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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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IMMUNOTHERAPY

Intervention / Treatment
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* Biological: Convalescent plasma
* Drug: Hydroxychloroquin with Azithromycin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Convalescent plasma group<br>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<br>* 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.<br>Drug: Hydroxychloroquin with Azithromycin<br>* 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.<br>|
| Other: Control group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |