Phase IIa Randomized Placebo Controlled Clinical Study of Codivir in Hospitalized Patients With Moderate COVID-19

• Status: Recruiting
• Trial end date: 2023-07-20
• Target enrollment: 0
• Participant gender: All

Summary

This is a double-blind, multicentre, multinational study to evaluate the safety and collect preliminary efficacy data of Codivir drug product in 130 hospitalized adults with moderate COVID-19 symptoms. COVID-19 symptoms (fever, cough, myalgia and changes in smell or taste) onset must be within 7 days prior enrolment. Treatment will begin in the hospital, participants will be discharged according to medical decision and continue the treatment until to Day 7 at home and followed up to day 28.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Code Pharma

Criteria

Inclusion Criteria:

• Age between 18 and 75 years

• Male or female

• SARS-CoV-2 infection indicated by confirmed RT-PCR test

• Moderate hospitalized COVID-19 (at least two out of three criterias below):

• Evidence of lower respiratory disease during clinical assessment (cough, fever, difficulty breathing) or imaging (X-rays)

• Oxygen saturation (SpO2) in room air < 93%

• <30 breaths per minute

• No signs of hemodynamic decompensation

• Absence of pregnancy in women of childbearing age

• Ability to understand and comply with the requirements of the protocol

• Consent to participate

• Consent to use at least one highly effective contraception methods (condoms, IUD, oral contraceptives) since the ICF signature and at least 30 days after the study.

Exclusion Criteria:

• Patients receiving oxygen supplementation except of nasal prongs, nasal intermittent positive pressure ventilation (NIPPV) or high flow nasal cannula (HFNC) that are allowed to be enrolled to the study).

• Positive RT-PCR test more than 72 hours prior to enrolment.

• Onset of symptoms more than 7 days prior to enrolment.

• Participant using drugs that are under clinical investigation in last 30 days.

• 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.

• Vaccination for any other infection in the 4 weeks prior to enrolment.

• Any condition that increases the risk of participating in the study, in the opinion of the investigator.