SAFETY, TOLERABILITY, & THERAPEUTIC POTENTIAL OF MTL-CEBPA IN COVID-19
Research type
Research Study
Full title
PHASE 1 CLINICAL STUDY TO ASSESS THE SAFETY AND THERAPEUTIC POTENTIAL OF MTL-CEBPA IN PATIENTS WITH ADVANCED COVID-19 AND CYTOKINE STORM
IRAS ID
282622
Contact name
Nagy Habib
Contact email
Sponsor organisation
MiNA Alpha Limited
Eudract number
2020-001563-93
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
The study is primarily aimed at establishing that the study drug (MTL-CEBPA) is safe to give to patients infected with coronavirus. The study is also aiming to confirm whether treatment with MTL-CEBPA in patients infected with coronavirus can decrease the incidence of Cytokine Storm, a condition when the immune system gets out of control. MTL-CEBPA's mode of action and data from animal studies provides evidence that supports the theory that MTL-CEBPA may help with some of the symptoms of coronavirus.
Hospitalized patients infected with coronavirus who are having difficulties breathing unassisted will be randomized into one of two groups:
• Best medical care plus MTL-CEBPA (40 participants)
• Best medical care alone (20 participants)The group of patients receiving study drug (MTL-CEBPA), which is administered via infusion, will receive drug six times whilst in hospital over a two-week period.
Whilst in hospital all patients in the study will have data collected on their general health, any procedures administered, and medications received. Cytokines (factors that indicate how a patient's immune system is working) will be measured throughout the patient's stay in hospital.
All patients will be followed for approximately one year after they leave hospital to check on their general health status.
A comparison on the data collected during the first 28 days in the study from each patient will be made to confirm whether MTL-CEBPA has any therapeutic benefits in patients infected with coronavirus.
The study will be conducted in a single university hospital in the United Kingdom.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
20/NW/0214
Date of REC Opinion
17 Apr 2020
REC opinion
Further Information Favourable Opinion