A prospective, multicenter, randomized, open-label, parallel design study to evaluate efficacy and safety of Aceinavir combined with supportive Standard of Care (SoC) with moderate Coronavirus disease (COVID-19) in hospitalized patients

Dyuthi Biosciences Private Limited0 个研究点目标入组 0 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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•Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF)
•1. Age 18-80 years (inclusive) at the time of signing ICF.
•2. SARS-CoV-2 positive report â?? rtPCR or Rapid Antigen
•3. Initial COVID-19 symptom onset within 4 days prior to Screening
•4. For female subjects: evidence of post-menopause, or for pre-menopause subjectâ??s negative pre-treatment serum or urine pregnancy test
•5. Eligible subjects of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment
•6. SpO2 >= 93% on room air
•7. Not participating in any other interventional drug clinical studies before completion of the present study.

•Subjects meeting any of the following criteria must not be enrolled in the study:
•1. Severe or critical COVID-19 illness: RR >=26, HR >=100, SpO2 <93% on room air or requires >2L/min oxygen by nasal cannula or mask to maintain SpO2 >=95%, systolic blood pressure < 110 mm Hg, diastolic blood pressure < 60 mm Hg or PaO2/FiO2 <300
•2. Inability to intake or tolerate oral medications.
•3. Known asthma or COPD
•4. Poorly controlled Diabetes
•5. Lobar or segmental consolidation on chest imaging or on clinical signs.
•6. Treatment with other drugs thought to possibly have activity against SARS-CoV-2
•7. ALT or AST > 5 x upper limit of normal (ULN)
•8. Female subject is pregnant or breastfeeding
•9. Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely.

发起方

Dyuthi Biosciences Private Limited