COVID-19 trials registries data warehouse

http://en.irct.ir/trial/47953

Sirous Zeinali

kbc@kawsar.ir

2020-05-13

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

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

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

2

Kowsar Biotechnology Co.

18

100

Iran

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

124

Clinical improvement within 14 days after patient admission Patient mortality rate in 14 days

Phase 3

[{"arm_notes": "", "treatment_id": 347, "treatment_name": "Coviglobulin (rabbit polyclonal antibody)", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]