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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
administration of the investigational product CODIVIR at a dose of 20 mg twice a day subcutaneously.
rapid test for the diagnosis of COVID-19 based on the detection of anti-SARS-CoV-2 in the blood.
blood collection for dosage of Anti SARS-CoV-2 antibodies.
Hospital Vera Cruz S A (Campinas-SP)
Campinas, State of São Paulo, Brazil
Incidence and severity of adverse events related to the investigational product.
Time frame: 28 days
Clinical evolution according to the score of the World Health Organization between admission and days 10 and 28.
Time frame: up to 28 days
Clinical evolution according to NEWS2 score between admission and days 10 and 28.
Time frame: up to 28 days
RT-PCR negative.
Time frame: up to 28 days
Evolution of IgM & IgG Anti-SARS-CoV-2.
Time frame: up to 28 days
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detection of viral RNA in nasopharyngeal and oropharyngeal samples by the Real Time Protein Chain Reaction technique.
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.
12-lead electrocardiogram with report.
evaluation by the principal investigator or assistant physician with a complete physical examination.
assessment of the participant by the NEWS-2 score.
assessment of the participant by the score of the World Health Organization.