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IRCT20200508047346N1 IRCT 2020-05-13 Kowsar Biotechnology Co. Evaluation of the effectiveness of rabbit antibody against coronavirus in patients Evaluation of the efficacy and safety of Rabbit polyclonal antibody (CoviGlobulin) in patients with coronavirus COVID-19 virus moderate to severe 2020-05-21 anticipated 124 Complete https://irct.ir/trial/47953 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Making a random number sequence of patients is done online by the sealed envelop site. Using randomly placed blocks, blocks (the size of each block is 4) will be made for a total of 124 patients. 3 Emerging pneumonia caused by the covid virus 19. 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 of 1-3 mg per kg body weight Body (1-3 mg / kg / d) for 2-4 days. (2) Receive the basic COVID-19 treatment based on the protocol approved by the Ministry of Health. Intervention 2: Control group: Receive basic COVID-19 treatment based on protocol approved by the Ministry of Health. Yes - There is a plan to make this available What will be shared: After the publication of the article, confidential information such as patient and hospital details, etc. will be deleted and other information will be provided to researchers. When: After publishing the article To whom: Medical professionals Conditions: Medical professionals can access data for research purposes Where to obtain: Refer to the email of the responsible author How to obtain: Official and academic email to the responsible author Comments:
public Sirous Zeinali
No. 41, Kosar Complex, 3rd Floor, Majlesi St., Valiasr St., Above Fatemi St., Tehran, Tehran
Tehran Iran (Islamic Republic of) 1595645513 +98 21 8893 9150 zeinali@gmail.com Kowsar Biotechnology Company scientific Mostafa Ghanei
Mulla Sadra, Sheikh Baha'i, Baqiyatallah Al-Azam Hospital
Tehran Iran (Islamic Republic of) 1435915371 +98 21 82162 mghaneister@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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 U07.1 COVID-19, virus identified Treatment - Other Treatment - Other 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 of 1-3 mg per kg body weight Body (1-3 mg / kg / d) for 2-4 days. (2) Receive the basic COVID-19 treatment based on the protocol approved by the Ministry of Health Control group: Receive basic COVID-19 treatment based on protocol approved by the Ministry of Health 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. 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. Kowsar Biotechnology Co. Approved 2020-04-19 Baqiyatallah University of Medical Sciences Mulla Sadar, Sheikh Baha'i, Baqiyatallah Al-Azam Hospital Tehran Tehran Iran (Islamic Republic of)