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Study of Codivir in Patients With COVID-19

NCT04930861 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-11-02

No results posted yet for this study

Summary

This is an open-label study to evaluate the safety and preliminary efficacy of Codivir in 12 mild or moderate COVID-19 patients and onset of symptoms within 72h prior to their inclusion. Treatment will begin in the hospital, participants will be discharged at Day 4 and continue the treatment up to Day 10 at home and followed up to day 28.

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.

Sponsors & Collaborators

  • Code Pharma

    lead INDUSTRY

Principal Investigators

  • Eynat Finkelshtein · Code Pharma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-29
Primary Completion
2021-05-27
Completion
2021-08-09

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04930861 on ClinicalTrials.gov