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 | NCT04393246 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Aug. 1, 2023, 4 p.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Aug. 1, 2023, 4 p.m. Source : ClinicalTrials.gov |
None |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-05-19 |
|
Recruitment status
Last imported at : Aug. 1, 2023, 4 p.m. Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Aug. 1, 2023, 4 p.m. Source : ClinicalTrials.gov |
general inclusion criteria: be aged 18 and over have clinical picture strongly suggestive of covid-19-related disease (with/without positive covid-19 test) and risk count (as defined below) >3 or risk count ≥3 if it includes "radiographic severity score >3" be hospitalized or eligible for hospitalization on clinical grounds be considered an appropriate subject for intervention with immunomodulatory or other disease modifying agents in the opinion of the investigator is able to swallow capsules/tablets general |
|
Exclusion criteria
Last imported at : June 12, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
- inability to supply direct informed consent from patient or from next of kin or independent healthcare provider on behalf of patient - invasive mechanical ventilation at time of screening - contraindications to study drugs, including hypersensitivity to the active substances or any of the excipients - currently on any of the study investigational medicinal products - concurrent participation in an interventional clinical trial (observational studies allowed) - patient moribund at presentation or screening - pregnancy at screening - unwilling to stop breastfeeding during treatment period - known severe hepatic impairment (with or without cirrhosis) - requiring dialysis cockcroft gault estimated creatinine clearance < 30 ml /min/1.73m2 at screening - inability to swallow at screening visit - any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the patient ineligible for inclusion because of a safety concern. edp1815-specific |
|
Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
3 |
|
Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Cambridge University Hospitals NHS Foundation Trust |
|
Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
|
Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
United Kingdom |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
No restriction on type of patients |
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
0: No restriction on type of patients |
|
Total sample size
Last imported at : Aug. 1, 2023, 4 p.m. Source : ClinicalTrials.gov |
454 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Time to incidence of the composite endpoint of: Death, Mechanical ventilation, ECMO, Cardiovascular organ support, or Renal failure |
|
Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 2/Phase 3 |
|
Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1407, "treatment_name": "Ambrisentan+dapagliflozin", "treatment_type": "Cardiovascular agents+metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 445, "treatment_name": "Edp1815", "treatment_type": "Anti-inflammatories", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |