Study: NCT05218356

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Covidir injections
Description: administration of the investigational product CODIVIR/Placebo at a dose of 20 mg twice a day subcutaneously at visits Day0-Day6 (7 days total)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Covidir injections
Description: administration of the investigational product CODIVIR/Placebo at a dose of 20 mg twice a day subcutaneously at visits Day0-Day6 (7 days total)

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Quantitative PCR SARS-CoV-2
Description: detection of viral RNA in nasopharyngeal and oropharyngeal samples by the Real Time Protein Chain Reaction technique.

Intervention type: DIAGNOSTIC_TEST
Group type: PLACEBO_COMPARATOR
Intervention: Quantitative PCR SARS-CoV-2
Description: detection of viral RNA in nasopharyngeal and oropharyngeal samples by the Real Time Protein Chain Reaction technique.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: IgM and IgG dosage
Description: lood collection for dosage of Anti SARS-CoV-2 antibodies.

Intervention type: DIAGNOSTIC_TEST
Group type: PLACEBO_COMPARATOR
Intervention: IgM and IgG dosage
Description: lood collection for dosage of Anti SARS-CoV-2 antibodies.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Screening Blood tests
Description: omplete blood count, urea, creatinine, uric acid, sodium, potassium, chloride, calcium, glucose, glycated hemoglobin, alkaline phosphatase (FA), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubins and fractions ( BTF), total proteins and fractions (PTF), lipid profile (total cholesterol, fractions and triglycerides); coagulogram (TP, aPTT); D-dimer; C-reactive protein; HIV, HBV, HCV serology; Ferritin; troponin, fibrinogen,Coagulogram (TP, aPTT); D-dimer, Pregnancy test for non-sterile women.

Intervention type: DIAGNOSTIC_TEST
Group type: PLACEBO_COMPARATOR
Intervention: Screening Blood tests
Description: omplete blood count, urea, creatinine, uric acid, sodium, potassium, chloride, calcium, glucose, glycated hemoglobin, alkaline phosphatase (FA), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubins and fractions ( BTF), total proteins and fractions (PTF), lipid profile (total cholesterol, fractions and triglycerides); coagulogram (TP, aPTT); D-dimer; C-reactive protein; HIV, HBV, HCV serology; Ferritin; troponin, fibrinogen,Coagulogram (TP, aPTT); D-dimer, Pregnancy test for non-sterile women.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Electrocardiogram
Description: valuation by the principal investigator or assistant physician with a complete physical examination

Intervention type: DIAGNOSTIC_TEST
Group type: PLACEBO_COMPARATOR
Intervention: Electrocardiogram
Description: valuation by the principal investigator or assistant physician with a complete physical examination

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: NEWS-2 score
Description: assessment of the participant by the NEWS-2 score.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: NEWS-2 score
Description: assessment of the participant by the NEWS-2 score.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: WHO score
Description: assessment of the participant by the score of the World Health Organization.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: WHO score
Description: assessment of the participant by the score of the World Health Organization.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Physical examination
Description: evaluation by the principal investigator or assistant physician

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Physical examination
Description: evaluation by the principal investigator or assistant physician

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: COVID-19-Related Symptoms assessment
Description: will be completed by the study staff member based on patient status and answers.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: COVID-19-Related Symptoms assessment
Description: will be completed by the study staff member based on patient status and answers.