A randomised double blind trial to evaluate the activity of SSV Formulation for management of SARS-CoV-2 Infection (COVID-19)

Shreepad Shree Vallabh SSV Phytopharmaceuticals0 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Quarantine/non hospitalized or hospitalized and fulfils WHO case definition, including a positive RT-PCR confirmed COVID-19 illness.
•Age more than 18 & less than 65 years of either sex.
•Mild to Moderately COVID-19 disease (NEWS score less than or equal to 8).
•Patients with oxygen saturation (SpO2) less than 95%.
•Respiratory rate is more than 20/min.
•Pulse rate more than 90/min.
•Imaging evidence of lung infection in the form of Reticulonodular opacities, ground-glass opacities and consolidation.

•Pregnant women.
•Breastfeeding women.
•Requiring ICU admission at screening.
•Patients above 65 years of age and below 18 Years.
•Past History of MI, Epileptic episodes.
•Any other co-morbidity (uncontrolled diabetes, severe hypertension from subject history) which is at critical stage at screening.
•Asymptomatic patients.
•Patients unwilling for informed consent.
•Patients with prolonged QTc interval on ECG.
•In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
•Participant with any immunosuppressive condition or hematological disease.
•Participation in any other A.S.U and H protocol.

发起方

Shreepad Shree Vallabh SSV Phytopharmaceuticals