CTRI/2024/01/061531
Recruiting
Phase 3
A prospective, randomized, comparative, multi-centric, adaptive design clinical study to evaluate efficacy, safety and tolerability of 101-PGC-005 (‘005) for the treatment of moderate COrona VIrus Disease (Covid-19) disease patients. - NA
axai Life Sciences Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: U071- COVID 19 virus identifiedHealth Condition 2: J988- Other specified respiratory disorders
- Sponsor
- axai Life Sciences Pvt Ltd
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female patients of age 18 to 65 years (both inclusive) who have been hospitalized for treatment of moderate COVID\-19 disease.
- •2\. Patients with moderate COVID\-19 disease severity, as defined by Comprehensive Guidelines for Management of COVID\-19 patients, Directorate General of Health Services, MoHFW, GOI, AND having any of the following symptoms and signs prior to randomization
- •a. Fever, cough, with or without sore throat, throat irritation, body ache, headache, malaise, weakness, diarrhoea or gastrointestinal upset, with or without anorexia, nausea, vomiting, with or without loss of smell and or taste, shortness of breath, breathlessness and difficulty in breathing
- •b. Respiratory rate of 24 to 30 breaths per min,
- •c. SpO2 90 – 93 percent on room air
- •3\. Patients with positive RT\-PCR test for SARS\-CoV\-2 in nasopharyngeal or oropharyngeal swabs (first RT\-PCR positive sample collected within 7 days prior to randomization)
- •4\. Elevated CRP, ESR or Ferritin levels
- •5\. In case of female patients of child\-bearing potential, a negative urine pregnancy test prior to beginning the therapy.
- •6\. Willing to sign voluntary informed consent for participation in the study and willing to adhere to all protocol procedures. In case the subject is unable to provide informed consent than the same should be obtained from legally acceptable representative (LAR).
Exclusion Criteria
- •1\. Patients with mild or severe COVID\-19 disease severity, as defined by latest Comprehensive Guidelines for Management of COVID\-19 patients, Directorate General of Health Services, MoHFW, GOI at the time of randomization. This includes any one or more of the following
- •a. Peripheral Blood oxygen saturation 94 percent or 90 percent
- •b. Respiratory Rate or less than 24 or more than 30 breaths per minute
- •2\. First positive RT\-PCR more than 7 days prior to treatment administration
- •3\. Patients with evidence of other serious infectious, malignant, autoimmune, kidney, hepatic, cardiovascular or other systemic disease and or laboratory abnormality, which, in the opinion of the investigator, prevent the patient from participating in the study
- •4\. Subjects with Chronic liver disease (Child Pugh class B or C) and chronic renal disease (GFR less than 30ml per min).
- •5\. Renal dysfunction \[Serum Creatinine more than 2\.5 times of ULN or calculated creatinine clearance less than 30ml per min], Liver Dysfunction \[Total Bilirubin more than 3 times ULN \& AST, ALT more than 5 times ULN].
- •6\. Chronic systemic glucocorticoid treatment or any immunosuppressive treatment
- •7\. History of human immunodeficiency virus (HIV) or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
- •8\. Pregnant and Lactating patients.
Outcomes
Primary Outcomes
Not specified
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