NCT04930861

Study of Codivir in Patients With COVID-19

Phase 1 Clinical Study of Codivir in Outpatients With COVID-19

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Code Pharma · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Covidir injections	administration of the investigational product CODIVIR at a dose of 20 mg twice a day subcutaneously.
DIAGNOSTIC_TEST	One Step Test	rapid test for the diagnosis of COVID-19 based on the detection of anti-SARS-CoV-2 in the blood.
DIAGNOSTIC_TEST	IgM and IgG dosage	blood collection for dosage of Anti SARS-CoV-2 antibodies.
DIAGNOSTIC_TEST	RT-PCR SARS-CoV-2	detection of viral RNA in nasopharyngeal and oropharyngeal samples by the Real Time Protein Chain Reaction technique.
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	ECG	12-lead electrocardiogram with report.
DIAGNOSTIC_TEST	Medical evaluation	evaluation by the principal investigator or assistant physician with a complete physical examination.
DIAGNOSTIC_TEST	NEWS-2 score	assessment of the participant by the NEWS-2 score.
DIAGNOSTIC_TEST	WHO score	assessment of the participant by the score of the World Health Organization.

Timeline

• Start date: 2021-03-29
• Primary completion: 2021-05-27
• Completion: 2021-08-09
• First posted: 2021-06-18
• Last updated: 2021-11-02

Locations

1 site across 1 country: Brazil