A Randomized Controlled Trial Of An Immunomodulator Mycobacterium w In Mild To Moderate Covid-19 Pneumonia

Phase 3

• Conditions: Health Condition 1: B342- Coronavirus infection, unspecified

• Registration Number: CTRI/2020/08/027475
• Lead Sponsor: Cadila Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Age More Than 18 in both genders.

Mild to moderate covid 19 pneumonia

Consented for study

Exclusion Criteria

Pregnancy,

Received cardiopulmonary resuscitation,

On long standing immunosuppressive therapy,

Unwilling to provide consent.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified