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Completed

NCT Number: NCT04441424

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akarkh Healt hdirectorate

Baghdad, 14222, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Alkarkh Health Directorate-Baghdad

Other Gov

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 22, 2020
Registry last updated
Jun 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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