COVI-DROPS in patients with asymptomatic/mild COVID-19 [COVID-19]
Research type
Research Study
Full title
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A SINGLE INTRANASAL DOSE OF STI-2099 (COVI-DROPS™) IN OUTPATIENT ADULTS WITH COVID-19
IRAS ID
299257
Contact name
Mike Royal
Contact email
Sponsor organisation
Sorrento Therapeutics Inc.
Eudract number
2021-002538-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 15 days
Research summary
The research aims to see how well a treatment works for COVID-19 patients. The treatment is a type of neutralising antibody that is given into the nose (intranasally).
The main aim of the study is to see if the treatment can reduce the viral load (the amount of virus in the body) 8 days after the treatment is given. The study will also look at how safe the treatment is, and whether patients can tolerate the treatment when it is given into the nose.
Patients can take part in the study if they are at least 18 years old, have had a positive COVID-19 test within 7 days of treatment, and have either no COVID-19 symptoms or mild symptoms.
We think that the study will be conducted as a ‘virtual’ trial. This means that no hospitals or other NHS facilities will be involved in the research. People with a COVID-19 positive test will be asked to enrol in the study by contacting a call centre, and the treatment will be given to them at home by a research nurse. The treatment is a one-time application given at the beginning of the study, and the research nurse will do some safety tests before the treatment is given. The nurse will also visit the patients home 1 week and 4 weeks after the treatment is given, and will also call the patients 1 day, 2 weeks, and 2 months after the treatment has been given to follow up with the patients. Patients will also be asked to download an app to their phone and record data each day whilst they are involved in the research, and they will also have the option to call the study team (or request a call back) at any point if they have any questions or concerns.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
21/YH/0133
Date of REC Opinion
16 Jun 2021
REC opinion
Further Information Favourable Opinion