Respiratory Distress Syndrome (& [Hyaline Membrane Disease])Phase 2NCT02190799
Anti-MERS-CoV Convalescent Plasma Therapy
A Phase 2 study testing Convalescent plasma in people with Respiratory Distress Syndrome (& [Hyaline Membrane Disease]), run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
Trial summary
Since the first report of the Middle East Respiratory Syndrome Corona virus (MERS- CoV) in September 2012, more than 800 cases have been reported to the World Health Organization (WHO) with substantial mortality. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Respiratory Distress Syndrome (& [Hyaline Membrane Disease])
- What is being tested?
- Convalescent plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- May 2014to Nov 2016
- Phase
- Phase 2
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age greater than or equal to 14 years of age
- Inpatients who are MERS-COV positive (by PCR)
- Willingness to have blood, respiratory and urine samples obtained and stored for subsequent analysis.
Who cannot join
- Clinical evidence (in the judgment of the site investigator) that the etiology of illness is primarily not MERS-CoV in origin.
- History of allergic reaction to blood or plasma products (as judged by the investigator)
- Known IgA deficiency
- Medical conditions in which receipt of 500mL volume may be detrimental to the patient (e.g., decompensated congestive heart failure)
- Females who are pregnant or breast feeding.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Intensive Care Unit, King Abdulaziz Medical City
Riyadh, 11426
About this study
Official title: Anti-MERS-COV Convalescent Plasma Therapy
Since the first report of the Middle East Respiratory Syndrome Corona virus (MERS- CoV) in September 2012, more than 800 cases have been reported to the World Health Organization (WHO) with substantial mortality.
Read the detailed description
World knowledge about this virus is accumulating but data about the clinical presentations of infected patients and common treatments, including ribavirin, interferon and methylprednisolone, lack evidence. Although drugs with anti- coronavirus (CoV) activities have been identified, as yet no anti- MERs- CoV drug has been approved and a vaccine has yet to be developed. Previous reports on other viral infections including SARS have suggested that convalescent plasma or serum is effective where no other treatment is available or in an emergency. A recently completed systematic review and meta-analysis by the University of Nottingham - World Health Organization Collaborating Center indicates that convalescent plasma therapy may be the most promising near-term therapy patients with for MERS- CoV infection. In this study, investigators will study the pharmacokinetics of immunoglobulin in response to convalescent plasma administration in order to inform a much larger study which will investigate the efficacy of convalescent plasma. Plasma will be collected from patients who recently recovered from MERS-CoV, Health Care Workers who had potential exposure and are tested for anti MERS-CoV serology and RT-PCR after obtaining their consent. This convalescent plasma will be stored in the blood bank as per their policies and procedures. Patients with MERS-CoV positive after meeting the eligibility criteria will receive 2 units of convalescent plasma . Clinical data as well as the standard laboratory studies will be collected at baseline, 30 mins after first dose, 30 mins after second dose, day 1, 3, 7, 14, 28 of hospital stay after enrollment.
- Being tested
- Convalescent plasma
- Keywords
- Corona Virus, Convalescent plasma, Serology
- Medical subject headings
- Respiratory Distress Syndrome, Hyaline Membrane Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Convalescent plasmaBiological
Convalescent plasma from patients who recently recovered from MERS-CoV, HCWs who had potential exposure and subjects who are willing to donate plasma and have their blood tested for anti MERS-CoV serology and RT-PCR after obtaining their consent
| Study group | Role | What they receive |
|---|---|---|
| Convalescent plasma | Experimental | Enrolled patients will receive 2 units of the convalescent plasma after meeting the eligibility criteria Receives: Biological: Convalescent plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital mortality
Hospital mortality will be death in the ICU during the same hospital admission
Measured: Death in the Hospital (ICU or ward) before or at 6 months after enrollment
Secondary outcomes (6)
ICU mortality
Death in the ICU during the same hospital admission.
Measured: Death in the ICU at or after 90 days of enrollment
ICU Length of Stay
Number of calendar days between admission and final discharge from ICU.
Measured: Number of days in ICU with an average expected duration of 10 days.
Duration of Mechanical Ventilation
Number of calendar days between start and final liberation from mechanical ventilation.
Measured: Number of days of mechanical ventilation with an expected average duration of 8 days
Viral load in tracheal aspirate
viral clearance from all sampled sites by day 3 after administration of CP
Measured: Serial levels in the first 28 days of enrollment
Inflammatory markers,
Epidermal Growth Factor (EGF), Eotaxin, Granulocyte colony-stimulating factor (G-CSF), Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), Interferon(IFN)-γ, IFN-a2, Interleukin (IL)-10, IL-12(p40), IL-12(p70), IL-13, IL-15, IL-17, IL-1ra, IL-1a, IL-1β, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, Interferon gamma-induced protein (IP)-10, Monocyte Chemotactic Protein (MCP)-1, Macrophage Inflammatory Protein (MIP)-1a, MIP-1β, Tumor Necrosis Factor-α (TNF-a), TNF-β, Vascular Endothelial Growth Factor (VEGF)
Measured: Serial levels in the first 28 days of enrollment
Anti-MERS-CoV antibodies
anti-MERS-CoV antibody level before and after administration of CP.
