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.: PACTR202101794986980 Date of Approval: 19/01/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title CROWN CORONATION; COVID-19 Research Outcomes Worldwide Network for CORONAvirus prevenTION
Official scientific title An international, Bayesian platform adaptive, randomized, placebo-controlled trial assessing the effectiveness of candidate interventions in preventing COVID-19 disease in Adults
Brief summary describing the background and objectives of the trial The CROWN (COVID-19 Research Outcomes Worldwide Network) COLLABORATIVE is an international, transdisciplinary, research network, established to assess rigorously and efficiently promising interventions for COVID-19. CROWN CORONATION (COVID-19 Research Outcomes Worldwide Network for CORONAvirus prevenTION) is a Bayesian, pragmatic participant-level randomized, multi-center, and international placebo-controlled platform trial, assessing candidate interventions that either modify the host immune response or target the virus implicated in COVID-19 - severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). The objective of CROWN CORONATION is the prevention of symptomatic COVID-19 by using combinations of approved and safe agents, with complementary mechanisms of action. The primary outcome of CROWN CORONATION is symptomatic COVID-19 by day 60 after commencement of study intervention (i.e. any of the following: cough, shortness of breath or difficulty breathing, fever, chills, muscle pain, sore throat, new loss of taste or smell, nausea, vomiting, or diarrhea) with laboratory confirmation (i.e. based on viral polymerase chain reaction). And also to observe whether prior exposure to the MR vaccine can boost the immune responses obtained from the specific COVID-19 (AstraZeneca) vaccine.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CROWN CORONATION
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Coronaviruses Disease COVID-19
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 29/01/2021
Actual trial start date
Anticipated date of last follow up 29/11/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants)
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 Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Measles Rubella MR (or MMR) vaccine one 0.5 ml dose deep subcutaneous injection 150days The vaccine is prepared from the live, attenuated strains of Edmonston-Zagreb measles virus and Wistar RA 27/3 rubella virus. Both measles and rubella viruses are propagated on human diploid cells (HDC). The vaccine is lyophilized and is provided with diluent. The product has the appearance of a yellowish-white dry cake. The vaccine meets the requirements of W.H.O. when tested by the methods outlined in W.H.O., TRS 840 (1994). 75
Control Group Normal Saline 0.5 ml 150 days Sodium Chloride (sodium chloride (sodium chloride injection) injection) Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The nominal pH is 5.5 (4.5 to 7.0). Composition, osmolarity, and ionic concentration are shown below: 0.45% Sodium Chloride Injection, USP contains 4.5 g/L Sodium Chloride (sodium chloride (sodium chloride injection) injection) , USP (NaCl) with an osmolarity of 154 mOsmol/L (calc). It contains 77 mEq/L sodium and 77 mEq/L chloride. 0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride (sodium chloride (sodium chloride injection) injection) , USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride. 75 Placebo
Experimental Group Astra Zeneca 0.5mls 90 days These are multidose vials which contain 8 doses or 10 doses of 0.5 ml per vial (see section 6.5). One dose (0.5 ml) contains: Chimpanzee Adenovirus encoding the SARS-CoV-2 Spike glycoprotein (ChAdOx1-S)*, not less than 2.5 × 108 infectious units (Inf.U) *Produced in genetically modified human embryonic kidney (HEK) 293 cells and by recombinant DNA technology. This product contains genetically modified organisms ( 150
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Volunteers without clinical evidence of COVID-19 infection aged 18 years and older. 2. Participants who are at high risk of SARS-CoV-2 infection, defined as adults whose locations or circumstances put them at appreciable risk of exposure to SARS-CoV-2 and COVID-19. 3. Must have a mobile phone and access to the Internet for data collection purposes. 4. Participants who are willing and able to provide informed consent via an electronic consent process. 1. Weight outside range 50 kg – 120 kg (110 lbs – 265 lbs). 2. Self-reported or laboratory confirmed previous or current diagnosis of SARS-CoV-2. 3. Self-reported current acute respiratory infection. 4. Concurrent and/or recent use of the investigational product, a product considered to be equivalent to the investigational product, or any other product that is likely to interfere with the investigational products in this trial or the interpretation of trial data . 5. Self-reported known allergies to any of the IMPs and excipients of the IMPs and placebo. 6. Self-reported presence or history of the conditions listed in the appendices. 7. Self-reported current use of medication with known to interact with any of the medications listed in the appendices. 8. Inability or unwillingness to be followed up for the trial period 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 01/12/2020 UGMC IRB
Ethics Committee Address
Street address City Postal code Country
Akilagpa Sawyerr Accra GA3376980 Ghana
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 05/01/2021 Korle Bu Teaching Hospital Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Harley Street Accra KB 77 Ghana
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 29/09/2020 Noguchi Memorial Institute for Medical Research Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Akilapa Sawyer Accra LG 581 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Symptomatic COVID-19: Clinical diagnosis of COVID-19 with laboratory confirmation (i.e. based on viral PCR), and symptoms of COVID-19 (cough, shortness of breath or difficulty breathing, fever, chills, muscle pain, sore throat, new loss of taste or smell, nausea, vomiting, or diarrhea) by day 60 from commencement of trial intervention. By day 60 from time the intervention is administered.
