130
Participants
Start Date
January 20, 2022
Primary Completion Date
December 20, 2024
Study Completion Date
July 20, 2025
Covidir injections
administration of the investigational product CODIVIR/Placebo at a dose of 20 mg twice a day subcutaneously at visits Day0-Day6 (7 days total)
Quantitative PCR SARS-CoV-2
detection of viral RNA in nasopharyngeal and oropharyngeal samples by the Real Time Protein Chain Reaction technique.
IgM and IgG dosage
lood collection for dosage of Anti SARS-CoV-2 antibodies.
Screening Blood tests
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.
Electrocardiogram
valuation by the principal investigator or assistant physician with a complete physical examination
NEWS-2 score
assessment of the participant by the NEWS-2 score.
WHO score
assessment of the participant by the score of the World Health Organization.
Physical examination
evaluation by the principal investigator or assistant physician
COVID-19-Related Symptoms assessment
will be completed by the study staff member based on patient status and answers.
RECRUITING
Hospital de Amor, Paulo Prata
RECRUITING
Infection Control, Prado
RECRUITING
Instituto Lobus, Casa de Pedra
RECRUITING
A2Z Clinical, Vila Martina
RECRUITING
Casa de Saude, Centro
Lead Sponsor
Code Pharma
INDUSTRY