BSVL GETS NOD FOR TRIAL OF ULINASTATIN FOR COVID-19

BSVL GETS NOD FOR TRIAL OF ULINASTATIN FOR COVID-19

Bharat Serums and Vaccines Ltd. (BSVL) has received approval from DCGI to conduct phase III clinical study on Ulinastatin for mild to moderate Acute Respiratory Distress Syndrome (ARDS) patients with COVID–19

The mortality risk is higher when an individual with COVID–19 infections develops ARDS and pneumonia

Ulinastatin can be administered as a remedy to combat teh underlying inflammatory condition related to ARDS in COVID-19 patients

Acute respiratory distress syndrome (ARDS): A type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs

Acute respiratory distress syndrome was first described in 1967  

Signs and symptoms may include shortness of breath, fast breathing, and a low oxygen level in the blood due to abnormal ventilation. Other include muscle fatigue and general weakness, low blood pressure, a dry, hacking cough, and fever

The annual rate of ARDS is generally 13–23 people per 100,000 in the general population

Rates increased in 2020 due to COVID-19 with some cases also appearing similar to HAPE

Pneumonia and sepsis are the most common triggers, and pneumonia is present in up to 60% of patients and may be either causes or complications of ARDS. Alcohol excess appears to increase the risk of ARDS. Diabetes was originally thought to decrease the risk of ARDS, but this has shown to be due to an increase in the risk of pulmonary edema

There are direct and indirect causes of ARDS. Direct causes include pneumonia (including bacterial and viral), aspiration, inhalational lung injury, lung contusion, chest trauma, and near-drowning. Indirect causes include sepsis, shock, pancreatitis, trauma (e.g. fat embolism), cardiopulmonary bypass, TRALI, burns, increased intracranial pressure

Bottom of Form

Pneumonia: Infection in one or both lungs

Symptoms of pneumonia: coughing, fever, sweating or chills, shortness of breath, chest pain, tiredness or fatigue, loss of appetite, nausea or vomiting, headaches

The infection causes inflammation in the air sacs in your lungs, which are called alveoli. The alveoli fill with fluid or pus, making it difficult to breathe

Bacteria, viruses, and fungi cause it.

Bacterial pneumonia: Most common cause is Streptococcus pneumoniae. Other include: Mycoplasma pneumoniae, Haemophilus influenza, Legionella pneumophila

Viral pneumonia: Influenza (flu), respiratory syncytial virus (RSV), rhinoviruses (common cold)

Viral pneumonia is usually milder and can improve in one to three weeks without treatment.

Fungal pneumonia: Fungi from soil or bird droppings can cause pneumonia. It include: Pneumocystis jirovecii, Cryptococcus species, Histoplasmosis species

Pneumonia may cause complications, especially in people with weakened immune systems or chronic conditions, such as diabetes.