Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000173796
Ethics application status
Approved
Date submitted
13/01/2022
Date registered
2/02/2022
Date last updated
21/05/2024
Date data sharing statement initially provided
2/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
CO-Sprout: Broccoli sprout powder pilot trial for COVID-19 positive pregnant women on the duration of symptoms
Scientific title
CO-Sprout: A pilot double-blinded randomised control trial of broccoli sprout powder supplementation for pregnant women with COVID-19 on the duration of symptoms
Secondary ID [1] 306176 0
Nil known
Universal Trial Number (UTN)
U1111-1273-1651
Trial acronym
CO-Sprout
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 324883 0
SARS-CoV-2 324884 0
Pregnancy 324885 0
Condition category
Condition code
Reproductive Health and Childbirth 322320 322320 0 0
Fetal medicine and complications of pregnancy
Infection 322321 322321 0 0
Other infectious diseases
Respiratory 322419 322419 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Broccoli sprout powder capsules (producing 21mg sulforaphane)

Oral

2 capsules (10.5mg sulforaphane) twice a day, morning and night (BD).
Total daily dose 42mg of sulforaphane daily

The administration of the trial intervention will cease after 14 days of treatment or in the event the patient is unable to continue oral supplementation

Adherence to trial intervention will be measured by return of capsules at end of trial and with use of a study participant drug diary
Intervention code [1] 322583 0
Treatment: Drugs
Comparator / control treatment
2 capsules matching placebo opaque capsules of microcrystalline cellulose twice a day, morning and night (BD).

The administration of the placebo will cease after 14 days of treatment or in the event the patient is unable to continue oral supplementation
Control group
Placebo

Outcomes
Primary outcome [1] 330087 0
Duration of COVID-19 associated symptoms (days) as self-reported by trial participants. Secondary outcomes will be assessed using data-linkage to medical records.
Timepoint [1] 330087 0
Duration of symptoms counted from first day of symptom development until last day of symptoms with a consecutive 48 hour symptom-free period
Secondary outcome [1] 404848 0
Requirement for admission to intensive care unit (ICU)

Secondary maternal outcomes will be assessed using data-linkage to medical records
Timepoint [1] 404848 0
Within 28 days of commencing study intervention
Secondary outcome [2] 404849 0
Diagnosis of maternal ARDS (acute respiratory distress syndrome)

Secondary maternal outcomes will be assessed using data-linkage to medical records
Timepoint [2] 404849 0
Within 28 days of commencing study intervention
Secondary outcome [3] 404850 0
Requirement for mechanical ventilation

Secondary maternal outcomes will be assessed using data-linkage to medical records
Timepoint [3] 404850 0
Within 28 days of commencing study intervention
Secondary outcome [4] 405679 0
Requirement for ECMO (extra-corporeal membrane oxygenation)

Secondary maternal outcomes will be assessed using data-linkage to medical records
Timepoint [4] 405679 0
Within 28 days of commencing study intervention
Secondary outcome [5] 405680 0
Maternal death

Secondary maternal outcomes will be assessed using data-linkage to medical records
Timepoint [5] 405680 0
Within 28 days of commencing study intervention
Secondary outcome [6] 405682 0
Duration of hospital admission (days)

Secondary maternal outcomes will be assessed using data-linkage to medical records
Timepoint [6] 405682 0
Within 28 days of commencing study intervention
Secondary outcome [7] 405706 0
Documented SpO2 <94% on room air

Secondary maternal outcomes will be assessed using data-linkage to medical record
Timepoint [7] 405706 0
Within 28 days of commencing study intervention
Secondary outcome [8] 405707 0
Requirement for any oxygen therapy

Secondary maternal outcomes will be assessed using data-linkage to medical record
Timepoint [8] 405707 0
Within 28 days of commencing study intervention
Secondary outcome [9] 405708 0
Neonatal - Need for admission to neonatal intensive care unit (NICU) or special care nursery
Timepoint [9] 405708 0
Up until hospital discharge of neonate

