The subject of the contract is the preparation of clinical safety studies of HOCL.

The names and codes specified in the Common Procurement Vocabulary (CPV) were used to describe the subject of the contract. A detailed description of the subject of the contract (SOPZ), together with the required quantities, is set out in Annex 1 to the SWZ.

Scope of the service:

1) Obtaining the consent of the Bioethics Committee.

2) Recruiting healthy people/volunteers for clinical trials in the age range of 25 – 40 years.

3) Development of a detailed study methodology (clinical trial protocol) based on preliminary assumptions (below) and obtained results from previous studies, including preclinical ones (available on request).

4) Clinical observation of people subjected to a cyclic fogging process (HOCl) in the model of a mobile disinfection station; (it is planned not to exceed the maximum allowable instantaneous concentration (NDSch) of chlorine – 1.5mg/m3 in the case of a mobile disinfection station). Two study groups are envisaged: n = 40 people (20 women and 20 men) each, a total of 80 people not burdened with chronic diseases). In both arms of the SHORT and LONG studies, 50% of people are randomly included in the study group and 50% of people in the control group:

a) the first group "SHORT" with a shorter exposure time, will be tested for 3 consecutive days (+ 2 final/control days, during which participants will be subjected daily to 3 exposure cycles at intervals of 3 hours: n = 20 control group exposed to a solution of 0.9%, n = 20 test group exposed to HOCl solution at a concentration and time determined from the results of preclinical studies. With 3 hours of breaks between exposures on a given day, the tests mentioned in points 5) and 6) will be carried out.

Test cycle: First day: 1) tests > 60 min. before the first exposure, 2) I exposure – tests > 10 min. after I exposure, 3) II exposure – tests > 10 min. after II exposure, 4) III exposure > 10 min. after the third exposure. Second and third day of examination: 1) tests > 60 min. before I exposure, 2) I; II; III exposure, 3) tests > 10 min. after the third exposure. Day five and ten: check-ups without exposure

(b) the second test group "LONG" with a longer exposure time.

Test cycle: First day: 1) 60 min tests. before I exposure, 2) I exposure – tests > 60 min. after I exposure. Subsequent days of research from the second to the ninth: 1) exposure – tests > 60 min. after exposure. The concentration will be determined on the basis of the results of preclinical tests.

5) The following tests will be carried out:

(a) badania krwi: IL -1BETA; IL-6; IL-8; IL-10; IL-12; TNF-LFA;

(b) morphology with a smear;

(c) AST; AIAT, Creatine kinase, urea, creatinine, cholinesterase, GGTP, CRP, total serum IgE, cortisol.

6) Laryngological examinations: anterior and posterior rhinoscopy and nasal swab, cytology (cytogram).

7) Elaboration of the obtained results of medical and laboratory examinations with a summary and conclusions, in accordance with the accepted principles in scientific research.

8) Preparation of the final report on the performed tests in accordance with the template provided by the Contracting Authority and the rules adopted by the NCBiR.