19 disease.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
516

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 11835
      • Cairo, Egypt
        • Clinical Trial Unit National Research Center
        • Contact:
          • Wafaa Abdel Aal, MD
        • Contact:
          • Osama Azmy, MD
      • Cairo, Egypt
        • Egyptian Military Medical Services (Hospitals)
    • Giza
      • Cairo, Giza, Egypt, 12622
        • National Research Center, Egypt (Clinical and Molecular Pharmacology)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marawan Abdelbaset, PhD
        • Principal Investigator:
          • Bassim Mohamed, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients tested positive (PCR) for SARS-CoV-2 and clinically symptomatic.
  • Adult patients with age >18 years.
  • Patients willing and able to sign the study informed consent form.

Exclusion Criteria:

  • Critically severe disease patients (having Respiratory failure requiring mechanical ventilation, or signs of septic shock or multiple organ failure requiring ICU admission).
  • Patients who are unconscious
  • Patients who have convulsions
  • Patients suffering from central cyanosis with SPO2< 90% (for asthmatic patients with SPO2<88%)
  • Pregnant or lactating women
  • Patients with a known history of pro-inflammatory diseases (patients with autoimmune diseases, patients receiving chemotherapy for cancer, patients with malabsorption, patients with inflammatory bowel disease, Crohn's disease or ulcerative colitis).
  • History or suspected immunosuppressive or immunodeficient state including HIV infection, or chronic immunosuppressant medication (more than 14 days) within the past 3 months (inhaled and topical steroids are allowed).
  • Patients with severe renal impairment (GFR <60 ml/min/1.73m2 as measured by the Cockcroft-Gault formula).
  • Patient with severe hepatic impairment, biliary cirrhosis or cholestasis
  • Patients who received immunoregulatory therapy within one month before the start of the study.
  • Patients with Known or suspected allergy or any contraindications to Lactoferrin.
  • Any condition, according to the judgment of the investigator, would interfere with the patient's ability to comply with all study requirements or that would place the patient at unacceptable risk by his/her participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Arm 01 (SOC + Lactoferrin 1200 mg QID)
Patients randomized to this group will receive two 600 mg Lactoferrin tablets QID plus the Standard of Care (SOC) treatment(s).
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.
Placebo Comparator: Arm 02 (SOC + Placebo QID)
Patients randomized to this group will receive two placebo tablets QID plus the SOC treatment(s).
Drug: Placebo of excipient(s) will be administered
Placebo of the equivalent excipient will be administered to placebo group
Other Names:
  • excipient(s)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Survival rate.
Time Frame: up to 8 weeks.
Comparing the influence of the intervention on the Survival rate.
up to 8 weeks.
Rate of disease remission.
Time Frame: up to 4 weeks.

For mild/moderate symptoms patients: fever, cough and other symptoms relieved with improved lung CT

