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