v3.0.7
Please consider this website is continuously evolving and still under development
to harmonize automatic data extraction and integrate manual data annotation.
| Column | Value |
|---|---|
| Trial registration number | NCT04682873 |
|
Full text link
Last imported at : Dec. 26, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
Clinical Enquiry Manager, Farmak-Clinical-Affairs@regenold.com (PI email not reported) |
|
Registration date
Last imported at : Dec. 26, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
2020-12-24 |
|
Recruitment status
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : Dec. 26, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Dec. 26, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Dec. 26, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : Dec. 26, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : Dec. 26, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : Dec. 26, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: each subject must meet all of the following inclusion criteria to be randomized to treatment: willing and able to provide written informed consent aged ≥ 18 years sars-cov-2 infection confirmed by pcr ≤ 4 days before randomization currently hospitalized due to sars-cov-2 infection with fever, defined as body temperature ≥ 37.8 °c modified world health organization (who) ordinal scale for clinical status patient state in covid-19: score 4 i.e. hospitalized, virus-positive, oxygen by mask or nasal prongs |
|
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
the subject is excluded from the trial if any of the following criteria apply: concurrent treatment with other agents with actual or possible direct acting antiviral activity against sars-cov-2 is prohibited < 24 hours prior to start of imp treatment requiring mechanical ventilation at screening or it is expected within 24 h after inclusion expected survival time < 72 hours for any reason positive pregnancy test breastfeeding woman presence of renal dysfunction defined as estimated glomerular filtration rate (egfr) <60 ml/min, total bilirubin ≥ 2.0 mg/dl, thyroid stimulating hormone (tsh) outside normal range and / or aspartate aminotransferase (asat)/ alanine aminotransferase (alat) above threefold upper limit of normal range (known from patients medical history) known hypersensitivity to the trial drug, the metabolites, or formulation excipient history or presence of drug or alcohol abuse history or presence of diseases of thyroid gland |
|
Number of arms
Last imported at : Dec. 26, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Dec. 26, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Joint Stock Company "Farmak" |
|
Inclusion age min
Last imported at : Dec. 26, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Dec. 26, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
99 |
|
Countries
Last imported at : Dec. 26, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Ukraine |
|
Type of patients
Last imported at : Dec. 26, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Moderate disease at enrollment |
|
Severity scale
Last imported at : Dec. 26, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
3: Moderate disease at enrollment |
|
Total sample size
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
592 |
|
primary outcome
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
Efficacy - Time from day of randomization to an improvement of at least two points (from the status at randomization) on severity rating (SR) scale in days |
|
Notes
Last imported at : Dec. 26, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : Dec. 26, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 461, "treatment_name": "Enisamium", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |