Study of Codivir in Patients With COVID-19

Covid19 Clinical Trial

— Codivir  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04930861
• Other study ID #: 20-01-ZM
• Status: Completed
• Phase: Phase 1
• Start date: March 29, 2021
• Est. completion date: August 9, 2021

Study information

• Verified date: November 2021
• Source: Code Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 9, 2021
• Est. primary completion date: May 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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.
• IgM and IgG dosage
blood collection for dosage of Anti SARS-CoV-2 antibodies.
• RT-PCR SARS-CoV-2
detection of viral RNA in nasopharyngeal and oropharyngeal samples by the Real Time Protein Chain Reaction technique.
• 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.
• ECG
12-lead electrocardiogram with report.
• Medical evaluation
evaluation by the principal investigator or assistant physician with a complete physical examination.
• NEWS-2 score
assessment of the participant by the NEWS-2 score.
• WHO score
assessment of the participant by the score of the World Health Organization.

Locations

Country	Name	City	State
Brazil	Hospital Vera Cruz S A (Campinas-SP)	Campinas	State Of São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Code Pharma

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events related to the investigational product.		28 days
Secondary	Clinical evolution according to the score of the World Health Organization between admission and days 10 and 28.		up to 28 days
Secondary	Clinical evolution according to NEWS2 score between admission and days 10 and 28.		up to 28 days
Secondary	RT-PCR negative.		up to 28 days
Secondary	Evolution of IgM & IgG Anti-SARS-CoV-2.		up to 28 days