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COVID-19 Convalescent Plasma Treatment in SARS-CoV-2 Infected Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04474340
Recruitment Status : Recruiting
First Posted : July 16, 2020
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
Sondus AlSharidah, Ministry of Health, Kuwait

Brief Summary:

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

Detailed Description:
This is a prospective multicenter interventional observational study will be conducted in 4 major tertiary hospitals (Al-Sabah, Farwaniya , Mubarak Al-Kabeer and Jahra) in Kuwait .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: CCP patients
  1. Patient has to fulfil the inclusion/exclusion criteria of the ward or the ICU
  2. Valid consent.
  3. Request the CCP from the central blood bank (200-250 ml/dose - can be repeated again in 12 hours) this is through the local hospital blood bank.

How to transfuse CCP:

  1. Dose required is 200-250 ml/hr (one dose, can be repeated in 12 hrs), max total 500ml.
  2. Premedication prior to administration of CCP (Acetaminophen, diphenhydramine,steriods) or according to hospital guidelines.
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients aged ≥18 years old ( those who are younger are involved after case based discussion)
  2. Confirmed laboratory diagnosis with SARS-CoV-2 ,and admission diagnosis of SARS-CoV-2.
  3. Patients with moderate or severe COVID-19 (moderate COVID-19 disease defined as the presence of any signs of pneumonia (fever, cough, dyspnoea fast breathing) including SpO2 >90 on room air , but no signs of severe pneumonia (severe pneumonia have the above plus one of the following: respiratory rates >30 breaths/minutes or SpO2<90% on room air), or admission to intensive care unit (ICU) for respiratory support (i.e.high flow nasal cannula, non-invasive mechanical ventilation and intubation).

Exclusion Criteria:

  1. -Contraindication to transfusion (volume overload, history of anaphylaxis to blood products).
  2. - Patients presenting with acute severe multiorgan failure, hemodynamic instability.

3- Severe disseminated coagulopathy (DIC), septic shock and those with expected survival of less than 48 hours.


Information from the National Library of Medicine

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


Contacts
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Contact: Sundos Alsharida 0096566691663 salsharidah@moh.gov.kw

Locations
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Kuwait
Ministry Of Health Recruiting
Kuwait, Kuwait
Contact: Sondus AlSharidah, MD    0096566691663    salsharidah@moh.gov.kw   
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         
Sponsors and Collaborators
Ministry of Health, Kuwait
Investigators
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Principal Investigator: Sondus AlSharidah, MD MOH
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Responsible Party: Sondus AlSharidah, Sondus Alsharidah, Ministry of Health, Kuwait
ClinicalTrials.gov Identifier: NCT04474340    
Other Study ID Numbers: MOHKuwait
First Posted: July 16, 2020    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sondus AlSharidah, Ministry of Health, Kuwait:
convalescent plasma
respiratory infection
COVID-19
SARS-CoV-2
pneumonia
Additional relevant MeSH terms:
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Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases