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Early reporting very likely imho.......Gla ;-)
E.5.1.1 Timepoint(s) of evaluation of this end point: Day 15 (where day 1 is the first day of treatment)
E.5.2 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
ps rebarm....hope that helps...;-))))
E.8.7 Trial has a data monitoring committee: No
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial: last day 29 for last participant
E.8.9 Initial estimate of the duration of the trial
E.8.9.1 In the Member State concerned years: 1
E.8.9.1 In the Member State concerned months: 1
E.8.9.1 In the Member State concerned days: 0
E.8.9.2 In all countries concerned by the trial years: 1
E.8.9.2 In all countries concerned by the trial months: 1
E.8.9.2 In all countries concerned by the trial days: 0
F. Population of Trial Subjects
F.1 Age Range
F.1.1 Trial has subjects under 18: No
F.1.1 Number of subjects for this age range: 0
F.1.1.1 In Utero: No
F.1.1.1.1 Number of subjects for this age range: 0
F.1.1.2 Preterm newborn infants (up to gestational age < 37 weeks): No
F.1.1.2.1 Number of subjects for this age range: 0
F.1.1.3 Newborns (0-27 days): No
F.1.1.3.1 Number of subjects for this age range: 0
F.1.1.4 Infants and toddlers (28 days-23 months): No
F.1.1.4.1 Number of subjects for this age range: 0
F.1.1.5 Children (2-11years): No
F.1.1.5.1 Number of subjects for this age range: 0
F.1.1.6 Adolescents (12-17 years): No
F.1.1.6.1 Number of subjects for this age range: 20
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
F.2 Gender
F.2.1 Female: Yes
F.2.2 Male: Yes
F.3 Group of trial subjects
F.3.1 Healthy volunteers: No
F.3.2 Patients: Yes
F.3.3 Specific vulnerable populations: No
F.3.3.1 Women of childbearing potential not using contraception : No
F.3.3.2 Women of child-bearing potential using contraception: No
F.3.3.3 Pregnant women: No
F.3.3.4 Nursing women: No
F.3.3.5 Emergency situation: No
F.3.3.6 Subjects incapable of giving consent personally: No
F.3.3.7 Others: No
F.4 Planned number of subjects to be included
F.4.1 In the member state: 300
F.4.2 For a multinational trial
F.4.2.1 In the EEA: 300
F.4.2.2 In the whole clinical trial: 300
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition): As the trial 14 day treatment is for for an acute illness it would not be
appropriate for participants to continue to receive their trial treatment after the end of the trial.
Trial treatment will not be made available to participants at the end of the trial.
