An Open-Label, Two-Arm, Parallel Design, Prospective, Single-Center, Phase 3 study to assess the safety and efficacy of CoroQuil-Zn in comparison to the standard of care for the treatment of mild to moderate COVID-19

Remedium Therapeutics Private Limited0 个研究点目标入组 114 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Written signed and dated informed consent (patient or LAR).
•2.Both genders, aged >=18 to <=75 years,
•3.Patients with RT-qPCR confirmed COVID-19 patients
•4.SpO2>=90% and respiratory rate <=30/minute
•5.Healthy adult patients with ASA I to II
•6.A score of between 3 to 5 on the Modified WHO Ordinal Scale for Clinical Improvement (refer protocol appendix 23.1)
•7.Patients who agree to abide by the study requirements

•1.Pregnant and lactating women
•2.Children <18 yrs. of age; elderly >75 years
•3.SpO2 <90% for adults and respiratory rate >30/minute
•4.Patients having persistent nausea/vomiting
•5.Need for direct admission to the intensive care unit for mechanical ventilation
•6.Underlying chronic obstructive pulmonary disease stage III-IV
•7.Patients simultaneously participating in another clinical study.
•8.History of stroke with significant neurologic deficit.
•9.Patients with any concurrent pre-existing severe/uncontrolled, clinically significant systemic disease [e.g. heart failure (NYHA 2 or above)], cancer, liver disease, kidney disease or anaemia etc.) that, in the opinion of investigator precludes the subjectâ??s participation in the study or interferes with the interpretation of the study results.
•10.Patients with history of serology tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus.
•11.Medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
•12.A subject who is judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above.

发起方

Remedium Therapeutics Private Limited