Phase IIa Randomized Placebo Controlled Clinical Study of Codivir in Hospitalized Patients with Moderate 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.

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.

Sponsors & Collaborators

• Code Pharma

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-20

Primary Completion

2024-12-20

Completion

2025-07-20

Countries

• Brazil

Study Locations