Sponsor study identifier
Secondary identifiers
OTHER · Ministry of Health of Russia
interventional
100
1 country
6
Study Start
June 1, 2020
Actual (reported)Primary Completion
July 20, 2020
Actual (reported)Study Completion
July 20, 2020
Actual (reported)It is a multicenter, open-label, randomized, parallel-group study of the efficacy and safety of Tigerase® (GENERIUM JSC, Russia) with standard therapy versus standard therapy in patients with COVID-19.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 20, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2020
Actual (reported)July 3, 2020
Actual (reported)July 7, 2020
Actual (reported)July 20, 2020
Actual (reported)July 20, 2020
Actual (reported)The proportion of patients with mechanical ventilation
Day 8
Category change on WHO Ordinal Scale for Clinical Improvement
Day 8
The proportion of patients with mechanical ventilation
Day 28
Category change on WHO Ordinal Scale for Clinical Improvement
Best available care and Tigerase®/nebulised dornase alfa \[2.5 mg BID\] for 7 days
Patients will receive the usual care in accordance with good practice.
Nebulised dornase alfa \[2.5 mg BID\] for 7 days
Patients will receive the usual care in accordance with good practice.
City Clinical Hospital #15
Moscow, 111539, Russia
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow, 119991, Russia
City Clinical Hospital #51
Moscow, 121309, Russia
City Clinical Hospital #52
Moscow, 123182, Russia
N.V. Sklifosovsky Scientific Research Institute of First Aid
Moscow, 129090, Russia
Siberian State Medical University (SibMed)
Moscow, 634050, Russia
Oksana A. Markova, MD
AO GENERIUM
100 participants (actual enrollment reported by the registry).
First Submitted
July 3, 2020
First Posted
July 7, 2020
Study Start
June 1, 2020
Actual (reported)Primary Completion
BromhexIne And Spironolactone For CoronаVirUs Infection Requiring HospiTalization
Day 28
Proportion of patients surviving 28 days after inclusion in the study
Day 28
Number of days of oxygen therapy during the treatment period
Day 8
Change in C-reactive protein level
Days 3, 5, 8
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
July 20, 2020
Actual (reported)Study Completion
July 20, 2020
Actual (reported)Last Updated
October 14, 2020
Record last verified: 2020-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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