COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04473053

Annya Bruce, PhD

Annya.Bruce@ed.ac.uk

2020-07-16

Recruiting

RCT

Randomized

Adaptive

Blind label

single-center

Treatment

inclusion criteria: - provision of informed consent from the patient or representative - aged at least 16 years - if the patient is of child bearing potential, the patient, and their partner(s), agree to use medically-accepted double-barrier methods of contraception (eg, barrier methods, including male condom, female condom or diaphragm with spermicidal gel) during the study (if randomised to a treatment arm) and for at least 90 days after termination of study therapy. a vasectomised partner would be considered an appropriate birth control method provided that the partner is the sole male sexual partner and the absence of sperm has been confirmed. - covid-19 positive

- current or recent history, as determined by the investigator, of severe, progressive, and/or uncontrolled cardiac disease (nyha class iv), uncontrolled renal disease (egfr <30 ml/min/1.73 m2), severe liver dysfunction (alt/ast >5x uln) or bone marrow failure (hb <80 g/l and anc<0.5 mm3 and platelet count <50,000 ul) - women who are pregnant or breastfeeding. - participation in another clinical trial of an investigational medicinal product (ctimp) - known hypersensitivity to the imp or excipients (e.g. lactose) - pre-existing or cconcomittant use of off-label treatments for covid-19 that are not recognised as locally approved standard care. - significant electrolyte disturbance (hyperkalaemia potassium >5.0 mmol/l or hyponatraemia sodium < 120mmol/l) - patient currently receiving potassium sparing diuretics that cannot be reasonably withheld - patient currently receiving prophylactic or therapeutic anticoagulantsanticoagulation or antiplatelet agents that cannot be reasonably withheld if randomised to nafamostat - patients (or their partners) planning on donating sperm/eggs during the trial period - ongoing dialysis - history of serious liver disease (child pugh score > 10) - hemoglobin < 80 g/l - any known allergy to the imp/excipients - severe uncontrolled diabetes mellitus - in the investigator's opinion, patient is unwilling or unable to comply with drug administration plan, laboratory tests or other study procedures.

3

University of Edinburgh

16

100

United Kingdom

No restriction on type of patients

0: No restriction on type of patients

200

The safety of the candidate therapies in COVID-19 patients by measuring physiological changes in the circulatory and respiratory system.;The safety of the candidate therapies in COVID-19 patients by recording the number of treatment related adverse events.

None

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 1267, "treatment_name": "Td139", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 854, "treatment_name": "Nafamostat mesilate", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]