Covid19NCT04764747
Effectiveness of Convalescent Plasma in Hospitalized Patients With COVID-19
An observational study of Covid19, run by Kufa University at 2 sites in Iraq.
Trial summary
Multicenter retrospective cohort study from June to August 2020 on hospitalized COVID-19 patients admitted to Al-Hakeem and Al-Amal hospital in Al-Najaf Governorate, Iraq, in order to evaluating the effectiveness of plasma therapy in hospitalized patients with COVID-19 and analyzing factors that affect therapeutic… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Covid19
- How many people
- 400 participants
- Where
- 2 sitesIraq
- Study dates
- 1 Nov 2020to 25 Apr 2021
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients diagnosed with COVID-19
Who may be able to join
- Adult 18 years old or older.
- COVID-19 confirmed by reverse transcriptase-polymerase chain reaction (RT-PCR).
- hospitalized adult patients with COVID-19.
Who cannot join
- Patients with history of alleragy to plasma transfusion.
- Patients with history of autoimmune disease or selective IgA deficiency.
- Patients with suspected coronavirus.
- Patients with incomplete data in his record.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Evaluating Effectiveness of Convalescent Plasma and Factors Influencing Therapeutic Outcome in Hospitalized Patients With COVID-19
Multicenter retrospective cohort study from June to August 2020 on hospitalized COVID-19 patients admitted to Al-Hakeem and Al-Amal hospital in Al-Najaf Governorate, Iraq, in order to evaluating the effectiveness of plasma therapy in hospitalized patients with COVID-19 and analyzing factors that affect therapeutic outcome, either related to patients or related to donors.
Read the detailed description
Coronavirus Disease 2019 (COVID-19) is a contagious disease with high rate of fatality caused by severe acute respiratory syndrome coronavirus 2 (SARS-COV-2). In Wuhan, the capital of China's Hubei province, the disease was first detected in December 2019 and has since spread globally, resulting in the continuing 2019 and 2020 coronavirus pandemic. The World Health Organization (WHO) has proclaimed that on 30 January 2020, the outbreak will be a public health emergency of international concern and will be known as a pandemic on 11 March 2020. To date, no unique antiviral therapy or effective disease-containing vaccine exists. Therefore, it is an urgent need to look for an alternative strategy for COVID-19 treatment, especially among severe patients. For more than a century, convalescent plasma (CP) therapy, a classic adaptive immunotherapy, has been used to prevent and treat many infectious diseases. CP therapy has been successfully used in the treatment of severe acute respiratory syndrome (SARS), Middle east respiratory syndrome (MERS), and the 2009 H1N1 pandemic with adequate effectiveness and protection over the past two decades. For patients with serious or life-threatening COVID-19, the US Food and Drug Administration (FDA) recently approved the emerging use of convalescent plasma. While the use of convalescent plasma looks promising, there is still little evidence supporting its use in the treatment of COVID-19 and its use is therefore still investigational.
Also, there is lack of standardization and evidence-based rationale in donor eligibility requirements account for factors such as age, sex, weight, symptom course, antibody titer and it is association with clinical outcome. Additionally, recipient related factors including age, sex, weight, disease severity, time of CP use and concomitant treatment must be considered in prediction the response to CP therapy and this may help to explain the varied therapeutic effects of CP seen in a variety of studies. Considering the above-mentioned facts and high number of patients treated with CP in AL Najaf-Hakeem hospital and Amal hospital we designed this study to evaluate the effectiveness of CP therapy in hospitalized patients with COVID-19 and find patients and donor related factors to predicts the responders and not responders.
- Conditions
- Covid19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clinical improvement
modified six-point ordinal scale of COVID-19
Measured: 14 days
Find the prediction factors associated with good outcome of patients on CP therapy
Demographic data and clinical parameters of patients associated with positive therapeutic outcome for CP measured as number of patients discharge from hospital with complete recovery (negative PCR for COVID-19). The association determined by univariate and multivariate analysis
Measured: 14 days
Time to negative PCR
number of days required for patients to be have negative PCR (free viral load)
Measured: 14 days
Secondary outcomes (3)
Mortality rate
number of deaths
Measured: 21 days
Hospital stay time
duration of stay in hospital
Measured: 21 days
Adverse effect of plasma therapy
to asses the frequency of adverse effect of convalescent plasma
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Nov 2020
- Primary completion25 Apr 2021
- Study completion25 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kufa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zainab Hadi Ibadi, Kufa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764747
- Sponsor's protocol ID
- CP in COVID-19 patients
- Status last verified
- May 2021
- First submitted
- 18 Feb 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chauhan S. Comprehensive review of coronavirus disease 2019 (COVID-19). Biomed J. 2020 Aug;43(4):334-340. doi: 10.1016/j.bj.2020.05.023. Epub 2020 Jun 1.
