Convalescent Plasma Trial in COVID -19 Patients
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| ClinicalTrials.gov Identifier: NCT04356534 |
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Recruitment Status :
Completed
First Posted : April 22, 2020
Last Update Posted : October 26, 2021
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Plasma therapy using convalescent plasma has been shown to be effective in severe acute respiratory syndrome, Ebola virus infection and in H1N1 influenza. More recently there has been a report of the use of convalescent plasma in the treatment of 5 ventilated COVID-19 patients with the suggestion of expedited recovery as the patients improved 1 week after the transfusion. However, this was not a clinical trial and the patients were on other antiviral medication.; therefore, there is a need to undertake such a trial to see if deploying plasma with SARS-CoV-2 neutralizing antibody has utility in managing patients infected with COVID-19 in respiratory distress.
The objective of this pilot study is to compare plasma therapy using convalescent plasma with antibody against SARS-CoV-2 to usual supportive therapy in COVID-19 patients with pneumonia and hypoxia, and to determine if the clinical course is improved. The difference between groups will allow an effect size to be determined for a definitive clinical trial.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| SARS-CoV 2 COVID-19 | Other: plasma therapy using convalescent plasma with antibody against SARS-CoV-2 Other: Routine care for COVID-19 patients | Not Applicable |
Coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and has developed into a pandemic with serious global public health and economic sequelae. As of March 30, 2020, over 750,000 cases have been confirmed worldwide leading to over 34,000 deaths (https://coronavirus.jhu.edu/map.html). There is no current vaccine available, but there have been a number of reports of medication such as hydroxychloroquine having antiviral properties with efficacy against SARS-CoV-2.
Plasma therapy using convalescent plasma has been shown to be effective in severe acute respiratory syndrome, Ebola virus infection and in H1N1 influenza. More recently there has been a report of the use of convalescent plasma in the treatment of 5 ventilated COVID-19 patients with the suggestion of expedited recovery as the patients improved 1 week after the transfusion. However, this was not a clinical trial and the patients were on other antiviral medication; therefore, there is a need to undertake such a trial to see if deploying plasma with SARS-CoV-2 neutralizing antibody has utility in managing patients infected with COVID-19 in respiratory distress.
The objective of this pilot study is to compare plasma therapy using convalescent plasma with antibody against SARS-CoV-2 to usual supportive therapy in COVID-19 patients with pneumonia and hypoxia, and to determine if the clinical course is improved. The difference between groups will allow an effect size to be determined for a definitive clinical trial
Could using convalescent plasma transfusion, from recovered COVID19 patients with antibody against COVID-19 be beneficial in treatment of COVID19 patients with hypoxia and pneumonia, in order to avoid or delay the need for invasive ventilation?
This is a prospective, interventional and randomized open label trial involving 40 patients with COVID-19 who are in respiratory distress, with the criteria that all require oxygen therapy and have radiological evidence of pneumonia, 20 of whom will receive a single transfusion of convalescent patient plasma plus routine care, compared to 20 COVID-19 patients who will receive routine care alone.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | This is a prospective, interventional and randomized open label trial involving 40 patients with COVID-19 who are in respiratory distress, with the criteria that all require oxygen therapy and have radiological evidence of pneumonia, 20 of whom will receive a transfusion of convalescent patient plasma plus routine care, compared to 20 COVID-19 patients who will receive routine care alone. |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Use of Convalescent Plasma Therapy for COVID-19 Patients With Hypoxia: a Prospective Randomized Trial |
| Actual Study Start Date : | April 19, 2020 |
| Actual Primary Completion Date : | June 15, 2020 |
| Actual Study Completion Date : | July 9, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Control group
local standard of care which include antivirals and supportive care
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Other: Routine care for COVID-19 patients
local standard of care which include antivirals and supportive care |
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Experimental: Intervention group
convalescent patient plasma 400ml given as 200ml over 2 hours in 2 consecutive days, plus routine local standard of care
