COVID-19Phase 2NCT05783180
LACTYFERRIN™ Forte and ZINC Defense™ and Standard of Care (SOC) vs SOC in the Treatment of Non-hospitalized Patients With COVID-19
A Phase 2 study testing Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ in people with COVID-19, run by Jose David Suarez, MD at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn about the safety and efficacy of Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ in non-hospitalized patients with COVID-19. The main question is: Is there a reduction in the signs and symptoms of COVID-19 from baseline to end of treatment? Participants will complete… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2023to Nov 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient or legally authorized representative must be willing to sign an informed consent.
- Male or female ≥18 years of age at the time of enrollment.
- COVID-19 diagnosis confirmed by SARS-CoV-2 detection by polymerase chain reaction (PCR) or other commercial or public health assays in any specimen documented by any of the following:
- PCR positive in samples collected ≤ 72h.
- PCR positive in samples collected >72h and less than 7 days of disease progression.
- Mild to moderate symptoms of COVID-19 as determined by investigators following the criteria from NIH COVID 19 Treatment Guidelines for (APPENDIX I. SEVERITY OF ILLNESS CATEGORIES).
Who cannot join
- Hospitalized patients.
- Breast-feeding or pregnant (any woman of childbearing age and potential must have a negative test within 24 hours of starting treatment).
- Allergy to any of the components of the study medication.
- AST or ALT > x3 the upper limit value
- Estimated Glomerular Filtration Rate (eGFR) < 30
- Concomitant antiviral therapy such as lopinavir or ritonavir
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- Concomitant immunosuppressive or immunomodulatory drugs (e.g., interleukins, interleukin antagonists or receptor blockers, anticancer drugs, immunosuppressant)
- Concomitant therapy with corticosteroids at a dose > 20mg per day was administered for more than 14 days before the study medication.
- Human immunodeficiency virus infection under highly active antiretroviral therapy (HAART).
- Has participated in another clinical trial within the last 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ (Liposomal Bovine Lactoferrin (LbLf) and Liposomal Zn (LZn)) and Standard of Care (SOC) vs SOC in the Treatment of Non-hospitalized Patients With COVID-19
The goal of this clinical trial is to learn about the safety and efficacy of Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ in non-hospitalized patients with COVID-19.
The main question is:
Read more
Is there a reduction in the signs and symptoms of COVID-19 from baseline to end of treatment? Participants will complete the following activities.
- Screening and first day of treatment
- Treatment that will be administered for up to 10 days, two treatment evaluation visits will be completed
- After treatment completion. Two visits are scheduled, one 28 days after the last dose and the other 60 days after the last dose.
Researchers will compare Treatment Group (Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ + Standard of care (SOC)) with the Control group (Placebo +SOC) to see if there is Reduction in the signs and symptoms of COVID-19 at the end of treatment
Read the detailed description
This is a placebo-controlled, randomized, parallel-group, adaptive, phase 2 study to evaluate the safety and efficacy of Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ (LbLf+LZn) + SOC compared to Placebo+SOC in non-hospitalized patients with COVID-19. The primary endpoint is the reduction in the signs and symptoms of COVID-19 from baseline to D11/D28 (end of treatment).
The study duration will be up to 70 days including.
- Screening and randomization (Day0/D1): Screening and the first day of treatment
- Treatment period: from (D0 to D10). Treatment will be administered for up to 10 days, and treatment evaluation visits on D11 (EOT) and D28.
- Follow-up (FU): Will start after treatment completion on day 10. Two visits are scheduled during this period: one 28 days after the last dose (D38) and the other 60 days after the last dose (D70).
Patient population None hospitalized Individuals with mild to moderate SARS-CoV-2 infection with less than 7 days of symptoms evolution. This corresponds to a score of 1 or 2 (moderate to mild disease) on the WHO 9-point ordinal scale
Number of subjects Approximately: 40
Treatment Group: Sesderma LACTYFERRIN™ Forte (64mg/20ml, TID) and Sesderma ZINC Defense™ (20mg/20ml QD) + SOC (N=20).
Control group: Placebo +SOC (N=20)
Intervention groups At baseline, subjects will be randomized in a 1:1 ratio to either treatment or control groups.
- Conditions
- COVID-19
- Being tested
- Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™, Placebo
- Keywords
- Liposomal lactoferrin, liposomal Zinc, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™Drug
Sesderma LACTYFERRIN™ Forte (64mg/20ml, TID) and Sesderma ZINC Defense™ (20mg/20ml QD)
PlaceboDrug
Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ (Placebo)
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Sesderma LACTYFERRIN™ Forte (64mg/20ml, TID) and Sesderma ZINC Defense™ (20mg/20ml QD) + SOC (N=20). Receives: Drug: Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ |
| Control | Placebo comparator | Placebo +SOC (N=20) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the signs and symptoms of COVID-19 from baseline to Day 11 (end of treatment, EOT).
