Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: B998- Other infectious disease
Conditions
Interventions
Intervention1: EDP1815: 2 capsules twice daily for 14 days
Control Intervention1: Ambrisentan: 5mg OD for 14 days
Control Intervention2: Dapagliflozin: 10 mg OD for 14 days
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Spectra Hospitals Services Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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 ï?³3 if it includes â??Radiographic severity score >3â?? 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 Risk count (score 1 point for each of the following): Radiographic severity score >3 Male gender Non-white ethnicity Diabetes Hypertension Neutrophils >8.0 x109/L Age >40 years CRP >40 mgl/L
Exclusion criteria
Exclusion criteria: General 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 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. Drug specific exclusion criteria EDP1815 Specific Exclusions 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. Dapagliflozin and Ambrisentan Specific Exclusions 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 venous pH 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death Invasive mechanical ventilation ECMO Cardiovascular organ support Renal failureTimepoint: 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Biomarkers thought to be associated with progression of COVID-19: Ferritin, CRP, D-Dimer, neutrophil to lymphocyte ratio, LDH Change in clinical status as assessed on 7-point ordinal scale compared to baseline Time to each of the individual endpoints of the composite primary outcome measure Proportion of patients with adverse events of special interest in each arm SpO2/FiO2 Time to Sp02 94% on room air Time to first negative SARS-CoV2 PCRTimepoint: 14 days | — |
Countries
India, Mexico, United Kingdom
Contacts
Public ContactDr V Ramasubramanian
Apollo Hospitals
Outcome results
None listed