Secondary Outcome Secondary outcome of special interest is: Severity of COVID-19 over the study period 1.Primary endpoint, but instead of the 60-day time-window, over the course of the first 30 days of treatment; 2.Symptomatic COVID-19 (with subsequent virological confirmation) during the 5-month study period; 3.Incident COVID-19 during the 60-day study period, which includes asymptomatic infections identified by serology samples taken at the time-point of study exit. 1.By day 30 over the course of first treatment . 2.During the 5 month study period , 3. During the 60 day study period
Secondary Outcome To observe whether prior exposure to the MR vaccine can boost the immune response obtained from the specific COVID-19 AstraZeneca Vaccine 4 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Komfo Anokye Teaching Hospital Okomfo Anokye Road Kumasi Ghana
Korle Bu Teaching Hospital Guggisberg Avenue Accra Ghana
Pentecost Convention Centre Millennium City Road Kasoa Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Therapeutics Accelerator and Bill and Melinda Gates Foundation Seattle Washington D.C Washington D.C United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Noguchi Memorial Institute for Medical Research Akilagpa Sawyerr Accra LG 581 Ghana Research Institute
COLLABORATORS
Name Street address City Postal code Country
NMIMR Akilakpa Sawyer Accra GA3376980 Ghana
University College of London Gower street London United Kingdom
Washington University School of Medicine S Euclid Avenue St Louis MO63110 United States of America
University of Ghana Medical Center Akilapa Sawyer Accra LG 25 Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kwadwo A. Koram kkoram@noguchi.ug.edu.gh 233204313130 Akilagpa Sawyerr
City Postal code Country Position/Affiliation
Accra Ghana Principal Investigator
Role Name Email Phone Street address
Public Enquiries Susan Adu Amankwah sadu-amankwah@noguchi.ug.edu.gh 0244734811 Akilagpa Sawyerr
City Postal code Country Position/Affiliation
Accra Ghana Co Principal investigator
Role Name Email Phone Street address
Scientific Enquiries George Kyei Boateng gkyei@noguchi.ug.edu.gh 0551989937 Akilagpa Sawyerr
City Postal code Country Position/Affiliation
Accra Ghana Co Principal Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Participants information will be shared with researchers from other countries and organisations from across the world. This includes researchers from countries taking part in the trial as well as those who might request use of their information after the trial is completed. None of their contact details will be shared. Organisations that the data will be shared with include: The Bill and Melinda Gates Foundation (https://www.gatesfoundation.org/); The World Health Organisation (WHO) (https://www.who.int/); The Infectious Disease Data Observatory (https://www.iddo.org/); PRA Health Sciences (https://www.prahs.com/); Washington University School of Medicine the Coordinating Centre or the study. Informed Consent Form,Statistical Analysis Plan,Study Protocol The data will be available for 25 years. 1. Request for the data will be reviewed by data access committee 2. Data will be available for use after IRB review and ethical approval issuance 3. Consent forms will be reviewed to ascertain participants preference for future use.
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