CTRI/2022/02/040055招募中2 期
A prospective, randomized, double-blind, parallel-group, placebo-controlled clinical study to evaluate the efficacy and safety of APRG64 as an adjunct to Standard therapy in mild to moderate COVID-19 patients
APRG Co Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male or female between 20 to 65 years (both inclusive) of age at the time of enrolment.
- •2.Subjects or Legally Acceptable Representative (LAR) who have signed the written informed consent form approved by Ethics Committee after understanding the explanations regarding the study.
- •3.Confirmed with mild to moderate COVID-19 symptoms through RT-PCR test within 48 hours at the time of screening under any of the following:
- •A. Mild: Individuals who have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who do not have shortness of breath, dyspnea, or abnormal chest imaging.
- •B. Moderate: Individuals who show evidence of lower respiratory disease during clinical assessment or imaging and who have an oxygen saturation (SpO2) ââ?°Â¥94% on room air at sea level.
- •4.Willing to be hospitalized for the treatment duration (i.e., at least 7 days).
- •5.Develops or presents with one or more of the following symptoms within 5 days prior to IP treatment:
- •f. Headache
- •g. Sore throat
- •h. Loss of smell/taste
- •i. Stuffy nose
- •j. Runny nose
- •l. Nausea or vomiting
- •m. Diarrhea
- •6.Able to comply with the requirements and process in the clinical study.
- •7.Negative to urine pregnancy test during screening (Women of childbearing potential).
排除标准
- •1.Known hypersensitivity to APRG64, or any of its constituents and lactate.
- •2.Suspected active bacterial, fungal, viral, or other respiratory infections (besides COVID-19) (Ex: Tuberculosis, pneumonia etc.,).
- •3.Known history of Tuberculosis.
- •4.Presenting with Severe symptoms:
- •a. SpO2 <94% in room condition, PaO2/FiO2 <300 mmHg, Respiratory frequency >30 times/min
- •b. Requiring High Flow Oxygen, Extracorporeal membrane Oxygenation (ECMO), Continuous Renal Replacement therapy (CRRT).
- •5.Admitted in Intensive care unit (ICU) at screening or at randomization.
- •6.Use of immunosuppressor or immunomodulatory drugs within the past 3 months and patients with autoimmune disease.
- •7.Use of Corticosteroids and antiviral drugs within 6 weeks before screening.
- •8.Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 5 x upper limit of normal (ULN) at screening.
- •9.Absolute neutrophil count (ANC) < 1000/Ã?µL at screening.
- •10.Platelet count < 50,000/ Ã?µL at screening.
- •11.Serum creatinine > 2 mg/dL ( > 176.8 Ã?¼mol/L) or estimated creatinine clearance < 30 ml/min measured or calculated by Cockroft Gault equation.
- •12.History of major active or chronic unstable psychiatric illness (e.g., bipolar disorder, obsessive compulsive disorder, and schizophrenia)
- •13.Any history or presence of conditions precluding ingestion or absorption of the investigational product, inflammatory bowel disease, short bowel syndrome, or other major gastrointestinal disease.
- •14.Subjects with conditions that affect the study in the opinion of the treating physician (Ex: severe acute respiratory distress syndrome, septicemia).
- •15.Participated in another clinical trial within 1 month before screening.
- •16.Pregnant or breastfeeding woman.
研究者
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