Created at Source Raw Value Validated value
Dec. 15, 2020, 2:47 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Design Participants will receive an oral/via NG tube course for 7 days of the drug (56 patients) or control (56 patients) and will be studied over a 7-day period to see whether the type of respiratory support increases; stays constant; or decreases during that time period. Participants will be approached for entry into the trial if they experiencing symptoms of COVID-19. They must fulfil the inclusion/exclusion criteria for entry. Females of childbearing potential will have to undertake a urine pregnancy test prior to inclusion. Those participants unable to consent for themselves; written consent will be sought from a legal representative. Participants will be randomised using a bespoke computer software package and will be blinded to their trial treatment along with their treating physician and all members of the trial teams. As part of the trial; participants will be asked to have blood samples taken on a daily basis for plasma almitrine levels; lactate and liver function tests for 7 days whilst on trial treatment. Participants will also have their level of respiratory support recorded. Interventions All participants will be given a loading oral dose of 100 mg almitrine/placebo; followed by 50 mg almitrine/placebo 4 hourly for 7 days. Sub-study (30 participants in total): Arterial blood sampling from existing arterial catheter before drug administration and then hourly for 4 hours after drug administration (for arterial oxygen and for plasma almitrine levels). Pharmacokinetics/dose Physiological sub-study: Prior studies (Reyes et al; 1988; Prost et al; 1991; Esnault et al; 2019) used an intravenous infusion of either 0.25 mg/kg or 0.5 mg", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 68, "treatment_name": "Almitrine", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}]