Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: B998- Other infectious disease
Conditions
Interventions
Intervention1: Eflornithine: Treatment arm 1: Dose 2.5g, Oral solution administered every 6 hours + Standard of Care (SoC) excluding antimalarials and antivirals
Treatment arm 2: Dose 5.0, oral soluti
Sponsors
Dr Abhay Vispute Shantaram
Eligibility
Inclusion criteria
Inclusion criteria: 1. Has laboratory-confirmed positive COVID-19 infection as determined by RT-PCR or other commercial or public health assay in any specimen, an RT-PCR (Nasopharynx and Throat) test shall be repeated to assess eligibility. 2. Symptomatic male or non-pregnant female adult requiring hospitalization, with or without comorbidities between the age group of 18-85 years of age at time of enrollment. 3. Illness or condition of any duration, and at least one of the following: - Fever defined as temperature greater than or equal to 36.6C (98.4F) measured by an infrared body temperature detection device. - Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR - Clinical assessment (evidence of rales/crackles on exam) AND SpO2 less than or equal to 94% on room air, OR - Requiring supplemental oxygen, OR - Requiring mechanical ventilation. 4. Women of childbearing potential must agree to either abstain or use at least one primary form of contraception not including hormonal contraception from the time of screening to the end of study (Day 28 or live hospital discharge, whichever is earlier). 5. Agrees to not participate in another clinical trial for the treatment of COVID-19 until the end of study (Day 28 or live hospital discharge, whichever is earlier). 6. Subject (or legally authorized representative) providing written informed consent prior to initiation of any study procedures. 7. Has a personal (mobile/cellular) phone, and is able to nominate at least one locator individual (e.g. a family member, friend or recovery mentor) with a verifiable address and a telephone number to assist with the arrangement of follow-up appointments as required.
Exclusion criteria
Exclusion criteria: 1. Testing positive for HIV, HbsAg and HCV infection. 2. Females who are currently pregnant or breastfeeding. 3. Allergy or other contraindication to one of the investigational products. 4. Has received Eflornithine within the last 10 days. 5. Has received anti-viral, anti-malarial or anti-bacterial within the last 14 days. 6. Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN). 7. QTc interval >= 500ms. 8. Recent Myocardial Infarction (within last 6 months). 9. Known case of (K/C/O) Congestive heart failure. 10. K/C/O Chronic Kidney Disease. 11. K/C/O active Tuberculosis. 12. History of drug or alcohol dependence in the past 6 months. 13. 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. 14. Anticipated transfer to another hospital which is not a study site within 72 hours. 15. K/C/O of epilepsy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Negative Viral Test: will be assessed by the time taken from initiation of the study treatment (i.e. the first study dose) to the day when the RT-PCR test results are first shown to be negative from samples collected from all of the below: a) Nasopharynx b) Throat An ICMR approved RT-PCR test resulting negative in the first instance, will be reconfirmed â?¥ 24 hours apart with fresh samples from the same sites (a) Nasopharynx and (b) Throat.Timepoint: 1, 4, 7, 14, 21 and 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to Clinical Improvement (TTCI) 2. Eight-point ordinal 14-day analysis 3. Eight-point ordinal 28-day analysis 4. Oxygen free days 5. Duration of hospitalization in survivors and non-survivors 6. Subject 14-day mortality 7. Subject 28-day mortality 8. Time to death 9. Percentage Change in Biochemical Analysis Safety Endpoints: i) Cumulative incidence of Grade 3 and 4 adverse events (AEs) and Serious Adverse Events (SAEs) ii)Cumulative incidence of Hearing ImpairmentTimepoint: 1, 4, 7, 14, 21 and 28 days | — |
Countries
India
Contacts
Public ContactDr Abhay Vispute Shantaram
Dept. of Medicine, SRV Hospital
Outcome results
None listed