Phase IIa Randomized Placebo Controlled Clinical Study of Codivir in Hospitalized Patients with Moderate COVID-19
NCT ID: NCT05218356
Last Updated: 2024-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
130 participants
INTERVENTIONAL
2022-01-20
2025-07-20
Brief Summary
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Detailed Description
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If they have progressed well, they will continue the treatment up to Day 7 at home, receiving a nurse's home visit twice a day to administer Codivir and collect vital signs. Participants will be followed up to Day 28 by telemedicine. A doctor will call them periodically to monitor the clinical evolution, collect adverse events, concomitant medication and instruct the participants. In case of unfavorable evolution, the participants will remain hospitalized receiving the appropriate care. The investigator will decide whether or not the investigational medication will continue, considering the participant's health and well-being.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Codivir treatment
20 mg administrated by subcutaneous (SC) injection, twice a day, for 7 days
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.
Placebo treatment
Placebo administrated in subcutaneous (SC) injection, twice a day, for 7 days
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Code Pharma
INDUSTRY
Responsible Party
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Locations
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Hospital de Amor
Paulo Prata, Barretos/SP/BRA, Brazil
Infection Control
Prado, Belo Horizonte/MG/BRA, Brazil
Instituto Lobus
Casa de Pedra, Volta Redonda/RJ/BRA, Brazil
A2Z Clinical
Vila Martina, Volta Redonda/RJ/BRA, Brazil
Casa de Saude
Centro, , Brazil
Countries
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Facility Contacts
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Cesar Mauricio da Silva, Dr.
Role: backup
Carlos Ernesto Ferreira Starling, Dr.
Role: backup
Vicente Lopes da Silva Junior, Dr.
Role: backup
Dr. Ricardo Sobhie Diaz, Dr.
Role: backup
Other Identifiers
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CP-21-01
Identifier Type: -
Identifier Source: org_study_id
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