A Phase 2/3 interventional study of azoximer bromide and Placebo in Infections, Coronavirus, sponsored by NPO Petrovax. Completed at 14 sites in 2 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-08-23.
Sponsored by NPO Petrovax · Phase 2/3, Interventional, and Treatment
The purpose of this study is to demonstrate the superiority of Polyoxidonium®, lyophilizate for solution for injections and topical application, 6 mg over placebo in hospitalized patients with coronavirus disease (COVID-19). This is a multicentre prospective, randomized, double-blind, placebo-controlled, parallel-group phase IIb\IIIa clinical trial.
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).
952 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.
This study's enrollment of 394 is above the median of 110 across 549 interventional studies indexed under Coronavirus Infections.
Browse Coronavirus Infections studies →NPO Petrovax is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
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Illness (coronavirus disease COVID-19) of any duration, and at least one of the following:
Exclusion Criteria:
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
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).
Other: Placebo
Investigational medicinal product
Also known as: Polyoxidonium
Placebo
Clinical status of the patient (according to 7-point ordinal scale)
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.
Time frame: Day 15
Clinical status of the patient (according to 7-point ordinal scale)
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.
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.
NEWS
The time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first. Change in NEWS from baseline.
Time frame: Change in NEWS from baseline on days 3, 5, 8, 11, 15, 29.
Oxygenation
Oxygenation free days. Incidence and duration of new oxygen use.
Time frame: Oxygenation free days in the first 28 days (to day 29). Incidence and duration of new oxygen use during the study.
Mechanical Ventilation
Ventilator free days. Incidence and duration of new mechanical ventilation use.
Time frame: Ventilator free days in the first 28 days (to day 29). Incidence and duration of new mechanical ventilation use during the trial.
Mortality
Time frame: 28-day mortality
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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NPO Petrovax