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

NCT05489770 | Completed Results DMC

• 1 other identifier: 2020/COVID19/11
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief 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

COVID-19

Outcome Measures

Primary Outcomes (1)

• Sambucol Reduces the Severity of Symptoms by at Least 30% by Day 10 in People Who Are Symptomatic With the SARS-CoV-2 (COVID-19) Virus, Compared to Placebo.

  To determine whether Sambucol reduces the severity of symptoms by 30% by day 10 in people who are symptomatic with the COVID-19 virus, as determined by Visual Analogue Scale score. where 0 was worst health and 100 best health

  10 days

Secondary Outcomes (2)

• To Determine Whether Sambucol Reduces Hospital Admissions by Day 28.

  28 days

• To Determine if Sambucol Reduces the Severity of Symptoms at Day 3, 7, 14 and 28 Days

  28 days

Other Outcomes (1)

• Reduction in Hospital Admission as Per Participant Hospital Admission Rates

  28 days

Study Arms (2)

Sambucol® Black Elderberry Original (Sambucus nigra) Liquid

ACTIVE COMPARATOR

Constituents: 29.4 % (w/w) Black Elderberry (Sambucus nigra) fruit juice, 70% (w/w) of glucose syrup. The main ingredient is black elderberry juice and it meets the requirements of the European Parliaments Directive (2012/12/EU) relating to fruit juices. The product also contains two food additives: citric acid (E330) as acidity regulator and potassium sorbate (E202) as preservative. Primary packaging: Plastic Polyethylene terephthalate (PET) amber bottles 120ml. Caps are white tamper-proof caps with security seal. Secondary Packaging: None. Outer Carton: Cardboard 376mm x 191mm x 116mm. 32 bottles per case.

Dietary Supplement: Sambucol® Black Elderberry Original (Sambucus nigra) Liquid

Placebo for Sambucol® Black Elderberry Original (Sambucus nigra) Liquid

PLACEBO COMPARATOR

Constituents: 70% (w/w) of glucose syrup, Flavouring agent: Elderberry Blossom. Colourants: Carmoisine (311804) (E-122) and Brilliant Black (419358) E-151. The product also contains two food additives: citric acid (E330) as acidity regulator and potassium sorbate (E202) as preservative. Primary packaging: Plastic PET amber bottles 120ml. Caps are white tamper-proof caps with security seal. Secondary Packaging: None. Outer Carton: Cardboard 376mm x 191mm x 116mm. 32 bottles per case.

Dietary Supplement: Placebo for Sambucol® Black Elderberry Original (Sambucus nigra)

Interventions

Sambucol® Black Elderberry Original (Sambucus nigra) Liquid DIETARY_SUPPLEMENT

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.

Sambucol® Black Elderberry Original (Sambucus nigra) Liquid

Placebo for Sambucol® Black Elderberry Original (Sambucus nigra) DIETARY_SUPPLEMENT

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

Placebo for Sambucol® Black Elderberry Original (Sambucus nigra) Liquid

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• East Kent Hospitals University NHS Foundation Trust: lead

Study Sites (1)

East Kent Hospitals University NHS Foundation trust

Canterbury, Kent, CT1 3NG, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Interventions

Fluid Therapy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Dr Jane Povey- Research Facilitator
• Organization: EKHUFT

jane.povey2@nhs.net

01227766877

Study Officials

• Jessica Evans

  EKHUFT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The placebo has comparable appearance and taste to Sambucol® Black Elderberry Original Liquid. Trial participants, trial statistician and outcome assessors will be blinded to which arm the participant has been randomised. Investigators, the research delivery team, clinical trial pharmacist and study staff not involved in assessing outcomes will not be blinded. All research delivery team members will be aware that they are not to divulge the randomised arm to participants at any time point. Participants will remain blind to their allocated trial arm for the duration of the trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This study is a superiority test of Sambucol to placebo in the treatment of COVID 19 positive patients, with a parallel design. Single Centre, placebo controlled, single blinded, two arm, randomised controlled trial.

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: August 5, 2022
• Study Start: January 5, 2021
• Primary Completion: May 16, 2022
• Study Completion: May 16, 2022
• Last Updated: December 6, 2024
• Results First Posted: December 6, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)