IMMUNOTHERAPY
Conditions
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.
Interventions
BIOLOGICALConvalescent 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.
DRUGHydroxychloroquin 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.
Sponsors
Alkarkh Health Directorate-Baghdad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Iraq
Outcome results
None listed