Measured: Serial levels in the first 28 days of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome (& [Hyaline Membrane Disease])Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yaseen M Arabi, MD, Principal investigator, King Abdullah International Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190799
- Sponsor's protocol ID
- RC13-244
- Status last verified
- Nov 2018
- First submitted
- 12 Jun 2014
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Arabi Y, Balkhy H, Hajeer AH, Bouchama A, Hayden FG, Al-Omari A, Al-Hameed FM, Taha Y, Shindo N, Whitehead J, Merson L, AlJohani S, Al-Khairy K, Carson G, Luke TC, Hensley L, Al-Dawood A, Al-Qahtani S, Modjarrad K, Sadat M, Rohde G, Leport C, Fowler R. Feasibility, safety, clinical, and laboratory effects of convalescent plasma therapy for patients with Middle East respiratory syndrome coronavirus infection: a study protocol. Springerplus. 2015 Nov 19;4:709. doi: 10.1186/s40064-015-1490-9. eCollection 2015.
PubMed 26618098
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-MERS-COV Convalescent Plasma Therapy
- ClinicalTrials.gov ID
- NCT02190799
- Acronym / sponsor ID
- RC13-244
- Keywords
- Corona Virus, Convalescent plasma, Serology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 15 Jul 2014 (estimated)
- 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.
Since the first report of the Middle East Respiratory Syndrome Corona virus (MERS- CoV) in September 2012, more than 800 cases have been reported to the World Health Organization (WHO) with substantial mortality.
Detailed description
World knowledge about this virus is accumulating but data about the clinical presentations of infected patients and common treatments, including ribavirin, interferon and methylprednisolone, lack evidence. Although drugs with anti- coronavirus (CoV) activities have been identified, as yet no anti- MERs- CoV drug has been approved and a vaccine has yet to be developed. Previous reports on other viral infections including SARS have suggested that convalescent plasma or serum is effective where no other treatment is available or in an emergency. A recently completed systematic review and meta-analysis by the University of Nottingham - World Health Organization Collaborating Center indicates that convalescent plasma therapy may be the most promising near-term therapy patients with for MERS- CoV infection. In this study, investigators will study the pharmacokinetics of immunoglobulin in response to convalescent plasma administration in order to inform a much larger study which will investigate the efficacy of convalescent plasma. Plasma will be collected from patients who recently recovered from MERS-CoV, Health Care Workers who had potential exposure and are tested for anti MERS-CoV serology and RT-PCR after obtaining their consent. This convalescent plasma will be stored in the blood bank as per their policies and procedures. Patients with MERS-CoV positive after meeting the eligibility criteria will receive 2 units of convalescent plasma . Clinical data as well as the standard laboratory studies will be collected at baseline, 30 mins after first dose, 30 mins after second dose, day 1, 3, 7, 14, 28 of hospital stay after enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Convalescent plasma | Experimental | Biological: Convalescent plasmaEnrolled patients will receive 2 units of the convalescent plasma after meeting the eligibility criteria |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than or equal to 14 years of age
- Inpatients who are MERS-COV positive (by PCR)
- Willingness to have blood, respiratory and urine samples obtained and stored for subsequent analysis.
Key exclusion criteria (5 listed)
- Clinical evidence (in the judgment of the site investigator) that the etiology of illness is primarily not MERS-CoV in origin.
- History of allergic reaction to blood or plasma products (as judged by the investigator)
- Known IgA deficiency
- Medical conditions in which receipt of 500mL volume may be detrimental to the patient (e.g., decompensated congestive heart failure)
- Females who are pregnant or breast feeding.
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 |
|---|---|---|
| Convalescent plasmaConvalescent plasma from patients who recently recovered from MERS-CoV, HCWs who had potential exposure and subjects who are willing to donate plasma and have their blood tested for anti MERS-CoV serology and RT-PCR after obtaining their consent | Biological | Convalescent plasma |
Primary outcome
Hospital mortality
Time frame: Death in the Hospital (ICU or ward) before or at 6 months after enrollment
Hospital mortality will be death in the ICU during the same hospital admission
6 secondary outcomes
ICU mortality
Time frame: Death in the ICU at or after 90 days of enrollment
ICU Length of Stay
Time frame: Number of days in ICU with an average expected duration of 10 days.
Duration of Mechanical Ventilation
Time frame: Number of days of mechanical ventilation with an expected average duration of 8 days
Viral load in tracheal aspirate
Time frame: Serial levels in the first 28 days of enrollment
Inflammatory markers,
Time frame: Serial levels in the first 28 days of enrollment
Anti-MERS-CoV antibodies
Time frame: Serial levels in the first 28 days of enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
- Derived from this study: PubMed 26618098Arabi Y, Balkhy H, Hajeer AH, Bouchama A, Hayden FG, Al-Omari A, Al-Hameed FM, Taha Y, Shindo N, Whitehead J, Merson L, AlJohani S, Al-Khairy K, Carson G, Luke TC, Hensley L, Al-Dawood A, Al-Qahtani S, Modjarrad K, Sadat M, Rohde G, Leport C, Fowler R. Feasibility, safety, clinical, and laboratory effects of convalescent plasma therapy for patients with Middle East respiratory syndrome coronavirus infection: a study protocol. Springerplus. 2015 Nov 19;4:709. doi: 10.1186/s40064-015-1490-9. eCollection 2015.
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.
Yaseen M Arabi, MD principal investigator
King Abdullah International Medical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Convalescent plasma in people with Respiratory Distress Syndrome (& [Hyaline Membrane Disease]), run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 21 Nov 2018. 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 Saudi Arabia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Hospital mortality (time frame: Death in the Hospital (ICU or ward) before or at 6 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02190799, which also lists 1 linked publication.
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 21 Nov 2018.