PubMed 32788071Li L, Zhang W, Hu Y, Tong X, Zheng S, Yang J, Kong Y, Ren L, Wei Q, Mei H, Hu C, Tao C, Yang R, Wang J, Yu Y, Guo Y, Wu X, Xu Z, Zeng L, Xiong N, Chen L, Wang J, Man N, Liu Y, Xu H, Deng E, Zhang X, Li C, Wang C, Su S, Zhang L, Wang J, Wu Y, Liu Z. Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19: A Randomized Clinical Trial. JAMA. 2020 Aug 4;324(5):460-470. doi: 10.1001/jama.2020.10044.
PubMed 32492084Duan K, Liu B, Li C, Zhang H, Yu T, Qu J, Zhou M, Chen L, Meng S, Hu Y, Peng C, Yuan M, Huang J, Wang Z, Yu J, Gao X, Wang D, Yu X, Li L, Zhang J, Wu X, Li B, Xu Y, Chen W, Peng Y, Hu Y, Lin L, Liu X, Huang S, Zhou Z, Zhang L, Wang Y, Zhang Z, Deng K, Xia Z, Gong Q, Zhang W, Zheng X, Liu Y, Yang H, Zhou D, Yu D, Hou J, Shi Z, Chen S, Chen Z, Zhang X, Yang X. Effectiveness of convalescent plasma therapy in severe COVID-19 patients. Proc Natl Acad Sci U S A. 2020 Apr 28;117(17):9490-9496. doi: 10.1073/pnas.2004168117. Epub 2020 Apr 6.
PubMed 32253318Farhat RM, Mousa MA, Daas EJ, Glassberg MK. Treatment of COVID-19: Perspective on Convalescent Plasma Transfusion. Front Med (Lausanne). 2020 Jul 28;7:435. doi: 10.3389/fmed.2020.00435. eCollection 2020.
PubMed 32850916
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Effectiveness of Convalescent Plasma and Factors Influencing Therapeutic Outcome in Hospitalized Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04764747
- Acronym / sponsor ID
- CP in COVID-19 patients
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Kufa UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 25 Apr 2021 (actual)
- Study completion
- 25 Apr 2021 (actual)
- First posted
- 21 Feb 2021 (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.
Multicenter retrospective cohort study from June to August 2020 on hospitalized COVID-19 patients admitted to Al-Hakeem and Al-Amal hospital in Al-Najaf Governorate, Iraq, in order to evaluating the effectiveness of plasma therapy in hospitalized patients with COVID-19 and analyzing factors that affect therapeutic outcome, either related to patients or related to donors.
Detailed description
Coronavirus Disease 2019 (COVID-19) is a contagious disease with high rate of fatality caused by severe acute respiratory syndrome coronavirus 2 (SARS-COV-2). In Wuhan, the capital of China's Hubei province, the disease was first detected in December 2019 and has since spread globally, resulting in the continuing 2019 and 2020 coronavirus pandemic. The World Health Organization (WHO) has proclaimed that on 30 January 2020, the outbreak will be a public health emergency of international concern and will be known as a pandemic on 11 March 2020. To date, no unique antiviral therapy or effective disease-containing vaccine exists. Therefore, it is an urgent need to look for an alternative strategy for COVID-19 treatment, especially among severe patients. For more than a century, convalescent plasma (CP) therapy, a classic adaptive immunotherapy, has been used to prevent and treat many infectious diseases. CP therapy has been successfully used in the treatment of severe acute respiratory syndrome (SARS), Middle east respiratory syndrome (MERS), and the 2009 H1N1 pandemic with adequate effectiveness and protection over the past two decades. For patients with serious or life-threatening COVID-19, the US Food and Drug Administration (FDA) recently approved the emerging use of convalescent plasma. While the use of convalescent plasma looks promising, there is still little evidence supporting its use in the treatment of COVID-19 and its use is therefore still investigational.
Also, there is lack of standardization and evidence-based rationale in donor eligibility requirements account for factors such as age, sex, weight, symptom course, antibody titer and it is association with clinical outcome. Additionally, recipient related factors including age, sex, weight, disease severity, time of CP use and concomitant treatment must be considered in prediction the response to CP therapy and this may help to explain the varied therapeutic effects of CP seen in a variety of studies. Considering the above-mentioned facts and high number of patients treated with CP in AL Najaf-Hakeem hospital and Amal hospital we designed this study to evaluate the effectiveness of CP therapy in hospitalized patients with COVID-19 and find patients and donor related factors to predicts the responders and not responders.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients diagnosed with COVID-19
Key inclusion criteria (3 listed)
- Adult 18 years old or older.
- COVID-19 confirmed by reverse transcriptase-polymerase chain reaction (RT-PCR).
- hospitalized adult patients with COVID-19.
Key exclusion criteria (4 listed)
- Patients with history of alleragy to plasma transfusion.
- Patients with history of autoimmune disease or selective IgA deficiency.
- Patients with suspected coronavirus.
- Patients with incomplete data in his record.
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
Time to clinical improvement
Time frame: 14 days
modified six-point ordinal scale of COVID-19
Find the prediction factors associated with good outcome of patients on CP therapy
Time frame: 14 days
Demographic data and clinical parameters of patients associated with positive therapeutic outcome for CP measured as number of patients discharge from hospital with complete recovery (negative PCR for COVID-19). The association determined by univariate and multivariate analysis
Time to negative PCR
Time frame: 14 days
number of days required for patients to be have negative PCR (free viral load)
3 secondary outcomes
Mortality rate
Time frame: 21 days
Hospital stay time
Time frame: 21 days
Adverse effect of plasma therapy
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Background: PubMed 32788071Chauhan S. Comprehensive review of coronavirus disease 2019 (COVID-19). Biomed J. 2020 Aug;43(4):334-340. doi: 10.1016/j.bj.2020.05.023. Epub 2020 Jun 1.
- Background: PubMed 32492084Li L, Zhang W, Hu Y, Tong X, Zheng S, Yang J, Kong Y, Ren L, Wei Q, Mei H, Hu C, Tao C, Yang R, Wang J, Yu Y, Guo Y, Wu X, Xu Z, Zeng L, Xiong N, Chen L, Wang J, Man N, Liu Y, Xu H, Deng E, Zhang X, Li C, Wang C, Su S, Zhang L, Wang J, Wu Y, Liu Z. Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19: A Randomized Clinical Trial. JAMA. 2020 Aug 4;324(5):460-470. doi: 10.1001/jama.2020.10044.
- Background: PubMed 32253318Duan K, Liu B, Li C, Zhang H, Yu T, Qu J, Zhou M, Chen L, Meng S, Hu Y, Peng C, Yuan M, Huang J, Wang Z, Yu J, Gao X, Wang D, Yu X, Li L, Zhang J, Wu X, Li B, Xu Y, Chen W, Peng Y, Hu Y, Lin L, Liu X, Huang S, Zhou Z, Zhang L, Wang Y, Zhang Z, Deng K, Xia Z, Gong Q, Zhang W, Zheng X, Liu Y, Yang H, Zhou D, Yu D, Hou J, Shi Z, Chen S, Chen Z, Zhang X, Yang X. Effectiveness of convalescent plasma therapy in severe COVID-19 patients. Proc Natl Acad Sci U S A. 2020 Apr 28;117(17):9490-9496. doi: 10.1073/pnas.2004168117. Epub 2020 Apr 6.
- Background: PubMed 32850916Farhat RM, Mousa MA, Daas EJ, Glassberg MK. Treatment of COVID-19: Perspective on Convalescent Plasma Transfusion. Front Med (Lausanne). 2020 Jul 28;7:435. doi: 10.3389/fmed.2020.00435. eCollection 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Kufa University at 2 sites in Iraq.
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 4 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: finished, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iraq. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to clinical improvement (time frame: 14 days). The study lists 3 primary outcomes in all. 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 NCT04764747, which also lists 4 linked publications.
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 2 Jun 2021.