Covid19Phase 3MV-COVID19NCT04357028
Measles Vaccine in HCW
A Phase 3 study testing Measles-Mumps-Rubella Vaccine in people with Covid19, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Till now, mortality reports among children below 9 years remains extremely low despite that the incidence of death toll is high and exceeding 50,000 patients among older population, One speculation for lower SARS infectivity is that cross-protective antibodies against measles vaccine ( MV). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Measles-Mumps-Rubella Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Jul 2020to 1 Jan 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-50 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Measles Vaccine in Health Care Professionals During COVID-19 Outbreak (Randomized Controlled Trial)
Till now, mortality reports among children below 9 years remains extremely low despite that the incidence of death toll is high and exceeding 50,000 patients among older population, One speculation for lower SARS infectivity is that 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,
The primary objective of the present study is to determine the benefit of measles vaccine in health care professional to decrease the incidence of COVID-19.
We Hypothesized that, measles vaccine may lower the incidence of serologically proven SARS-CoV-2 infection and reported respiratory illness
- Conditions
- Covid19
- Being tested
- Measles-Mumps-Rubella Vaccine, Placebos
- Keywords
- MMR vaccine, Respiratory failure,
- Medical subject headings
- COVID-19, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measles-Mumps-Rubella VaccineDrug
Measles mumps Rubella vaccine is a weak attenuated life vaccine
PlacebosDrug
0.5 ml subcutaneous of saline will be injected in posterior triceps aspect of upper arm
| Study group | Role | What they receive |
|---|---|---|
| MMR vaccine | Experimental | 0.5 ml subcutaneous of MMR vaccine will be injected in posterior triceps aspect of upper arm Receives: Drug: Measles-Mumps-Rubella Vaccine |
| Control | Placebo comparator | 0.5 ml subcutaneous of saline will be injected in posterior triceps aspect of upper arm Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 disease incidence
Number of participants with asymptomatic or mild COVID-19 disease defined as fever (using self-reported questionnaire), plus at least one sign or symptom of respiratory disease including cough, runny/blocked nose (using self-reported questionnaire), plus positive SARS-Cov-2 test (PCR or serology)
Measured: Time Frame: Measured over the 6 months following randomization
Secondary outcomes (3)
SARS-CoV-2 pneumonia
Number of pneumonia cases (abnormal chest X-ray) (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test
Measured: Time Frame: Measured over the 6 months following randomization
Critical care admission duration with SARS-CoV-2
Number of days admitted to critical care (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test
Measured: Time Frame: Measured over the 6 months following randomization
Oxygen therapy with SARS-CoV-2
Need for oxygen therapy (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test
Measured: Time Frame: Measured over the 6 months following randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start13 Jul 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Why it stopped: Failure of subject recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mukhtar, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357028
- Sponsor's protocol ID
- N-30-2020
- Acronym
- MV-COVID19
- Status last verified
- Dec 2020
- First submitted
- 19 Apr 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Measles Vaccine in Health Care Professionals During COVID-19 Outbreak (Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT04357028
- Acronym / sponsor ID
- MV-COVID19 / N-30-2020
- Conditions
- Covid19
- Keywords
- MMR vaccine, Respiratory failure,
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Failure of subject recruitment
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Till now, mortality reports among children below 9 years remains extremely low despite that the incidence of death toll is high and exceeding 50,000 patients among older population, One speculation for lower SARS infectivity is that 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,
The primary objective of the present study is to determine the benefit of measles vaccine in health care professional to decrease the incidence of COVID-19.
We Hypothesized that, measles vaccine may lower the incidence of serologically proven SARS-CoV-2 infection and reported respiratory illness
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MMR vaccine | Experimental | Drug: Measles-Mumps-Rubella Vaccine0.5 ml subcutaneous of MMR vaccine will be injected in posterior triceps aspect of upper arm |
| Control | Placebo comparator | Drug: Placebos0.5 ml subcutaneous of saline will be injected in posterior triceps aspect of upper arm |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-50 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
Key exclusion criteria (10 listed)
- acute severe illness
- recent receipt of a blood product
- history of thrombocytopenia
- Pregnant females
- any chronic medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measles-Mumps-Rubella VaccineMeasles mumps Rubella vaccine is a weak attenuated life vaccine | Drug | MMR vaccine |
| Placebos0.5 ml subcutaneous of saline will be injected in posterior triceps aspect of upper arm | Drug | Control |
Primary outcome
COVID-19 disease incidence
Time frame: Time Frame: Measured over the 6 months following randomization
Number of participants with asymptomatic or mild COVID-19 disease defined as fever (using self-reported questionnaire), plus at least one sign or symptom of respiratory disease including cough, runny/blocked nose (using self-reported questionnaire), plus positive SARS-Cov-2 test (PCR or serology)
3 secondary outcomes
SARS-CoV-2 pneumonia
Time frame: Time Frame: Measured over the 6 months following randomization
Critical care admission duration with SARS-CoV-2
Time frame: Time Frame: Measured over the 6 months following randomization
Oxygen therapy with SARS-CoV-2
Time frame: Time Frame: Measured over the 6 months following randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Measles-Mumps-Rubella Vaccine in people with Covid19, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 disease incidence (time frame: Time Frame: Measured over the 6 months following randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.