Evaluating therapies for COVID-19
DEFINE - Evaluating Therapies for COVID-19
This study is testing new treatments for COVID-19 to see if they can help both hospitalized and community patients feel better and reduce lung damage.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | University of Edinburgh Academic / other |
| Locations | 1 site (Edinburgh) |
| Trial ID | NCT04473053 on ClinicalTrials.gov |
What this trial studies
This trial aims to investigate potential treatments for COVID-19, focusing on safety and pharmacokinetic/pharmacodynamic profiles of repurposed therapies. It includes both community-based and hospitalized patients, with interventions such as Nafamostat Mesilate and TD139 compared to standard care. The study is designed to gather initial data that could support further development of effective treatments for COVID-19. By addressing the mechanisms of lung damage in COVID-19 patients, the trial seeks to mitigate respiratory failure associated with the disease.
Who should consider this trial
Good fit: Ideal candidates include COVID-19 positive patients aged 16 and older, both in community settings and hospitalized.
Not a fit: Patients with severe, progressive, or uncontrolled conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to effective treatments for COVID-19, improving patient outcomes and reducing mortality.
How similar studies have performed: Other studies have shown promise with repurposed therapies for COVID-19, but this approach is also exploring novel combinations and mechanisms.
Eligibility criteria
Show full inclusion / exclusion criteria
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: 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 Exclusion Criteria: * 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.
Where this trial is running
Edinburgh
- NHS Lothian — Edinburgh, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Kev Dhaliwal — University of Edinburgh
- Study coordinator: Annya Bruce, PhD
- Email: Annya.Bruce@ed.ac.uk
- Phone: 01312429180
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.