Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Covidir | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Covidir injections | Drug | administration of the investigational product CODIVIR at a dose of 20 mg twice a day subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events related to the investigational product. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical evolution according to the score of the World Health Organization between admission and days 10 and 28. | up to 28 days | |
| Clinical evolution according to NEWS2 score between admission and days 10 and 28. | up to 28 days |
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eynat Finkelshtein | Code Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Vera Cruz S A (Campinas-SP) | Campinas | State of São Paulo | 13092-108 | Brazil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| D000087123 | COVID-19 Nucleic Acid Testing |
| D004562 | Electrocardiography |
| D010808 | Physical Examination |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| One Step Test | Diagnostic 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 | Diagnostic Test | blood collection for dosage of Anti SARS-CoV-2 antibodies. |
|
|
| RT-PCR SARS-CoV-2 | Diagnostic Test | detection of viral RNA in nasopharyngeal and oropharyngeal samples by the Real Time Protein Chain Reaction technique. |
|
|
| Screening blood test | Diagnostic 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 | Diagnostic Test | 12-lead electrocardiogram with report. |
|
|
| Medical evaluation | Diagnostic Test | evaluation by the principal investigator or assistant physician with a complete physical examination. |
|
|
| NEWS-2 score | Diagnostic Test | assessment of the participant by the NEWS-2 score. |
|
| WHO score | Diagnostic Test | assessment of the participant by the score of the World Health Organization. |
|
| RT-PCR negative. | up to 28 days |
| Evolution of IgM & IgG Anti-SARS-CoV-2. | up to 28 days |
| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000086742 | COVID-19 Testing |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D004568 | Electrodiagnosis |