COVID-19, Convalescent Plasma TreatmentPhase 2NCT04644198
Convalescent Plasma Transfusion in Severe COVID-19 Patients in Jamaica
A Phase 2 study testing Convalescent Plasma Infusion in people with COVID-19, Convalescent Plasma Treatment, run by The University of The West Indies at 1 site in Jamaica.
Trial summary
Corona virus Disease 2019 (COVID-19) can be a severe respiratory illness caused by Severe Acute Respiratory Syndrome (SARS-CoV2) for which there is no standard treatment in affected persons nor a vaccine to prevent the infection. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Convalescent Plasma Treatment
- What is being tested?
- Convalescent Plasma Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteJamaica
- Study dates
- 1 Jun 2021to 1 Dec 2021
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older:
- Laboratory confirmed COVID-19:
- Severe or immediately life-threatening COVID-19:
- Severe disease is defined as one or more of the following:
Who cannot join
- Patients with mild or moderate COVID-19 infection that do not need in-patient care:
- Patients with a history of severe allergic reaction to plasma infusion:
- Patients who do not give consent or withdraw consent from study:
Trial locations and contacts
1 site in 1 country.
Jamaica1 site, 1 recruiting
- Recruiting
University of the West Indies
Kingston, 7
Tomlin Paul, 8769272556, tomlin.paul@uwimona.edu.jm
Giliian G Wharfe, MB, BS, DM
About this study
Official title: Pilot Study of Convalescent COVID-19 Plasma Transfusion in Severe COVID-19 Patients at a Type A Teaching Hospital in Jamaica
Corona virus Disease 2019 (COVID-19) can be a severe respiratory illness caused by Severe Acute Respiratory Syndrome (SARS-CoV2) for which there is no standard treatment in affected persons nor a vaccine to prevent the infection. The investigators propose to test whether the use of Convalescent plasma given to patients with severe COVID-19 disease will decrease risk of death, decrease use of ventilatory support decrease biomarkers of inflammation and improve measures of viral replication compared with controls subjects who were not transfused.Convalescent plasma, will be collected from persons who are more than 21 days post negative viral testing or 28 days post resolution of symptoms.
Read the detailed description
Coronavirus Disease 2019 (COVID-19) can be a severe respiratory illness caused by SARS-CoV2 for which there is no standard treatment in affected persons nor a vaccine to prevent the infection. This condition has and continues to cause significant burden on Health care systems with affected persons needing prolonged stay on ventilators in Intensive Care Units.
Convalescent plasma has been used in the treatment of other life-threatening conditions such as Novel Influenza A (H1N1) pandemic, SARS-COV-1 epidemic and Middle East respiratory syndrome -related Coronavirus (MERS-CoV) epidemic. Since convalescent plasma has been found to be beneficial in some diseases but is not always successful in all conditions in which it has been tried, there is no guarantee of success in this disease, and so it is necessary to conduct this study.
A sample of 30 patients with severe and life threatening COVID-19 disease will participate in phase 2 clinical trials. Convalescent Plasma will be administered to participants fulfilling the criteria due to its proven effect on H1N1 pandemic, SARS-COV-1 and MERS-COV epidemic. Although it has proven beneficial in some diseases, there is no guarantee that it will bring the desired outcome , hence the importance of the clinical trials. The observation will consist of three groups, namely, donor, participants and a control group. These patients must recover from all COVID-19 symptoms.
The participants who fulfill the inclusion criteria will receive convalescent plasma, collected from persons who are more than 21 days post negative viral testing or 28 days post resolution of symptoms. Potential participants will be approached by a research assistant within 24 hours of diagnosis and be told about the study and informed consent obtained only after the participants are identified as meeting the inclusion criteria for either participation as donor or recipient of plasma. If in the case of recipients, the recipients are intubated or otherwise unable to give consent, the recipients proxy will be required to do the same before participation is allowed. Plasma donations will also be solicited on the University of the West Indies (UWI) and University Hospital of the West Indies (UHWI) websites and Mona Messaging platform of UWI as well as social media platforms that will be managed by the UHWI public relations department. In addition, the investigators will also use electronic news media publications to inform interested persons about the study.
A sample of the recipients plasma will be kept for future studies as yet unknown. If any of these are genetic studies, attempts will be made to re-contact the donors to consent to these studies. The duration for this first study will be for one year.
The recipients for this plasma infusion must fulfill criteria for severe or immediately life-threatening infection. The control group will also fulfill the criteria for severe or life-threatening disease but have a contraindication to receiving plasma. The plasma donors must fulfill the criteria for selection of blood donors but in addition would have been recovered from COVID-19.
The data analysis will include changes in means of the objectives using Student's t-test.
Each participant will be assigned a study identification (ID) number and data linked to the study ID will only be accessible to researchers using a password protected computer.
The participants name and study ID number will be kept in a locked filing cabinet with access only to the research team.
This is a moderate risk study and participants will be informed that no personal benefit will be derive from participating in this study.
Limitations include not getting enough persons for plasma donation if the infection rate in Jamaica remains low, or the age of the affected persons is outside of the accepted range of our blood donor requirements. As this is a pilot however, the investigators may be able to achieve the sample size which should allow the investigators to identify any challenges in conducting a larger trial.
