search
Back to results

Efficacy and Safety of Recovered Covid 19 Plasma Transfusion to Covid 19 Severly Ill Patients

Primary Purpose

Covid19

Status
Unknown status
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
recovered covid 19 patients plasma
Sponsored by
South Valley University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients ≥ 18 years, with confirmed laboratory covid-19, and have one or more of the following 4 conditions:

    • 1. respiratory frequency ≥ 30/min,
    • 2. blood oxygen saturation ≤ 93% on room air,
    • 3. partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300 mmHg,
    • 4. pulmonary infiltrates occupying more than 50% of both lungs.

Exclusion criteria

  • Any patient with prior allergic history to plasma or
  • allergy to plasma products or
  • septic shock or
  • multiple organ failure.

Sites / Locations

  • South Valley UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Recovered covid 19 plasma

controlled

Arm Description

Outcomes

Primary Outcome Measures

Satisfactory outcome
Patients' response to recovered Covid 19 plasma (RCP) during 5 days after transfusion, was our primary goal. It was categorized into either satisfactory or unsatisfactory outcomes. We defined satisfactory outcome as two or more of the following 4 conditions/ or otherwise unsatisfactory: 1. respiratory frequency < 30/min, 2. Sustain blood oxygen saturation ≥93% on room air, 3. partial pressure of arterial oxygen to fraction of inspired oxygen ratio > 300 mmHg, 4. Regression of pulmonary infiltrates occupying less than 50% of both lungs.

Secondary Outcome Measures

Full Information

First Posted
August 26, 2020
Last Updated
August 27, 2020
Sponsor
South Valley University
search

1. Study Identification

Unique Protocol Identification Number
NCT04530370
Brief Title
Efficacy and Safety of Recovered Covid 19 Plasma Transfusion to Covid 19 Severly Ill Patients
Official Title
Efficacy and Safety of Recovered Covid 19 Plasma Transfusion to Covid 19 Severly Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 29, 2020 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The discovery of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the outbreak of coronavirus disease 2019 (COVID-19) are causing public health emergencies. A handful pieces of literature have summarized its clinical and radiologic features, whereas therapies for COVID-19 are rather limited. To evaluate the efficacy of convalescent plasma therapy in COVID-19 patients.
Detailed Description
Coronavirus disease 2019 (COVID-19) is a highly contagious pulmonary disease caused by a newly discovered strains of coronavirus family. The clinical pictures could range from a symptomatic to severe and can lead to hospitalization, breathing difficulties and death. Unfortunately, no vaccine or specific treatment is available so far. 1 There have been encouraging clinical researches using immunotherapy as a recent treatment modality against Covid 19 viral infections. Of particular interest, is passive immunotherapy which is the passive transfer of readymade antibodies (humoral immunity) from recovered individuals to patients in active illness. 2 Plasma of recovered patients, a classic cell transfer therapy, has been used successfully to prevent and treat many infectious diseases in the past including: H1N1 pandemic influenza A, avian influenza A (H5N1), SARS-CoV and, Ebola virus disease, MERS-CoV respiratory syncytial virus, Zika viruses, human cytomegalovirus and rabies. Unfortunately, recovered plasma did not show successful results in combating Ebola outbreak3 Neutralizing antibody from recovered SARS patients could interfere with SARS-CoV-2 from penetrating through host cells in vitro. 4 Moreover, neutralizing antibodies (NAbs) from recovered SARS-CoV patients were highly correlated, peaking at month 4 after the onset of disease, could be titrated in plasma of 90% of patients for as long as 2 years, decreasing gradually thereafter.5 SARS-CoV-2 is a member of β-coronavirus family. It is a single-stranded RNA genome consists of 30 kb nucleotides, which transcript 4 main structural proteins: spike (S), membrane (M), envelope (E), and nucleocapsid (N) proteins. The virus characteristic appearance stems from, the S protein which is club shape glycoprotein radiating in a crown like configuration. 6 Genome researches have shown that interlocking between the receptor-binding domain of S protein and the angiotensin-converting enzyme 2 (ACE2) facilitates SARS-CoV-2 entry into the host cells. 7 The similarity of the receptor-binding sites between SARS-CoV-2 and SARS-CoV explains their shared pathogenicity and biological traits. Moreover, both covid-19 and SARS share common clinical (fever, cough, body aches, and dyspnea) and typical radiological manifestations (multifocal ground-glass opacities (GGOs) and subsegmental areas of consolidation). 8 Nevertheless, both viruses are highly contagious with incubation period range from several days to two weeks. Patients with SARS-CoV-2 infection produce different antibodies against different viral antigenic proteins (epitomes), and some of these antibodies mediate their action by virus neutralization or by phagocytosis and antibody gated cell toxicity.9 There have been published studies claiming successful patient outcome after transfusion of recovered plasma. One study showed improved clinical pictures, higher discharge rate. 10 Another study demonstrated that viral RNA disappeared in patient serums a week post transfusion. 11 Another study compared the clinical improvement of recovered plasma transfusion with steroids in SARS patients with critical condition. They observed that recovered plasma patients had a high hospital discharge rate, better clinical outcome than the steroid group, with no transfusion related unwanted effects.12 A large meta-analysis of 1703 influenza pneumonia patients who had been transfused recovered plasma, showed a marked decrease of viral load and 21% decrease in mortality. 13 There are fast growing numbers of new COVID-19 cases every day, and disease-related morbidity and mortality is increasing. The purpose of our study was to test the efficacy and safety of transfusing plasma from patients who have recovered from COVID-19, to patients with COVID-19 in severe condition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recovered covid 19 plasma
Arm Type
Experimental
Arm Title
controlled
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
recovered covid 19 patients plasma
Intervention Description
we transfused 150 ml of recovered covid 19 plasma to severely ill patients with confirmed covid 19 disease
Primary Outcome Measure Information:
Title
Satisfactory outcome
Description
Patients' response to recovered Covid 19 plasma (RCP) during 5 days after transfusion, was our primary goal. It was categorized into either satisfactory or unsatisfactory outcomes. We defined satisfactory outcome as two or more of the following 4 conditions/ or otherwise unsatisfactory: 1. respiratory frequency < 30/min, 2. Sustain blood oxygen saturation ≥93% on room air, 3. partial pressure of arterial oxygen to fraction of inspired oxygen ratio > 300 mmHg, 4. Regression of pulmonary infiltrates occupying less than 50% of both lungs.
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients ≥ 18 years, with confirmed laboratory covid-19, and have one or more of the following 4 conditions: 1. respiratory frequency ≥ 30/min, 2. blood oxygen saturation ≤ 93% on room air, 3. partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300 mmHg, 4. pulmonary infiltrates occupying more than 50% of both lungs. Exclusion criteria Any patient with prior allergic history to plasma or allergy to plasma products or septic shock or multiple organ failure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ossama h salman, MD,PhD
Phone
+201223001113
Email
ossamas@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gad s Gad, MD
Organizational Affiliation
South Valley University
Official's Role
Study Chair
Facility Information:
Facility Name
South Valley University
City
Qinā
ZIP/Postal Code
83523
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gad S Gad, MD
Phone
+201099075675
Email
Kmashson@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
34013969
Citation
Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of Recovered Covid 19 Plasma Transfusion to Covid 19 Severly Ill Patients

We'll reach out to this number within 24 hrs