Coronavirus (COVID-19)NCT04445610
Measles Vaccine: Is There a Protective Role in COVID 19 Pandemic?
An observational study of Coronavirus (COVID-19), run by Ain Shams University at 1 site in Egypt.
Trial summary
The following two mechanisms that explain the ability of measles vaccine to cause partial protection against COVID-19. The first is that measles vaccine may increase the ability of the immune system to fight off pathogens other than measles due to the generated bystander immunity that would enhance the overall… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronavirus (COVID-19)
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2020to 1 Nov 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients with confirmed COVID-19 presented to Ain Shams Hospital
Who may be able to join
- All patients with confirmed COVID 19.
- Any age or gender
Who cannot join
- - Any patient refusing to be involved in the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
Cairo, Non-US, 11566
About this study
The following two mechanisms that explain the ability of measles vaccine to cause partial protection against COVID-19. The first is that measles vaccine may increase the ability of the immune system to fight off pathogens other than measles due to the generated bystander immunity that would enhance the overall immunity against the new coronavirus. The second is that SARS-CoV-2 is proven to have structure similarities with measles, which may cause cross-reactivity and immunity between measles vaccines and COVID-19, leading to partial protection against COVID-19 in vaccinated subjects
Read the detailed description
Objectives:
- To identify Measles IgG titre in SARS-COV2 infected patients .
- correlate level of Measles IgG titre with the clinical severity of COVID-19 disease.
Secondary Objective To find an association of the postulated protective role of measles vaccine and SARS-COV2 infection
Criteria:
Inclusion criteria:included patients would be divided into 3 groups according to clinical severity of COVID-19 disease (mild ,moderate \& severe)
- All patients with confirmed COVID 19 confirmed by positive PCR . .
- Any age or gender.
Exclusion criteria:
- Any patient refusing to be involved in the study.
Methods:
- Informed consent will be taken from each subject
- Full clinical examination.
- Evaluation of Measles Antibody Titer:
The measles virus IgG antibody titer will be determined quantitatively by ELISA for quantitative determination of IgG class antibodies against Measles virus in human serum or plasma (citrate, heparin).
- Anonymous data will be retrieved from the admitted patients' files, such as:
- CBC, CRP, AST, ALT, ESR, Serum ferritin \& SARS CoV 2 RNA PCR swab results.
- Chest X ray and/or CT chest.
- Conditions
- Coronavirus (COVID-19)
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | mild | |
| B | moderate | |
| C | severe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral clearance
Achievement of two consecutive negative PCR results for COVID 19 and discharge from hospital
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start1 Jul 2020 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus (COVID-19)Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Al Balakosy, Ain Shams University
- Investigators
- Amira Al Balakosy, M.D, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445610
- Sponsor's protocol ID
- FMASU P31a/ 2020
- Status last verified
- Jun 2020
- First submitted
- 23 Jun 2020
- Last updated
- 26 Jun 2020
- Results posted
- No
- 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 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measles Vaccine: Is There a Protective Role in COVID 19 Pandemic?
- ClinicalTrials.gov ID
- NCT04445610
- Acronym / sponsor ID
- FMASU P31a/ 2020
- Conditions
- Coronavirus (COVID-19)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 24 Jun 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.
The following two mechanisms that explain the ability of measles vaccine to cause partial protection against COVID-19. The first is that measles vaccine may increase the ability of the immune system to fight off pathogens other than measles due to the generated bystander immunity that would enhance the overall immunity against the new coronavirus. The second is that SARS-CoV-2 is proven to have structure similarities with measles, which may cause cross-reactivity and immunity between measles vaccines and COVID-19, leading to partial protection against COVID-19 in vaccinated subjects
Detailed description
Objectives:
- To identify Measles IgG titre in SARS-COV2 infected patients .
- correlate level of Measles IgG titre with the clinical severity of COVID-19 disease.
Secondary Objective To find an association of the postulated protective role of measles vaccine and SARS-COV2 infection
Criteria:
Inclusion criteria:included patients would be divided into 3 groups according to clinical severity of COVID-19 disease (mild ,moderate \& severe)
- All patients with confirmed COVID 19 confirmed by positive PCR . .
- Any age or gender.
Exclusion criteria:
- Any patient refusing to be involved in the study.
Methods:
- Informed consent will be taken from each subject
- Full clinical examination.
- Evaluation of Measles Antibody Titer:
The measles virus IgG antibody titer will be determined quantitatively by ELISA for quantitative determination of IgG class antibodies against Measles virus in human serum or plasma (citrate, heparin).
- Anonymous data will be retrieved from the admitted patients' files, such as:
- CBC, CRP, AST, ALT, ESR, Serum ferritin \& SARS CoV 2 RNA PCR swab results.
- Chest X ray and/or CT chest.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | – | –mild |
| B | – | –moderate |
| C | – | –severe |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients with confirmed COVID-19 presented to Ain Shams Hospital
Key inclusion criteria (2 listed)
- All patients with confirmed COVID 19.
- Any age or gender
Key exclusion criteria (1 listed)
- - Any patient refusing to be involved in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Viral clearance
Time frame: 6 months
Achievement of two consecutive negative PCR results for COVID 19 and discharge from hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 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.
Amira Al Balakosy, M.D principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus (COVID-19), run by Ain Shams University 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 1 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: status not confirmed, as of the sponsor's last update on 26 Jun 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Amira Al Balakosy, MD (01221977455, drbalakosy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral clearance (time frame: 6 months). 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 26 Jun 2020.