COVID-19 Convalescent Plasma Treatment in SARS-CoV-2 Infected Patients
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|ClinicalTrials.gov Identifier: NCT04474340|
Recruitment Status : Recruiting
First Posted : July 16, 2020
Last Update Posted : July 21, 2020
Due to the limitations of COVID-19 treatment and in the absence of licensed antiviral for COVID-19, the historical choice of therapeutic convalescent plasma (CP) is considered especially against RNA viruses .It was known that convalescent plasma does not only neutralize the pathogens but provide passive immunomodulatory properties that allows the recipient to control the exaggerated inflammatory cascade. However, still there is a lack of understanding of the mechanism of action of CCP therapeutic components. Reports from open label trials and case series show that CCP is safe and might be effective in severe cases with COVID-19 . Therefore, the World health organisation (WHO) and Food and Drug Administration (FDA) issued guidelines for the CCP usage and standardised the donor selection , which was further supported by Emergency use Authorisation (EUA) .
Therefore, the aim in the current study is to assess the effect of CCP on time to clinical improvement, hospital mortality and to evaluate the changes on oxygen saturation and laboratory markers (lymphocyte counts and C-reactive protein) compared with standard treatment alone in patients with moderate or severe COVID-19 disease.
|Condition or disease||Intervention/treatment||Phase|
|Moderate COVID-19 Pneumonia, Severe COVID-19 Pneumonia Pneumonia, Viral||Drug: COVID-19 Convalscent Plasma||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||COVID-19 Convalescent Plasma Treatment in SARS-CoV-2 Infected Patients: Multicenter Interventional Study|
|Actual Study Start Date :||May 21, 2020|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||December 30, 2020|
Experimental: CCP patients
How to transfuse CCP:
Drug: COVID-19 Convalscent Plasma
The source convalescent plasma is typically collected from individuals who have recovered from COVID-19 which contains antibodies titer against SARS-CoV-2 and is administered to patients with COVID-19. Donor eligibility criteria and qualification are based on American Accredited Blood Banks ( AABB) standards , including questionnaires and relevant transfusion-transmitted infections testing are performed. Furthermore, pathogen inactivation will be performed for each unit, CCP was only collected from individuals who meet all donor eligibility requirements (21 CFR 630.10 and 21 CFR 630.15). Donors must be found positive at a diagnostic test of nasopharyngeal swab at the time of illness and positive serological test for SARS-CoV-2 antibodies after recovery. All donors should have negative HLA antibodies.
No Intervention: Control
Standard COVID-19 treatment.
- Time to clinical improvement [ Time Frame: 30 days ]Time to clinical improvement is defined as a time frame from CCP administration till 30 days or discharge, defined as a 2-grade decrease on an ordinal WHO clinical scale . The WHO clinical scale based on the following 7-grade ordinal levels: 1= ambulatory, independent; 2= ambulatory with assistance; 3=hospitalised, not requiring supplemental oxygen; 4= hospitalised, requiring supplemental oxygen; 5= hospitalised, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6= hospitalised, requiring extracorporeal membrane oxygenation, invasive mechanical ventilation, or both; and 7= death.
- All cause mortality [ Time Frame: 30 days ]
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): NCT04474340
|Contact: Sundos Alsharidaemail@example.com|
|Ministry Of Health||Recruiting|
|Contact: Sondus AlSharidah, MD 0096566691663 firstname.lastname@example.org|
|Principal Investigator: Sondus AlSharida, MD|
|Sub-Investigator: Mariam Ayed, Md|
|Sub-Investigator: Reem Ameen, PhD|
|Sub-Investigator: Najat Rouhaldeen, MD|
|Sub-Investigator: Fatmah Alhuraish, MD|
|Sub-Investigator: Abdullah Alsaedi, MD|
|Sub-Investigator: Wasel Aladsani, MD|
|Sub-Investigator: Salem Alqahtani, MD|
|Principal Investigator:||Sondus AlSharidah, MD||MOH|