Participants will have every effort made to maintain confidentiality by using only study ID numbers on data collection sheets and laboratory studies.
- Conditions
- COVID-19, Convalescent Plasma Treatment
- Being tested
- Convalescent Plasma Infusion
- Keywords
- Donor, Recipients, Transfusion, Convalescent plasma, COVID Viral Load
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Convalescent Plasma InfusionBiological
250 mls of convalescent plasma on day 1 \& 2.
| Study group | Role | What they receive |
|---|---|---|
| Convalescent Plasma Treatment | Active comparator | Convalescent Plasma Receives: Biological: Convalescent Plasma Infusion |
| Control | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Number of deaths
Measured: Time from Admission up 28 days post-discharge
Viral load
COVID-19 Viral titres
Measured: Change in viral titres up to 28 days after transfusion measured on day 1, 3, 5, 7, 14, 28 after receiving transfusion
Antibody titre for Immunoglobulin (IgG) anti-SARS-CoV-2 antibody
Antibody titre for IgG anti-SARS-CoV-2 antibody
Measured: Change in antibody titres up to 28 days after transfusion measured on day 1, 3, 5, 7, 14, 28 after receiving transfusion
Antibody titre for Immunoglobulin A (IgA) anti-SARS-CoV-2 antibody
Antibody titre for IgA anti-SARS-CoV-2 antibody
Measured: Change in antibody titres up to 28 days after transfusion measured on day 1, 3, 5, 7, 14, 28 after receiving transfusion
Procalcitonin titres
Procalcitonin levels
Measured: Change in titres up to 28 days after transfusion measured on day 1, 3, 5, 7, 14, 28 after receiving transfusion
Interleukin 6 (IL-6)
Interleukin 6 (IL-6) levels
Measured: Change in titres up to 28 days after transfusion measured on day 1, 3, 5, 7, 14, 28 after receiving transfusion
D-dimer
D-dimer levels
Measured: Change in titres up to 28 days after transfusion measured on day 1, 3, 5, 7, 14, 28 after receiving transfusion
C-reactive protein
C- reactive protein levels
Measured: Change in titres up to 28 days after transfusion measured on day 1, 3, 5, 7, 14, 28 after receiving transfusion
Ferritin
Ferritin levels
Measured: Change in titres up to 28 days after transfusion measured on day 1, 3, 5, 7, 14, 28 after receiving transfusion
Secondary outcomes (2)
Length of ICU admission
Duration of stay in ICU
Measured: Number of days from hospital admission up to day of discharge assessed up to 100 days
Days to recovery
Time to recovery
Measured: Number of days from hospital admission up to the day of recovery assessed up to 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start1 Jun 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19, Convalescent Plasma TreatmentStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilian G Wharfe, Principal investigator, University of the West Indies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644198
- Sponsor's protocol ID
- ECP/195,19/20
- Status last verified
- Nov 2020
- First submitted
- 18 Nov 2020
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Convalescent COVID-19 Plasma Transfusion in Severe COVID-19 Patients at a Type A Teaching Hospital in Jamaica
- ClinicalTrials.gov ID
- NCT04644198
- Acronym / sponsor ID
- ECP/195,19/20
- Conditions
- COVID-19, Convalescent Plasma Treatment
- Keywords
- Donor, Recipients, Transfusion, Convalescent plasma, COVID Viral Load
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 25 Nov 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.
Corona virus Disease 2019 (COVID-19) can be a severe respiratory illness caused by Severe Acute Respiratory Syndrome (SARS-CoV2) for which there is no standard treatment in affected persons nor a vaccine to prevent the infection. The investigators propose to test whether the use of Convalescent plasma given to patients with severe COVID-19 disease will decrease risk of death, decrease use of ventilatory support decrease biomarkers of inflammation and improve measures of viral replication compared with controls subjects who were not transfused.Convalescent plasma, will be collected from persons who are more than 21 days post negative viral testing or 28 days post resolution of symptoms.
Detailed description
Coronavirus Disease 2019 (COVID-19) can be a severe respiratory illness caused by SARS-CoV2 for which there is no standard treatment in affected persons nor a vaccine to prevent the infection. This condition has and continues to cause significant burden on Health care systems with affected persons needing prolonged stay on ventilators in Intensive Care Units.
Convalescent plasma has been used in the treatment of other life-threatening conditions such as Novel Influenza A (H1N1) pandemic, SARS-COV-1 epidemic and Middle East respiratory syndrome -related Coronavirus (MERS-CoV) epidemic. Since convalescent plasma has been found to be beneficial in some diseases but is not always successful in all conditions in which it has been tried, there is no guarantee of success in this disease, and so it is necessary to conduct this study.
A sample of 30 patients with severe and life threatening COVID-19 disease will participate in phase 2 clinical trials. Convalescent Plasma will be administered to participants fulfilling the criteria due to its proven effect on H1N1 pandemic, SARS-COV-1 and MERS-COV epidemic. Although it has proven beneficial in some diseases, there is no guarantee that it will bring the desired outcome , hence the importance of the clinical trials. The observation will consist of three groups, namely, donor, participants and a control group. These patients must recover from all COVID-19 symptoms.
The participants who fulfill the inclusion criteria will receive convalescent plasma, collected from persons who are more than 21 days post negative viral testing or 28 days post resolution of symptoms. Potential participants will be approached by a research assistant within 24 hours of diagnosis and be told about the study and informed consent obtained only after the participants are identified as meeting the inclusion criteria for either participation as donor or recipient of plasma. If in the case of recipients, the recipients are intubated or otherwise unable to give consent, the recipients proxy will be required to do the same before participation is allowed. Plasma donations will also be solicited on the University of the West Indies (UWI) and University Hospital of the West Indies (UHWI) websites and Mona Messaging platform of UWI as well as social media platforms that will be managed by the UHWI public relations department. In addition, the investigators will also use electronic news media publications to inform interested persons about the study.
A sample of the recipients plasma will be kept for future studies as yet unknown. If any of these are genetic studies, attempts will be made to re-contact the donors to consent to these studies. The duration for this first study will be for one year.
The recipients for this plasma infusion must fulfill criteria for severe or immediately life-threatening infection. The control group will also fulfill the criteria for severe or life-threatening disease but have a contraindication to receiving plasma. The plasma donors must fulfill the criteria for selection of blood donors but in addition would have been recovered from COVID-19.
The data analysis will include changes in means of the objectives using Student's t-test.
Each participant will be assigned a study identification (ID) number and data linked to the study ID will only be accessible to researchers using a password protected computer.
The participants name and study ID number will be kept in a locked filing cabinet with access only to the research team.
This is a moderate risk study and participants will be informed that no personal benefit will be derive from participating in this study.
Limitations include not getting enough persons for plasma donation if the infection rate in Jamaica remains low, or the age of the affected persons is outside of the accepted range of our blood donor requirements. As this is a pilot however, the investigators may be able to achieve the sample size which should allow the investigators to identify any challenges in conducting a larger trial.
Participants will have every effort made to maintain confidentiality by using only study ID numbers on data collection sheets and laboratory studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Convalescent Plasma Treatment | Active comparator | Biological: Convalescent Plasma InfusionConvalescent Plasma |
| Control | No intervention | –Standard of care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older:
- Laboratory confirmed COVID-19:
- Severe or immediately life-threatening COVID-19:
- Severe disease is defined as one or more of the following:
Key exclusion criteria (3 listed)
- Patients with mild or moderate COVID-19 infection that do not need in-patient care:
- Patients with a history of severe allergic reaction to plasma infusion:
- Patients who do not give consent or withdraw consent from study:
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 Plasma Infusion250 mls of convalescent plasma on day 1 \& 2. | Biological | Convalescent Plasma Treatment |
Primary outcome
Mortality
Time frame: Time from Admission up 28 days post-discharge
Number of deaths
Viral load
Time frame: Change in viral titres up to 28 days after transfusion measured on day 1, 3, 5, 7, 14, 28 after receiving transfusion
COVID-19 Viral titres
Antibody titre for Immunoglobulin (IgG) anti-SARS-CoV-2 antibody
Time frame: Change in antibody titres up to 28 days after transfusion measured on day 1, 3, 5, 7, 14, 28 after receiving transfusion
Antibody titre for IgG anti-SARS-CoV-2 antibody
Antibody titre for Immunoglobulin A (IgA) anti-SARS-CoV-2 antibody
Time frame: Change in antibody titres up to 28 days after transfusion measured on day 1, 3, 5, 7, 14, 28 after receiving transfusion
Antibody titre for IgA anti-SARS-CoV-2 antibody
Procalcitonin titres
Time frame: Change in titres up to 28 days after transfusion measured on day 1, 3, 5, 7, 14, 28 after receiving transfusion
Procalcitonin levels
Interleukin 6 (IL-6)
Time frame: Change in titres up to 28 days after transfusion measured on day 1, 3, 5, 7, 14, 28 after receiving transfusion
Interleukin 6 (IL-6) levels
D-dimer
Time frame: Change in titres up to 28 days after transfusion measured on day 1, 3, 5, 7, 14, 28 after receiving transfusion
D-dimer levels
C-reactive protein
Time frame: Change in titres up to 28 days after transfusion measured on day 1, 3, 5, 7, 14, 28 after receiving transfusion
C- reactive protein levels
Ferritin
Time frame: Change in titres up to 28 days after transfusion measured on day 1, 3, 5, 7, 14, 28 after receiving transfusion
Ferritin levels
2 secondary outcomes
Length of ICU admission
Time frame: Number of days from hospital admission up to day of discharge assessed up to 100 days
Days to recovery
Time frame: Number of days from hospital admission up to the day of recovery assessed up to 100 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
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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.
Gilian G Wharfe principal investigator
University of the West Indies
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 Infusion in people with COVID-19, Convalescent Plasma Treatment, run by The University of The West Indies at 1 site in Jamaica.
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 4 inclusion and 3 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 12 May 2021. 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 Jamaica. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Time from Admission up 28 days post-discharge). The study lists 9 primary outcomes in all. 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 12 May 2021.