Evaluating the therapeutic effect of Convalescent Plasma and Plasma-derived Immunoglobulin-enriched solution on COVID-19 Patients
A hospital-based, parallel-group, single-blind, and randomized controlled trial
Settings and conduct:
_COVID-19 patients (2 subgroups) & Controls:
_Patients will treat with IV convalescent plasma and or plasma-derived immunoglobulin-enriched solution (PDIES), respectively.
_PDIES will produce by an improved Cohn method.
_Assessment of the patients' clinical and paraclinical improvement.
Participants/Inclusion and exclusion criteria:
_Inclusion criteria for the intervention groups:1- COVIDE-19 Patients who have specified COVIDE-19 clinical symptoms, the positive RT-qPCR test result, positive CT scan, and informed consent; and those who do not respond to routine treatments or are in critical condition.
_Inclusion criteria for Plasma donors: patients who meet all of the following characteristics: 1- Individuals with a recovery period longer than one week after discharge, 2- negative RT-qPCR test result, 3- age ranged 20-45 years old, 4- Individuals who their tests result for Hepatitis B, C, AIDS, syphilis, HTLV-1, and influenza is 100% negative.
_Exclusion criteria:1. Pregnant and Lactating Women, 2. Patients with/or with a history of dangerous underlying diseases 4, Individuals who exhibit specific allergic reactions to intravenous administration. 5. Smokers
Intervention group 1 & 2: Suspected COVID-19 Patients who meet all of the following characteristics:
1- Patients with clinical signs of COVID-19
2- The positive CT scan
3- A Positive RT-PCR Test Result
4- Patients who do not respond to routine treatment or are in critical condition.
5- Informed Consent
Main outcome variables:
Complete remission of clinical signs
The negative qRT-PCR test
Improved CT scan
Normal levels of biomarkers