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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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2021-03-29
2021-08-09
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 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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Covidir
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.
Covidir injections
administration of the investigational product CODIVIR at a dose of 20 mg twice a day subcutaneously.
One Step Test
rapid test for the diagnosis of COVID-19 based on the detection of anti-SARS-CoV-2 in the blood.
IgM and IgG dosage
blood collection for dosage of Anti SARS-CoV-2 antibodies.
RT-PCR SARS-CoV-2
detection of viral RNA in nasopharyngeal and oropharyngeal samples by the Real Time Protein Chain Reaction technique.
Screening blood 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.
ECG
12-lead electrocardiogram with report.
Medical evaluation
evaluation 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.
Interventions
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Covidir injections
administration of the investigational product CODIVIR at a dose of 20 mg twice a day subcutaneously.
One Step Test
rapid test for the diagnosis of COVID-19 based on the detection of anti-SARS-CoV-2 in the blood.
IgM and IgG dosage
blood collection for dosage of Anti SARS-CoV-2 antibodies.
RT-PCR SARS-CoV-2
detection of viral RNA in nasopharyngeal and oropharyngeal samples by the Real Time Protein Chain Reaction technique.
Screening blood 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.
ECG
12-lead electrocardiogram with report.
Medical evaluation
evaluation 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male or female;
3. SARS-CoV-2 infection indicated by rapid test and confirmed by RT-PCR.
4. Mild or moderate COVID-19:
* The oxygen saturation in room air \>93%;
* \<30 breaths per minute;
5. No signs of hemodynamic decompensation.
6. Absence of pregnancy in women of childbearing age.
7. Able to understand and comply with the requirements of the protocol.
8. Consent to participate
Exclusion Criteria
2. Onset of symptoms or rapid test or positive RT-PCR for more than 72 hours of inclusion.
3. 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;
4. Body mass index less than 19.9 or greater than 35;
5. 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;
6. Concomitant HIV, HBV or HCV infection.
7. Pregnancy or lactation;
8. Participation in another clinical trial in the 12 months preceding inclusion;
9. Anti-COVID-19 vaccination at any time;
10. Vaccination for any other infection in the 4 weeks prior to inclusion;
11. Any condition that increases the risk of participating in the study, in the opinion of the investigator.
18 Years
60 Years
ALL
No
Sponsors
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Code Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Eynat Finkelshtein
Role: STUDY_DIRECTOR
Code Pharma
Locations
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Hospital Vera Cruz S A (Campinas-SP)
Campinas, State of São Paulo, Brazil
Countries
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Other Identifiers
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20-01-ZM
Identifier Type: -
Identifier Source: org_study_id