lactyferrin™ forte and zinc defense™ and standard of care (soc) vs soc in the treatment of non-hospitalized patients with covid-19

Conditions: COVID-19

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

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.

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.

Keywords: liposomal lactoferrin liposomal zinc covid-19