Investigating potential new therapies for COVID-19.

Phase 1

• Conditions: COVID-19; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-002230-32-GB
• Lead Sponsor: niversity of Edinburgh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-11
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

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 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

Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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/LAND 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 concomittant use of off-label treatments for COVID-19
•Significant electrolyte disturbance (hyperkalaemia K+ >5.0 mmol/L or hyponatraemia Na+ < 120mmol/L)
•Patient currently receiving potassium sparing diuretics that cannot be reasonably withheld
•Patient currently receving prophylactic or therapeutic anticoagulants or antiplatelet agents that cannot be reasonably withheld

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified