A multi-centre, adaptive, randomized, double-blind, placebo-controlled comparative clinical study of the safety and efficacy of 12 mg Polyoxidonium®, lyophilizate solution for injections (NPO Petrovax Pharm LLC, Russia) in patients with coronavirus disease (COVID-19).

Phase 1

• Conditions: MedDRA version: 21.1Level: PTClassification code 10035737Term: Pneumonia viralSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001782-37-SK
• Lead Sponsor: PO Petrovax Pharm, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-15
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 464

Inclusion Criteria

1.Hospitalized (at the time of recruitment) male and female patients from 18 to 85 years of age.
2.The patient (or his/her legal representative, if the patient is not able to sign the form) signed an Informed Consent form for participation in this study before any initiation of any study procedures.
3.The patient (or his/her legal representative, if the patient is not able to sign the form) can understand all protocol requirements, perform the study procedures, and agree to all limitations specified in the protocol.
4.Confirmed diagnosis of coronavirus disease (COVID-19): laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen < 14 days prior to randomization.
5.Illness (coronavirus disease COVID-19) of any duration, and at least one of the following:
-Radiographic/tomographic chest infiltrates by imaging (chest x-ray, CT scan, etc.), OR
-Evidence of rales/crackles on clinical exam AND SpO2 = 94% on room air, OR
-Indications for mechanical ventilation and/or supplemental oxygen.
6.Agrees to use adequate contraception methods (the methods with at least 90% efficacy include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), condom with intravaginal spermicide, cervical caps with spermicide, diaphragms with spermicide, bilateral tubal occlusion, vasectomised partner) or complete sexual abstinence for the study period and within 30 days after completion of the study (applicable for male patients and women of childbearing potential).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 227
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 227

Exclusion Criteria

1.History of clinically significant allergic reactions.
2.Hypersensitivity and/or intolerability to any ingredient of the investigational product or placebo.
3.Anticipated transfer to another hospital which is not a study centre within the next 72 hours.
4.Acute or chronic renal failure.
5.History of HIV infection, tuberculosis.
6.Conditions associated with primary immunodeficiency, established by assessing the history and by interviewing the patient..
7.Concomitant use of medications cytostatic drugs (including but not limited to alkylating agents, platinum analogues, dna intercalating agents, anticancer antibiotics, mitosisinhibitors, taxanes, topoisomerase inhibitors, antimetabolites) to treat a concomitant disease.
8. Systemic connective tissue diseases.
9. Need for the prohibited medications that are not part of the locally/internationally approved treatment of COVID-19.
10. Administration of convalescent plasma or intravenous immunoglobulin (IVIg) for coronavirus disease COVID-19 therapy ever.
11. Administration of any live vaccine within 4 weeks before screening or intending to receive a live vaccine during the study.
12. Administration of medications that are prohibited or unauthorized by the protocol within 2 weeks before the expected randomization date.
13. Administration or intending to receive an extracorporeal blood purification (EBP) device to remove pro-inflammatory cytokines from the blood, such as a cytokine filtering or absorption device (for example, CytoSorb ®).
14. History of alcohol or drug dependence.
15. History of malignant tumours of any location with remission for less than 2 years.
16. History of psychic (including depressive) disorders, physical and other factors that do not allow for adequate self-assessment of one’s behaviour and for compliance with the protocol requirements, including history of psychiatric disorders.
17. Pregnancy or breastfeeding.
18. IV injections and/or sampling of the required amount of blood is not possible.
19. Positive pregnancy test (in patients with childbearing potential).
20. Participation in any clinical study within 30 days before enrolment in this study.
21. History of any condition that the study doctor considers significant enough to prevent enrolment of this patient.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified