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BERRY- a Study of Sambucol ® in the Treatment, and Reduction of Symptoms in Participants With Coronavirus 19

Sponsored by East Kent Hospitals University NHS Foundation Trust

About this trial

Last updated 5 months ago

Study ID

2020/COVID19/11

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18 to 100 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 3 years ago

What is this trial about?

Severe acute respiratory syndrome (SARS) coronavirus 2 (CoV 2) (COVID19) is a readily transmissible virus that has a wide ranging incubation period of 2-14 days. The symptoms include fever, cough and loss of taste and smell. Symptoms range from mild to severe. Pre-existing potential drug therapies are under investigation, but so far few have demonstrated any benefit and only in patients with severe symptoms. There is a scarcity of other pre-existing drug treatments that change the outcomes/symptoms in non-hospitalised patients with COVID-19. Prophylaxis and prevention is currently dependent on social distancing and isolating with vaccines remaining in development, potentially not for mass use in the near future. Sambucus extract has well documented anti-viral properties both in vitro and in clinical trials of influenza, it has a low side effect profile so may be effective in reducing duration of symptoms and progression to more severe disease in patients with mild/ moderate COVID19. Black Elderberry Original Liquid (Sambucus nigra) (Sambucol®) is sold as a food supplement in heath food shops and supermarkets, does not require a prescription and has no known side effects, meaning it would be a well-tolerated treatment in early disease in comparison with other potential medications. The study will be conducted at East Kent Hospitals. Potential participants with mild or moderate confirmed COVID19 infection will be identified from the drive-through hospital test centre and accident and emergency. Following an eligibility check and consenting they would be randomised to placebo or Sambucol® Black Elderberry (Sambucus nigra) 15ml four times daily for 14 days which they will take at home. Telephone consultations with the research team and patient daily diaries will used to document symptoms on days 1,3,7,10,14 and a follow up on day 28. Time to clinical improvement will be compared between the 2 groups.

What are the participation requirements?

Yes

Inclusion Criteria

- Symptomatic Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) infection - Positive SARS-CoV2 swab test result within the last 5 days - Capacity to provide written or electronic informed consent - Able to complete follow up visits required via phone/email - Able to provide a positive swab result

No

Exclusion Criteria

Known allergy to Sambucus (Elderberries) or food colourants - Pregnant or breast feeding - Poorly controlled diabetes - Treatment with any immunosuppressive medicines including Prednisolone 10mg daily or equivalent. Oral anti-inflammatory medicines such as Ibuprofen are allowed. - Participation in any COVID 19 research study involving prophylactic or therapeutic Investigational Medicinal Products (IMPs) in the last 30 days. - Previous participation in this trial. - Already taking Sambucol or any form of elderberry supplement

Locations

Location

Status