NCT05218356

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for phase_2 covid19

Timeline
Completed

Started Jan 2022

Longer than P75 for phase_2 covid19

Geographic Reach
1 country

5 active sites

Status
recruiting

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

First Submitted

Initial submission to the registry

January 19, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

January 20, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2025

Completed
Last Updated

October 2, 2024

Status Verified

October 1, 2024

Enrollment Period

2.9 years

First QC Date

January 19, 2022

Last Update Submit

October 1, 2024

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Change in World Health Organization Ordinal Scale for clinical improvement

    change in World Health Organization Ordinal Scale for clinical improvement in the treatment group in comparison with Placebo. the scale min score - 0 and max score - 8. the higher the scores mean a worse outcome

    up to 28 days

Secondary Outcomes (4)

  • Change in COVID-19-Related Symptoms score (measured on days 7, 14, 21, 28) in the treatment group in comparison with Placebo).

    up to 28 days

  • adverse events

    up to 28 days

  • RT-PCR viral load

    up to 28 days

  • IgM & IgG anti-SARS-CoV-2

    up to 28 days

Study Arms (2)

Codivir treatment

EXPERIMENTAL

20 mg administrated by subcutaneous (SC) injection, twice a day, for 7 days

Drug: Covidir injectionsDiagnostic Test: Quantitative PCR SARS-CoV-2Diagnostic Test: IgM and IgG dosageDiagnostic Test: Screening Blood testsDiagnostic Test: ElectrocardiogramOther: NEWS-2 scoreOther: WHO scoreOther: Physical examinationOther: COVID-19-Related Symptoms assessment

Placebo treatment

PLACEBO COMPARATOR

Placebo administrated in subcutaneous (SC) injection, twice a day, for 7 days

Drug: Covidir injectionsDiagnostic Test: Quantitative PCR SARS-CoV-2Diagnostic Test: IgM and IgG dosageDiagnostic Test: Screening Blood testsDiagnostic Test: ElectrocardiogramOther: NEWS-2 scoreOther: WHO scoreOther: Physical examinationOther: COVID-19-Related Symptoms assessment

Interventions

Covidir injectionsDRUG

administration of the investigational product CODIVIR/Placebo at a dose of 20 mg twice a day subcutaneously at visits Day0-Day6 (7 days total)

Also known as: Experimental drug administration
Codivir treatmentPlacebo treatment
Quantitative PCR SARS-CoV-2DIAGNOSTIC_TEST

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

Codivir treatmentPlacebo treatment
IgM and IgG dosageDIAGNOSTIC_TEST

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

Codivir treatmentPlacebo treatment
Screening Blood testsDIAGNOSTIC_TEST

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.

Codivir treatmentPlacebo treatment
ElectrocardiogramDIAGNOSTIC_TEST

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

Also known as: ECG
Codivir treatmentPlacebo treatment
NEWS-2 scoreOTHER

assessment of the participant by the NEWS-2 score.

Codivir treatmentPlacebo treatment
WHO scoreOTHER

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

Codivir treatmentPlacebo treatment
Physical examinationOTHER

evaluation by the principal investigator or assistant physician

Codivir treatmentPlacebo treatment
COVID-19-Related Symptoms assessmentOTHER

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

Codivir treatmentPlacebo treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 75 years
  • Male or female
  • SARS-CoV-2 infection indicated by confirmed RT-PCR test
  • Moderate hospitalized COVID-19 (at least two out of three criterias below):
  • Evidence of lower respiratory disease during clinical assessment (cough, fever, difficulty breathing) or imaging (X-rays)
  • Oxygen saturation (SpO2) in room air \< 93%
  • \<30 breaths per minute
  • No signs of hemodynamic decompensation
  • Absence of pregnancy in women of childbearing age
  • Ability to understand and comply with the requirements of the protocol
  • Consent to participate
  • Consent to use at least one highly effective contraception methods (condoms, IUD, oral contraceptives) since the ICF signature and at least 30 days after the study.

You may not qualify if:

  • Patients receiving oxygen supplementation except of nasal prongs, nasal intermittent positive pressure ventilation (NIPPV) or high flow nasal cannula (HFNC) that are allowed to be enrolled to the study).
  • Positive RT-PCR test more than 72 hours prior to enrolment.
  • Onset of symptoms more than 7 days prior to enrolment.
  • Participant using drugs that are under clinical investigation in last 30 days.
  • 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.
  • Vaccination for any other infection in the 4 weeks prior to enrolment.
  • 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 (5)

Hospital de Amor

Paulo Prata, Barretos/SP/BRA, 147844-000, Brazil

RECRUITING

Infection Control

Prado, Belo Horizonte/MG/BRA, 30.110-063, Brazil

RECRUITING

Instituto Lobus

Casa de Pedra, Volta Redonda/RJ/BRA, 27253-003, Brazil

RECRUITING

A2Z Clinical

Vila Martina, Volta Redonda/RJ/BRA, 13271-130, Brazil

RECRUITING

Casa de Saude

Centro, 13015-240, Brazil

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

ElectrocardiographyRestraint, Physical

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisBehavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
the study is a double-blind study: neither the participants nor the investigators will be aware of arm allocation of each study participant. Blindness is important to avoid bias. Monitoring and reporting of the success of blindness are important for the reader's confidence of the trial results. Groups should be marked by capital letter and blindness should maintain throughout the study.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2022

First Posted

February 1, 2022

Study Start

January 20, 2022

Primary Completion

December 20, 2024

Study Completion

July 20, 2025

Last Updated

October 2, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

BR(5)