Evaluation of the effectiveness of intravenous infusion of human COVID-19 hyperimmune plasma with specific antibody titer in hospitalized patients with Covid-19: a randomized clinical trial

Phase 3

Recruiting

Conditions: COVID-19.
Covid-19
U07.1

Registration Number: IRCT20201004048922N1

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 75

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

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ength 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 Outcome Measures

Name	Time	Method
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.