Neonatal outcomes will be obtained via data-linkage to medical records
Secondary outcome [10] 405717 0
Neonatal - Severe neonatal morbidity index (SNMI)
As defined by at least 1 of the following morbidities:
• bronchopulmonarydysplasia,
• hypoxic-ischemic encephalopathy,
• sepsis,
• anaemia requiring transfusion,
• patent ductus arteriosus,
• intraventricular hemorrhage,
• necrotizing enterocolitis,
• or retinopathy of prematurity

Neonatal outcomes will be obtained via data-linkage to medical records
Timepoint [10] 405717 0
Up until hospital discharge of neonate
Secondary outcome [11] 405718 0
Neonatal - Severe perinatal morbidity and mortality index (SPMMI)

Includes any of the indicators from SNMI and additionally
• Intrauterine fetal death
• Neonatal death, or
• Neonatal intensive care unit admission > 7 days

Neonatal outcomes will be obtained via data-linkage to medical records
Timepoint [11] 405718 0
Up until hospital discharge of neonate
Secondary outcome [12] 405719 0
Gestational age at delivery (weeks)

Secondary maternal outcomes will be assessed using data-linkage to medical records
Timepoint [12] 405719 0
Duration of pregnancy
Secondary outcome [13] 412063 0
Hospital admission for any cause for >24 hours within 28 days obtained via data-linkage to medical records
Timepoint [13] 412063 0
Within 28 days of commencing study participation
Secondary outcome [14] 412064 0
Maximal disease severity of COVID-19 as defined by the Society for Maternal and Fetal Medicine (SMFM) via data-linkage to medical records

- Asymptomatic or presymptomatic disease or presumptive infection is defined as a positive COVID-19 test result with no symptoms.

- Mild disease is defined as flu-like symptoms, such as fever, cough, myalgias, and anosmia without dyspnea, shortness of breath, or abnormal chest imaging.

- Moderate disease is defined by evidence of lower respiratory tract disease with clinical assessment (dyspnea, pneumonia on imaging, abnormal blood gas results, refractory fever of 39.0 °C /102.2 °F or greater not alleviated with acetaminophen) while maintaining an oxygen saturation of greater than or equal to 94% on room air at sea level
.
- Severe disease is defined by a respiratory rate greater than 30 breaths per minute (bpm), hypoxia with oxygen saturation less than 94%, a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen of less than 300, or greater than 50% lung involvement on imaging.

- Critical disease is defined as multi-organ failure or dysfunction, shock, or respiratory failure requiring mechanical ventilation or high-flow nasal cannula.

- Refractory hypoxemia is defined as persistent, inadequate oxygenation and/or ventilation despite substantial and appropriate measures to optimize it and represents a further escalation of severity on the spectrum of disease.
Timepoint [14] 412064 0
Within 28 days of trial recruitment

Eligibility
Key inclusion criteria
• Currently pregnant with singleton gestation from 20+0 - 36+0 weeks
• Positive COVID-19 test including (viral polymerase chain reaction (PCR) positive test for SARS-CoV-2) or positive rapid antigen test (RAT) within 5 days
• Unvaccinated, partially, fully (+/- booster dose) vaccinated against COVID-19
• Signs or symptoms of COVID-19 that began less than or equal to 7 days of trial recruitment including but not limited to shortness of breath, anosmia, fevers, sore throat, headache and myalgia
• Able to tolerate oral supplementation and willing to complete the expected 14 day course
• Deemed capable of understanding the information provided and able to give written informed consent (with interpreter use as required).
• greater than or equal to 18 years of age
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Current use of broccoli or broccoli sprout supplement
• Contraindications to use (e.g., intolerance of broccoli)
• Significant uncertainty in ensuring gestational age is within limits
• Unwillingness or inability to follow the procedures outlined in the PICF (patient information consent form)
• Mentally, cognitively or legally incapacitated or ineligible to provide informed consent
• Co-recruitment/participation in another clinical trial where there is a pharmaceutical or herbal or nutritional intervention (such trial interventions would also include: multi-vitamins, minerals, antiviral, immunomodulatory or complementary and alternative medicines)
• Current antibiotic, antiviral or monoclonal antibody treatment related to acute illness at time of recruitment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation will be performed at the time of recruitment using RedCap through allocation tables created using Program R including stratification by centre and gestational age
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) using R and then including stratification by site and gestational age
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Total n = 60 (30 in both arms)

