COVID-19
Conditions
Interventions
Product Name: TD139
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: TD139
Current Sponsor code: TD139
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrat
Sponsors
University of Edinburgh
NHS Lothian
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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 5x ULN) or bone marrow failure (Hb 5.0 mmol/L or hyponatraemia Na+ 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of candidate agents as add-on therapy to standard of care in patients with COVID-19. Safety will be assessed using: • Haematological and biochemical safety laboratory investigations (blood tests). • Physical examination • Vital signs (blood pressure/heart rate/temperature and respiratory rate) • Daily electrocardiogram (ECG) readings • Adverse events ;Secondary Objective: 1) To determine what the drugs does to the body (pharmacodynamics) and what the body does to the drug (pharmacokinetics) of the proposed trial treatments in COVID-19 patients. 2) Assess the response of key exploratory biomarkers/pathways during treatment period. 3)To evaluate the improvement or deteroriation of patients in each treatment arm. 4) To evaluate the number of oxygen-free days. 5) To evaluate ventilator-free days and incidence and duration of any form of new ventilation use. 6) To evaluate the amount of virus in the patient using saliva/oropharyngeal/nose samples To evaluate time to discharge 7) Duration of total hospital stay 8) To evaluate the use of renal dialysis or haemofiltration for each treatment arm. ;Primary end point(s): Safety will be assessed using: • Haematological and biochemical safety laboratory investigations. • Physical examination • Vital signs (blood pressure/heart rate/temperature and respiratory rate) • Daily electrocardiogram (ECG) readings • Adverse events ;Timepoint(s) of evaluation of this end point: Daily assessments | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To determine the PK/PD of the proposed trial treatments in COVID-19 patients. Assess the response of key exploratory biomarkers during treatment period. To evaluate the improvement or deteroriation of patients in each treatment arm. To evaluate the number of oxygen-free days. To evaluate ventilator-free days and incidence and duration of any form of new ventilation use. Change in the ratio of the oxygen saturation to fraction of inspired oxygen concentration (SpO2/FiO2) To evaluate SARS-CoV-2 viral load. To evaluate time to discharge To evaluate the use of renal dialysis or haemofiltration for each treatment arm. ;Timepoint(s) of evaluation of this end point: For each drug, characterise the PK/PD of each drug treatment. Evaluate the change from baseline values for key exploratory biomarkers of target engagement for each treatment. Record changes to WHO ordinal scale and NEWS2 score Duration (days) of oxygen use and oxygen-free days. • Duration (days) of ventilation and ventilation-free days. • Incidence of any form of new ventilation use and duration (days) of new ventilation use. • SpO2/FiO2, measured daily from randomisation to Day 15, hospital discharge, or death Qualitative and quantitative polymerase chain reaction (PCR) determination of severe acute respiratory syndrome • Duration of total hospital stay • Duration to discharge following treatment Record requirement for renal dialysis or haemofiltration | — |
Countries
United Kingdom
Contacts
Public ContactAnnya Bruce
University of Edinburgh
Outcome results
None listed