Covid19
Conditions
Keywords
Corona, Coronavirus, COVID-19, SARS-CoV-2
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.
Interventions
administration of the investigational product CODIVIR at a dose of 20 mg twice a day subcutaneously.
DIAGNOSTIC_TESTOne Step Test
rapid test for the diagnosis of COVID-19 based on the detection of anti-SARS-CoV-2 in the blood.
DIAGNOSTIC_TESTIgM and IgG dosage
blood collection for dosage of Anti SARS-CoV-2 antibodies.
DIAGNOSTIC_TESTRT-PCR SARS-CoV-2
detection of viral RNA in nasopharyngeal and oropharyngeal samples by the Real Time Protein Chain Reaction technique.
DIAGNOSTIC_TESTScreening 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.
DIAGNOSTIC_TESTECG
12-lead electrocardiogram with report.
DIAGNOSTIC_TESTMedical evaluation
evaluation by the principal investigator or assistant physician with a complete physical examination.
DIAGNOSTIC_TESTNEWS-2 score
assessment of the participant by the NEWS-2 score.
DIAGNOSTIC_TESTWHO score
assessment of the participant by the score of the World Health Organization.
Sponsors
Code Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 60 years; 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
1. Participants in need of O2 supplementation by catheter or mask, invasive mechanical ventilation, or vasopressors. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events related to the investigational product. | 28 days |
Secondary
| Measure | 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 |
| RT-PCR negative. | up to 28 days |
| Evolution of IgM & IgG Anti-SARS-CoV-2. | up to 28 days |
Countries
Brazil
Outcome results
None listed