COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45627

Dr Shweta Ram Chandankhede

shwets0106@gmail.com

2020-08-31

Recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

Age More Than 18 in both genders. <br/ >Mild to moderate covid 19 pneumonia <br/ >Consented for study

Pregnancy, <br/ >Received cardiopulmonary resuscitation, <br/ >On long standing immunosuppressive therapy, <br/ >Unwilling to provide consent. <br/ >Complete blood count serum Dâ??dimer, Câ??reactive protein (CRP), procalcitonin and IL6 levels will be done for all patients. As per our institutional protocol, all patients will receive standard medical care comprising oral paracetamol (for fever), oral proton pump inhibitor for stress ulcer prophylaxis (pantoprazole 40 mg/day), and low molecular weight heparin for deep venous thrombosis prophylaxis (enoxaparin 1 mg/kg, once daily). Therapeutic anticoagulation (enoxaparin 1 mg/kg, twice daily) will be given in patients who will have D dimer levels >500 ng/ mL. Dexamethasone 6 mg iv daily will be used for 7 days. Antibiotics (azithromycin or doxycycline ) will be used in patients with a total leukocyte count of >11,000 cell/μL, procalcitonin >0.5 ng/mL, or if they have hypotension (mean arterial blood pressure <65 mmHg). We will not use hydroxychloroquine in any of these patients. We will use intradermal Mw (0.3 mL/day [0.1 mL contains 0.5 Ã? 109 heat- killed Mw] for 3 consecutive days, in addition to standard medical care. <br/ >

2

Cadila Pharmaceuticals Limited

18

100

India

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

30

28 days mortalityTimepoint: 28 days mortality

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "", "treatment_id": 843, "treatment_name": "Mycobacterium indicus pranii", "treatment_type": "Microbiota intervention", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]