RE: Trial details23 Oct 2020 22:25
The original trial link gave detailed information on the make up of the trial, but can't be accessed at the moment aprt from the brief summary below, although i did copy and post the following segment when the link was still open to the full description of the trial. Gl ;-)
Investigating a sample size of 300 subjects, the study will compare outcomes for 300mg SFX-01 taken orally, once daily, plus best standard of care (BSC) versus placebo taken orally, once daily plus BSC. The primary outcome of the trial is the clinical status of patients on day 15 based on a seven point scale, recommended by the World Health Organisation as the optimal clinical trial endpoint for COVID-19 studies.
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.
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.
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."
https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-003486-19/GB
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EU Trials Register
EudraCT Number: 2020-003486-19 Sponsor Protocol Number: 1.002.20 Start Date*: Information not available in EudraCT
Sponsor Name:University of Dundee
Full Title: 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 con...
Medical condition: Community acquired pneumonia with suspected or confirmed SARS-CoV-2 infection
Disease: Version SOC Term Classification Code Term Level
20.1