Convalescent Plasma Therapy on Critically-ill Novel Coronavirus (COVID-19) Patients
- Conditions
- IMMUNOTHERAPY
- Interventions
- Biological: Convalescent plasma
- Registration Number
- NCT04441424
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
- 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.
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Convalescent plasma group Hydroxychloroquin with Azithromycin 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. Convalescent plasma group Convalescent plasma 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. Control group Hydroxychloroquin with Azithromycin 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.
- Primary Outcome Measures
Name Time Method Death versus survival of treated patients 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
Name Time Method The length of stay in hospitals 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
Trial Locations
- Locations (1)
Akarkh Healt hdirectorate
🇮🇶Baghdad, Iraq