Back to resultsStudy of Codivir in Patients With COVID-19 (Codivir)
Primary Purpose
Covid19
Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Covidir injections
One Step Test
IgM and IgG dosage
RT-PCR SARS-CoV-2
Screening blood test
ECG
Medical evaluation
NEWS-2 score
WHO score
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring Corona, Coronavirus, COVID-19, SARS-CoV-2
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Participants in need of O2 supplementation by catheter or mask, invasive mechanical ventilation, or vasopressors.
- Onset of symptoms or rapid test or positive RT-PCR for more than 72 hours of inclusion.
- Participants in use or expected to use within 24 hours prior to the inclusion of drugs that are under clinical investigation as a therapeutic option for the treatment of COVID-19 (eg hydroxychloroquine, chloroquine, ivermectin, nitazoxanide, among others) during the study period;
- 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;
- Participation in another clinical trial in the 12 months preceding inclusion;
- Anti-COVID-19 vaccination at any time;
- Vaccination for any other infection in the 4 weeks prior to inclusion;
- Any condition that increases the risk of participating in the study, in the opinion of the investigator.
Sites / Locations
- Hospital Vera Cruz S A (Campinas-SP)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Covidir
Arm Description
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.
Outcomes
Primary Outcome Measures
Incidence and severity of adverse events related to the investigational product.
Secondary Outcome Measures
Clinical evolution according to the score of the World Health Organization between admission and days 10 and 28.
Clinical evolution according to NEWS2 score between admission and days 10 and 28.
RT-PCR negative.
Evolution of IgM & IgG Anti-SARS-CoV-2.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04930861
Brief Title
Study of Codivir in Patients With COVID-19
Acronym
Codivir
Official Title
Phase 1 Clinical Study of Codivir in Outpatients With COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
March 29, 2021 (Actual)
Primary Completion Date
May 27, 2021 (Actual)
Study Completion Date
August 9, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Code Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Eligible participants who agree to participate will be submitted to safety assessments, an RT-PCR and a quick test for COVID-19. Everyone will receive the treatments indicated for their case, except for other investigational medications. Codivir will be administered in addition to these treatments at a dose of 20 mg SC twice daily for 10 days. Participants will remain hospitalized for the first 3 days.
If they have progressed well, they will continue the treatment up to Day 10 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Corona, Coronavirus, COVID-19, SARS-CoV-2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Covidir
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Covidir injections
Other Intervention Name(s)
Experimental drug administration
Intervention Description
administration of the investigational product CODIVIR at a dose of 20 mg twice a day subcutaneously.
Intervention Type
Diagnostic Test
Intervention Name(s)
One Step Test
Other Intervention Name(s)
Covid-19 test
Intervention Description
rapid test for the diagnosis of COVID-19 based on the detection of anti-SARS-CoV-2 in the blood.
Intervention Type
Diagnostic Test
Intervention Name(s)
IgM and IgG dosage
Other Intervention Name(s)
Blood test
Intervention Description
blood collection for dosage of Anti SARS-CoV-2 antibodies.
Intervention Type
Diagnostic Test
Intervention Name(s)
RT-PCR SARS-CoV-2
Other Intervention Name(s)
Covid-19 test
Intervention Description
detection of viral RNA in nasopharyngeal and oropharyngeal samples by the Real Time Protein Chain Reaction technique.
Intervention Type
Diagnostic Test
Intervention Name(s)
Screening blood test
Other Intervention Name(s)
Blood test
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
ECG
Other Intervention Name(s)
Electrocardiogram
Intervention Description
12-lead electrocardiogram with report.
Intervention Type
Diagnostic Test
Intervention Name(s)
Medical evaluation
Other Intervention Name(s)
Physical examination
Intervention Description
evaluation by the principal investigator or assistant physician with a complete physical examination.
Intervention Type
Diagnostic Test
Intervention Name(s)
NEWS-2 score
Intervention Description
assessment of the participant by the NEWS-2 score.
Intervention Type
Diagnostic Test
Intervention Name(s)
WHO score
Intervention Description
assessment of the participant by the score of the World Health Organization.
Primary Outcome Measure Information:
Title
Incidence and severity of adverse events related to the investigational product.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Clinical evolution according to the score of the World Health Organization between admission and days 10 and 28.
Time Frame
up to 28 days
Title
Clinical evolution according to NEWS2 score between admission and days 10 and 28.
Time Frame
up to 28 days
Title
RT-PCR negative.
Time Frame
up to 28 days
Title
Evolution of IgM & IgG Anti-SARS-CoV-2.
Time Frame
up to 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Participants in need of O2 supplementation by catheter or mask, invasive mechanical ventilation, or vasopressors.
Onset of symptoms or rapid test or positive RT-PCR for more than 72 hours of inclusion.
Participants in use or expected to use within 24 hours prior to the inclusion of drugs that are under clinical investigation as a therapeutic option for the treatment of COVID-19 (eg hydroxychloroquine, chloroquine, ivermectin, nitazoxanide, among others) during the study period;
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;
Participation in another clinical trial in the 12 months preceding inclusion;
Anti-COVID-19 vaccination at any time;
Vaccination for any other infection in the 4 weeks prior to inclusion;
Any condition that increases the risk of participating in the study, in the opinion of the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eynat Finkelshtein
Organizational Affiliation
Code Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Vera Cruz S A (Campinas-SP)
City
Campinas
State/Province
State Of São Paulo
ZIP/Postal Code
13092-108
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Codivir in Patients With COVID-19
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