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Corona Virus InfectionPhase 2COVID-19_LFNCT04412395

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

A Phase 2 study testing Lactoferrin (Apolactoferrin) in people with Corona Virus Infection and Middle East Respiratory Syndrome (MERS), run by National Research Centre, Egypt at 4 sites in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Lactoferrin (Apolactoferrin)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
516 participants
Where
4 sitesEgypt
Study dates
1 Feb 2022to 30 Dec 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 12Show fewer
  • 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.

Trial locations and contacts

4 sites in 1 country.

Rehab Hegazy, PhD contact

+201001507676

rehab_hegazy@hotmail.com

Osama Azmy, MD contact

+201223103084

osamaazmy@yahoo.com

Egypt4 sites

  • National Research Center, Egypt (Clinical and Molecular Pharmacology)

    Cairo, Giza Governorate, 12622

    Marawan Abdelbaset, PhD, +0201002227202, dr.marawan@gmail.com

    Bassim Mohamed, PhD, Bassim.mohamed@umontreal.ca

  • Clinmax CRO (Clinical Research Organization)

    Cairo, 11835

    Khaled Prince, B Pharm, +20106725802, Khaled.prince@clinmax.net

    Christine Gindy, B Pharm, christine.gindy@clinmax.net

  • Clinical Trial Unit National Research Center

    Cairo

    Wafaa Abdel Aal, MD

    Osama Azmy, MD

  • Egyptian Military Medical Services (Hospitals)

    Cairo

Other trials in Egypt

About this study

Official title: 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.

Read the 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.

Being tested
Lactoferrin (Apolactoferrin), Placebo of excipient(s) will be administered
Keywords
Lactoferrin, Apolactoferrin, Immuno-modulatory, Cytokine-storm, Antiviral, 2019nCoV, 2019 new coronavirus (2019nCoV), Middle East Respiratory Syndrome (MERS), Acute Respiratory Distress Syndrome (ARDS), COVID-19, SARS-CoV 2
Medical subject headings
Coronavirus Infections, Respiratory Distress Syndrome, COVID-19, Cytokine Release Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lactoferrin (Apolactoferrin)Dietary supplement

    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 of excipient(s) will be administeredDrug

    Also called excipient(s)

    Placebo of the equivalent excipient will be administered to placebo group

Study groups in NCT04412395
Study groupRoleWhat they receive
Arm 01 (SOC + Lactoferrin 1200 mg QID)Active comparatorPatients randomized to this group will receive two 600 mg Lactoferrin tablets QID plus the Standard of Care (SOC) treatment(s).
Receives: Dietary Supplement: Lactoferrin (Apolactoferrin)
Arm 02 (SOC + Placebo QID)Placebo comparatorPatients randomized to this group will receive two placebo tablets QID plus the SOC treatment(s).
Receives: Drug: Placebo of excipient(s) will be administered

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival rate.

    Comparing the influence of the intervention on the Survival rate.

    Measured: up to 8 weeks.

  2. Rate of disease remission.

    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.

    Measured: up to 4 weeks.

  3. The number of patients with PCR negative results.

    Comparing the influence of the intervention on the PCR negative results.

    Measured: up to 4 weeks.

Secondary outcomes (32)

  1. Mean change in the disease severity (clinical assessment).

    Recording the changes from severe to moderate or mild and the time taken.

    Measured: up to 4 weeks.

  2. Mean change in blood pressure.

    Recording the changes in blood pressure mmHg.

    Measured: up to 4 weeks.

  3. Mean change in heart beats.

    Recording the changes in heart rate in beat/second.

    Measured: up to 4 weeks.

  4. Mean change in body temperature.

    Recording the changes in body temperature in Celsius.

    Measured: up to 4 weeks.

  5. Mean change in body respiratory rate.

    Recording the changes in the respiratory rate in breath/minute.

    Measured: up to 4 weeks.

  6. Mean change in oxygen saturation.

    Recording the changes in arterial oxygen saturation in mmHg.

    Measured: up to 4 weeks.

  7. Mean change in the ratio in arterial oxygen partial pressure to fractional inspired oxygen (PF ratio).

    Recording the changes in the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PF ratio).

    Measured: up to 4 weeks.

  8. Mean change in complete blood picture (CBC).

    Recording the changes in complete blood picture (CBC) in cells per liter.

    Measured: up to 4 weeks.

  9. Mean change in C reactive protein (CRP).

    Recording the changes in C reactive protein (CRP) in mg/L.

