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

NCT05218356 · tracked via the Priya Life Science Brazil tracker

Sponsor

Code Pharma

Phase

Phase 2

Started

2022-01-20

Last updated

2024-10-02

Condition(s) studied

COVID-19

Investigational drug(s) / intervention(s)

Covidir injectionsQuantitative PCR SARS-CoV-2IgM and IgG dosageScreening Blood testsElectrocardiogramNEWS-2 scoreWHO scorePhysical examinationCOVID-19-Related Symptoms assessment

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)

Quantitative PCR SARS-CoV-2: detection of viral RNA in nasopharyngeal and oropharyngeal samples by the Real Time Protein Chain Reaction technique.

IgM and IgG dosage: lood collection for dosage of Anti SARS-CoV-2 antibodies.

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.

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

NEWS-2 score: assessment of the participant by the NEWS-2 score.

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

Physical examination: evaluation by the principal investigator or assistant physician

COVID-19-Related Symptoms assessment: will be completed by the study staff member based on patient status and answers.

Study 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

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Change in World Health Organization Ordinal Scale for clinical improvement — up to 28 days
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

Trial sites (5)

Facility	City	Region	Status
Hospital de Amor	Paulo Prata	Barretos/SP/BRA	Recruiting
Infection Control	Prado	Belo Horizonte/MG/BRA	Recruiting
Instituto Lobus	Casa de Pedra	Volta Redonda/RJ/BRA	Recruiting
A2Z Clinical	Vila Martina	Volta Redonda/RJ/BRA	Recruiting
Casa de Saude	Centro	Brazil	Recruiting

More Code Pharma trials in Brazil

Clinical Trial to Evaluate the Efficacy and Safety of Codivir® in Addition to Standard Antiretroviral Treatment for HIV Infection in Antiretroviral-naïve Participants Recruiting

Other trials for the same condition

Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV) Recruiting

The Role of BCG Vaccine in the Clinical Evolution of COVID-19 and in the Efficacy of Anti-SARS-CoV-2 Vaccines Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05218356 on ClinicalTrials.gov ↗ ← All trials in Brazil