COVID-19. Covid-19
Conditions
Interventions
Intervention 1: Intervention group: Human COVID-19 hyperimmune plasma with a specific antibody titer, volume 500ml, intravenous infusion over 4 hours
In addition to routine treatment based on the latest update of the national protocol. Intervention 2: Intervention group: Routine Human COVID-19 hyperimmune plasma, volume 500ml, intravenous infusion
In addition to routine treatment based on the latest update of the national protocol. Intervention 3: Control group: Routine treatment based on the latest update of the national protocol.
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Confirmed or suspected COVID-19 pneumonia based on PCR or pulmonary imaging; Presenting clinical symptoms of COVID-19 (fever, cough, dyspnea); O2 saturation equal or less than 93%; Age equal or more than 18 years old; The patient has informed and free written consent to participate in the study; Less than 7 days passed from the onset of clinical symptoms to the time of enrollment; The patient should not attend another clinical trial at the same time.
Exclusion criteria
Exclusion criteria: Advanced renal or liver disease; Active cancer; Known Hypersensitivity reaction to Plasma-derived drugs; Pregnancy; Lactation; The patient may be excluded from the study during the first 48 hours.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of hospital stay due to covid-19. Timepoint: Daily until discharge or death. Method of measurement: Count the days of hospitalization from the time of admission to the hospital until discharge or death. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mortality rate on day 28. Timepoint: Day 28 from enrollment. Method of measurement: Clinical assessment.;Requirement rate of mechanical ventilation. Timepoint: day 1 to 7. Method of measurement: Clinical assessment.;Requirement rate of receiving ICU care. Timepoint: Day 1 to 7. Method of measurement: Clinical assessment.;The 7-point ordinal scale. Timepoint: Day 1 and 7. Method of measurement: Clinical assessment.;National Early Warning Score 2 (NEWS2) changes. Timepoint: Day 1 and 7. Method of measurement: Clinical assessment and laboratory findings.;Chest CT-scan score changes. Timepoint: Day 1 and 28. Method of measurement: Chest CT scan.;Side effects. Timepoint: Day 1 to 7. Method of measurement: Clinical assessment. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHamidreza Abtahi
Tehran University of Medical Sciences
Outcome results
None listed