G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
N. Review by the Competent Authority or Ethics Committee in the country concerned
N. Competent Authority Decision: Authorised
N. Date of Competent Authority Decision: 2020-09-04
N. Ethics Committee Opinion of the trial application: Favourable
N. Ethics Committee Opinion: Reason(s) for unfavourable opinion:
N. Date of Ethics Committ
5. Hospitalised, on non-invasive ventilation or high flow oxygen devices;
6. Hospitalised, on invasive mechanical ventilation or ECMO (Extracorporeal membrane oxygenation)
7. Death.
E.5.1.1 Timepoint(s) of evaluation of this end point: Day 15 (where day 1 is the first day of treatment)
E.5.2 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
E.5.2.1 Timepoint(s) of evaluation of this end point: See above
E.6 and E.7 Scope of the trial
E.6 Scope of the Trial
E.6.1 Diagnosis: No
E.6.2 Prophylaxis: No
E.6.3 Therapy: Yes
E.6.4 Safety: Yes
E.6.5 Efficacy: Yes
E.6.6 Pharmacokinetic: No
E.6.7 Pharmacodynamic: No
E.6.8 Bioequivalence: No
E.6.9 Dose response: No
E.6.10 Pharmacogenetic: No
E.6.11 Pharmacogenomic: No
E.6.12 Pharmacoeconomic: No
E.6.13 Others: No
E.7 Trial type and phase
E.7.1 Human pharmacology (Phase I): No
E.7.1.1 First administration to humans: No
E.7.1.2 Bioequivalence study: No
E.7.1.3 Other: No
E.7.1.3.1 Other trial type description:
E.7.2 Therapeutic exploratory (Phase II): Yes
E.7.3 Therapeutic confirmatory (Phase III): No
E.7.4 Therapeutic use (Phase IV): No
E.8 Design of the trial
E.8.1 Controlled: Yes
E.8.1.1 Randomised: Yes
E.8.1.2 Open: No
E.8.1.3 Single blind: No
E.8.1.4 Double blind: Yes
E.8.1.5 Parallel group: No
E.8.1.6 Cross over: No
E.8.1.7 Other: No
E.8.2 Comparator of controlled trial
E.8.2.1 Other medicinal product(s): No
E.8.2.2 Placebo: Yes
E.8.2.3 Other: No
E.8.3 The trial involves single site in the Member State concerned: No
E.8.4 The trial involves multiple sites in the Member State concerned: Yes
E.8.4.1 Number of sites anticipated in Member State concerned: 10
E.8.5 The trial involves multiple Member States: No
E.8.6 Trial involving sites outside the EEA
E.8.6.1 Trial being conducted both within and outside the EEA: No
E.8.6.2 Trial being conducted completely outside of the EEA: No
E.8.7 Trial has a data monitoring com
E.2.1 Main objective of the trial: To compare the effectiveness of a new drug, SFX-01, against placebo for treating patients with suspected COVID19 respiratory infection.
E.2.2 Secondary objectives of the trial: 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.
E.2.3 Trial contains a sub-study: No
E.3 Principal 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.
E.4 Principal 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.
E.5 End points
E.5.1 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 de
D.3.9.3 Other descriptive name: Sulforaphane/a-Cyclodextrin complex
D.3.9.4 EV Substance Code: AS1
D.3.10 Strength
D.3.10.1 Concentration unit: mg milligram(s)
D.3.10.2 Concentration type: equal
D.3.10.3 Concentration number: 300
D.3.11 The IMP contains an
D.3.11.1 Active substance of chemical origin: Yes
D.3.11.2 Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP): No
D.3.11.3 Advanced Therapy IMP (ATIMP): No
D.3.11.3.1 Somatic cell therapy medicinal product: No
D.3.11.3.2 Gene therapy medical product: No
D.3.11.3.3 Tissue Engineered Product: No
D.3.11.3.4 Combination ATIMP (i.e. one involving a medical device): No
D.3.11.3.5 Committee on Advanced therapies (CAT) has issued a classification for this product: No
D.3.11.4 Combination product that includes a device, but does not involve an Advanced Therapy: No
D.3.11.5 Radiopharmaceutical medicinal product: No
D.3.11.6 Immunological medicinal product (such as vaccine, allergen, immune serum): No
D.3.11.7 Plasma derived medicinal product: No
D.3.11.8 Extractive medicinal product: No
D.3.11.9 Recombinant medicinal product: No
D.3.11.10 Medicinal product containing genetically modified organisms: No
D.3.11.11 Herbal medicinal product: No
D.3.11.12 Homeopathic medicinal product: No
D.3.11.13 Another type of medicinal product: No
D.8 Information on Placebo
D.8 Placebo: 1
D.8.1 Is a Placebo used in this Trial? Yes
D.8.3 Pharmaceutical form of the placebo: Capsule, hard
D.8.4 Route of administration of the placebo: Oral use
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1 Medical condition(s) being investigated: Community acquired pneumonia with suspected or confirmed SARS-CoV-2 infection
E.1.1.1 Medical condition in easily understood language: Pneumonia lung disease
E.1.1.2 Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
MedDRA Classification
E.1.2 Medical condition or disease under investigation:
E.1.2 Version: 20.1
E.1.2 Level: LLT
E.1.2 Classification code: 10066724
E.1.2 Term: Acute pneumonia
E.1.2 System Organ Class: 10021881 - Infections and infestations
E.1.2 Medical condition or disease under investigation:
E.1.2 Version: 20.1
E.1.2 Level: LLT
E.1.2 Classification code: 10010120
E.1.2 Term: Community acquired pneumonia
E.1.2 System Organ Class: 10021881 - Infections and infestations
E.1.2 Medical condition or disease under investigation:
E.1.2 Version: 23.0
E.1.2 Level: PT
E.1.2 Classification code: 10084380
E.1.2 Term: COVID-19 pneumonia
E.1.2 System Organ Class: 10021881 - Infections and infestations
E.1.2 Medical condition or disease under investigation:
E.1.2 Version: 21.1
E.1.2 Level: PT
E.1.2 Classification code: 10001052
E.1.2 Term: Acute respiratory distress syndrome
E.1.2 System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
E.1.3 Condition being studied is a rare disease: No
E.2 Objective o
Try this one rebarm...;-)
This file contains full details on each clinical trial selected for download. Where multi-state trials have been downloaded full information for each of the member states/countries involved in the trial are included separately.
