A Randomized, Double-blind, Two arm, controlled clinical trial to compare the Efficacy and Safety of Mycobacterium w (Mw) administered along with Standard of care versus Placebo administered along with Standard of care, in adult, COVID 19 positive patients hospitalized but not critically ill.

Cadila Pharmaceuticals Limited0 个研究点目标入组 481 人开始时间: 待定最近更新: 2022年10月17日

试验速览

暂无简介。

•1. COVID-19 positive patients with ordinal scale score of 3 with comorbid illness including diabetes mellitus, hypertension, chronic lung disease, immunocompromised status, active malignancy, chronic kidney disease, chronic liver disease, obesity (BMI >25Kg/m2), or subjects who have doubling of CRP compared to baseline or have Neutrophil-to-Lymphocyte Ratio Ã¢â?°Â¥3.5.
•2. Patients of either gender, age Ã¢â?°Â¥ 18 years at the time of enrollment.
•3. Female patients who are currently using reliable methods of contraception (barrier methods and intrauterine contraceptive device), with a negative urine pregnancy test during screening and agree to informed compliance of contraceptive method until at least 3 months post-dosing.
•4. The patients must be able and willing to comply with the study protocol, available and willing to complete all the study assessments and must have signed an Informed Consent Form.

•1. Patient with ordinal scale of Ã¢â?°Â¥4 at the time of hospital admission and randomization.
•2. Pregnant and / or lactating female patients.
•3. A family history of congenital or hereditary immunodeficiency.
•4. Any disease condition requiring ICU admission.
•5. History of dialysis, silicosis, solid organ transplantation such as renal or cardiac transplants, and disorders of the heart, or nervous system, or other metabolic inflammatory conditions, psychiatric, occupational problems that make it unlikely that the patients will comply with the protocol as determined by the investigator.
•6. History of administration of any immunoglobulins, any immunotherapy (antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, and corticosteroids use) and/or any blood products within the 3 months preceding study dosing, or planned future administrations during the study period.
•7. History of allergic reactions or anaphylaxis to Mw or its component.
•8. Presence of any severe systemic/autoimmune disorders as determined by medical history and/or physical examination at the time of screening, which in the judgment of the Investigator would compromise the patientÃ¢â?¬•s health or is likely to result in nonconformance to the protocol or a patientÃ¢â?¬•s ability to give written informed consent.

发起方