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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: COVID-19

In brief

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

Key facts

Study ID

NCT05783180

Run by

Jose David Suarez, MD

People needed

0

Starts

2023-06-01

Expected to finish

2024-11-01

Last updated by the study team

2023-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Keralty Hospital Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.