Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Aceinavir (1 gram uncoated tablet): Arm A would enroll 22 moderately symptomatic COVID-19 subjects treated with Aceinavir (Investigational Product) and Standard of Care (SoC).
Dose is
Sponsors
Dyuthi Biosciences Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 2L/min oxygen by nasal cannula or mask to maintain SpO2 >=95%, systolic blood pressure 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Clinical recovery on a 7-point ordinal scale The scale is as follows: 0) No clinical or virological evidence of infection; 1) No limitation of activities 2) Limitation of activities 3) Hospitalized, no oxygen therapy 4) Oxygen by mask or nasal prongs 5)Non-invasive ventilation or high-flow oxygen 6) Intubation and mechanical ventilation 7) Ventilation + additional organ support â?? pressors, RRT, ECMO 8) Death Timepoint: At the end of the study (Time of clinical recovery) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Proportions (Aceinavir vs. SOC) of subjects experiencing treatment-emergent adverse events 2) Percent of subjects with SARS-CoV-2 detectable in nasopharyngeal sample (Time Frame: Day 0 (if available) & Day 5,) 3) Quantitative SARS-CoV-2 virus in nasopharyngeal sample (Time Frame: Days 0 (if available), & Day-5) 4) Correlation of clinical status with serology and inflammatory markers Timepoint: 1) Throughout the study 2) Day 0 (if available) and Day 5 3) Day 0 (if available) and Day 5 4) Serology on Day 6 and inflammatory markers on Day 0 and Day 6 | — |
Countries
India
Contacts
Public ContactDr Shashank Acharya
TrialGuna
Outcome results
None listed