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azoximer bromideWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (3)

Name (Synonyms) Correlation
drug2189 Sample Collection/Performance Evaluation (A) Wiki 1.00
drug2190 Sample Collection/Performance Evaluation (B) Wiki 1.00
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 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).

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.

NCT04381377 Infections, Coronavirus Drug: azoximer bromide Other: Placebo
MeSH:Coronavirus Infections

Primary Outcomes

Description: 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.

Measure: Clinical status of the patient (according to 7-point ordinal scale)

Time: Day 15

Secondary Outcomes

Description: 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.

Measure: Clinical status of the patient (according to 7-point ordinal scale)

Time: Clinical status of the patient and the average change in the ordinal scale from baseline, both on days 3, 5, 8, 11, 29.

Description: The time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first. Change in NEWS from baseline.

Measure: NEWS

Time: Change in NEWS from baseline on days 3, 5, 8, 11, 15, 29.

Description: Oxygenation free days. Incidence and duration of new oxygen use.

Measure: Oxygenation

Time: Oxygenation free days in the first 28 days (to day 29). Incidence and duration of new oxygen use during the study.

Description: Ventilator free days. Incidence and duration of new mechanical ventilation use.

Measure: Mechanical Ventilation

Time: Ventilator free days in the first 28 days (to day 29). Incidence and duration of new mechanical ventilation use during the trial.

Measure: Mortality

Time: 28-day mortality

No related HPO nodes (Using clinical trials)