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

IMMUNOTHERAPY Clinical Trial

Official title:

The Therapeutic Potential of Convalescent Plasma Therapy on Treating Critically-ill COVID-19 Patients Residing in Respiratory Care Units in Hospitals in Baghdad, Iraq

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04441424
• Other study ID #: CPT-COVID-19
• Status: Completed
• Phase: N/A
• Start date: April 3, 2020
• Est. completion date: June 1, 2020

Study information

• Verified date: June 2020
• Source: Alkarkh Health Directorate-Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Objectives: The current COVID-19 pandemic needs unconventional therapies to tackle the resulted high morbidity and mortality. Convalescent plasma is one of the therapeutic approaches that might be of benefit. Methods: Forty nine early-stage critically-ill COVID-19 patients residing in respiratory care units (RCU) of three hospitals in Baghdad, Iraq were included, 21 received convalescent plasma while 28 did not receive, namely control group. Recovery or death, length of stay in hospital, and improvement in the clinical course of the disease were monitored clinically along with laboratory monitoring through SARS-CoV-2 RNA detection via PCR, and SARS-CoV-2 IgG and IgM serological monitoring.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 49 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.

Exclusion Criteria:

• The exclusion criteria of the COVID-19 patients were:

• 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

Related Conditions & MeSH terms

• Critical Illness
• IMMUNOTHERAPY

Intervention

Biological:
• Convalescent plasma
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.

Drug:
• Hydroxychloroquin with Azithromycin
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.

Locations

Country	Name	City	State
Iraq	Akarkh Healt hdirectorate	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
Alkarkh Health Directorate-Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The length of stay in hospitals	this outcome is about measuring the length of stay (in days) of treated patients with convalescent plasma versus tose who were treated with conventional therapies	Up to 8 weeks