Summary
EudraCT Number: 2020-003486-19
Sponsor's Protocol Code Number: 1.002.20
National Competent Authority: UK - MHRA
Clinical Trial Type: EEA CTA
Trial Status: Ongoing
Date on which this record was first entered in the EudraCT database: 2020-08-14
Link: https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-003486-19/GB/
A. Protocol Information
A.1 Member State Concerned: UK - MHRA
A.2 EudraCT number: 2020-003486-19
A.3 Full title of the trial: A randomised, double-blind, placebo-controlled trial of SFX-01 or placebo on a backbone of best standard care, to improve outcomes in patients with community acquired pneumonia and suspected or confirmed SARS-CoV-2 infection
A.3.1 Title of the trial for lay people, in easily understood, i.e. non-technical, language: SFX-01 treatment for Acute Respiratory Infections (STAR-Covid19)
A.3.2 Name or abbreviated title of the trial where available: SFX-01 treatment for Acute Respiratory Infections (STAR-Covid19)
A.4.1 Sponsor's protocol code number: 1.002.20
A.7 Trial is part of a Paediatric Investigation Plan: No
A.8 EMA Decision number of Paediatric Investigation Plan:
B. Sponsor Information
Sponsor 1
B.1.1 Name of Sponsor: University of Dundee
B.1.3.4 Country: United Kingdom
B.3.1 and B.3.2 Status of the sponsor: Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1 Name of organisation providing support: LifeArc
B.4.2 Country: United Kingdom
B.4.1 Name of organisation providing support: Evgen Pharma plc
B.4.2 Country: United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1 Name of organisation: University of Dundee
B.5.2 Functional name of contact point: James Chalmers
B.5.3 Address
B.5.3.1 Street Address: Ninewells Hospital, Level 5 Mailbox 12
B.5.3.2 Town/ city: Dundee
B.5.3.3 Post code: DD1 9SY
B.5.3.4 Country: United Kingdom
B.5.4 Telephone number: 01382383642
B.5.6 E-mail: j.chalmers@dundee.ac.uk
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3 IMP Role: Test
D.2 Status of the IMP to be used in the clinical trial
D.2.1 IMP to be used in the trial has a marketing authorisation: No
D.2.5 The IMP has been designated in this indication as an orphan drug in the Community: No
D.2.5.1 Orphan drug designation number:
D.3 Description of the IMP
D.3.1 Product name: Sulforadex
D.3.2 Product code: SFX-01
D.3.4 Pharmaceutical form: Capsule, hard
D.3.4.1 Specific paediatric formulation: No
D.3.7 Routes of administration for this IMP:
Nasogastric use (Noncurrent)
Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8 INN - Proposed INN: Sulforadex
D.3.9.1 CAS number: 1039704-32-9
D.3.9.2 Cu