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/08/2022
Actual
23/08/2022
Date of last participant enrolment
Anticipated
31/12/2023
Actual
14/06/2023
Date of last data collection
Anticipated
Actual
1/03/2024
Sample size
Target
60
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 21448 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 21449 0
Dandenong Hospital- Monash Health - Dandenong
Recruitment hospital [3] 21450 0
Casey Hospital - Berwick
Recruitment hospital [4] 21451 0
Jessie McPherson Private Hospital - Clayton
Recruitment postcode(s) [1] 36350 0
3168 - Clayton
Recruitment postcode(s) [2] 36351 0
3175 - Dandenong
Recruitment postcode(s) [3] 36352 0
3806 - Berwick

Funding & Sponsors
Funding source category [1] 310520 0
Charities/Societies/Foundations
Name [1] 310520 0
Monash Health Foundation
Country [1] 310520 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
Monash Medical Centre
246 Clayton Road
CLAYTON VIC
3168
Country
Australia
Secondary sponsor category [1] 311691 0
None
Name [1] 311691 0
Address [1] 311691 0
Country [1] 311691 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310144 0
Monash Health Human Research and Ethics Committee
Ethics committee address [1] 310144 0
Ethics committee country [1] 310144 0
Australia
Date submitted for ethics approval [1] 310144 0
01/11/2021
Approval date [1] 310144 0
13/07/2022
Ethics approval number [1] 310144 0
RES-21-0000-708A

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116634 0
Dr Neville Fields
Address 116634 0
Clayton Hospital
Monash Health
246 Clayton Road
Clayton
VIC 3168
Country 116634 0
Australia
Phone 116634 0
+61395945145
Fax 116634 0
+61395946438
Email 116634 0
neville.fields1@monash.edu
Contact person for public queries
Name 116635 0
Neville Fields
Address 116635 0
Clayton Hospital
Monash Health
246 Clayton Road
Clayton
VIC 3168
Country 116635 0
Australia
Phone 116635 0
+61395945145
Fax 116635 0
+61395946438
Email 116635 0
neville.fields1@monash.edu
Contact person for scientific queries
Name 116636 0
Sarah Marshall
Address 116636 0
27-31 Wright Street CLAYTON VIC 3168
Country 116636 0
Australia
Phone 116636 0
+61 417530140
Fax 116636 0
+61395946438
Email 116636 0
sarah.marshall@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All individual de-identified data collected during the study
When will data be available (start and end dates)?
After the publication of the first paper of the CO-Sprout study and available for 5 years after publication
Available to whom?
Scientific investigators interested in the field whom contact the Chief Principal Investigator with a request for access to the data
Available for what types of analyses?
The data will be made available pending discussion with the chief investigator of the study and the study team for CO-Sprout. External analyses of the trial data will occur following discussion with the study team and subsequent approval by the Chief Principal Investigator.
How or where can data be obtained?
The data will be shared either through publication in a peer reviewed journal or by those parties who are interested, emailing the Chief Principal Investigator (neville.fields1@monash.edu) directly to seek more information about the trial.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14743Study protocol    This will be made available and published online a... [More Details]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCO-Sprout-A Pilot Double-Blinded Placebo-Controlled Randomised Trial of Broccoli Sprout Powder Supplementation for Pregnant Women with COVID-19 on the Duration of COVID-19-Associated Symptoms: Study Protocol.2023https://dx.doi.org/10.3390/nu15183980
N.B. These documents automatically identified may not have been verified by the study sponsor.