Plasma therapy in patient with COVID-19
- Conditions
- Coronavirus disease (COVID-19).The code for the confirmed diagnosis of COVID-19RA01.0
- Registration Number
- IRCT20200416047099N1
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
Inclusion criteria of plasma donor (1-9) Recovery from 2019-nCoV infection according to clinical and laboratory criteria
Pass the at least 28 days after hospital discharge
Negative RT-PCR test ( 2 times with 48 h interval)
Negative results of serum/plasma for HBV, HCV, HTLV, HIV, and Syphilis
ABO, and RH antigens determination
Fill informed consent to collect 650-1300 apheresis
Inclusion criteria of recipient (11-15)
Confirmed the diagnosis of nCoV infection by RT-PCR
Respiratory > 30 beats/min
SaO2< 93%
PaO2 / FiO2 =300 mmHg
Fill informed consent
Exclusion criteria of plasma donor (2-13)
Active respiratory infection symptoms: cough, dyspnea, oxygen requirements during 3 days ago
History of Cardiac congestion, pulmonary hypertension, and other situation leading to apheresis failure
Bleeding history and anti-coagulant agent therapy
HBV vaccination during last week Receiving live-attenuated vaccines including BCG, yellow fever, measles, mumps, polio and typhoid fever during over the past three weeks
Receiving IVIG injection, anti-tetanus, and other passive immunization over the past 6 weeks
Small pox vaccination or contact with a person who receive Small pox vaccine
Undefined loss weight > 4.5 kg, apheresis over the past three months
Diagnosis of Dengue fever, Induced abortion, and blood transfusion over the past 6 months
Exclusion criteria of recipient (11-14)
Pregnancy, breast-feeding
Patients with psychosis, severe systemic disease, and malignancy
Patients with serious underlying disease for expample hematological disorder, cachexia, active bleeding, malnutrition, cardiovascular, renal, lung, and liver dysfunction
Uncontrolled infection
Patients who participated in other clinical trialsCoinfection with HIV, Syphilis, Syphilis, tuberculosis, flu infection, adenovirus infection, and other respiratory viral infection
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Size of lesion area in lung. Timepoint: On day of 1, 4,7,14, and 38 after plasma therapy. Method of measurement: Chest CT scan.;Fever duration. Timepoint: On day of 1, 4,7,14, and 38 after plasma therapy. Method of measurement: termometer.;Respiratory rate. Timepoint: On day of 1, 4,7,14, and 38 after plasma therapy. Method of measurement: the number of breaths per minute.;PaO2/FiO2 ratio. Timepoint: On day of 1, 4,7,14, and 38 after plasma therapy. Method of measurement: ventilator equipment.
- Secondary Outcome Measures
Name Time Method