mulTi-Arm Therapeutic study in pre-ICu patients admitted with Covid-19 – Experimental drugs and mechanisms (TACTIC-E)

Phase 1

• Conditions: SARS-Cov-2; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2020-002229-27-GB
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-28
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1407

Inclusion Criteria

To be included in the trial the participant must:
• be aged 18 or over
• have clinical picture strongly suggestive of COVID-19-related disease (with/without positive COVID-19 test) AND
- Risk count (as defined above) >3
OR
- Risk count >=3 if it includes Radiographic severity score >3”
• 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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 281
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1126

Exclusion Criteria

The presence of any of the following will preclude participant inclusion:

• 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)
• Stage 4 severe chronic kidney disease or requiring dialysis (i.e. Cockcroft Gault estimated creatinine clearance < 30 ml /min)
• 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.
• Patient is taking a systemic immunosuppressive agent such as, but not limited to, oral steroids, methotrexate, azathioprine, ciclosporin or tacrolimus, unless these are given as part of COVID standard of care treatment.
• Type 1 diabetes
• Known idiopathic pulmonary fibrosis
• Previous hospital admission with ketoacidosis
• History of symptomatic heart failure within 3 months of admission
• Sustained blood pressure below 90/60 mmHg at admission
• Metabolic acidosis defined as pH< 7.25 (or venous bicarbonate <15 mmol/l) AND ketones > 3.0 mmol/L
• Alanine transaminase and/or aspartate transaminase (ALT and/or AST) > 3 times the upper limit of normal (only one needs to be measured)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified