| Participants |
100 participants, ≥ 18 years, female and male
Inclusion criteria:
Provision of informed consent from the patient or representative Aged at least 16 years If the patient is of childbearing potential, the patient, and their partner(s), agree to use medically‐accepted double‐barrier methods of contraception (e.g. barrier methods, including male condom, female condom or diaphragm with spermicidal gel) during the study and for at least 90 days after the 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 > 5 x ULN) or bone marrow failure (Hb < 8 g/dL and absolute neutrophil count < 0.5 mm³ and platelet count <50,000 µL) Women who are pregnant or breastfeeding Participation in another clinical trial of an investigational medicinal product Known hypersensitivity to the investigational medicinal product or excipients Pre‐existing or concomitant use of off‐label treatments for COVID‐19
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| Outcomes |
Primary
Safety of candidate agents as add‐on therapy to standard care in patients with COVID‐19 measured at 30, 60 and 90 days post‐treatment using: -
Haematological and biochemical safety laboratory investigations:
Haematology: full blood count and differential white cell count Coagulation: D‐dimer, fibrinogen, aPTT, prothrombin time, INR, Cd39, ecto‐ADPase, nitrous oxide, PGI2, antithrombin, thrombomodulin, protein c, electronic patient care reporting, kallikrein Biochemistry: random glucose, urea and electrolytes (urea, sodium, potassium, chloride, magnesium, bicarbonate, creatinine); liver function tests (total protein, albumin, globulin, total bilirubin, AST, ALT, GGT, LDH, alkaline phosphatase); C‐reactive protein (CRP); ferritin; triglycerides; troponin; creatine kinase (MB fraction)
Physical examination performed at screening, including assessment of presenting symptoms. At subsequent assessments, a symptom‐directed (targeted) physical examination will be performed as required by the condition of the patient and the presenting complaint Vital signs (blood pressure/heart rate/temperature and respiratory rate) Daily ECG readings AEs that are not related to the patient’s underlying condition or clinical interventions will be recorded following consent. In the case of an AE, the Investigator should initiate the appropriate treatment according to their medical judgment
Secondary
Pharmacokinetic (PK)/pharmacodynamic (PD) information measured using daily blood samples Response of key exploratory biomarkers during treatment period, namely IL‐1ß, IL‐6, IL‐8 and TNF‐a, CXCL‐10 and IL‐1ra. Due to the nature of this research additional analytical tests may be developed or required in order to profile COVID‐19 and develop therapies Improvement or deterioration of patients measured using WHO ordinal scale and NEWS2 at 30, 60 and 90 days post treatment Number of oxygen‐free days measured at 30, 60 and 90 days post‐treatment Ventilator‐free days and incidence and duration of any form of new ventilation use measured at 30, 60 and 90 days post‐treatment SpO2/FiO2, measured daily from randomisation to day 15, hospital discharge, or death SARS‐CoV‐2 viral load measured using qualitative and quantitative PCR determination of SARS‐CoV‐2 in oropharyngeal/nasal/saliva swab while hospitalised on days 1, 3, 5, 8, 11, 15 Time to discharge (days) The use of renal dialysis or haemofiltration (not used/used and duration of use) at 30, 60 and 90 days post‐treatment
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