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Convalescent Plasma Therapy for COVID-19 Patients

Primary Purpose

SARS-CoV Infection

Status
Unknown status
Phase
Early Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
convalescent plasma
Sponsored by
Lahore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS-CoV Infection focused on measuring COVID-19, Convalescent plasma therapy

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Severe or critically ill COVID-19 patients tested positive in respiratory tract test.
  • The COVID-19 patients who are not severe or critically ill, but in a state of immunity suppression;
  • or have low CT values in the virus nucleic acid testing but with a rapid disease progression in the lungs.
  • Severe or immediately life-threatening COVID-19, for example,
  • Severe disease is defined as one or more of the following:

    • shortness of breath (dyspnea),
    • respiratory frequency ≥ 30/min,
    • blood oxygen saturation ≤ 93%,
    • partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300,
    • lung infiltrates > 50% within 24 to 48 hours
  • Within 3 to 21 days from onset of symptoms

Exclusion criteria:

• Life-threatening disease is defined as one or more of the following: respiratory failure, septic shock, multiple organ dysfunction or failure

Critically ill COVID-19 patients will not considered suitable for being transfusion as inflammatory pathway is already set in, so antibodies will not make that much of difference.

Sites / Locations

  • Muhammad Irfan Malik

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group intervene with convalescent plasma

Arm Description

Review effect of Plasma therapy as clinical trial among hospitalized patients with COVID-19 infection. Transfuse 2 aliquots of plasma (200 mL x 2) per patient. Transfuse first aliquot for 2-3 hours (~1.4 to 2 mL/min) Transfuse second aliquot at same rate 2 hours after completion of first aliquot

Outcomes

Primary Outcome Measures

clinical outcome after plasma therapy
Clinical Improvement of COVID-19 patients by giving them passive immunization

Secondary Outcome Measures

Clinical response to treatment
Overall survival of COVID-19 patients after plasma administration.

Full Information

First Posted
September 24, 2020
Last Updated
December 4, 2020
Sponsor
Lahore General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04565197
Brief Title
Convalescent Plasma Therapy for COVID-19 Patients
Official Title
Convalescent Plasma for Passive Immunization in COVID-19 ICU Patients: An Interventional Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lahore General Hospital

