Lactoferrin Use in (SARS-CoV-2) Management

Z

Zagazig University

Status

Unknown

Conditions

Covid19

Treatments

Dietary Supplement: Lactoferrin

Study type

Interventional

Funder types

Other

Identifiers

NCT04860219
COVID-1937

Details and patient eligibility

About

Background: Preventive, adjunctive and curative properties of lactoferrin have been evaluated since the first wave of severe acute respiratory syndrome coronavirus (SARS-CoV), viral respiratory disease, emerged 18 years ago. Despite the discovery of new vaccine candidates, there is currently no widely approved treatment for SARS-CoV-2 (COVID-19). Strict adherence to infection prevention and control procedures, as well as vaccines, can, however, prevent the spread of SARS-CoV-2. Objective: Hence, this study evaluated the efficacy of lactoferrin treatment in improving clinical symptoms and laboratory indices among individuals with mild to moderate coronavirus disease-19 (COVID-19). Design and Participants: A randomized, prospective, interventional pilot study conducted between July 8 and September 18, 2020 used a hospital-based sample of 54 laboratory confirmed participants with mild to moderate symptoms of COVID-19. Randomization into a control and two treatment groups ensured all groups received the approved Egyptian COVID-19 management protocol; only treatment group participants received lactoferrin at different doses for seven days. Clinical symptoms and laboratory indices were assessed on Days 0, 2 and 7 after starting treatments. Mean values with standard deviation and one-way analysis of variance with least significant difference post hoc of demographic and laboratory data between control and treatment groups were calculated. Key Results: Our study showed no stastically significant difference among studied groups regarding recovery of symptoms or laboratory improvement. Conclusion: Further research into therapeutic properties particularly related to dosage, duration and follow-up after treatment with lactoferrin in individuals with COVID-19 is required.

Enrollment

54 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • participants over 20 years of age
  • positive for nasopharyngeal swab reverse transcriptase polymerase chain reaction (RT-PCR) for COVID-19
  • blood oxygen saturation (SpO2) > 93%.

Exclusion criteria

  • pregnant and breastfeeding women
  • individuals confirmed to be allergic to milk protein
  • those with a medical history of bronchial hyperactivity or pre-existing respiratory diseases
  • ICU inpatients with COVID-19.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

54 participants in 3 patient groups

Control Group
No Intervention group
Description:
None of the participants in the Control Group received lactoferrin
200 mg lactoferrin orally once daily Group
Active Comparator group
Description:
received 200 mg lactoferrin orally once daily
Treatment:
Dietary Supplement: Lactoferrin
200 mg lactoferrin orally twice daily Group
Active Comparator group
Description:
received 200 mg lactoferrin orally twice daily
Treatment:
Dietary Supplement: Lactoferrin

Trial contacts and locations

1

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Central trial contact

mohamed ghoniem, MD

Data sourced from clinicaltrials.gov

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