Status:
COMPLETED
DEFINE - Evaluating Therapies for COVID-19
Lead Sponsor:
University of Edinburgh
Collaborating Sponsors:
University of Oxford
Latus Therapeutics
Conditions:
COVID-19
Eligibility:
All Genders
16+ years
Phase:
PHASE1
PHASE2
Brief Summary
COVID-19 is a community acquired pneumonia caused by infection with a novel coronavirus, SARS CoV2 and is a serious condition with high mortality in hospitalised patients, for which there is no curren...
Detailed Description
This trial platform aims to support the repurposing of promising therapeutic assets with prior use in humans but without prior information on use in COVID-19, to determine the PK-PD profile of the age...
Eligibility Criteria
Inclusion
- Eligibility criteria for each arm is specified in the appendix and may vary depending on the intervention. As an example, eligibility criteria from the Nafamostat and TD139 arms has been provided:
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
July 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2025
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT04473053
Start Date
July 3 2020
End Date
April 30 2025
Last Update
August 7 2025
Active Locations (1)
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1
NHS Lothian
Edinburgh, United Kingdom, EH16 4TJ