CTRI/2022/12/048284
Completed
Phase 2
A prospective, randomized, comparative, multi-centric, adaptive design clinicalstudy 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. LTD.,0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- 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
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patients willing and able to provide voluntary written informed consent and to follow the protocol specific requirements.
- •2\. Male or female patients of age 18 to 65 years (both inclusive).
- •3\. 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/min,
- •c. SpO2: 90 – 93% on room air
- •4\. Patients with positive RT\-PCR test for SARS\-CoV\-2 in nasopharyngeal or oropharyngeal swabs (sample collected within 7 days prior to randomization)
- •5\. Elevated CRP, ESR or Ferritin levels
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% or \<90%
- •b. Respiratory Rate or \<24 or \=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 \<30ml/min).
- •5\. Renal dysfunction \[Serum Creatinine \> 2\.5 times of ULN or calculated creatinine clearance \< 30ml/min], Liver Dysfunction \[Total Bilirubin \> 3times ULN \& AST/ALT \> 5times 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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