The scale used by Serrano et al., 2020 during the Phase 1 Sesderma LACTYFERRIN™ Forte trial quantified the presence of COVID-19 signs and symptoms, and their reduction during treatment time will be used in this phase with the same purpose
Measured: 11 days (one day after last study medication dose)
Secondary outcomes (4)
The proportion of patients with disease progression on Day 28
The proportion of patients with disease progression on Day 28, are defined as the proportion of patients who are not alive or who have respiratory failure. Respiratory failure is defined as the need for invasive or non-invasive mechanical ventilation, high-flow oxygen, or ECMO.
Measured: up to 28 days after first study medication dose
Time to recover or Odds of Ratio for Improvement in WHO 9-point ordinal scale
Time to recover or Odds of Ratio for Improvement in WHO 9-point ordinal scale from Baseline to D5/D11 (EOT)/D28.
Measured: 5,11 and 28 days after first study medication dose
The change in blood levels of inflammatory biomarkers
The change in blood levels CRP, CRP/albumin, ferritin, iron, and D-Dimer from baseline, D5, D11 (EOT), and 28.
Measured: 5,11 and 28 days after first study medication dose
Adverse event
Assessment of adverse events.
Measured: through study completion, an average of 70 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study startJun 2023 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionNov 2024 (estimated)
Why it stopped: Sponsor decided not to move forward with the trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment Group: Sesderma LACTYFERRIN™ Forte (64mg/20ml, TID) and Sesderma ZINC Defense™ (20mg/20ml QD) + SOC (N=20). Control group: Placebo +SOC (N=20) Intervention groups At baseline, subjects will be randomized in a 1:1 ratio to either treatment or control groups.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jose David Suarez, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Sesderma S.L., Westchester General Hospital Inc. DBA Keralty Hospital Miami, MGM Technology Corp
- Responsible party
- Sponsor-investigator, Jose David Suarez, MD, Keralty Hospital, Miami
- Investigators
- Jose D Suarez, Principal investigator, Keralty Hospital, Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783180
- Sponsor's protocol ID
- SES-LFZN-001
- Status last verified
- Nov 2023
- First submitted
- 9 Mar 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Martorell P, Llopis S, Gonzalez N, Ramon D, Serrano G, Torrens A, Serrano JM, Navarro M, Genoves S. A nutritional supplement containing lactoferrin stimulates the immune system, extends lifespan, and reduces amyloid beta peptide toxicity in Caenorhabditis elegans. Food Sci Nutr. 2016 Jul 28;5(2):255-265. doi: 10.1002/fsn3.388. eCollection 2017 Mar.
PubMed 28265360
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ (Liposomal Bovine Lactoferrin (LbLf) and Liposomal Zn (LZn)) and Standard of Care (SOC) vs SOC in the Treatment of Non-hospitalized Patients With COVID-19
- ClinicalTrials.gov ID
- NCT05783180
- Acronym / sponsor ID
- SES-LFZN-001
- Conditions
- COVID-19
- Keywords
- Liposomal lactoferrin, liposomal Zinc, COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decided not to move forward with the trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jose David Suarez, MDUniversity, hospital or other
- Collaborators
- Sesderma S.L., Westchester General Hospital Inc. DBA Keralty Hospital Miami, MGM Technology Corp
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 24 Mar 2023 (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.
The goal of this clinical trial is to learn about the safety and efficacy of Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ in non-hospitalized patients with COVID-19.
The main question is:
Is there a reduction in the signs and symptoms of COVID-19 from baseline to end of treatment? Participants will complete the following activities.
- Screening and first day of treatment
- Treatment that will be administered for up to 10 days, two treatment evaluation visits will be completed
- After treatment completion. Two visits are scheduled, one 28 days after the last dose and the other 60 days after the last dose.
Researchers will compare Treatment Group (Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ + Standard of care (SOC)) with the Control group (Placebo +SOC) to see if there is Reduction in the signs and symptoms of COVID-19 at the end of treatment
Detailed description
This is a placebo-controlled, randomized, parallel-group, adaptive, phase 2 study to evaluate the safety and efficacy of Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ (LbLf+LZn) + SOC compared to Placebo+SOC in non-hospitalized patients with COVID-19. The primary endpoint is the reduction in the signs and symptoms of COVID-19 from baseline to D11/D28 (end of treatment).
The study duration will be up to 70 days including.
