ANZCTR - Registration

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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]

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

SARS-CoV-2

Pregnancy

Condition category

Condition code

Reproductive Health and Childbirth

Fetal medicine and complications of pregnancy

Infection

Other infectious diseases

Respiratory

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]

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]

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]

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]

Requirement for admission to intensive care unit (ICU)

Secondary maternal outcomes will be assessed using data-linkage to medical records

Timepoint [1]

Within 28 days of commencing study intervention

Secondary outcome [2]

Diagnosis of maternal ARDS (acute respiratory distress syndrome)

Secondary maternal outcomes will be assessed using data-linkage to medical records

Timepoint [2]

Within 28 days of commencing study intervention

Secondary outcome [3]

Requirement for mechanical ventilation

Secondary maternal outcomes will be assessed using data-linkage to medical records

Timepoint [3]

Within 28 days of commencing study intervention

Secondary outcome [4]

Requirement for ECMO (extra-corporeal membrane oxygenation)

Secondary maternal outcomes will be assessed using data-linkage to medical records

Timepoint [4]

Within 28 days of commencing study intervention

Secondary outcome [5]

Maternal death

Secondary maternal outcomes will be assessed using data-linkage to medical records

Timepoint [5]

Within 28 days of commencing study intervention

Secondary outcome [6]

Duration of hospital admission (days)

Secondary maternal outcomes will be assessed using data-linkage to medical records

Timepoint [6]

Within 28 days of commencing study intervention

Secondary outcome [7]

Documented SpO2 <94% on room air

Secondary maternal outcomes will be assessed using data-linkage to medical record

Timepoint [7]

Within 28 days of commencing study intervention

Secondary outcome [8]

Requirement for any oxygen therapy

Secondary maternal outcomes will be assessed using data-linkage to medical record

Timepoint [8]

Within 28 days of commencing study intervention

Secondary outcome [9]

Neonatal - Need for admission to neonatal intensive care unit (NICU) or special care nursery

Timepoint [9]

Up until hospital discharge of neonate

Neonatal outcomes will be obtained via data-linkage to medical records

Secondary outcome [10]

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]

Up until hospital discharge of neonate

Secondary outcome [11]

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]

Up until hospital discharge of neonate

Secondary outcome [12]

Gestational age at delivery (weeks)

Secondary maternal outcomes will be assessed using data-linkage to medical records

Timepoint [12]

Duration of pregnancy

Secondary outcome [13]

Hospital admission for any cause for >24 hours within 28 days obtained via data-linkage to medical records

Timepoint [13]

Within 28 days of commencing study participation

Secondary outcome [14]

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]

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]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [2]

Dandenong Hospital- Monash Health - Dandenong

Recruitment hospital [3]

Casey Hospital - Berwick

Recruitment hospital [4]

Jessie McPherson Private Hospital - Clayton

Recruitment postcode(s) [1]

3168 - Clayton

Recruitment postcode(s) [2]

3175 - Dandenong

Recruitment postcode(s) [3]

3806 - Berwick

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Monash Health Foundation

Address [1]

Monash Health Foundation
Monash Medical Centre
246 Clayton Road
CLAYTON VIC
3168

Country [1]

Australia

Primary sponsor type

Hospital

Name

Monash Health

Address

Monash Medical Centre
246 Clayton Road
CLAYTON VIC
3168

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health Human Research and Ethics Committee

Ethics committee address [1]

Monash Medical Centre
246 Clayton Road
CLAYTON VIC
3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/11/2021

Approval date [1]

13/07/2022

Ethics approval number [1]

RES-21-0000-708A

Summary

Brief summary

CO-Sprout clinical trial will investigate whether broccoli sprout powder capsules given to pregnant women infected with SARS-CoV-2 (COVID-19) can help reduce the duration of COVID-19 associated symptoms. Additional outcomes measured will include hospital admissions, maternal respiratory outcomes, obstetric and birthing outcomes, as well as neonatal outcomes. It is hoped that providing pregnant women with this natural supplement during COVID-19 infection, will help reduce the levels of inflammation and improve their symptoms hopefully leading to reduced need for hospital and ICU admissions. Broccoli sprout powder contains the naturally occurring phytonutrient sulforaphane which is hoped to improve maternal and neonatal outcomes during pregnancy from infection with the SARS-CoV-2 virus.

Trial website

Nil

Trial related presentations / publications

Nil

Public notes

Contacts

Principal investigator

Name

Dr Neville Fields

Address

Clayton Hospital
Monash Health
246 Clayton Road
Clayton
VIC 3168

Country

Australia

Phone

+61395945145

Fax

+61395946438

Email

[email protected]

Contact person for public queries

Name

Neville Fields

Address

Clayton Hospital
Monash Health
246 Clayton Road
Clayton
VIC 3168

Country

Australia

Phone

+61395945145

Fax

+61395946438

Email

[email protected]

Contact person for scientific queries

Name

Sarah Marshall

Address

27-31 Wright Street CLAYTON VIC 3168

Country

Australia

Phone

+61 417530140

Fax

+61395946438

Email

[email protected]

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 ([email protected]) directly to seek more information about the trial.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
14743	Study 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

Source	Title	Year of Publication	DOI
Embase	CO-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.	2023	https://dx.doi.org/10.3390/nu15183980

N.B. These documents automatically identified may not have been verified by the study sponsor.