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

NCT05489770 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2024-12-06

Study results available
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Summary

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Sambucol® Black Elderberry Original (Sambucus nigra) Liquid

Sambucol® Black Elderberry Original (Sambucus nigra) Liquid has been used as a supplement since 1991 with no reports of adverse effects received by the Manufacturer.

DIETARY_SUPPLEMENT

Placebo for Sambucol® Black Elderberry Original (Sambucus nigra)

Placebo for Sambucol® Black Elderberry Original (Sambucus nigra) Liquid Constituents: 70% (w/w) of glucose syrup, Flavouring agent: Elderberry Blossom

Sponsors & Collaborators

  • East Kent Hospitals University NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Jessica Evans · EKHUFT

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-05
Primary Completion
2022-05-16
Completion
2022-05-16

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05489770 on ClinicalTrials.gov