Novel Coronavirus Pneumonia (COVID-19)Coronavirus (COVID-19). COVID-19, virus identified
Conditions
Interventions
Intervention 1: Intervention group: patients in this group (Laboratory confirmed COVID-19 by PCR), will receive conventional therapy with Infusion of convalescent plasma, 200-500ml, two IV infusions
Sponsors
Artesh University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 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) 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactRamin Hamidi Farahani
Artesh University of Medical Sciences
Outcome results
None listed