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

Pneumonia, Viral Clinical Trial

Official title:

COVID-19 Convalescent Plasma Treatment in SARS-CoV-2 Infected Patients: Multicenter Interventional Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04474340
• Other study ID #: MOHKuwait
• Status: Recruiting
• Phase: Phase 1
• Start date: May 21, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: July 2020
• Source: Ministry of Health, Kuwait
• Contact: Sundos Alsharida
• Phone: 0096566691663
• Email: salsharidah[@]moh.gov.kw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Moderate COVID-19 Pneumonia, Severe COVID-19 Pneumonia
• Pneumonia
• Pneumonia, Viral

Intervention

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.

Locations

Country	Name	City	State
Kuwait	Ministry Of Health	Kuwait

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health, Kuwait

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to clinical improvement	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.	30 days
Secondary	All cause mortality		30 days