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.
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