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.: PACTR202004693933092 Date of Approval: 16/04/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of Measles Vaccine in Health Care Professionals During COVID-19 Outbreak (Randomized Controlled Trial)
Official scientific title Effectiveness of Measles Vaccine in Health Care Professionals During COVID-19 Outbreak (Randomized Controlled Trial)
Brief summary describing the background and objectives of the trial In December 2019 an outbreak of respiratory illness started in Wuhan, China and soon spread to the whole world including Egypt. The new virus was labelled by the World Health Organization (WHO) as Severe Acute Respiratory Syndrome Coronavirus-2(SARS-CoV-2) and the disease called Coronavirus disease 2019(COVID-19). (1) A common and prominent complication of advanced COVID-19 is acute hypoxemic respiratory insufficiency or failure requiring oxygen and ventilation therapies. (2) Healthcare providers, who are tasked with taking care of critically ill patients, need to perform the best practices of intubation and ventilation which put them at great risk of acquiring the infection. In 2003, the incidence of infection of SARS among healthcare worker was 20% (3) The incidence of mortality of COVID19 ranged from 0.3 to 15 % with the highest mortality in the age above 65 years and patients with comorbidities. (2) . Till now, mortality reports among children below 9 years remains extremely low despite that the incidence of the death toll is high and exceeding 50,000 patients among the older population. (4) 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 (5) Measles is a highly infectious disease as COVID-19, associated with an erythematous rash similar to COVID-19 (6). Interestingly, Italy suffered from measles outbreaks in the last couple of years as well as New York the current epicenter of COVID-19 in the United States. Physicians in Italy have one of the lowest rates of measles vaccination which may be the cause for such high infections among physicians there (7) The primary objective of the present study is to determine the benefit of measles vaccine in health care professional to decrease the incidence of COVID19.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied COVID-19
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 15/04/2020
Actual trial start date
Anticipated date of last follow up 30/06/2020
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Health care workers aged 18-50 years old 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 • Participants who test positive for COVID-19 serology prior to randomization Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 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 09/04/2020 Misr University for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Al-Motamayez District 6th October 00077 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Serologic evidence of infection Post vaccination blood samples will be drawn 14 days, 1 month and 2 months thereafter.
Secondary Outcome Incidence of respiratory illness defined as two or more of the following o Fever o Sore throat o Dry cough o Runny nose o Shortness of breath  Participants will be phoned weekly for assessment and reporting any symptoms and if participant complains of any respiratory symptom he will be evaluated clinically and COVID-19 PCR swab will be sent and if they test positive they will be treated as per national protocol and clinical outcome will be reported  Incidence of admission to hospital Throughout study period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Misr University for Science and Technology Hospital Al-Motamayez District 6th October 00077 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Misr University for Science and Technology Al-Motamayez District 6th October 00077 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Misr University for Science and Technology Al-Motamayez District 6th October 00077 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr. Mahmoud Nassar Al-Motamayez District 6th October Egypt
Professor Ahmed Mukhtar Kasr Alainy School of Medicine Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mostafa Alfishawy malfishawy@kasralainy.edu.eg +201550079112 Al-Motamayez District
City Postal code Country Position/Affiliation
6th October Egypt Chief of Infectious Diseases
Role Name Email Phone Street address
Public Enquiries Mahmoud Nassar dr.nassar@aucegypt.edu +201000037609 Al-Motamayez District
City Postal code Country Position/Affiliation
6th October 00077 Egypt investigator
Role Name Email Phone Street address
Scientific Enquiries Ahmed Mukhtar Ahmed.Mukhtar@kasralainy.edu.eg +201114208444 Kasr Alainy School of Medicine
City Postal code Country Position/Affiliation
Cairo Egypt investigator
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 14/04/2020 Correction to include max age of 50 years Adult: 19 Year-44 Year Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 14/04/2020 Requirement for registration Undecided No
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 14/04/2020 Requirement for registeration Experimental Group, Measles Mumps and Rubella vaccine, 0.5 ml, Once, Measles, Mumps & Rubella Vaccine, 100,
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 14/04/2020 Details added Dr. Mahmoud Nassar, Al-Motamayez District , 6th October, , Egypt
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 14/04/2020 details added Professor Ahmed Mukhtar, Kasr Alainy School of Medicine, Cairo, , Egypt
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 15/04/2020 missing data No Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 15/04/2020 missing data Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 15/04/2020 missing data Beginning 9 months and ending 36 months after the publication of the study
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 15/04/2020 missing data Outside investigators upon scientific review of the merits of their proposed research plan
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 15/04/2020 missing data Study Protocol