Convalescent Plasma Trial in COVID -19 Patients

NCT04356534 | Completed DMC

• 1 other identifier: BDF/R&REC/2020-423
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Plasma therapy using convalescent plasma has been shown to be effective in severe acute respiratory syndrome, Ebola virus infection and in H1N1 influenza. More recently there has been a report of the use of convalescent plasma in the treatment of 5 ventilated COVID-19 patients with the suggestion of expedited recovery as the patients improved 1 week after the transfusion. However, this was not a clinical trial and the patients were on other antiviral medication.; therefore, there is a need to undertake such a trial to see if deploying plasma with SARS-CoV-2 neutralizing antibody has utility in managing patients infected with COVID-19 in respiratory distress. The objective of this pilot study is to compare plasma therapy using convalescent plasma with antibody against SARS-CoV-2 to usual supportive therapy in COVID-19 patients with pneumonia and hypoxia, and to determine if the clinical course is improved. The difference between groups will allow an effect size to be determined for a definitive clinical trial.

Conditions

SARS-CoV 2; COVID-19

Keywords

Plasma Therapy; COVID-19

Outcome Measures

Primary Outcomes (1)

• Requirement for invasive ventilation

  Could the plasma therapy avoid or delay the need for invasive ventilation

  through study completion up to 28 days

Secondary Outcomes (11)

• Change in viral clearance

  through study completion up to 28 days

• Radiological change

  through study completion up to 28 days

• Change in white cell count

  through study completion up to 28 days

• C reactive protein measurement

  through study completion up to 28 days

• lactate dehydrogenase measurement

  through study completion up to 28 days

Study Arms (2)

Control group

ACTIVE COMPARATOR

local standard of care which include antivirals and supportive care

Other: Routine care for COVID-19 patients

Intervention group

EXPERIMENTAL

convalescent patient plasma 400ml given as 200ml over 2 hours in 2 consecutive days, plus routine local standard of care

Other: plasma therapy using convalescent plasma with antibody against SARS-CoV-2

Interventions

plasma therapy using convalescent plasma with antibody against SARS-CoV-2 OTHER

convalescent patient plasma plus routine local standard of care

Intervention group

Routine care for COVID-19 patients OTHER

local standard of care which include antivirals and supportive care

Control group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COVID-19 diagnosis
• Hypoxia, (Oxygen saturation of less than or equal 92% or PO2 \< 60mmHg on arterial blood gas analysis) and patient requiring oxygen therapy
• Evidence of infiltrates on Chest Xray or CT scan
• Able to give informed consent
• Patients between the ages of 21 and above with no upper age.

You may not qualify if:

• Patients with mild disease not requiring oxygen therapy
• Patients with normal CXR \& CT scan
• Patients requiring ventilatory support
• Patients with a history of allergy to plasma, sodium citrate or methylene blue
• Patients with a history of autoimmune disease or selective IGA deficiency.

Sponsors & Collaborators

• Royal College of Surgeons in Ireland - Medical University of Bahrain: lead
• Salmaniya Medical Complex: collaborator
• Bahrain Defence Force Hospital: collaborator
• Mohammed Bin Khalifa Bin Sulman Al Khalifa Cardiac Centre, Awali: collaborator

Study Sites (1)

Royal College of Surgeons in Ireland - Bahrain

Manama, Bahrain

Location

Related Publications (16)

• Soo YO, Cheng Y, Wong R, Hui DS, Lee CK, Tsang KK, Ng MH, Chan P, Cheng G, Sung JJ. Retrospective comparison of convalescent plasma with continuing high-dose methylprednisolone treatment in SARS patients. Clin Microbiol Infect. 2004 Jul;10(7):676-8. doi: 10.1111/j.1469-0691.2004.00956.x.

  PMID: 15214887 BACKGROUND

• Sahr F, Ansumana R, Massaquoi TA, Idriss BR, Sesay FR, Lamin JM, Baker S, Nicol S, Conton B, Johnson W, Abiri OT, Kargbo O, Kamara P, Goba A, Russell JB, Gevao SM. Evaluation of convalescent whole blood for treating Ebola Virus Disease in Freetown, Sierra Leone. J Infect. 2017 Mar;74(3):302-309. doi: 10.1016/j.jinf.2016.11.009. Epub 2016 Nov 17.

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  PMID: 21248066 BACKGROUND

• Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.

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• Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Tissot Dupont H, Honore S, Colson P, Chabriere E, La Scola B, Rolain JM, Brouqui P, Raoult D. RETRACTED: Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Jul;56(1):105949. doi: 10.1016/j.ijantimicag.2020.105949. Epub 2020 Mar 20.

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• Birkett MA, Day SJ. Internal pilot studies for estimating sample size. Stat Med. 1994 Dec 15-30;13(23-24):2455-63. doi: 10.1002/sim.4780132309.

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• Knol MJ, Groenwold RH, Grobbee DE. P-values in baseline tables of randomised controlled trials are inappropriate but still common in high impact journals. Eur J Prev Cardiol. 2012 Apr;19(2):231-2. doi: 10.1177/1741826711421688. No abstract available.

  PMID: 22512015 BACKGROUND

• Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6.

  PMID: 37162745 DERIVED

• Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 Feb 1;2(2):CD013600. doi: 10.1002/14651858.CD013600.pub5.

  PMID: 36734509 DERIVED

• 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.

  PMID: 34013969 DERIVED

• AlQahtani M, Abdulrahman A, Almadani A, Alali SY, Al Zamrooni AM, Hejab AH, Conroy RM, Wasif P, Otoom S, Atkin SL, Abduljalil M. Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease. Sci Rep. 2021 May 11;11(1):9927. doi: 10.1038/s41598-021-89444-5.

  PMID: 33976287 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

• Manaf Al Qahtani, Dr.

  Royal College of Surgeons in Ireland - Bahrain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, interventional and randomized open label trial involving 40 patients with COVID-19 who are in respiratory distress, with the criteria that all require oxygen therapy and have radiological evidence of pneumonia, 20 of whom will receive a transfusion of convalescent patient plasma plus routine care, compared to 20 COVID-19 patients who will receive routine care alone.

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 22, 2020
• Study Start: April 19, 2020
• Primary Completion: June 15, 2020
• Study Completion: July 9, 2020
• Last Updated: October 26, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Dr Manaf will act as the data custodian and is responsible for the storage, handling and quality of the study data. Data will be collected in the case report form to allow for cross referencing to check validity. Study documents (paper and electronic) will be retained in a secure (kept locked when not in use) location during and after the trial has finished. All essential documents including source documents will be retained for a period of 5 years after study completion (last patient, last study point). A label stating the date after which the documents can be destroyed will be placed on the inside front cover of the case notes of trial participants.
• Access Criteria: Study documents (paper and electronic) will be retained in a secure (kept locked when not in use) location during and after the trial has finished.

Locations

BA (1)