Phase IIa Randomized Placebo Controlled Clinical Study of Codivir in Hospitalized Patients with Moderate COVID-19

PHASE2RecruitingINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

January 20, 2022

Primary Completion Date

December 20, 2024

Study Completion Date

July 20, 2025

Conditions
COVID-19
Interventions
DRUG

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)

DIAGNOSTIC_TEST

Quantitative PCR SARS-CoV-2

detection of viral RNA in nasopharyngeal and oropharyngeal samples by the Real Time Protein Chain Reaction technique.

DIAGNOSTIC_TEST

IgM and IgG dosage

lood collection for dosage of Anti SARS-CoV-2 antibodies.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

Electrocardiogram

valuation by the principal investigator or assistant physician with a complete physical examination

OTHER

NEWS-2 score

assessment of the participant by the NEWS-2 score.

OTHER

WHO score

assessment of the participant by the score of the World Health Organization.

OTHER

Physical examination

evaluation by the principal investigator or assistant physician

OTHER

COVID-19-Related Symptoms assessment

will be completed by the study staff member based on patient status and answers.

Trial Locations (5)

147844-000

RECRUITING

Hospital de Amor, Paulo Prata

30.110-063

RECRUITING

Infection Control, Prado

27253-003

RECRUITING

Instituto Lobus, Casa de Pedra

13271-130

RECRUITING

A2Z Clinical, Vila Martina

13015-240

RECRUITING

Casa de Saude, Centro

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Code Pharma

INDUSTRY