Study of Codivir in Patients With COVID-19

• Status: Completed
• Trial end date: 2021-08-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Code Pharma
• Collaborator: Zion Medical

Criteria

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.