COVID-19 trials registries data warehouse

https://www.isrctn.com/ISRCTN51124684

Diane Havard

diane.havard@nottingham.ac.uk

2021-01-13

Not recruiting

RCT

Randomized

Cluster

Blind label

multi-center

Prevention

1. Residents from 26 participating care homes (residential and nursing) with 16 participants from each 2. Aged =65 years 3. Currently consuming a normal diet 4. Willing to take treatment having taste-tested a beetroot shot

1. Unwilling to participate or opted-out of the trial (resident, or family, if resident lacks capacity) 2. Currently consuming a soft diet or using a thickener 3. Using antiseptic mouthwash 4. Identified by care home staff to be in the last few days of life 5. Short-term respite care 6. Care home staff

2

University of Nottingham

65

100

United Kingdom

High risk patients

N/A

416

1. Feasibility of conducting a larger scale trial assessed using data on the recruitment of care homes; recruitment of residents; assessment of background infection rate; assessment of background dietary nitrate intake; adherence to the intervention; ability to measure the ordinal outcome; an estimation of the intra-cluster correlation (ICC); and incidence of death between baseline and 60 days 2. Severity of the first infection measured using a 5 level ordinal outcome (using the worst level if >1 event; where a score of: 0 represents no symptoms of infection; 1 represents symptoms of infection; 2 represents symptoms of infection needing healthcare advice such as a call to 111; or GP appointment; 3 represents hospitalisation for any reason; or intention to hospitalise but advance directive precluded this; or 4 represents death from any cause) between baseline and 60 days

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 2

[{"arm_notes": "", "treatment_id": 890, "treatment_name": "Nitric oxide gas", "treatment_type": "Gas inhalation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]