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

NCT ID: NCT04474340

Last Updated: 2020-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-21
• Study Completion Date: 2020-12-30

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.

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 .

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

COVID-19 Convalscent Plasma

Intervention Type: DRUG

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.

Control

Standard COVID-19 treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Kuwait

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sondus AlSharidah

Sondus Alsharidah

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sondus AlSharidah, MD

Role: PRINCIPAL_INVESTIGATOR

MOH

Locations

Ministry Of Health

Kuwait City, , Kuwait

Site Status: RECRUITING

Countries

Kuwait

Central Contacts

Sundos Alsharida

Role: CONTACT

salsharidah@moh.gov.kw

0096566691663

Facility Contacts

Sondus AlSharidah, MD

Role: primary

salsharidah@moh.gov.kw

0096566691663

Other Identifiers

MOHKuwait

Identifier Type: -

Identifier Source: org_study_id