Study of Codivir in Patients With COVID-19

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

March 29, 2021

Primary Completion Date

May 27, 2021

Study Completion Date

August 9, 2021

Conditions
Covid19
Interventions
DRUG

Covidir injections

administration of the investigational product CODIVIR at a dose of 20 mg twice a day subcutaneously.

DIAGNOSTIC_TEST

One Step Test

rapid test for the diagnosis of COVID-19 based on the detection of anti-SARS-CoV-2 in the blood.

DIAGNOSTIC_TEST

IgM and IgG dosage

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

DIAGNOSTIC_TEST

RT-PCR SARS-CoV-2

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

DIAGNOSTIC_TEST

Screening blood test

complete 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; fibrinogen, Pregnancy test for non-sterile women.

DIAGNOSTIC_TEST

ECG

12-lead electrocardiogram with report.

DIAGNOSTIC_TEST

Medical evaluation

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

DIAGNOSTIC_TEST

NEWS-2 score

assessment of the participant by the NEWS-2 score.

DIAGNOSTIC_TEST

WHO score

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

Trial Locations (1)

13092-108

Hospital Vera Cruz S A (Campinas-SP), Campinas

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Code Pharma

INDUSTRY