COVID-19 viral disease
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: B998- Other infectious disease
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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/
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 < 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.
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 < 7.3 (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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Death <br/ ><br>Invasive mechanical ventilation <br/ ><br>ECMO <br/ ><br>Cardiovascular organ support <br/ ><br>Renal failureTimepoint: 14 days
- Secondary Outcome Measures
Name Time Method Biomarkers thought to be associated with progression of COVID-19: Ferritin, CRP, D-Dimer, neutrophil to lymphocyte ratio, LDH <br/ ><br>Change in clinical status as assessed on 7-point ordinal scale compared to baseline <br/ ><br>Time to each of the individual endpoints of the composite primary outcome measure <br/ ><br>Proportion of patients with adverse events of special interest in each arm <br/ ><br>SpO2/FiO2 <br/ ><br>Time to Sp02 94% on room air <br/ ><br>Time to first negative SARS-CoV2 PCRTimepoint: 14 days