Emerging pneumonia caused by the covid virus 19. COVID-19, virus identified
Conditions
Interventions
Intervention 1: The intervention group includes patients with moderate to severe COVID-19 symptoms who have been diagnosed with coronavirus by PCR: (1) CoviGlobulin (rabbit polyclonal antibody) intake
Sponsors
Kowsar Biotechnology Co.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Based on clinical and laboratory symptoms, the person has been confirmed to have COVID-19. The patient is over 18 years old The patient is hospitalized and shows one of the moderate to severe clinical symptoms of COVID-19, including the following: Severe clinical symptoms: Having any of the following: shortness of breath, respiratory rate more than 30 times per minute , Oxygen saturation of blood less than 93% (at rest), ratio of arterial oxygen pressure to inhaled oxygen less than 300, pulmonary infiltration more than 50% over 24 to 48 hours. Volunteer to participate in the study and sign a conscious consent form for yourself or your legal guardian. Admission of patients is random and grouped to participate in the study (control or treatment group). The patient is hospitalized before the end of the clinical study and is available for any further evaluation
Exclusion criteria
Exclusion criteria: People with a history of allergies to blood products such as IVIG or albumin. The patient has critical conditions such as multiple organ failure. pregnant women. Breastfeeding mothers. The patient is receiving treatment and medication outside the standard COVID 19 treatment protocol, and the physician believes that the patient is not suitable to participate in this trial. Known sensitivity to rabbit proteins
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical improvement within 14 days after patient admission. Timepoint: every day. Method of measurement: 2-point decrease in the patient's level compared to the admission time level. 6-point scale includes: score 6: death score 5: hospitalization for ECMO and (or) mechanical ventilation score 4: non-invasive ventilation or high-current oxygen therapy score 3: hospitalization for oxygen therapy (not high current and mechanical ventilation) Not required) Score 2: Hospitalization Score 1: Clearance.;Patient mortality rate in 14 days. Timepoint: every day. Method of measurement: Clinical observation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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: every day. Method of measurement: Examination and history.;ECMO duration. Timepoint: every day. 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: every day. Method of measurement: Examination and history. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSirous Zeinali
Kowsar Biotechnology Company
Outcome results
None listed