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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04441424
Recruitment Status : Completed
First Posted : June 22, 2020
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed Sahib Abdulamir, Alkarkh Health Directorate-Baghdad

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.

Condition or disease Intervention/treatment Phase
IMMUNOTHERAPY Biological: Convalescent plasma Drug: Hydroxychloroquin with Azithromycin Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 3, 2020
Actual Primary Completion Date : June 1, 2020
Actual Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Convalescent plasma group
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
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.

Control group

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
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.




Primary Outcome Measures :
  1. Death versus survival of treated patients [ Time Frame: Up to 8 weeks ]
    evaluate the role of convalescent plasma in saving life of treated patients by measuring the final outcome whether treated patients survived or died


Secondary Outcome Measures :
  1. The length of stay in hospitals [ Time Frame: Up to 8 weeks ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04441424


Locations
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Iraq
Akarkh Healt hdirectorate
Baghdad, Iraq, 14222
Sponsors and Collaborators
Alkarkh Health Directorate-Baghdad
Investigators
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Principal Investigator: Ahmed S Abdulamir, PhD Alkarkh health directorate
  Study Documents (Full-Text)

Documents provided by Ahmed Sahib Abdulamir, Alkarkh Health Directorate-Baghdad:
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Responsible Party: Ahmed Sahib Abdulamir, Professor in Virology and infectious diseases, Alkarkh Health Directorate-Baghdad
ClinicalTrials.gov Identifier: NCT04441424    
Other Study ID Numbers: CPT-COVID-19
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes
Azithromycin
Hydroxychloroquine
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents