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

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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

Tracking Information
First Submitted Date  ICMJE June 12, 2020
First Posted Date  ICMJE June 22, 2020
Last Update Posted Date June 23, 2020
Actual Study Start Date  ICMJE April 3, 2020
Actual Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2020)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Convalescent Plasma Therapy on Critically-ill Novel Coronavirus (COVID-19) Patients
Official Title  ICMJE The Therapeutic Potential of Convalescent Plasma Therapy on Treating Critically-ill COVID-19 Patients Residing in Respiratory Care Units in Hospitals in Baghdad, Iraq
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE IMMUNOTHERAPY
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Biological: Convalescent plasma
    • Drug: Hydroxychloroquin with Azithromycin
  • 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.

    Intervention: Drug: Hydroxychloroquin with Azithromycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2020)
49
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 1, 2020
Actual Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iraq
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04441424
Other Study ID Numbers  ICMJE CPT-COVID-19
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ahmed Sahib Abdulamir, Alkarkh Health Directorate-Baghdad
Study Sponsor  ICMJE Alkarkh Health Directorate-Baghdad
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ahmed S Abdulamir, PhD Alkarkh health directorate
PRS Account Alkarkh Health Directorate-Baghdad
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP