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Clinical Trials/CTRI/2020/07/026529
CTRI/2020/07/026529Not yet recruitingPhase 2

An open label, randomized, three treatment, three arm, parallel group, investigator initiated, comparative clinical trial to evaluate the safety and efficacy of Eflornithine against the standard of care in human adult hospitalized COVID-19 patients

Dr Abhay Vispute Shantaram0 sites0 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility 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

  • •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
  • •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
  • •15. K/C/O of epilepsy.

Investigators

Sponsor
Dr Abhay Vispute Shantaram

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