comparative clinical trial to evaluate safety and efficacy of test drug plus standard of care and standard of care alone in COVID 19 Acute Respiratory Distress Syndrome (ARDS) patients with non-invasive ventilation.

Phase 2

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2021/12/038778
• Lead Sponsor: Reliance Life Sciences Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Age: ââ?°Â¥18 ââ?¬â?? ââ?°Â¤65 years old, male and female patients hospitalized for Covid 19 infection.

2. Recently admitted in ICU (i.e. Enrollment/Randomization should occur within 48 hours of ICU admission).

3. Radiologically confirmed pneumonia.

4. Laboratory confirmed Covid19 infection.

5. Severe COVID 19 pneumonia with ARDS defined as patients with clinical signs of pneumonia plus one of the following:

a. respiratory rate >30 breaths/min

b. severe respiratory distress or SpO2 <90% on room air.

6. Patients on different modalities of oxygen therapy ââ?¬â?? High Flow Nasal Cannula Oxygen ( >0.4 FiO /30 L/min of oxygen flow) or non-invasive ventilation.

7. Presence of raised inflammatory markers in any one of the following: CRP (CRP > 75 mg/L) or Ferritin (â�¥ 5 times Upper Limit of Normal) or IL-6 ( >40 pg/ml) or D dimer ( >1.5 �¼gFEU/ml).

8. Procalcitonin in normal range ( <0.3 �¼g/L).

9. Women of childbearing potential or men capable of fathering children must agree to use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilization) during the study and for 6 months after receiving the last administration of study drug. Women of childbearing potential must test negative for pregnancy at screening.

Exclusion Criteria

1. Unable to obtain informed consent from subject or LAR.

2. Patients with ALT/AST � 5 x upper limit of normal (ULN).

3. Patients with heart disease or clinical symptoms that cannot be well controlled, such as NYHA class II or above of cardiac insufficiency, unstable angina, myocardial infarction within one year, supraventricular or ventricular arrhythmias that need treatment or intervention.

4. Allergic to Bevacizumab and its components.

5. Treatment with immunosuppressive or immunomodulatory therapy (including bevacizumab) within the past 3 months.

6. Platelet count of < 1,00,000 /cmm or absolute neutrophil count (ANC) < 2000/cmm at screening

7. Respiratory failure due to other secondary infections /bacterial sepsis or evidence of multiorgan failure

8. Clinical or laboratory evidence of active tuberculosis or active secondary infections.

9. Subjects who are HIV, HBsAg, HCV test positive.

10. Pregnant women, lactating women and planned pregnancy.

11. Have participated in other clinical trials in the last 3 months or the investigator is of opinion that it is not in the best interest of patient to get enrolled in the study or any other condition wherein the patient participation would cause concerns about his / her safety.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Cumulative Proportion of patients requiring mechanical ventilation (invasive mechanical ventilation or extracorporeal membrane oxygenation) or death byTimepoint: Day 28