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

NCT04352751 | Unknown DMC

• 1 other identifier: PIPK- 0000 /NIBD-0000/2020
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Covid-19

Outcome Measures

Primary Outcomes (1)

• Change in COVID-19 severity status

  Improvement in disease severity will be regarded as a shift from Critical to Severe or from Severe to Mild disease category. The various disease categories are defined as following (17): 1. Mild COVID-19, defined by the absence of features given in criteria for moderate and severe disease. 2. Severe COVID-19, defined by the presence of any of the following features: i. Shortness of breath ii. Respiratory rate ≥ 30/min, iii. Arterial blood oxygen saturation ≤ 93%, iiii. Lung infiltrates \> 50% within 24 to 48 hours c. Critical COVID-19, defined by the presence of any of the following features: i. Respiratory failure, ii. Shock iii. Multiple organ dysfunction

  Up to 09 days

Study Arms (1)

Single Arm

EXPERIMENTAL

Intervention: Convalescent plasma (Frozen Solution for infusion) obtained from COVID-19 recovered patients. The dosage depends upon the clinical situation and underlying disorder. Children: 15 ml/kg over 4-6 hours once in patients under 35 kg body weight. Adults: maximum 450 - 500 ml over 4-6 hours once in all adults patients.

Other: convalescent plasma

Interventions

convalescent plasma OTHER

* 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

Single Arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• FOR DONORS:
• Volunteer enrolment (Informed consent will be obtained; Annexures-2A \& 2B).
• All the regulations related to ICH-GCP and Blood Transfusion Authority (BTA) Pakistan will be followed.
• Should fulfill all the criteria of a healthy blood donor (with the exception of history of COVID-19 during last 4-8 weeks.
• History of COVID-19 during last 4-8 weeks
• RT-PCR negative for SARS-CoV-2 RNA (carried out on nasopharyngeal or oropharyngeal specimen)
• Age cutoff: 18-55years
• Body weight cut off: \>50 kg for men and \> 45kg for women
• FOR RECIPIENTS:
• Volunteer enrolment (Informed consent will be obtained; Annexures-3A \& 3B).
• Confirmed COVID-19 cases confirmed by RT-PCR laboratory tests
• Severe or Critical COVID-19 related features (8):
• a. Severe COVID-19, defined by the presence of any of the following features: i. Shortness of breath ii. Respiratory rate ≥ 30/min, iii. Arterial blood oxygen saturation ≤ 93%, iv. Lung infiltrates \> 50% within 24 to 48 hours b. CriticalCOVID-19, defined by the presence of any of the following features: i. Respiratory failure, ii. Shock iii. Multiple organ dysfunction

You may not qualify if:

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

Sponsors & Collaborators

• Hilton Pharma: lead

Study Sites (1)

National Institute of Blood Diseases and Bone Marrow Transplantation (NIBD)

Karachi, Sindh, 75300, Pakistan

RECRUITING

Related Publications (5)

• 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.

  PMID: 7769272 BACKGROUND

• 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.

  PMID: 7985997 BACKGROUND

• 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.

  PMID: 21248066 BACKGROUND

• 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.

  PMID: 20154602 BACKGROUND

• Khan TNS, Mukry SN, Masood S, Meraj L, Devrajani BR, Akram J, Fatima N, Maqsood S, Mahesar A, Siddiqui R, Ishaque S, Afzal MB, Mukhtar S, Ahmed S, Naz A, Shamsi TS. Usefulness of convalescent plasma transfusion for the treatment of severely ill COVID-19 patients in Pakistan. BMC Infect Dis. 2021 Sep 27;21(1):1014. doi: 10.1186/s12879-021-06451-7.

  PMID: 34579646 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dr. Tahir Shamsi, FRCP MRCPath

  National Institute of Blood Diseases and Bone Marrow Transplantation (NIBD)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Arshi Naz, PhD,Diplab

CONTACT

00923232234376; labarshi@yahoo.com

Dr. Neeta Maheshwary, MBBS Mphil

CONTACT

00923208247773; drneeta@hiltonpharma.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm, open label, clinical trial employing WHO recognized monitored emergency use of unregistered and experimental interventions (MEURI) study.

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 20, 2020
• Study Start: May 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: September 29, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)