Efficacy and Safety of Polyoxidonium® in Hospitalized Patients With Coronavirus Disease COVID-19
- Conditions
- Infections, Coronavirus
- Registration Number
- NCT04381377
- Lead Sponsor
- NPO Petrovax
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 394
Inclusion Criteria:<br><br> 1. Male and female patients from 18 to 85 years of age.<br><br> 2. The patient (or his/her legal representative, if the patient is not able to sign the<br> form) signed an Informed Consent form for participation in this study before any<br> initiation of any study procedures.<br><br> 3. The patient can understand all protocol requirements, perform the study procedures,<br> and agree to all limitations specified in the protocol.<br><br> 4. Confirmed diagnosis of coronavirus disease (COVID-19): laboratory-confirmed<br> SARS-CoV-2 infection as determined by PCR, or other commercial or public health<br> assay in any specimen < 14 days prior to randomization.<br><br> 5. Illness (coronavirus disease COVID-19) of any duration, and at least one of the<br> following:<br><br> - Radiographic/tomographic chest infiltrates by imaging (chest x-ray, CT scan,<br> etc.), OR<br><br> - Evidence of rales/crackles on clinical exam AND SpO2 = 94% on room air, OR<br><br> - Indications for mechanical ventilation and/or supplemental oxygen.<br><br> 6. Agrees to use adequate contraception methods (the methods with at least 90% efficacy<br> include non-hormonal intrauterine devices; condom with intravaginal spermicide;<br> cervical caps<br><br>Exclusion Criteria:<br><br> 1. History of clinically significant allergic reactions.<br><br> 2. Hypersensitivity and/or intolerability to any ingredient of the investigational<br> product or placebo.<br><br> 3. Anticipated transfer to another hospital which is not a study centre within the next<br> 72 hours.<br><br> 4. Acute or chronic renal failure.<br><br> 5. History of HIV infection, tuberculosis.<br><br> 6. Conditions associated with primary immunodeficiency.<br><br> 7. Concomitant use of cytostatic medications to treat a concomitant disease.<br><br> 8. Systemic connective tissue diseases.<br><br> 9. Need for the prohibited medications.<br><br> 10. Administration of medications that are prohibited or unauthorized by the protocol<br> within 2 weeks before the expected randomization date.<br><br> 11. History of alcohol or drug dependence.<br><br> 12. History of malignant tumours of any location with remission for less than 2 years.<br><br> 13. History of psychic (including depressive) disorders, physical and other factors that<br> do not allow for adequate self-assessment of one's behaviour and for compliance with<br> the protocol requirements, including history of psychiatric disorders.<br><br> 14. Pregnancy or breastfeeding.<br><br> 15. Intravenous injections and/or sampling of the required amount of blood is not<br> possible.<br><br> 16. Positive pregnancy test (in patients with childbearing potential).<br><br> 17. Participation in any clinical study within 3 months before enrolment in this study.<br><br> 18. History of any condition that the study doctor considers significant enough to<br> prevent enrolment of this patient.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical status of the patient (according to 7-point ordinal scale)
- Secondary Outcome Measures
Name Time Method Clinical status of the patient (according to 7-point ordinal scale);NEWS;Oxygenation;Mechanical Ventilation;Mortality