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Utility of Lactoferrin as an Adjunct Therapeutic Agent for COVID-19

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ClinicalTrials.gov Identifier: NCT04421534
Recruitment Status : Not yet recruiting
First Posted : June 9, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Gamal Esmat, Cairo University

Brief Summary:

There is currently no clinically proven specific antiviral agent available for SARS-CoV-2 infection. Supportive treatment, including oxygen therapy, remains the most important management strategy.

Since its discovery, lactoferrin and its related peptides are mainly considered to be important non-specific host defense molecules against a broad range of viruses including SARS-CoV, which is closely related to SARS-CoV-2 that causes COVID-19. Lactoferrin has been found to experimentally inhibit viral entry in murine coronavirus, and human coronaviruses hCOV-NL63 and pseudotyped SARS-CoV. Besides reducing viral entry, lactoferrin can also suppress virus replication after the viral entry.

Another major aspect of lactoferrin bioactivity relates to its immunomodulatory and anti-inflammatory functions. Current thinking suggests that mortality from COVID-19 is not simply due to viral infection but is a result of a cytokine storm associated with hyper-inflammation leading to acute respiratory distress and subsequent mortality. A cytokine profile in severe COVID-19 cases is characterized by increases in cytokines and acute phase reactants and ferritin. In this regard, lactoferrin was demonstrated to reduce IL-6, TNF a, and downregulate ferritin in experimental settings simulating sepsis.

In this study, we aim to study the potential application of lactoferrin against SARS-CoV-2 and propose the possibility of using different doses of supplemental lactoferrin as a potential adjunct treatment for COVID-19.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: Lactoferrin Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Lactoferrin as an Adjunct Therapeutic Agent for COVID-19
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : November 2020

Arm Intervention/treatment
Experimental: Standard of care in addition to 400 mg lactoferrin
Standard of care treatment; as per MOHP protocol, in addition to 400 mg oral lactoferrin daily [two sachets 100 mg granules (Pravotin sachets, Hygint, Egypt) in 1/4 glass of water twice a day before meals]
Drug: Lactoferrin
adding lactoferrin to standard of care treatment regimens
Other Name: Standard of care treatment regimens

Experimental: Standard of care in addition to 600 mg lactoferrin
Standard of care treatment; as per MOHP protocol, in addition to 600 mg oral lactoferrin daily [three sachets 100 mg granules (Pravotin sachets, Hygint, Egypt) in 1/4 glass of water twice a day before meals]
Drug: Lactoferrin
adding lactoferrin to standard of care treatment regimens
Other Name: Standard of care treatment regimens

Active Comparator: Standard of care only
Standard of care treatment; as per MOHP protocol
Drug: Lactoferrin
adding lactoferrin to standard of care treatment regimens
Other Name: Standard of care treatment regimens




Primary Outcome Measures :
  1. Time to clinical improvement [ Time Frame: 28 days ]
    time from randomization to improvement of two points on used scale or live discharge from the hospital, whichever came first.


Secondary Outcome Measures :
  1. Rate of virological cure [ Time Frame: 28 days ]
    time from randomization to cure (2 SARS-COV-2 PCR samples negative with 48 hours apart)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive reverse-transcriptase-polymerase chain- reaction (RT-PCR) assay for SARS- CoV-2 in a respiratory tract sample.

Exclusion Criteria:

  • Known allergy or hypersensitivity to the used medications
  • Severe symptoms: respiratory insufficiency that requires admission in intensive care unit or mechanical ventilation
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Responsible Party: Gamal Esmat, Professor of Endemic Medicine, Cairo University
ClinicalTrials.gov Identifier: NCT04421534    
Other Study ID Numbers: CUKA-001
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gamal Esmat, Cairo University:
COVID-19
lactoferrin
Additional relevant MeSH terms:
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Lactoferrin
Anti-Infective Agents