RecruitingPhase 2NCT05218356

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

Sponsor

Code Pharma

Enrollment

130 participants

Start Date

Jan 20, 2022

Study Type

INTERVENTIONAL

Conditions

COVID-19

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying COVID-19-Related Symptoms assessment, a drug called Covidir injections, and others for people with covid-19. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCovidir 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_TESTQuantitative PCR SARS-CoV-2

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

DIAGNOSTIC_TESTIgM and IgG dosage

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

DIAGNOSTIC_TESTScreening 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_TESTElectrocardiogram

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

OTHERNEWS-2 score

assessment of the participant by the NEWS-2 score.

OTHERWHO score

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

OTHERPhysical examination

evaluation by the principal investigator or assistant physician

OTHERCOVID-19-Related Symptoms assessment

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