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Other: plasma therapy using convalescent plasma with antibody against SARS-CoV-2
convalescent patient plasma plus routine local standard of care |
- Requirement for invasive ventilation [ Time Frame: through study completion up to 28 days ]Could the plasma therapy avoid or delay the need for invasive ventilation
- Change in viral clearance [ Time Frame: through study completion up to 28 days ]Through the use of CT values
- Radiological change [ Time Frame: through study completion up to 28 days ]Chest Xray
- Change in white cell count [ Time Frame: through study completion up to 28 days ]As a measure of a change in inflammation
- C reactive protein measurement [ Time Frame: through study completion up to 28 days ]A change in C reactive protein as a measure of a change in inflammation
- lactate dehydrogenase measurement [ Time Frame: through study completion up to 28 days ]A change in lactate dehydrogenase as a measure of an improvement in the severity of the disease process
- Procalcitonin measurement [ Time Frame: through study completion up to 28 days ]A change in procalcitonin as a measure of an improvement in the severity of the disease process
- D Dimer measurement [ Time Frame: through study completion up to 28 days ]A change in D Dimer as a measure of an improvement in the severity of the disease process
- Ferritin measurement [ Time Frame: through study completion up to 28 days ]A change in Ferritin as a measure of an improvement in the severity of the disease process
- Troponin T measurement [ Time Frame: through study completion up to 28 days ]A change in troponin T as a measure of an improvement in the severity of the disease process
- Brain naturetic peptide measurement [ Time Frame: through study completion up to 28 days ]A change in brain naturetic peptide as a measure of an improvement in the severity of the disease process
- Mortality rate [ Time Frame: Up to 28 days of the study ]Mortality rate due to COVID-19
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| Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- COVID-19 diagnosis
- Hypoxia, (Oxygen saturation of less than or equal 92% or PO2 < 60mmHg on arterial blood gas analysis) and patient requiring oxygen therapy
- Evidence of infiltrates on Chest Xray or CT scan
- Able to give informed consent
- Patients between the ages of 21 and above with no upper age.
Exclusion Criteria:
- Patients with mild disease not requiring oxygen therapy
- Patients with normal CXR & CT scan
- Patients requiring ventilatory support
- Patients with a history of allergy to plasma, sodium citrate or methylene blue
- Patients with a history of autoimmune disease or selective IGA deficiency.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04356534
| Bahrain | |
| Royal College of Surgeons in Ireland - Bahrain | |
| Manama, Bahrain | |
| Principal Investigator: | Manaf Al Qahtani, Dr. | Royal College of Surgeons in Ireland - Bahrain |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Royal College of Surgeons in Ireland - Medical University of Bahrain |
| ClinicalTrials.gov Identifier: | NCT04356534 |
| Other Study ID Numbers: |
BDF/R&REC/2020-423 |
| First Posted: | April 22, 2020 Key Record Dates |
| Last Update Posted: | October 26, 2021 |
| Last Verified: | July 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Monitoring, audits, and REC review will be permitted and provide direct access to source data and documents. The Lead PI and the researchers assigned by him will have access to the stored data/specimens. Only the Lead PI and the researchers assigned working on this study will be eligible to obtain the data/specimens from the participants during data collection. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) Analytic Code |
| Time Frame: | Dr Manaf will act as the data custodian and is responsible for the storage, handling and quality of the study data. Data will be collected in the case report form to allow for cross referencing to check validity. Study documents (paper and electronic) will be retained in a secure (kept locked when not in use) location during and after the trial has finished. All essential documents including source documents will be retained for a period of 5 years after study completion (last patient, last study point). A label stating the date after which the documents can be destroyed will be placed on the inside front cover of the case notes of trial participants. |
| Access Criteria: | Study documents (paper and electronic) will be retained in a secure (kept locked when not in use) location during and after the trial has finished. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Plasma Therapy COVID-19 |
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COVID-19 Pneumonia, Viral Pneumonia Respiratory Tract Infections Infections Virus Diseases Coronavirus Infections Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Antibodies Immunologic Factors Physiological Effects of Drugs |