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

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 intermittentpositive pressure ventilation (NIPPV) or high flow nasal cannula (HFNC) that areallowed 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, autoimmunediseases, liver, kidney or heart failure; another systemic disease and / orlaboratory abnormality, which, in the investigator's opinion, prevent the patientfrom 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 opinionof the investigator.