COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45475

Dr Abhay Vispute Shantaram

drasv@rediffmail.com

2020-07-13

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

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. <br/ >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. <br/ >3. Illness or condition of any duration, and at least one of the following: <br/ > - Fever defined as temperature greater than or equal to 36.6C (98.4F) measured by an infrared body temperature detection device. <br/ > - Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR <br/ > - Clinical assessment (evidence of rales/crackles on exam) AND SpO2 less than or equal to 94% on room air, OR <br/ > - Requiring supplemental oxygen, OR <br/ > - Requiring mechanical ventilation. <br/ >4. Women of childbearing potential must agree to either abstain or use at <br/ >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). <br/ >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). <br/ >6. Subject (or legally authorized representative) providing written informed consent prior to initiation of any study procedures. <br/ >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. <br/ >

1. Testing positive for HIV, HbsAg and HCV infection. <br/ >2. Females who are currently pregnant or breastfeeding. <br/ >3. Allergy or other contraindication to one of the investigational products. <br/ >4. Has received Eflornithine within the last 10 days. <br/ >5. Has received anti-viral, anti-malarial or anti-bacterial within the last 14 <br/ >days. <br/ >6. Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) <br/ > > 5 X upper limit of normal (ULN). <br/ >7. QTc interval â?¥ 500ms. <br/ >8. Recent Myocardial Infarction (within last 6 months). <br/ >9. Known case of (K/C/O) Congestive heart failure. <br/ >10. K/C/O Chronic Kidney Disease. <br/ >11. K/C/O active Tuberculosis. <br/ >12. History of drug or alcohol dependence in the past 6 months. <br/ >13. In the opinion of the clinical team, progression to death is imminent and <br/ >inevitable within the next 24 hours, irrespective of the provision of <br/ >treatments. <br/ >14. Anticipated transfer to another hospital which is not a study site within <br/ >72 hours. <br/ >15. K/C/O of epilepsy.

2

Dr Abhay Vispute Shantaram

18

85

India

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

18

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: <br/ >a) Nasopharynx <br/ >b) Throat <br/ >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 <br/ >

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 449, "treatment_name": "Eflornithine", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]