COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48386

Divya C

divya@bioagiletherapeutics.com

2021-02-01

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Is a Confirmed Case of Moderate COVID-19 infection. <br/ > <br/ >2.The patient must exhibit the following criteria: <br/ > a)SpO2: <94% (range 90-94%) on room air. <br/ > b)Respiratory Rate: â?¥ 24/ minute (range â?¥ 24 - 30), <br/ > <br/ >3.The patient may show any one or more of the below clinical symptoms: <br/ > a)Fever <br/ > b)Cough <br/ > c)Dyspnoea and/or hypoxia <br/ > <br/ >4.Male or non-pregnant female adult requiring hospitalization, with or without comorbidities between the age group of 18-65 years of age at time of screening. <br/ > <br/ >5.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). <br/ > <br/ >6.Agrees not to 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/ > <br/ >7.Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. <br/ > <br/ >8.Patients ability in the investigators opinion to comply with the protocol procedures. <br/ >

1.Is a Confirmed Case of Mild COVID-19 infection (defined as per ICMR guidelines) without evidence of breathlessness or Hypoxia (normal saturation). <br/ >2.Is a Confirmed Case of Severe COVID-19 infection (defined as per ICMR guidelines) exhibiting the following signs & symptoms: <br/ > a)SpO2: <90% (on room air). <br/ > b)Respiratory Rate: > 30/ minute, <br/ > c)Chest imaging shows (Chest X ray and portable bed side lung ultrasound): <br/ > bilateral opacities, not fully explained by effusions, lobar or lung <br/ > collapse, or nodules. <br/ >3.Testing positive for HIV, HbsAg and HCV infection. <br/ >4.Females who are currently pregnant or breastfeeding. <br/ >5.Has a known allergy or other contraindication to Eflornithine. <br/ >6.Has received Eflornithine within the last 10 days. <br/ >7.Has received anti-viral or anti-malarial or anti-bacterial within the last 14 days. <br/ >8.Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN). <br/ >9.QTc interval â?¥ 500ms. <br/ >10.Recent Myocardial Infarction (within last 6 months). <br/ >11.Known case of (K/C/O) Congestive heart failure. <br/ >12.K/C/O Chronic Kidney Disease. <br/ >13.K/C/O of epilepsy. <br/ >14.K/C/O active Tuberculosis. <br/ >15.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. <br/ >16.The patient has participated in other clinical trials in the last three months. <br/ >17.Anticipated transfer to another hospital which is not a study site within 72 hours. <br/ >

2

Navin Saxena Research and Technology NSRTPvt Ltd

18

65

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

208

Ordinal Scale Improvement (OSI): To evaluate the number and percentage of patients in the treatment arms showing an improvement of at least two or more points on a seven-point ordinal scale.Timepoint: Day 1 to Day 14

| Declared number of arm (3.0) differs from found arms (4.0)

Phase 2

[{"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"}]