STC3141 safety and effect in COVID19 severe pneumonia
Research type
Research Study
Full title
A Randomized, Open-Label, Multi-Centre, Phase 2a Study to Evaluate the Safety and Effect of STC3141 Continuous Infusion in Subjects with Severe COVID-19 Pneumonia
IRAS ID
306117
Contact name
Marcel Tanudji
Contact email
Sponsor organisation
Grand Medical Pty Ltd
Eudract number
2021-000399-12
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 31 days
Research summary
This is a clinical trial in hospitalized patients with severe pneumonia due to a confirmed SARS-COV-2 infection (COVID19)
Randomization makes that 4 out of every 5 patients will receive the study treatment, STC3141, in 1 of the 2 doses proposed for the trial, 1 out of 5 will only receive the standard of care. The treatment will be administered via an IV infusion up to 72 hours, and in combination with the current standard of care that is provided to all COVID19 patients at the hospital.
The majority of the examinations done for the trial are not different than the standard examinations done at the hospital in these patients. On top of the standard examinations, there will be daily ECG’s during treatment, and urine will be analysed. They will undergo CT scans or X-rays to assess the pneumonia and they will regularly have to undergo physical exams by the investigators, as well as blood sampling for laboratory analysis. For women of childbearing potential, 2 pregnancy tests will be done in the blood.
Patients will be in the trial for up to 30 days, also depending on their stay at the hospital. As long as they are in the hospital, the investigator will assess the health and safety for the trial up until discharge or 30 days (whichever comes first). They will have to return for a follow up visit 30 days after the start of the trial, if not hospitalized anymore.
The purpose of this trial is to assess the safety and the potential effect of a new treatment in patients with this condition.REC name
London - Fulham Research Ethics Committee
REC reference
21/HRA/4972
Date of REC Opinion
18 Nov 2021
REC opinion
Unfavourable Opinion