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: www.pactr.org
Trial no.: PACTR202006883882711 Date of Approval: 30/06/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of Measles, Mumps and Rubella Vaccine in Health Care Professionals for COVID-19
Official scientific title Effectiveness of Measles, Mumps and Rubella Vaccine in Health Care Professionals for COVID-19
Brief summary describing the background and objectives of the trial Since the World Health Organization (WHO) labelled the new disease that originated in Wuhan, China Coronavirus disease 2019(COVID-19) all the world has been suffering from its consequences including health, economic and political problems. Search for vaccine started and as a new vaccine may be difficult to find with unexpected side effects we thought of using an older vaccine. Till now, mortality reports among children below 9 years remains extremely low despite that the incidence of the death toll is high and exceeding 500,000 patients among the older population. One speculation for lower SARS infectivity is those cross-protective antibodies against measles vaccine ( MV). In mice susceptible to measles virus, recombinant MV induced the highest titers of neutralizing antibodies and fully protected immunized animals from intranasal infectious challenge with SARS-CoV We thought of Measles, Mumps and Rubella (MMR) vaccine as a potential preventive measure.
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 Prevention: Vaccines
Anticipated trial start date 01/07/2020
Actual trial start date
Anticipated date of last follow up 01/01/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo Once Placebo-controlled 100 Placebo
Experimental Group Measles Mumps and Rubella vaccine 0.5 ml Once Measles, Mumps & Rubella Vaccine booster dose 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 Age 18-80 years old  Subjects who are willing to comply with the requirements of the study protocol and scheduled visits (for example, completion of the subject diary, return for follow-up visits) and who are willing to make themselves available for the duration of the study with access to a consistent means of telephone contact,  Acute severe illness  Recent receipt of a blood product  History of thrombocytopenia  Pregnant females  Any chronic medical condition  Any participant receiving any immune suppressive medication  Immunocompromised staff  Participants who have egg allergy  Participants who care for immune compromised hosts at home  Participants who had documented COVID-19 either by RT-PCR or radiologically in the past six months 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) 80 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
No 29/06/2020 Dar Al Fouad Hospital
Ethics Committee Address
Street address City Postal code Country
26 July Street, The Touristic Zone 6th October 12568 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. COVID-19 incidence [ Time Frame: Measured over the 6 months following randomization] 2. Number of participants with asymptomatic or mild COVID-19 disease defined as I. fever (using a self-reported questionnaire), plus II. at least one sign or symptom of respiratory disease including cough, runny/blocked nose (using self-reported questionnaire), plus III. positive SARS-Cov-2 test (PCR or serology) post-vaccination at 1 month, and 2, 4, and 6 months thereafter
Secondary Outcome 1. SARS-CoV-2 pneumonia [ Time Frame: Measured over the 6 months following randomization] 2. Number of pneumonia cases (abnormal chest X-ray) (using a self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test 3. Critical care admission duration with SARS-CoV-2 [ Time Frame: Measured over the 6 months following randomization] 4. Number of days admitted to critical care (using a self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test 5. Oxygen therapy with SARS-CoV-2 [Time Frame: Measured over the 6 months following randomization] 6. Need for oxygen therapy (using a self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test 7. Critical care admissions with SARS-CoV-2 [Time Frame: Measured over the 6 months following randomization]. 8. Number of admission to critical care (using a self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test post-vaccination at 1 month, and 2, 4, and 6 months thereafter
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dar Al Fouad Hospital 26 July Street, The Touristic Zone 6th of October City 12568 Egypt
Dar Al Fouad Hospital AlNasr Road Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dar Al Fouad Hospital 26 July Street, The Touristic Zone 6th October Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dar Al Fouad Hospital 26 July Street, The Touristic Zone 6th October Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Amani El Kholy 26 July Street, The Touristic Zone 6th October Egypt
Jehan El Kholy AlNasr Road Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mostafa Alfishawy malfishawy@kasralainy.edu.eg +201550079112 26 July Street, The Touristic Zone
City Postal code Country Position/Affiliation
6th October Egypt Infectious Diseases Consultant
Role Name Email Phone Street address
Scientific Enquiries Amani El Kholy aaakholy@gmail.com +201001678063 26 July Street, The Touristic Zone
City Postal code Country Position/Affiliation
6th October Egypt Chief of Infection Prevention and Control
Role Name Email Phone Street address
Scientific Enquiries Jehan El Kholy jehanelkholy12@gmail.com +201001678057 AlNasr Road
City Postal code Country Position/Affiliation
Cairo Egypt Chief of Infection Prevention and Control
Role Name Email Phone Street address
Public Enquiries Hend Ibrahim hend.dr@gmail.com +201223639709 26 July Street, The Touristic Zone
City Postal code Country Position/Affiliation
6th October Egypt Pharmacist
Role Name Email Phone Street address
Public Enquiries Doaa Nagy doaahabiba123@gmail.com +201004673774 26 July Street, The Touristic Zone
City Postal code Country Position/Affiliation
6th October Egypt Pharmacist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Study Protocol Beginning 9 months and ending 36 months after the publication of the study Outside investigators upon scientific review of the merits of their proposed research plan
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
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 30/06/2020 Correction to include min age of 18 yrs and max age of 80 yrs Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s) Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 30/06/2020 Missing data Amani El Kholy, 26 July Street, The Touristic Zone, 6th October, , Egypt
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 30/06/2020 Missing data Jehan El Kholy, AlNasr Road, Cairo, , Egypt
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 30/06/2020 Missing data Dar Al Fouad Hospital, 26 July Street, The Touristic Zone, 6th October, , Egypt, Hospital,