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
Passive immunization involves the administration of antibodies against a given agent to a susceptible individual for the purpose of preventing or treating an infectious disease due to that agent. A general principle of passive antibody therapy is that it is more effective when used for prophylaxis than for treatment of disease. When used for therapy, antibody is most effective when administered shortly after the onset of symptoms
Detailed Description
Passive immunization involves the administration of antibodies against a given agent to a susceptible individual for the purpose of preventing or treating an infectious disease due to that agent. A general principle of passive antibody therapy is that it is more effective when used for prophylaxis than for treatment of disease. When used for therapy, antibody is most effective when administered shortly after the onset of symptoms. The reason for temporal variation in efficacy is not well understood but could reflect that passive antibody works by neutralizing the initial inoculums, which is likely to be much smaller than that of established disease . As an example, passive antibody therapy for pneumococcal pneumonia was most effective when administered shortly after the onset of symptoms, and there was no benefit if antibody administration was delayed past the third day of disease. Therapeutic and prophylactic significance was explored in influenza and measles . Transfusion of immune plasma is a standard treatment modality for various viral hemorrhagic fevers . Its efficacy in treating Ebola Virus Disease is also well established . Studies have reported reduction viral load in patients with H1N1 influenza .Efficacy of convalescent plasma has been anecdotally reported in SARS-CoV-2 infections . The largest study involved the treatment of 80 patients with SARS in Hong Kong. Patients treated before day 14 had improved prognosis defined by discharge from hospital before day 22, consistent with the notion that earlier administration is more likely to be effective . In the case of SARS-CoV-2, the anticipated mechanism of action by which passive antibody therapy mediated protection is viral neutralization. However, other mechanisms may be possible, such as antibody-dependent cellular cytotoxicity and/or phagocytosis. The only antibody type that is currently available for immediate use SARS-CoV-2 is that found in human convalescent sera. In China for SARS-CoV-2 disease, it has been found that the convalescent plasma therapy is effective for patients with a disease course exceeding three weeks and whose virus nucleic acid tests continuously to show positive from respiratory tracts specimen. It can speed up virus clearance, increase the numbers of the plasma lymphocytes and NK cells, reduce the level of plasma lactic acid, and improve renal functions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV Infection
Keywords
COVID-19, Convalescent plasma therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Qausi-experimental
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group intervene with convalescent plasma
Arm Type
Experimental
Arm Description
Review effect of Plasma therapy as clinical trial among hospitalized patients with COVID-19 infection. Transfuse 2 aliquots of plasma (200 mL x 2) per patient. Transfuse first aliquot for 2-3 hours (~1.4 to 2 mL/min) Transfuse second aliquot at same rate 2 hours after completion of first aliquot
Intervention Type
Biological
Intervention Name(s)
convalescent plasma
Other Intervention Name(s)
Plasma therapy
Intervention Description
Transfuse 2 aliquots of plasma (200 mL x 2) per patient. Transfuse first aliquot for 2-3 hours (~1.4 to 2 mL/min) Transfuse second aliquot at same rate 2 hours after completion of first aliquot
Primary Outcome Measure Information:
Title
clinical outcome after plasma therapy
Description
Clinical Improvement of COVID-19 patients by giving them passive immunization
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Clinical response to treatment
Description
Overall survival of COVID-19 patients after plasma administration.
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Severe or critically ill COVID-19 patients tested positive in respiratory tract test. The COVID-19 patients who are not severe or critically ill, but in a state of immunity suppression; or have low CT values in the virus nucleic acid testing but with a rapid disease progression in the lungs. Severe or immediately life-threatening COVID-19, for example, Severe disease is defined as one or more of the following: shortness of breath (dyspnea), respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, lung infiltrates > 50% within 24 to 48 hours Within 3 to 21 days from onset of symptoms Exclusion criteria: • Life-threatening disease is defined as one or more of the following: respiratory failure, septic shock, multiple organ dysfunction or failure Critically ill COVID-19 patients will not considered suitable for being transfusion as inflammatory pathway is already set in, so antibodies will not make that much of difference.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Irfan Malik, FCPS
Organizational Affiliation
Post-Graduate Medical Institute, Lahore General Hospital, Lahore Pakistan
Official's Role
Study Director
Facility Information:
Facility Name
Muhammad Irfan Malik
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54500
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
7769272
Citation
Robbins JB, Schneerson R, Szu SC. Perspective: hypothesis: serum IgG antibody is sufficient to confer protection against infectious diseases by inactivating the inoculum. J Infect Dis. 1995 Jun;171(6):1387-98. doi: 10.1093/infdis/171.6.1387.
Results Reference
background
PubMed Identifier
7985997
Citation
Casadevall A, Scharff MD. Serum therapy revisited: animal models of infection and development of passive antibody therapy. Antimicrob Agents Chemother. 1994 Aug;38(8):1695-702. doi: 10.1128/AAC.38.8.1695. No abstract available.
Results Reference
background
PubMed Identifier
28094110
Citation
Garraud O. Use of convalescent plasma in Ebola virus infection. Transfus Apher Sci. 2017 Feb;56(1):31-34. doi: 10.1016/j.transci.2016.12.014. Epub 2016 Dec 30.
Results Reference
background
PubMed Identifier
20154602
Citation
Luke TC, Casadevall A, Watowich SJ, Hoffman SL, Beigel JH, Burgess TH. Hark back: passive immunotherapy for influenza and other serious infections. Crit Care Med. 2010 Apr;38(4 Suppl):e66-73. doi: 10.1097/CCM.0b013e3181d44c1e.
Results Reference
background
PubMed Identifier
21248066
Citation
Hung IF, To KK, Lee CK, Lee KL, Chan K, Yan WW, Liu R, Watt CL, Chan WM, Lai KY, Koo CK, Buckley T, Chow FL, Wong KK, Chan HS, Ching CK, Tang BS, Lau CC, Li IW, Liu SH, Chan KH, Lin CK, Yuen KY. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011 Feb 15;52(4):447-56. doi: 10.1093/cid/ciq106. Epub 2011 Jan 19.
Results Reference
background
PubMed Identifier
3217871
Citation
Balabolkin MI. [Various problems of thyroidology]. Ter Arkh. 1988;60(9):136-41. No abstract available. Russian.
Results Reference
background

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Convalescent Plasma Therapy for COVID-19 Patients

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