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Phase IIa Randomized Placebo Controlled Clinical Study of Codivir in Hospitalized Patients with Moderate COVID-19
Sponsor: Code Pharma
Summary
This is a double-blind, multicentre, multinational study to evaluate the safety and collect preliminary efficacy data of Codivir drug product in 130 hospitalized adults with moderate COVID-19 symptoms. COVID-19 symptoms (fever, cough, myalgia and changes in smell or taste) onset must be within 7 days prior enrolment. Treatment will begin in the hospital, participants will be discharged according to medical decision and continue the treatment until to Day 7 at home and followed up to day 28.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2022-01-20
Completion Date
2025-07-20
Last Updated
2024-10-02
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (5)
Hospital de Amor
Paulo Prata, Barretos/SP/BRA, Brazil
Infection Control
Prado, Belo Horizonte/MG/BRA, Brazil
Instituto Lobus
Casa de Pedra, Volta Redonda/RJ/BRA, Brazil
A2Z Clinical
Vila Martina, Volta Redonda/RJ/BRA, Brazil
Casa de Saude
Centro, Brazil