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

Primary Purpose

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

Status

Unknown status

Phase

Phase 1

Locations

Kuwait

Study Type

Interventional

Intervention

COVID-19 Convalscent Plasma

About this trial

This is an interventional treatment trial for Moderate COVID-19 Pneumonia, Severe COVID-19 Pneumonia focused on measuring convalescent plasma, respiratory infection, COVID-19, SARS-CoV-2, pneumonia

Eligibility Criteria

15 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

-Contraindication to transfusion (volume overload, history of anaphylaxis to blood products).
- 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.

Sites / Locations

Ministry Of HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CCP patients

Control

Arm Description

Patient has to fulfil the inclusion/exclusion criteria of the ward or the ICU Valid consent. 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: Dose required is 200-250 ml/hr (one dose, can be repeated in 12 hrs), max total 500ml. Premedication prior to administration of CCP (Acetaminophen, diphenhydramine,steriods) or according to hospital guidelines.

Standard COVID-19 treatment.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

All cause mortality

Full Information

NCT ID

NCT04474340

First Posted

July 15, 2020

Last Updated

July 17, 2020

Sponsor

Ministry of Health, Kuwait

1. Study Identification

Unique Protocol Identification Number

NCT04474340

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

May 21, 2020 (Actual)

Primary Completion Date

September 30, 2020 (Anticipated)

Study Completion Date

December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ministry of Health, Kuwait

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CCP patients

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

No Intervention

Arm Description

Standard COVID-19 treatment.

Intervention Type

Drug

Intervention Name(s)

COVID-19 Convalscent Plasma

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time to clinical improvement

Description

Time Frame

30 days

Secondary Outcome Measure Information:

Title

All cause mortality

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: -Contraindication to transfusion (volume overload, history of anaphylaxis to blood products). - 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sundos Alsharida

Phone

0096566691663

salsharidah@moh.gov.kw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sondus AlSharidah, MD

Organizational Affiliation

MOH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ministry Of Health

City

Kuwait

Country

Kuwait

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sondus AlSharidah, MD

Phone

0096566691663

salsharidah@moh.gov.kw

First Name & Middle Initial & Last Name & Degree

Sondus AlSharida, MD

First Name & Middle Initial & Last Name & Degree

Mariam Ayed, Md

First Name & Middle Initial & Last Name & Degree

Reem Ameen, PhD

First Name & Middle Initial & Last Name & Degree

Najat Rouhaldeen, MD

First Name & Middle Initial & Last Name & Degree

Fatmah Alhuraish, MD

First Name & Middle Initial & Last Name & Degree

Abdullah Alsaedi, MD

First Name & Middle Initial & Last Name & Degree

Wasel Aladsani, MD

First Name & Middle Initial & Last Name & Degree

Salem Alqahtani, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

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