Lactoferrin Use in (SARS-CoV-2) Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-08

Study Completion Date

2021-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

None of the participants in the Control Group received lactoferrin

Group Type NO_INTERVENTION

No interventions assigned to this group

200 mg lactoferrin orally once daily Group

received 200 mg lactoferrin orally once daily

Group Type ACTIVE_COMPARATOR

Lactoferrin

Intervention Type DIETARY_SUPPLEMENT

7 successive days treatment of Lactoferrin started within day 0 of COVID-19 diagnosis by RT-PCR

200 mg lactoferrin orally twice daily Group

received 200 mg lactoferrin orally twice daily

Group Type ACTIVE_COMPARATOR

Lactoferrin

Intervention Type DIETARY_SUPPLEMENT

7 successive days treatment of Lactoferrin started within day 0 of COVID-19 diagnosis by RT-PCR

Interventions

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Lactoferrin

7 successive days treatment of Lactoferrin started within day 0 of COVID-19 diagnosis by RT-PCR

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No