Efficacy and Safety of Polyoxidonium® in Hospitalized Patients With Coronavirus Disease COVID-19
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|ClinicalTrials.gov Identifier: NCT04381377|
Recruitment Status : Recruiting
First Posted : May 8, 2020
Last Update Posted : May 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Infections, Coronavirus||Drug: azoximer bromide Other: Placebo||Phase 2 Phase 3|
This is a multicenter prospective, randomized, double-blind, placebo-controlled, parallel-group phase 3 IIb\IIIa trial to evaluate the efficacy of Polyoxidonium®, lyophilizate for solution for injections and topical application, 6 mg over placebo in hospitalized patients with coronavirus disease (COVID-19). A study will last for 29±3 days (maximum) for each participant and will include: screening (days -1...1); treatment period (17 days in total, days 1...17) with the administration of the investigational product Polyoxidonium/placebo (intravenous injections for 3 days, then intramuscular injections for 14 days), assessment of the clinical status, recording of AEs; follow-up period (days 18...29±3).
Haematology and blood chemistry tests will be performed at day -1 and days 1,3, 8 ±1, 17±1.
Assessment of the clinical status according to the 7-point ordinal scale and according to the National Early Warning Score (NEWS) scale will be done every day during hospitalization from day 1 up to and including day 17 and at the follow-up on day 29±3.
The safety and tolerability will be evaluated throughout the study (from signing the Informed Consent Form to the study completion visit).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||394 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Multi-centre, Adaptive, Randomized, Double-blind, Placebo-controlled Comparative Clinical Study of the Safety and Efficacy of Polyoxidonium®, Lyophilizate for Solution for Injections and Topical Application, 6 mg (NPO Petrovax Pharm LLC, Russia) in Patients With Coronavirus Disease (COVID-19).|
|Actual Study Start Date :||April 29, 2020|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
Polyoxidonium will be administered in the dose of 12 mg (contents of 2 vials) once daily intravenously (IV) for 3 days, then every other day intramuscularly (IM) on days 5-17 (the total treatment course is 10 injections).
Drug: azoximer bromide
Investigational medicinal product
Other Name: Polyoxidonium
Placebo Comparator: Placebo
Placebo will be administered (contents of 2 vials) once daily intravenously (IV) for 3 days, then every other day intramuscularly (IM) on days 5-17 (the total treatment course is 10 injections).
- Clinical status of the patient (according to 7-point ordinal scale) [ Time Frame: Day 15 ]The primary efficacy outcome will be defined based on the blinded analysis of data of the first 100 patients in the 1st part of the study. There is uncertainty about the clinical course and potential different trajectories according to baseline disease severity, so the day of the primary endpoint may be modified based on a blinded evaluation of the primary efficacy outcome in various days.
- Clinical status of the patient (according to 7-point ordinal scale) [ Time Frame: Clinical status of the patient and the average change in the ordinal scale from baseline, both on days 3, 5, 8, 11, 29. ]Time to improvement by one category from admission on the ordinal scale. Clinical status of the patient. Average change in the ordinal scale from baseline.
- NEWS [ Time Frame: Change in NEWS from baseline on days 3, 5, 8, 11, 15, 29. ]
The time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first.
Change in NEWS from baseline.
- Oxygenation [ Time Frame: Oxygenation free days in the first 28 days (to day 29). Incidence and duration of new oxygen use during the study. ]Oxygenation free days. Incidence and duration of new oxygen use.
- Mechanical Ventilation [ Time Frame: Ventilator free days in the first 28 days (to day 29). Incidence and duration of new mechanical ventilation use during the trial. ]Ventilator free days. Incidence and duration of new mechanical ventilation use.
- Mortality [ Time Frame: 28-day mortality ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04381377
|Contact: Nikolay Dodonov||+7 (495) 730-75-45 ext firstname.lastname@example.org|
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|Nizhny Novgorod, Russian Federation, 603022|
|Contact: E. G. Tikhomolova +7-831-2882-32-72 email@example.com|
|Federal State Budgetary Educational Institution of Higher Education "Orenburg State Medical University" of the Ministry of Health of the Russian Federation||Not yet recruiting|
|Orenburg, Russian Federation, 460000|
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|Saint Petersburg, Russian Federation, 197022|
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|Contact: I. G. Sitnikov|
|Principal Investigator:||Jean-Francois Rossi, Professor||University of Montpellier (Faculté de Médecine) and Institute Sainte Catherine|