Efficacy and safety of convalescent plasma in the treatment of COVID-19
- Conditions
- ovel Coronavirus Pneumonia (COVID-19)Coronavirus (COVID-19).COVID-19, virus identifiedU07.1
- Registration Number
- IRCT20200404046948N1
- Lead Sponsor
- Artesh University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Laboratory confirmed COVID-19 by PCR
Aged 18 to 70 years old
Being inpatients
The clinical severe or immediately life-threatening COVID-19 (Severe patients meet any of the following: Dyspnea, Respiratory frequency = 30/min, Blood oxygen saturation = 93% (in resting state), partial pressure of arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2)<300, and/or Lung infiltrates > 50% within 24 to 48 hours. Life-threatening disease is defined as: respiratory failure and need mechanical ventilation, septic shock, and/or multiple organ dysfunction or failure
The patient or his/her legal guardian will sign the informed consent and participate voluntarily
Accepting randomized allocation (allocating into any group)
Being hospitalized before the end of the clinical trial and available for any follow-up
Those who has history of allergy to blood products or plasma components and auxiliary materials (sodium citrate)
Critical conditions like multiple organ failure, and the estimated survival time is less than 3 days
Severe congestive heart failure (CHF), or any other conditions in which plasma transfusion is contraindicated decided by researchers
Any risk factor which may increase the risk of thrombosis,
Pregnant or breastfeeding women
Participation in another clinical trial
Taking any other medicine for COVID 19 treatment out of the protocol
The doctor believes that the patient is not suitable to participate in this trial
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical improvement within 14 days of admission. Timepoint: everyday. Method of measurement: Clinical improvement is defined as the patient's admission status of 6 grade scale score reduced by 2 points or patient discharge. (Clinical improvement was defined as a 2-point reduction or discharge of a 6-point scale for patient admission status. The 6-point scale includes: 6 points: death; 5 points: hospitalization for ECMO and / or mechanical ventilation; 4 points: non-invasive admission Ventilation and / or high-flow oxygen therapy; 3 points: hospitalization for oxygen therapy (but no high-flow or non-invasive ventilation is required); 2: points for hospitalization) Point1: discharge.
- Secondary Outcome Measures
Name Time Method Mortality in a two groups during 14 days. Timepoint: everyday. Method of measurement: Examination and history.;Hospitalization ??Duration. Timepoint: Patient discharge day. Method of measurement: Examination and history.;ICU Hospitalization Duration. Timepoint: everyday. Method of measurement: Examination and history.;Invasive mechanical ventilation. Timepoint: everyday. Method of measurement: Examination and history.;ECMO duration. Timepoint: everyday. Method of measurement: Examination and history.;Proportion of PCR negative (3 AND 7 days after transfusion). Timepoint: 3 days and 7 days after injection. Method of measurement: PCR.;Clinical characteristics including, Fever, Respiratory frequency(RF) and PaO2/FiO2. Timepoint: everyday. Method of measurement: Examination and history.