Study of Codivir in Patients With COVID-19
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): 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
Intervention type(s): Drug; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): 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.; 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.
Other intervention name(s): Experimental drug administration; Covid-19 test; Blood test; Covid-19 test; Blood test; Electrocardiogram; Physical examination
Intervention model: Single Group Assignment
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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Corona; Coronavirus; COVID-19; SARS-CoV-2