Study of Codivir in Patients With COVID-19

Code Pharma

Status and phase

Completed

Phase 1

Conditions

Covid19

Treatments

Diagnostic Test: Medical evaluation

Diagnostic Test: NEWS-2 score

Diagnostic Test: ECG

Diagnostic Test: Screening blood test

Diagnostic Test: IgM and IgG dosage

Drug: Covidir injections

Diagnostic Test: RT-PCR SARS-CoV-2

Diagnostic Test: One Step Test

Diagnostic Test: WHO score

Study type

Interventional

Funder types

Industry

Identifiers

NCT04930861

20-01-ZM

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age between 18 and 60 years;
Male or female;
SARS-CoV-2 infection indicated by rapid test and confirmed by RT-PCR.
Mild or moderate COVID-19:
- The oxygen saturation in room air >93%;
- <30 breaths per minute;
No signs of hemodynamic decompensation.
Absence of pregnancy in women of childbearing age.
Able to understand and comply with the requirements of the protocol.
Consent to participate

Exclusion criteria

Participants in need of O2 supplementation by catheter or mask, invasive mechanical ventilation, or vasopressors.
Onset of symptoms or rapid test or positive RT-PCR for more than 72 hours of inclusion.
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;
Body mass index less than 19.9 or greater than 35;
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;
Concomitant HIV, HBV or HCV infection.
Pregnancy or lactation;
Participation in another clinical trial in the 12 months preceding inclusion;
Anti-COVID-19 vaccination at any time;
Vaccination for any other infection in the 4 weeks prior to inclusion;
Any condition that increases the risk of participating in the study, in the opinion of the investigator.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

Covidir

Experimental group

Description:

Patient (adults aged ≥18 years) with mild or moderate COVID-19 and flu-symptoms onset within 72 hours prior to inclusion. Treatment begins at the hospital. On the 4th day, participants who are well will be discharged and continue treatment up to Day 10 at home. All participants will receive Codivir 20 mg SC 2 x daily.

Treatment: