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

NCT04474340 | Unknown Phase 1 DMC

• 1 other identifier: MOHKuwait
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

convalescent plasma; respiratory infection; COVID-19; SARS-CoV-2; pneumonia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• All cause mortality

  30 days

Study Arms (2)

CCP patients

EXPERIMENTAL

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

Control

NO INTERVENTION

Standard COVID-19 treatment.

Interventions

COVID-19 Convalscent Plasma 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.

CCP patients

Eligibility Criteria

• Age: 15 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥18 years old ( those who are younger are involved after case based discussion)
• Confirmed laboratory diagnosis with SARS-CoV-2 ,and admission diagnosis of SARS-CoV-2.
• 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).

You may not qualify if:

• Contraindication to transfusion (volume overload, history of anaphylaxis to blood products).
• \- Patients presenting with acute severe multiorgan failure, hemodynamic instability.
• Severe disseminated coagulopathy (DIC), septic shock and those with expected survival of less than 48 hours.

Sponsors & Collaborators

• Ministry of Health, Kuwait: lead

Study Sites (1)

Ministry Of Health

Kuwait City, Kuwait

RECRUITING

MeSH Terms

Conditions

Pneumonia, Viral; Respiratory Tract Infections; COVID-19; Pneumonia

Condition Hierarchy (Ancestors)

Infections; Virus Diseases; Lung Diseases; Respiratory Tract Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Sondus AlSharidah, MD

  MOH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sundos Alsharida

CONTACT

0096566691663; salsharidah@moh.gov.kw

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sondus Alsharidah

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 16, 2020
• Study Start: May 21, 2020
• Primary Completion: September 30, 2020
• Study Completion: December 30, 2020
• Last Updated: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

KU (1)