NCT04930861

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 covid19

Timeline
Completed

Started Mar 2021

Shorter than P25 for phase_1 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2021

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2021

Completed
Last Updated

November 2, 2021

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

June 16, 2021

Last Update Submit

November 1, 2021

Conditions

Covid19

Keywords

CoronaCoronavirusCOVID-19SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

  • Incidence and severity of adverse events related to the investigational product.

    28 days

Secondary Outcomes (4)

  • Clinical evolution according to the score of the World Health Organization between admission and days 10 and 28.

    up to 28 days

  • Clinical evolution according to NEWS2 score between admission and days 10 and 28.

    up to 28 days

  • RT-PCR negative.

    up to 28 days

  • Evolution of IgM & IgG Anti-SARS-CoV-2.

    up to 28 days

Study Arms (1)

Covidir

EXPERIMENTAL

Patient (adults aged ≥18 years) with mild or moderate COVID-19 and flu-symptoms onset within 72 hours prior to inclusion. Treatment begins at the hospital. On the 4th day, participants who are well will be discharged and continue treatment up to Day 10 at home. All participants will receive Codivir 20 mg SC 2 x daily.

Drug: Covidir injectionsDiagnostic Test: One Step TestDiagnostic Test: IgM and IgG dosageDiagnostic Test: RT-PCR SARS-CoV-2Diagnostic Test: Screening blood testDiagnostic Test: ECGDiagnostic Test: Medical evaluationDiagnostic Test: NEWS-2 scoreDiagnostic Test: WHO score

Interventions

Covidir injectionsDRUG

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

Also known as: Experimental drug administration
Covidir
One Step TestDIAGNOSTIC_TEST

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

Also known as: Covid-19 test
Covidir
IgM and IgG dosageDIAGNOSTIC_TEST

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

Also known as: Blood test
Covidir
RT-PCR SARS-CoV-2DIAGNOSTIC_TEST

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

Also known as: Covid-19 test
Covidir
Screening blood testDIAGNOSTIC_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.

Also known as: Blood test
Covidir
ECGDIAGNOSTIC_TEST

12-lead electrocardiogram with report.

Also known as: Electrocardiogram
Covidir
Medical evaluationDIAGNOSTIC_TEST

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

Also known as: Physical examination
Covidir
NEWS-2 scoreDIAGNOSTIC_TEST

assessment of the participant by the NEWS-2 score.

Covidir
WHO scoreDIAGNOSTIC_TEST

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

Covidir

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 60 years;
  • Male or female;
  • SARS-CoV-2 infection indicated by rapid test and confirmed by RT-PCR.
  • Mild or moderate COVID-19:
  • The oxygen saturation in room air \>93%;
  • \<30 breaths per minute;
  • No signs of hemodynamic decompensation.
  • Absence of pregnancy in women of childbearing age.
  • Able to understand and comply with the requirements of the protocol.
  • Consent to participate

You may not qualify if:

  • Participants in need of O2 supplementation by catheter or mask, invasive mechanical ventilation, or vasopressors.
  • Body mass index less than 19.9 or greater than 35;
  • Comorbidities such as: other serious infections, active malignancies, autoimmune diseases, liver, kidney or heart failure; another systemic disease and / or laboratory abnormality, which, in the investigator's opinion, prevent the patient from participating in the study;
  • Concomitant HIV, HBV or HCV infection.
  • Pregnancy or lactation;
  • Anti-COVID-19 vaccination at any time;
  • Any condition that increases the risk of participating in the study, in the opinion of the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Vera Cruz S A (Campinas-SP)

Campinas, State of São Paulo, 13092-108, Brazil

Location

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Interventions

Hematologic TestsCOVID-19 Nucleic Acid TestingElectrocardiographyPhysical Examination

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesCOVID-19 TestingHeart Function TestsDiagnostic Techniques, CardiovascularElectrodiagnosis

Study Officials

  • Eynat Finkelshtein

    Code Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2021

First Posted

June 18, 2021

Study Start

March 29, 2021

Primary Completion

May 27, 2021

Study Completion

August 9, 2021

Last Updated

November 2, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)