Community acquired pneumonia with suspected or confirmed SARS-CoV-2 infection MedDRA version: 20.1 Level: LLT Classification code 10066724 Term: Acute pneumonia System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.1 Level: LLT Classification code 10010120 Term: Community acquired pneumonia System Organ Class: 10021881 - Infections and infestations MedDRA version: 23.0 Level: PT Classification code 10084380 Term: COVID-19 pneumonia System Organ Class: 10021881 - Infect
Conditions
Interventions
Product Name: Sulforadex
Product Code: SFX-01
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Sulforadex
CAS Number: 1039704-32-9
Current Sponsor code: SFX-01
Other descriptive name: Sulforaph
Sponsors
University of Dundee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 18 years of age or older • Community acquired pneumonia (defined as a new radiographic infiltrate on chest x-ray or CT scan in a patient presenting with respiratory symptoms both of which are clinically evident less than 48 hours after hospitalization). • Tested for suspected SARS-CoV-2 infection via RT-PCR or another approved laboratory method* • Increased risk of mortality on admission (defined by CURB65 score greater than or equal to 1 or the presence of bilateral radiographic infiltrates) • Treatment can be commenced within 96 hours of hospital admission • Requires hospitalisation but NOT requiring mechanical ventilation at randomization • Participant (or legally authorized representative) provides written informed consent • Able to take oral medication at randomisation • Participant (or legally authorised representative) understands and agrees to comply with planned trial procedures. *for the avoidance of doubt, this trial permits inclusion of patients presenting with acute respiratory infections whether or not the test for SARS-CoV-2 is positive. Patients can be randomised to the study while awaiting the results of the test for SARS-CoV-2. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 180
Exclusion criteria
Exclusion criteria: • Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than 5 times the upper limit of normal, result within 72 hours of randomization (the result closest to randomization should be used if several results are available). • Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR less than 30), result within 72 hours of randomization (the result closest to randomization should be used if several results are available) • Pregnant or breast feeding. • Anticipated transfer to another hospital which is not a trial site within 24 hours. • Hospital-acquired pneumonia (defined as onset of respiratory illness more than 48 hours after admission to hospital) • Allergy to SFX-01 • Patients in whom active treatment is not considered appropriate. • Use of any investigational drug within five times of the elimination half-life after the last trial dose or within 30 days, whichever is longer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effectiveness of a new drug, SFX-01, against placebo for treating patients with suspected COVID19 respiratory infection. ;Secondary Objective: To measure the safety of the new drug, SFX-01, when used to treat patients with suspected COVID19 respiratory infection. To explore the mechanism by which the new drug is having its effects. ;Primary end point(s): Clinical status on 7-point ordinal scale: 1. Not hospitalised, no limitations on activities 2. Not hospitalised, limitation on activities; 3. Hospitalised, not requiring supplemental oxygen; 4. Hospitalised, requiring supplemental oxygen; 5. Hospitalised, on non-invasive ventilation or high flow oxygen devices; 6. Hospitalised, on invasive mechanical ventilation or ECMO (Extracorporeal membrane oxygenation) 7. Death.;Timepoint(s) of evaluation of this end point: Day 15 (where day 1 is the first day of treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical Severity; Time to an improvement of one category from admission using 7-point ordinal scale. Daily whilst hospitalised Participant clinical status on 7-point ordinal scale. Days 3, 5, 8, 11, 15 and 29. Participant change from baseline on 7-point ordinal scale. Day 15. Proportion of participants showing improvement on 7-point ordinal scale. Day 15. Mean change in the 7-point ordinal scale. Baseline to days 3, 5, 8, 11, 15 and 29 NEWS; Time to discharge or to a NEWS of = 2 and maintained for 24 hours, whichever occurs first Change from baseline Days 8, 15, 29 Oxygenation; Oxygen free days 0-29 days Incidence and duration of new oxygen use during the trial 0-29 days Mechanical Ventilation: Ventilator free days 0-29 days Incidence and duration of new mechanical ventilation use during the trial 0-29 days. Duration of hospitalisation; date of admission and discharge 15day and 28day mortality; date of death Cumulative incidence of serious Adverse events (SAEs) 0-29 days Discontinuation or temporary suspension of treatment 0-29 days ;Timepoint(s) of evaluation of this end point: See above | — |
Countries
United Kingdom
Contacts
Public ContactJames Chalmers
University of Dundee
Outcome results
None listed