LACTYFERRIN™ Forte and ZINC Defense™ and Standard of Care (SOC) vs SOC in the Treatment of Non-hospitalized Patients With COVID-19

• Status: Not yet recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

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 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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jose David Suarez, MD
• Collaborators: MGM Technology Corp; Sesderma S.L.; Westchester General Hospital Inc. DBA Keralty Hospital Miami

Criteria

INCLUSION CRITERIA

• 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).

EXCLUSION CRITERIA

• 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

• 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.