Phase IIa Randomized Placebo Controlled Clinical Study of Codivir in Hospitalized Patients with Moderate COVID-19
Code Pharma
130 participants
Jan 20, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria12
- 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 Criteria10
- 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.
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Interventions
administration of the investigational product CODIVIR/Placebo at a dose of 20 mg twice a day subcutaneously at visits Day0-Day6 (7 days total)
detection of viral RNA in nasopharyngeal and oropharyngeal samples by the Real Time Protein Chain Reaction technique.
lood collection for dosage of Anti SARS-CoV-2 antibodies.
omplete blood count, urea, creatinine, uric acid, sodium, potassium, chloride, calcium, glucose, glycated hemoglobin, alkaline phosphatase (FA), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubins and fractions ( BTF), total proteins and fractions (PTF), lipid profile (total cholesterol, fractions and triglycerides); coagulogram (TP, aPTT); D-dimer; C-reactive protein; HIV, HBV, HCV serology; Ferritin; troponin, fibrinogen,Coagulogram (TP, aPTT); D-dimer, Pregnancy test for non-sterile women.
valuation by the principal investigator or assistant physician with a complete physical examination
assessment of the participant by the NEWS-2 score.
assessment of the participant by the score of the World Health Organization.
evaluation by the principal investigator or assistant physician
will be completed by the study staff member based on patient status and answers.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05218356