LACTYFERRIN™ Forte and ZINC Defense™ and Standard of Care (SOC) vs SOC in the Treatment of Non-hospitalized Patients With COVID-19
COVID-19
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Liposomal lactoferrin, liposomal Zinc, COVID-19
Eligibility 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.
Sites / Locations
- Keralty Hospital Miami
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Treatment
Control
Sesderma LACTYFERRIN™ Forte (64mg/20ml, TID) and Sesderma ZINC Defense™ (20mg/20ml QD) + SOC (N=20).
Placebo +SOC (N=20)