Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Eflornithine and SoC: Eflornithine Granules (2.5 g/dose) (Orange Flavour
Sugar Free) (NSRT2020ââ??¢) for oral solution administered every 6 hours (10.0 g/day) plus Standard of Care for 14days
Intervention2: Treatment Arm-2: Eflornithine (NSRT2020ââ??¢) for oral solutio
Sponsors
Navin Saxena Research and Technology NSRTPvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Is a Confirmed Case of Moderate COVID-19 infection. 2.The patient must exhibit the following criteria: a)SpO2: b)Respiratory Rate: � 24/ minute (range � 24 - 30); 3.The patient may show any one or more of the below clinical symptoms: a)Fever b)Cough c)Dyspnoea and/or hypoxia 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. 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). 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). 7.Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. 8.Patients ability in the investigators opinion to comply with the protocol procedures.
Exclusion criteria
Exclusion criteria: 1.Is a Confirmed Case of Mild COVID-19 infection (defined as per ICMR guidelines) without evidence of breathlessness or Hypoxia (normal saturation). 2.Is a Confirmed Case of Severe COVID-19 infection (defined as per ICMR guidelines) exhibiting the following signs & symptoms: a)SpO2: b)Respiratory Rate: > 30/ minute; c)Chest imaging shows (Chest X ray and portable bed side lung ultrasound): bilateral opacities, not fully explained by effusions, lobar or lung collapse, or nodules. 3.Testing positive for HIV, HbsAg and HCV infection. 4.Females who are currently pregnant or breastfeeding. 5.Has a known allergy or other contraindication to Eflornithine. 6.Has received Eflornithine within the last 10 days. 7.Has received anti-viral or anti-malarial or anti-bacterial within the last 14 days. 8.Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN). 9.QTc interval � 500ms. 10.Recent Myocardial Infarction (within last 6 months). 11.Known case of (K/C/O) Congestive heart failure. 12.K/C/O Chronic Kidney Disease. 13.K/C/O of epilepsy. 14.K/C/O active Tuberculosis. 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. 16.The patient has participated in other clinical trials in the last three months. 17.Anticipated transfer to another hospital which is not a study site within 72 hours.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of hospitalization in survivors and non-survivors: Mean number of hospitalization days required in survivors {defined as time from randomization to day 28 or until a confirmatory RT-PCR test is performed (and is found to be negative) or the patient leaves the treatment site against medical advice, whichever is earlier} and non-survivors (defined as time from randomization to death)Timepoint: Day 1 to Day 29;Incidence of Negative RT-PCR test: Number and percentage of intent to treat patients turning RT-PCR negative on Days 7, 10 and 14.Timepoint: Day 1 to Day 14;Mortality Rate: Number and percentage of non-survivors falling into one of the two brackets Day 1 to 14 and Day 15 to 28. Date and cause of death will be monitored Timepoint: Day 1 to Day 28;Oxygen free days: Percentage of oxygen free days experienced during hospitalization, by the patients in each arm until day 14 or a first negative RT-PCR test (provided the confirmatory RT-PCR test is negative), whichever is earlier.Timepoint: Day 1 to Day 14;Percentage Change in Laboratory Analysis: Percentage change from baseline in all laboratory tests (Hematology and Biochemistry) compared to day 14 or upon meeting the hospital discharge criteria, whichever is earlier.Timepoint: Day 1 to Day 14;Polyamine Levels: Percentage change in serum/plasma polyamine (putrescine) levels in treatment arm 1 only from Day 1 (baseline) as compared to Day 14, or upon meeting the hospital discharge criteria, whichever is earlier.Timepoint: Day 1 to Day 14;Safety Endpoints: Cumulative incidence of Grade 3 and 4 adverse events (AEs) and Serious Adverse Events (SAEs): Cumulative AEs (Grade 3 and 4) and SAEs as per ICH guidelines, will be assessed in each treatment arm from randomization to day 28 or until resolution, whichever is earlier.Timepoint: Up to Day 28 or until resolution. | — |
Countries
India
Contacts
Public ContactIqbal Ahmad
Quantys Clinical Pvt. Ltd
Outcome results
None listed