Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: R-TPR-023: Day 0, It is administered as intravenous infusion in dose of 500 mg Bevacizumab should be mixed with 100 ml of 0.9% NaCl( standard of care).
Control Intervention1: 0.9% NacL
Sponsors
Reliance Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
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 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 (ââ?°Â¥ 5 times Upper Limit of Normal) or IL-6 ( >40 pg/ml) or D dimer ( >1.5 Ã?¼gFEU/ml). 8. Procalcitonin in normal range ( 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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Cumulative Proportion of patients requiring mechanical ventilation (invasive mechanical ventilation or extracorporeal membrane oxygenation) or death byTimepoint: Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cumulative Proportion of patients requiring mechanical ventilation (invasive mechanical ventilation or extracorporeal membrane oxygenation) or death byTimepoint: day14.;10. Days free of supplemental OxygenTimepoint: since Day 0;11. Duration of hospitalizationTimepoint: since Day 0;12. Duration of ICU admissionTimepoint: since Day 0;13. Proportion of patients with non-invasive ventilationTimepoint: Day 0 to Day 28 (Any time in between);14. Duration of non-invasive ventilationTimepoint: Day 0 to Day 28 (Any time Between);15. Duration of invasive mechanical ventilationTimepoint: Day 0 to Day 28 (Any time In Between);16. Cumulative incidence of SAEs, Grade 3 and 4 AEs, ADRTimepoint: Day 0 to Day 28 (Any time In between);2. The time to hospital discharge or readiness for discharge as assessed with the use of WHO eight-category ordinal scale (with categories ranging from 1 to 8. Higher categories indicating a worse condition)Timepoint: Day 0 to Day 28 (Any time in between);3. The time to at least a two-category improvement in clinical status relative to baseline on the WHO eight-category ordinal scale.Timepoint: Day 0 to Day 28 (Any time in between);4. The time to clinical failure (the time to death, mechanical ventilation, worsening by two categories from baseline on the eight category ordinal scale], or withdrawal [whichever occurred first]).Timepoint: Day 0 to Day 28 (Any time in Between);5. All-cause mortality.Timepoint: Day 0 to Day 28 (Any time in Between);6. Time to PaO2/FiO2 ratio greater than 200.Timepoint: Day o to Day 28 (Any time In Between);7. Proportion of patients whose clinical status on the World Health Organization 8point ordinal scale is as follows on day 28: Not hospitalized, no limitations on activities.Timepoint: Day 0 to Day 28 (Any time in Between);8. PaO2/FiO2 ratio on admissionTimepoint: Day 2 and Day 7.;9.SOFA (Sequential Organ Failure Assessment) score till patient is in ICU (at baselineTimepoint: Day 0, day 14 and 28 | — |
Countries
India
Contacts
Public ContactSachin Singh
Reliance Life Sciences Pvt Ltd
Outcome results
None listed