Todos Medical Ltd. announced that its majority-owned subsidiary 3CL Pharma Ltd. has finalized plans for a proposed safety and efficacy clinical trial for its 3CL protease inhibitor immune support dietary supplement Tollovid™ in patients with Long COVID. The 45-patient Part A of the study will be conducted as a 3-arm, randomized, controlled, observer-blinded clinical study evaluating Tollovid's effects on the structure/function of the immune system as measured by the presence of neutralizing antibodies, total anti SARS-CoV-2 antibodies (IgG, IgA, IgM) and VEGF cytokine levels. Participating subjects will be randomized into three cohorts: 1) a 15-patient cohort to receive 30-day treatment regimen of 12 capsules per day; 2) a 15-patient cohort to receive a 15-day treatment regimen of 12 capsules per day, followed by 15-day treatment regimen of 6 capsules per day; and 3) an untreated control group who will be eligible to receive Tollovid at the conclusion study.

All three groups will be allowed to continue taking their standard of care medications while on study, with the exception of other 3CL protease inhibitors. 3CL Pharma intends to initiate this clinical study in early fourth quarter of 2022. Two Long COVID clinics are in the process of finalizing contracts to participate in the study.

It is the intention that study participants can enroll and be evaluated both virtually via remote monitoring, as well as in person. The primary endpoints of Part A of the study are the numbers and severity of adverse events, serious adverse events (SAEs), clinical laboratory abnormalities and changes in vital signs after administration of Tollovid at day 30 following enrollment. The secondary structure/function endpoints of Part A of the study are changes in the Amerimmune/Provista Long Covid Panel, CRP and VEGF after administration of Tollovid at day 30 following enrollment.

The exploratory objectives of Part A of the study are to evaluate time to improvement over time in the Post-COVID-19 Functional Status Scale scores and in COVID-19 symptoms after administration of Tollovid at day 30 after enrollment. Biomarker data will be gathered at baseline upon enrollment prior to treatment, midway through the study and at the conclusion of the 30-day treatment regimen for all three groups. The Company expects Part A of the study to complete in the fourth quarter of 2022.

If successful, a Part B of the study will be opened to rapidly expand patient enrollment, and potentially extend into pediatric patients, with a yet to be determined clinical design based upon the results of Part A and discussions with regulatory agencies.