Convalescent Plasma Therapy on Critically-ill Novel Coronavirus (COVID-19) Patients

NCT04441424 | Completed DMC

• 1 other identifier: CPT-COVID-19
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Out of 49 early-stage critically-ill COVID-19 patients, 21 patients are the experimental group who take convalescent plasma compared to 28 patients receive only conventional therapy without taking Convalescent plasma. Recovery or death, length of stay in hospital, and improvement in the clinical course of the disease are monitored in relation to monitoring through severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) RNA detection via poly chain reaction (PCR), and SARS-CoV-2 immunoglobulin G (IgG) and immunoglobulin M (IgM) serological monitoring.

Conditions

IMMUNOTHERAPY

Outcome Measures

Primary Outcomes (1)

• Death versus survival of treated patients

  evaluate the role of convalescent plasma in saving life of treated patients by measuring the final outcome whether treated patients survived or died

  Up to 8 weeks

Secondary Outcomes (1)

• The length of stay in hospitals

  Up to 8 weeks

Study Arms (2)

Convalescent plasma group

EXPERIMENTAL

21 critically-ill COVID-19 patients were given convalescent plasma: 400 ml of convalescent plasma from COVID-19 recovered subjects. The plasma infusion lasts for one hour.

Biological: Convalescent plasma; Drug: Hydroxychloroquin with Azithromycin

Control group

OTHER

This group is 28 critically-ill COVID-19 patients who are at the same disease stage to those of experimental group that were treated with conventional therapy without taking convalescent plasma. The conventional therapy: 400 mg once PO Hydroxychloroquine/day with 250mg once PO Azithromycin.

Drug: Hydroxychloroquin with Azithromycin

Interventions

Convalescent plasma BIOLOGICAL

400 ml of convalescent plasma (plasma taken 2 weeks from the recovered COVID-19 patients) and was transfused over 1-2 hours to the recipients by blood donation set.

Convalescent plasma group

Hydroxychloroquin with Azithromycin DRUG

The control group of COVID-19 patients were given the conventional therapy approved in Iraq for COVID-19, namely Hydroxychloroquine 400mg PO twice per day for 5 days and Azithromycin once PO 500 mg per day for 5 days.

Control group; Convalescent plasma group

Eligibility Criteria

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

You may qualify if:

• critically-ill COVID-19 patients are included.
• All of the patients were with pneumonia and residing in RCU
• Age ≥ 18 y
• With dyspnea and oxygen saturation less than 90% in resting state.
• At their first 3 days in RCU either receiving O2 therapy, c-pap, or on ventilators.
• All of the patients were residing in infectious diseases wards before being transferred to RCU.

You may not qualify if:

• Previous allergic history to plasma or its ingredients such as sodium citrate.
• Cases with serious general conditions, such as severe organ dysfunction, that are not suitable for transfusion.
• Very late stage of the acute respiratory distress (ARDS) where Convalescent plasma (CP) has proved to be of low therapeutic benefit

Sponsors & Collaborators

• Alkarkh Health Directorate-Baghdad: lead

Study Sites (1)

Akarkh Healt hdirectorate

Baghdad, 14222, Iraq

Location

Related Publications (4)

• 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

• Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, 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. 2020 Oct 12;10:CD013600. doi: 10.1002/14651858.CD013600.pub3.

  PMID: 33044747 DERIVED

MeSH Terms

Interventions

Hydroxychloroquine; Azithromycin

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Ahmed S Abdulamir, PhD

  Alkarkh health directorate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Virology and infectious diseases

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 22, 2020
• Study Start: April 3, 2020
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)