Status:
COMPLETED
mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Experimental Drugs and Mechanisms
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
TACTIC-E is a randomised, parallel arm, open-label platform trial for investigating potential treatments for COVID-19 disease. While SARS-CoV infection evades detection by the immune system in the fir...
Detailed Description
TACTIC-E will assess the efficacy of the novel immunomodulatory agent EDP1815 and a combination of the approved cardiovascular drugs dapagliflozin and ambrisentan as potential treatments for COVID-19 ...
Eligibility Criteria
Inclusion
- General
- Be aged 18 and over
- Have clinical picture strongly suggestive of COVID-19-related disease (with/without positive COVID-19 test) AND
- Risk count (as defined below) \>3 OR
- Risk count ≥3 if it includes "Radiographic severity score \>3"
- Be hospitalized or eligible for hospitalization on clinical grounds
- Be considered an appropriate subject for intervention with immunomodulatory or other disease modifying agents in the opinion of the investigator
- Is able to swallow capsules/tablets
- General
Exclusion
- Inability to supply direct informed consent from patient or from Next of Kin or Independent Healthcare Provider on behalf of patient
- Invasive mechanical ventilation at time of screening
- Contraindications to study drugs, including hypersensitivity to the active substances or any of the excipients
- Currently on any of the study investigational medicinal products
- Concurrent participation in an interventional clinical trial (observational studies allowed)
- Patient moribund at presentation or screening
- Pregnancy at screening
- Unwilling to stop breastfeeding during treatment period
- Known severe hepatic impairment (with or without cirrhosis)
- Requiring dialysis Cockcroft Gault estimated creatinine clearance \< 30 ml /min/1.73m2 at screening
- Inability to swallow at screening visit
- Any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the patient ineligible for inclusion because of a safety concern.
- EDP1815-Specific
Key Trial Info
Start Date :
July 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2022
Estimated Enrollment :
454 Patients enrolled
Trial Details
Trial ID
NCT04393246
Start Date
July 3 2020
End Date
June 8 2022
Last Update
July 28 2023
Active Locations (1)
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1
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