    Measured: up to 4 weeks.

  10. Mean change in erythrocyte sedimentation rate (ESR).

    Recording the changes in erythrocyte sedimentation rate (ESR) in mm/hr.

    Measured: up to 4 weeks.

  11. Mean change in D-dimer.

    Recording the changes in D-dimer in ng/mL.

    Measured: up to 4 weeks.

  12. Mean change in ferritin.

    Recording the changes in ferritin in ng/mL.

    Measured: up to 4 weeks.

  13. Mean change in liver Albumin.

    Recording the changes in liver Albumin in g/L.

    Measured: up to 4 weeks.

  14. Mean change in total and direct Bilirubin.

    Recording the changes in total and direct Bilirubin in mg/dL.

    Measured: up to 4 weeks.

  15. Mean change in prothrombin time (PT) and partial thromboplastin time (PTT ).

    Recording the changes in prothrombin time (PT), partial thromboplastin time (PTT ) in seconds and calculating International Normalized Ratio (INR).

    Measured: up to 4 weeks.

  16. Mean change in aspartate aminotransferase (AST).

    Recording the changes in aspartate aminotransferase (AST) in IU/L.

    Measured: up to 4 weeks.

  17. Mean change in Alanine Aminotransferase (ALT).

    Recording the changes in Alanine Aminotransferase (ALT) in IU/L.

    Measured: up to 4 weeks.

  18. Mean change in Blood Urea Nitrogen (BUN).

    Recording the changes in Blood Urea Nitrogen (BUN) in mg/dL.

    Measured: up to 4 weeks.

  19. Mean change in Serum Creatinine.

    Recording the changes in Serum Creatinine in mg/dL.

    Measured: up to 4 weeks.

  20. Mean change in Serum Creatinine clearance.

    Recording the changes in Serum Creatinine in ml/min.

    Measured: up to 4 weeks.

  21. Mean change in Glomerular filtration rate (GFR ).

    Recording the changes in Glomerular filtration rate (GFR ) ml/min/m2.

    Measured: up to 4 weeks.

  22. The mean change in serum interleukin-1 (IL-1).

    Recording the changes in interleukin-1 (IL-1) in pg/ml.

    Measured: up to 4 weeks.

  23. The mean change in serum interleukin-6 (IL-6).

    Recording the changes in interleukin-6 (IL-6) in pg/ml.

    Measured: up to 4 weeks.

  24. The mean change in serum interleukin-10 (IL-10).

    Recording the changes in interleukin-10 (IL-10) in pg/ml.

    Measured: up to 4 weeks.

  25. The mean change in serum tumor necrosis factor-alpha (TNF alpha).

    Recording the changes in tumor necrosis factor-alpha (TNF alpha) in ng/ml.

    Measured: up to 4 weeks.

  26. Mean changes in immunoglobulin G (IgG).

    Recording the changes in immunoglobulin G (IgG) in ng/ml.

    Measured: up to 4 weeks.

  27. Mean changes in immunoglobulin M (IgM).

    Recording the changes in immunoglobulin M (IgM) in ng/ml.

    Measured: up to 4 weeks.

  28. The mean change in PCR viral load.

    Recording the changes in PCR viral load in copies/mL.

    Measured: up to 4 weeks.

  29. Mean change in lung CT manifestation.

    Recording the changes in lung CT.

    Measured: up to 4 weeks.

  30. Nature and severity of Adverse Events.

    Recording any unexpected Adverse Events of the intervention.

    Measured: up to 4 weeks.

  31. Time for lung recovery.

    Recording the changes (the average time of lung imaging recovery), as assessed by lung CT.

    Measured: up to 8 weeks.

  32. The number of missed drug doses among each treatment group.

    Recording the changes the event of missed drug doses.

    Measured: up to 4 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2020
  2. Study start1 Feb 2022 (estimated)
  3. Primary completion1 Aug 2022 (estimated)
  4. Study completion30 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, double-blind, placebo-controlled, clinical trial.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
516 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04412395
Sponsor's protocol ID
COVID-19_LF
Acronym
COVID-19_LF
Status last verified
Nov 2021
First submitted
15 May 2020
Last updated
15 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Not yet decided.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lactoferrin (Apolactoferrin) in people with Corona Virus Infection and Middle East Respiratory Syndrome (MERS), run by National Research Centre, Egypt at 4 sites in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rehab Hegazy, PhD (+201001507676, rehab_hegazy@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival rate. (time frame: up to 8 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04412395.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.

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