Covid19SARS-CoV-2NCT04860219
Lactoferrin Use in (SARS-CoV-2) Management
A study testing Lactoferrin in people with Covid19, run by Zagazig University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Lactoferrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Jul 2020to 30 Apr 2021
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine -Zagazig University
Zagazig
mohamed ghoniem, MD, 00966540845657, teto2006.km@gmail.com
About this study
Official title: The Prospect of Lactoferrin Use as Adjunctive Agent in Management of SARS COV-2 Patients: A Randomized Pilot Study
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.
- Conditions
- Covid19
- Being tested
- Lactoferrin
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactoferrinDietary supplement
7 successive days treatment of Lactoferrin started within day 0 of COVID-19 diagnosis by RT-PCR
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | None of the participants in the Control Group received lactoferrin |
| 200 mg lactoferrin orally once daily Group | Active comparator | received 200 mg lactoferrin orally once daily Receives: Dietary Supplement: Lactoferrin |
| 200 mg lactoferrin orally twice daily Group | Active comparator | received 200 mg lactoferrin orally twice daily Receives: Dietary Supplement: Lactoferrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to be symptoms free and normal laboratory results
duration from day 0 symptoms till 7 days symptoms free and normal laboratory findings
Measured: 7 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start8 Jul 2020
- Primary completion18 Sep 2020
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed E Ghoniem, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860219
- Sponsor's protocol ID
- COVID-1937
- Acronym
- SARS-CoV-2
- Status last verified
- Apr 2021
- First submitted
- 21 Apr 2021
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated and/or analyzed during the current study are available from the corresponding author upon request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prospect of Lactoferrin Use as Adjunctive Agent in Management of SARS COV-2 Patients: A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT04860219
- Acronym / sponsor ID
- SARS-CoV-2 / COVID-1937
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 18 Sep 2020 (actual)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –None of the participants in the Control Group received lactoferrin |
| 200 mg lactoferrin orally once daily Group | Active comparator | Dietary Supplement: Lactoferrinreceived 200 mg lactoferrin orally once daily |
| 200 mg lactoferrin orally twice daily Group | Active comparator | Dietary Supplement: Lactoferrinreceived 200 mg lactoferrin orally twice daily |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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%.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactoferrin7 successive days treatment of Lactoferrin started within day 0 of COVID-19 diagnosis by RT-PCR | Dietary supplement | 200 mg lactoferrin orally once daily Group, 200 mg lactoferrin orally twice daily Group |
Primary outcome
time to be symptoms free and normal laboratory results
Time frame: 7 days after enrollment
duration from day 0 symptoms till 7 days symptoms free and normal laboratory findings
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Individual participant dataSharing planned: No. The datasets generated and/or analyzed during the current study are available from the corresponding author upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactoferrin in people with Covid19, run by Zagazig University at 1 site 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 4 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 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 mohamed ghoniem, MD (00966540845657, teto2006.km@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to be symptoms free and normal laboratory results (time frame: 7 days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2021.