- For severe symptoms patients: fever, cough and other symptoms relieved with improved lung CT, and oxygen saturation by pulse oximetry (SPO2 )> 93% for nonasthmatic patients, and from 88-92% in asthmatic patients.
up to 4 weeks.
The number of patients with PCR negative results.
Time Frame: up to 4 weeks.
Comparing the influence of the intervention on the PCR negative results.
up to 4 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean change in the disease severity (clinical assessment).
Time Frame: up to 4 weeks.
Recording the changes from severe to moderate or mild and the time taken.
up to 4 weeks.
Mean change in blood pressure.
Time Frame: up to 4 weeks.
Recording the changes in blood pressure mmHg.
up to 4 weeks.
Mean change in heart beats.
Time Frame: up to 4 weeks.
Recording the changes in heart rate in beat/second.
up to 4 weeks.
Mean change in body temperature.
Time Frame: up to 4 weeks.
Recording the changes in body temperature in Celsius.
up to 4 weeks.
Mean change in body respiratory rate.
Time Frame: up to 4 weeks.
Recording the changes in the respiratory rate in breath/minute.
up to 4 weeks.
Mean change in oxygen saturation.
Time Frame: up to 4 weeks.
Recording the changes in arterial oxygen saturation in mmHg.
up to 4 weeks.
Mean change in the ratio in arterial oxygen partial pressure to fractional inspired oxygen (PF ratio).
Time Frame: up to 4 weeks.
Recording the changes in the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PF ratio).
up to 4 weeks.
Mean change in complete blood picture (CBC).
Time Frame: up to 4 weeks.
Recording the changes in complete blood picture (CBC) in cells per liter.
up to 4 weeks.
Mean change in C reactive protein (CRP).
Time Frame: up to 4 weeks.
Recording the changes in C reactive protein (CRP) in mg/L.
up to 4 weeks.
Mean change in erythrocyte sedimentation rate (ESR).
Time Frame: up to 4 weeks.
Recording the changes in erythrocyte sedimentation rate (ESR) in mm/hr.
up to 4 weeks.
Mean change in D-dimer.
Time Frame: up to 4 weeks.
Recording the changes in D-dimer in ng/mL.
up to 4 weeks.
Mean change in ferritin.
Time Frame: up to 4 weeks.
Recording the changes in ferritin in ng/mL.
up to 4 weeks.
Mean change in liver Albumin.
Time Frame: up to 4 weeks.
Recording the changes in liver Albumin in g/L.
up to 4 weeks.
Mean change in total and direct Bilirubin.
Time Frame: up to 4 weeks.
Recording the changes in total and direct Bilirubin in mg/dL.
up to 4 weeks.
Mean change in prothrombin time (PT) and partial thromboplastin time (PTT ).
Time Frame: up to 4 weeks.
Recording the changes in prothrombin time (PT), partial thromboplastin time (PTT ) in seconds and calculating International Normalized Ratio (INR).
up to 4 weeks.
Mean change in aspartate aminotransferase (AST).
Time Frame: up to 4 weeks.
Recording the changes in aspartate aminotransferase (AST) in IU/L.
up to 4 weeks.
Mean change in Alanine Aminotransferase (ALT).
Time Frame: up to 4 weeks.
Recording the changes in Alanine Aminotransferase (ALT) in IU/L.
up to 4 weeks.
Mean change in Blood Urea Nitrogen (BUN).
Time Frame: up to 4 weeks.
Recording the changes in Blood Urea Nitrogen (BUN) in mg/dL.
up to 4 weeks.
Mean change in Serum Creatinine.
Time Frame: up to 4 weeks.
Recording the changes in Serum Creatinine in mg/dL.
up to 4 weeks.
Mean change in Serum Creatinine clearance.
Time Frame: up to 4 weeks.
Recording the changes in Serum Creatinine in ml/min.
up to 4 weeks.
Mean change in Glomerular filtration rate (GFR ).
Time Frame: up to 4 weeks.
Recording the changes in Glomerular filtration rate (GFR ) ml/min/m2.
up to 4 weeks.
The mean change in serum interleukin-1 (IL-1).
Time Frame: up to 4 weeks.
Recording the changes in interleukin-1 (IL-1) in pg/ml.
up to 4 weeks.
The mean change in serum interleukin-6 (IL-6).
Time Frame: up to 4 weeks.
Recording the changes in interleukin-6 (IL-6) in pg/ml.
up to 4 weeks.
The mean change in serum interleukin-10 (IL-10).
Time Frame: up to 4 weeks.
Recording the changes in interleukin-10 (IL-10) in pg/ml.
up to 4 weeks.
The mean change in serum tumor necrosis factor-alpha (TNF alpha).
Time Frame: up to 4 weeks.
Recording the changes in tumor necrosis factor-alpha (TNF alpha) in ng/ml.
up to 4 weeks.
Mean changes in immunoglobulin G (IgG).
Time Frame: up to 4 weeks.
Recording the changes in immunoglobulin G (IgG) in ng/ml.
up to 4 weeks.
Mean changes in immunoglobulin M (IgM).
Time Frame: up to 4 weeks.
Recording the changes in immunoglobulin M (IgM) in ng/ml.
up to 4 weeks.
The mean change in PCR viral load.
Time Frame: up to 4 weeks.
Recording the changes in PCR viral load in copies/mL.
up to 4 weeks.
Mean change in lung CT manifestation.
Time Frame: up to 4 weeks.
Recording the changes in lung CT.
up to 4 weeks.
Nature and severity of Adverse Events.
Time Frame: up to 4 weeks.
Recording any unexpected Adverse Events of the intervention.
up to 4 weeks.
Time for lung recovery.
Time Frame: up to 8 weeks.
Recording the changes (the average time of lung imaging recovery), as assessed by lung CT.
up to 8 weeks.
The number of missed drug doses among each treatment group.
Time Frame: up to 4 weeks.
Recording the changes the event of missed drug doses.
up to 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Research Centre, Egypt

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Egyptian Military Medical Services

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Rehab Hegazy, PhD, National Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COVID-19_LF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Not yet decided.

IPD Sharing Time Frame

within 6 month

IPD Sharing Access Criteria

all valid data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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