- Screening and randomization (Day0/D1): Screening and the first day of treatment
- Treatment period: from (D0 to D10). Treatment will be administered for up to 10 days, and treatment evaluation visits on D11 (EOT) and D28.
- Follow-up (FU): Will start after treatment completion on day 10. Two visits are scheduled during this period: one 28 days after the last dose (D38) and the other 60 days after the last dose (D70).
Patient population None hospitalized Individuals with mild to moderate SARS-CoV-2 infection with less than 7 days of symptoms evolution. This corresponds to a score of 1 or 2 (moderate to mild disease) on the WHO 9-point ordinal scale
Number of subjects Approximately: 40
Treatment Group: Sesderma LACTYFERRIN™ Forte (64mg/20ml, TID) and Sesderma ZINC Defense™ (20mg/20ml QD) + SOC (N=20).
Control group: Placebo +SOC (N=20)
Intervention groups At baseline, subjects will be randomized in a 1:1 ratio to either treatment or control groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Treatment Group: Sesderma LACTYFERRIN™ Forte (64mg/20ml, TID) and Sesderma ZINC Defense™ (20mg/20ml QD) + SOC (N=20). Control group: Placebo +SOC (N=20) Intervention groups At baseline, subjects will be randomized in a 1:1 ratio to either treatment or control groups.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™Sesderma LACTYFERRIN™ Forte (64mg/20ml, TID) and Sesderma ZINC Defense™ (20mg/20ml QD) + SOC (N=20). |
| Control | Placebo comparator | Drug: PlaceboPlacebo +SOC (N=20) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient or legally authorized representative must be willing to sign an informed consent.
- Male or female ≥18 years of age at the time of enrollment.
- COVID-19 diagnosis confirmed by SARS-CoV-2 detection by polymerase chain reaction (PCR) or other commercial or public health assays in any specimen documented by any of the following:
- PCR positive in samples collected ≤ 72h.
- PCR positive in samples collected >72h and less than 7 days of disease progression.
Key exclusion criteria (10 listed)
- Hospitalized patients.
- Breast-feeding or pregnant (any woman of childbearing age and potential must have a negative test within 24 hours of starting treatment).
- Allergy to any of the components of the study medication.
- AST or ALT > x3 the upper limit value
- Estimated Glomerular Filtration Rate (eGFR) < 30
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 |
|---|---|---|
| Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™Sesderma LACTYFERRIN™ Forte (64mg/20ml, TID) and Sesderma ZINC Defense™ (20mg/20ml QD) | Drug | Treatment |
| PlaceboSesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ (Placebo) | Drug | Control |
Primary outcome
Reduction in the signs and symptoms of COVID-19 from baseline to Day 11 (end of treatment, EOT).
Time frame: 11 days (one day after last study medication dose)
The scale used by Serrano et al., 2020 during the Phase 1 Sesderma LACTYFERRIN™ Forte trial quantified the presence of COVID-19 signs and symptoms, and their reduction during treatment time will be used in this phase with the same purpose
4 secondary outcomes
The proportion of patients with disease progression on Day 28
Time frame: up to 28 days after first study medication dose
Time to recover or Odds of Ratio for Improvement in WHO 9-point ordinal scale
Time frame: 5,11 and 28 days after first study medication dose
The change in blood levels of inflammatory biomarkers
Time frame: 5,11 and 28 days after first study medication dose
Adverse event
Time frame: through study completion, an average of 70 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Background: PubMed 28265360Martorell P, Llopis S, Gonzalez N, Ramon D, Serrano G, Torrens A, Serrano JM, Navarro M, Genoves S. A nutritional supplement containing lactoferrin stimulates the immune system, extends lifespan, and reduces amyloid beta peptide toxicity in Caenorhabditis elegans. Food Sci Nutr. 2016 Jul 28;5(2):255-265. doi: 10.1002/fsn3.388. eCollection 2017 Mar.
- Serrano G, Kochergina I, Gutiérrez R, Reyes M, Albors A, Millan F, et al. Liposomal Lactoferrin and Liposomal Lactoferrin plus Zinc Induces Antiinflammatory and Immunomodulatory Effects by Activation of IFNγ. IJRHS. 2020 Dec 25;8(4):25-31.Link provided by the sponsor.
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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.
Jose D Suarez principal investigator
Keralty Hospital, Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ in people with COVID-19, run by Jose David Suarez, MD at 1 site in United States.
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 6 inclusion and 10 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: withdrawn, as of the sponsor's last update on 13 Nov 2023. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the signs and symptoms of COVID-19 from baseline to Day 11 (end of treatment, EOT). (time frame: 11 days (one day after last study medication dose)). 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 NCT05783180, which also lists 1 linked publication.
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 13 Nov 2023.