Trial Outcomes & Findings for BERRY- a Study of Sambucol ® in the Treatment, and Reduction of Symptoms in Participants With Coronavirus 19 (NCT NCT05489770)
NCT ID: NCT05489770
Last Updated: 2024-12-06
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
204 participants
Primary outcome timeframe
10 days
Results posted on
2024-12-06
Participant Flow
Participant milestones
| Measure |
Sambucol® Black Elderberry Original (Sambucus Nigra) Liquid
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.
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.
|
Placebo for Sambucol® Black Elderberry Original (Sambucus Nigra) Liquid
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.
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
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
102
|
|
Overall Study
COMPLETED
|
93
|
90
|
|
Overall Study
NOT COMPLETED
|
9
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BERRY- a Study of Sambucol ® in the Treatment, and Reduction of Symptoms in Participants With Coronavirus 19
Baseline characteristics by cohort
| Measure |
Sambucol® Black Elderberry Original (Sambucus Nigra) Liquid
n=102 Participants
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.
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.
|
Placebo for Sambucol® Black Elderberry Original (Sambucus Nigra) Liquid
n=102 Participants
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.
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
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
100 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
white
|
96 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed/Other
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
102 participants
n=5 Participants
|
102 participants
n=7 Participants
|
204 participants
n=5 Participants
|
|
Wellness score at day 0
|
60.9 units on a scale (0-100)
STANDARD_DEVIATION 20.5 • n=5 Participants
|
60.7 units on a scale (0-100)
STANDARD_DEVIATION 17.9 • n=7 Participants
|
60.8 units on a scale (0-100)
STANDARD_DEVIATION 19 • n=5 Participants
|
PRIMARY outcome
Timeframe: 10 daysPopulation: VAS score where 100 is best health and 0 is worst. AT this time point there were 90 participants who replied in the "test" group and 93 in the 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
Outcome measures
| Measure |
Sambucol® Black Elderberry Original (Sambucus Nigra) Liquid
n=90 Participants
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.
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.
|
Placebo for Sambucol® Black Elderberry Original (Sambucus Nigra) Liquid
n=93 Participants
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.
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
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|---|---|---|
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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.
|
84.3 score on a scale
Standard Deviation 13.8
|
86.5 score on a scale
Standard Deviation 9.9
|
SECONDARY outcome
Timeframe: 28 daysPopulation: No hospital admissions in either group
To determine whether Sambucol reduces number of hospital admissions by day 28.
Outcome measures
| Measure |
Sambucol® Black Elderberry Original (Sambucus Nigra) Liquid
n=84 Participants
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.
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.
|
Placebo for Sambucol® Black Elderberry Original (Sambucus Nigra) Liquid
n=87 Participants
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.
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
|
|---|---|---|
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To Determine Whether Sambucol Reduces Hospital Admissions by Day 28.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: The number analysed at each time point varies as not all participants replied at each time point
To determine if Sambucol reduces the severity of symptoms at day 3, 7, 14 and 28 days as determined by a Visual Analogue Scale \_(VAS) where 0 was worst health and 100 best health
Outcome measures
| Measure |
Sambucol® Black Elderberry Original (Sambucus Nigra) Liquid
n=102 Participants
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.
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.
|
Placebo for Sambucol® Black Elderberry Original (Sambucus Nigra) Liquid
n=102 Participants
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.
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
|
|---|---|---|
|
To Determine if Sambucol Reduces the Severity of Symptoms at Day 3, 7, 14 and 28 Days
Day 3
|
68.6 score on a scale
Standard Deviation 19.5
|
68.6 score on a scale
Standard Deviation 15.6
|
|
To Determine if Sambucol Reduces the Severity of Symptoms at Day 3, 7, 14 and 28 Days
Day 7
|
78.9 score on a scale
Standard Deviation 17
|
80.3 score on a scale
Standard Deviation 12.7
|
|
To Determine if Sambucol Reduces the Severity of Symptoms at Day 3, 7, 14 and 28 Days
DAy 14
|
88.7 score on a scale
Standard Deviation 13.9
|
91.1 score on a scale
Standard Deviation 8.8
|
|
To Determine if Sambucol Reduces the Severity of Symptoms at Day 3, 7, 14 and 28 Days
Day 28
|
93.5 score on a scale
Standard Deviation 11.4
|
94.8 score on a scale
Standard Deviation 7.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 daysPopulation: How many participants were admitted to hospital
Reduction in hospital admission as per participant hospital admission rates- for participants with mild or moderate COVID-19
Outcome measures
| Measure |
Sambucol® Black Elderberry Original (Sambucus Nigra) Liquid
n=84 Participants
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.
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.
|
Placebo for Sambucol® Black Elderberry Original (Sambucus Nigra) Liquid
n=87 Participants
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.
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
|
|---|---|---|
|
Reduction in Hospital Admission as Per Participant Hospital Admission Rates
|
0 Participants
|
0 Participants
|
Adverse Events
Sambucol® Black Elderberry Original (Sambucus Nigra) Liquid
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo for Sambucol® Black Elderberry Original (Sambucus Nigra) Liquid
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sambucol® Black Elderberry Original (Sambucus Nigra) Liquid
n=102 participants at risk
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.
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.
|
Placebo for Sambucol® Black Elderberry Original (Sambucus Nigra) Liquid
n=102 participants at risk
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.
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
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath and chest pain
|
0.98%
1/102 • Each participant was in the trial for 28 days , adverse event data will be collected over this period- 28 days
|
0.00%
0/102 • Each participant was in the trial for 28 days , adverse event data will be collected over this period- 28 days
|
Other adverse events
| Measure |
Sambucol® Black Elderberry Original (Sambucus Nigra) Liquid
n=102 participants at risk
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.
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.
|
Placebo for Sambucol® Black Elderberry Original (Sambucus Nigra) Liquid
n=102 participants at risk
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.
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
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
skin
|
6.9%
7/102 • Each participant was in the trial for 28 days , adverse event data will be collected over this period- 28 days
|
4.9%
5/102 • Each participant was in the trial for 28 days , adverse event data will be collected over this period- 28 days
|
|
Gastrointestinal disorders
Gastro
|
4.9%
5/102 • Each participant was in the trial for 28 days , adverse event data will be collected over this period- 28 days
|
3.9%
4/102 • Each participant was in the trial for 28 days , adverse event data will be collected over this period- 28 days
|
|
General disorders
general
|
6.9%
7/102 • Each participant was in the trial for 28 days , adverse event data will be collected over this period- 28 days
|
6.9%
7/102 • Each participant was in the trial for 28 days , adverse event data will be collected over this period- 28 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place