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Experimental Use of Convalescent Plasma for Passive Immunization in Current COVID-19 Pandemic in Pakistan in 2020

NCT04352751 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2020-09-29

No results posted yet for this study

Summary

Experimental Use of Convalescent Plasma of Passive Immunisation In Current COVID-19 Pandemic in Pakistan in 2020 Rationale \& Objective: This study would help to gather real-life setting clinical data in local population, ultimately leading to increased evidence based management of the disease condition in the said population.

Eligibility:

1. informed consent must have been obtained
2. confirmed COVID-19 cases confirmed by RT-PCR laboratory tests
3. moderately severe or severe life-threatening COVID-19 related features: a) Moderately Severe disease as defined by the following features: i) Shortness of breath, ii) respiratory rate ≥ 30/min, iii) arterial blood oxygen saturation ≤ 92%, iv) and/or lung infiltrates \> 25% within 24 to 48 hours 67 b) Severe Life-threatening disease as defined by: i) respiratory failure, ii) shock, and/or § multiple organ dysfunction

Exclusion Criteria:

Allergy history of plasma, sodium citrate and methylene blue; 2. For patients with history of autoimmune system diseases or selective IgA deficiency, 3. the application of convalescent plasma should be evaluated cautiously by clinicians.
4. Patients having evidence of uncontrolled cytokine release syndrome leading to end-stage multiorgan failure.

Methodology:

Total sample size is n=2000. A case report form (CRF) will have to be generated for each corona virus patient at baseline and the completion of study endpoint (at the time of discharge and at 4 weeks after experimental treatment modality using convalescent plasma.

* A unique identification number will be issued for each patient in this protocol.
* This data will be recorded in the national database. Data sources \& Analysis: Patient data originating from patient medical record and assessments (mentioned in table below) will be recorded in the study CRF. Safety data (AEs and SAEs) from any time point during the study will be recorded in the study CRF. All analyses will be performed by third party statistician on SPSS. For continuous variables, summary statistics included n (number of observations), mean, standard deviation, median, minimum and maximum values, as well as frequencies and percentages for categorical variables will be presented.

Conditions

Interventions

OTHER

convalescent plasma

* Plasmapheresis, 900 - 1000 mL each time. * Standard apheresis plasma collection protocol using Haemonetics MCS+ intermittent blood flow system or Terumo Optia, Cobe-Spectra, Trima or Fresenius continuous flow system to be used. * Isovolumic saline replacement should be done. * Each donor can donate convalescent plasma again after an interval of every 2 weeks

Sponsors & Collaborators

  • Hilton Pharma

    lead INDUSTRY

Principal Investigators

  • Dr. Tahir Shamsi, FRCP MRCPath · National Institute of Blood Diseases and Bone Marrow Transplantation (NIBD)

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04352751 on ClinicalTrials.gov