Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202203874034949 Date of Approval: 15/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Polyphenol-Rich Cocoa Powder As Adjuvant Therapy In Patients With Covid-19
Official scientific title Polyphenol-Rich Cocoa Powder As Adjuvant Therapy In Patients With Covid-19
Brief summary describing the background and objectives of the trial Background: COVID-19 caused by the novel severe acute respiratory coronavirus (SARS-Co-V-2) has, since March 2020, been declared a global pandemic by the World Health Organization (WHO). The virus has ravaged the health, economic, and social life of countries and millions of individuals across the globe. As of 5th February 2021, the WHO reported global confirmed cases to be 104, 165, 066 million and 2, 265, 354 million deaths1. Some reports points to endothelial dysfunction as the cause of the complications and multi-organ failure in COVID-19. Though several COVID-19 vaccines have received emergency use authorization, global access, procurement, and distribution is a challenge while no definitive treatment exists and therefore search for new and adjunct therapies continues. Polyphenol-rich cocoa is noted for its potent antioxidant, antihypertensive, antiplatelet, antiatherogenic, anti-inflammatory and improved vascular function and might be useful in reversing aspects of endothelial dysfunction implicated in the pathogenesis of COVID-19. Study Goals and Objective General objective: To evaluate effects of polyphenol-rich cocoa as adjuvant therapy in COVID 19 patients. Specific objectives: 1. To determine the effects of natural polyphenol-rich natural cocoa powder (5 % v/w) (as adjuvant therapy) on symptom resolution in COVID-19 patients. 2. To determine the effects of natural polyphenol-rich natural cocoa powder (5 % v/w) on D-dimer, fibrinogen, ferritin, and C-Reactive protein levels in COVID-19 patients. 3. To determine the effects of natural polyphenol-rich natural cocoa powder (5 % v/w) on rate of clearance of SARS-CoV-2 in COVID-19 patients 4. To determine the effects of natural polyphenol-rich natural cocoa powder (5% v/w) on prognostic indicators such as need for ICU care or need for ventilation in COVID-19 patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Respiratory
Sub-Disease(s) or condition(s) being studied COVID-19
Purpose of the trial Supportive care
Anticipated trial start date 15/03/2022
Actual trial start date 15/03/2022
Anticipated date of last follow up 15/08/2022
Actual Last follow-up date 15/08/2022
Anticipated target sample size (number of participants) 126
Actual target sample size (number of participants) 126
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Royale cocoa powder The beverage will be administered twice daily (12 hourly) for 14 days or until discharge - whichever comes earlier.63 14 days Polyphenol-rich cocoa is noted for its potent antioxidant, antihypertensive, antiplatelet, antiatherogenic, anti-inflammatory and improved vascular function and might be useful in reversing aspects of endothelial dysfunction implicated in the pathogenesis of COVID-19. Poly-rich cocoa (10gram) contains the following: Total Fat=1.06g Total Carbo=5.10g Crude Fiber= 0.12g Sugars=0.47g Protein=2.14g Vitamin A=0.03meg Vitamin C=0.14mg Iron=1.19mg Calcium=5.82mg Sodium=2.14mg 63
Control Group Sugar 10ml of sugar and 1 ml of Rayner’s food colour will be dissolved in 200 milliliters 14 days A sugar solution will be given as a placebo to the control group. Rayner's food colour (chocolate brown) will be added to the sugar solution to change its colour and give it a cocoa flavour. Rayner's chocolate brown colour is a colour ant that can be used as a colourant in desserts or cakes. The ingredients it contains include: water, chocolate brown HT E155, brilliant blue FCF E133, acetic acid. It has its origin from England and the brand is Rayner's with 28ml as content. 63 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
. Confirmed COVID-19 positivity at admission . Ability to tolerate oral medication and oral food intake • Patients who are unable to swallow/receive oral medication • Patients requiring ICU care on screening • Pregnant or lactating COVID-19 patients - based on their declaration and pregnancy test results when required. • Self-reported known allergies or intolerance to natural cocoa • Inability or unwillingness to be followed up for the trial period Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 12 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/10/2021 Ghana Health Service Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Castle Road Accra 233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcomes will be improvement in COVID-19 symptoms and laboratory evidence of decrease in coagulation parameters. Day 3, 7, 14, 28
Secondary Outcome • Rate of decline of SARS-CoV-2 viral load from baseline and 96 hours later • Duration of hospital admission • Time to clinical recovery • Final clinical prognosis and need for ICU management • Proxy measures of improvement in endothelial function. Days 3, 7, 14, 28
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ga East Municipal Hospital Atomic Hills Estate ST Accra 233 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Ghana Cocoa Board Adjabeng Rd Accra 233 Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ghana Cocoa Board Adjabeng Road Accra 233 Ghana Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator George Obeng gadjei@ug.edu.gh +233208114973 Annie Jiagge Road
City Postal code Country Position/Affiliation
Accra 233 Ghana University of Ghana
Role Name Email Phone Street address
Public Enquiries Lade Wosornu ladewosornu@gmail.com +233274723333 Second Food Research Road
City Postal code Country Position/Affiliation
Accra 233 Ghana Ghana Academy of Arts and Sciences
Role Name Email Phone Street address
Scientific Enquiries Edward Amporful amporful221065@yahoo.com +233249140881 Graphic Road
City Postal code Country Position/Affiliation
Accra 233 Ghana COCOBOD
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Participant’s information that will underlie the study results will be shared with researchers and health organizations to inform treatment measure for COVID-19 patients. The statistical analysis that will be emerged from the study will be available to researcher inside or outside the country. None of participants contact or identifiable information will be made available. The data will be available to researchers 3 month after the trial final report. The results will be made available to the Ghana Health Service and Cocoa Board. Clinical Study Report Three months after the clinical report The results will also be disseminated through digital science communication platforms, including academic social media, to extend its outreach and usefulness.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information