COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55585

Dr Naveen Naik B

navin.amc123@gmail.com

2021-04-30

Not recruiting

RCT

Randomized

Parallel

Open label

unclear

Treatment

1. Patients aged 18 years or above of either gender <br/ >2. Confirmed SARS-CoV-2 (COVID-19) infection by RT-PCR with PaO2:FIO2 ratio of less than 200 on admission <br/ >3. Use of one of the following for hypoxia: <br/ >a. Oxygen supplementation with an oxygen flow of at least 10 L/min independent of delivery system <br/ >b. Non-invasive ventilation or HFNC OR <br/ >c. Invasive mechanical ventilation <br/ >4. Within 48 hrs of initiation of standard therapy if <br/ >a. PaO2:FIO2 ratio worsens by more than 50 from baseline value and <br/ >b. Oxygenation or ventilation device is upgraded and <br/ >c. Increasing or static CRP <br/ >5. Imaging with chest X-ray/CT-Chest suggestive of COVID 19 related lung opacities. <br/ >6. Signature of informed consent by the patient, family member or legal representative <br/ >

1. known history of dexamethasone or Tocilizumab allergy <br/ >2. Prior history of immunosuppression and use of immunosuppressive drugs <br/ >3. Use of corticosteroids for indications other than COVID-19 <br/ >4. Invasive fungal infection <br/ >5. Active tuberculosis <br/ >6. Liver injury or failure (AST/ALT � 5x Upper limit of normal) <br/ >7. Leukocytes < 2 � 103/μl <br/ >8. Thrombocytes < 50 � 103/μl <br/ >9. Severe bacterial infection (Procalcitonin > 3ng/ml) <br/ >10. Acute or chronic diverticulitis <br/ >11. unwilling or unable to participate or complete the study <br/ >

2

Post Graduate Institute of Medical Education and Research

18

90

India

Moderate disease at enrollment

3: Moderate disease at enrollment

42

Ventilator free days (VFD) Timepoint: 0-28days following admission

| Declared number of arm (3.0) differs from found arms (4.0)

Not reported

[{"arm_notes": "", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1299, "treatment_name": "Tocilizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}]