CTRI/2021/12/038637Active, not recruitingPhase 4
A post approval for restricted use under emergency situation study to evaluate the Safety and Efficacy of DESREM LQTM in patients with Moderate to Severe Covid-19 in Indian population.
Mylan Laboratories Limited13 sites in 1 country202 target enrollmentStarted: January 29, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Active, not recruiting
- Sponsor
- Mylan Laboratories Limited
- Enrollment
- 202
- Locations
- 13
- Primary Endpoint
- Incidence of treatment emergent AEs and SAEs
Study Overview
Brief Summary
This will be a post approval for restricted use under emergency situation study, interventional, prospective, multi-center, open-label study to evaluate the safety and efficacy of DESREM LQTM in Indian patients with moderate to severe Covid-19 disease.
Primary objective is to assess the Safety and Tolerability of DESREM LQ TMin patients with moderate to severe Covid 19, by determining incidence of Adverse events during
DESREM LQ TM treatment and upto Day 28 from enrollment.
Secondary objective is to determine mortality at day 28
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Confirmed Covid-19 infection
- •Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures
- •Subject (or legally authorized representative) understands and agrees to comply with planned study procedures
- •Male or non-pregnant female adult ≥ 18 years of age at time of enrollment
- •Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen, as documented by either or the following: • PCR positive in sample collected < 72 hours prior to enrollment; OR • PCR positive in sample collected ≥ 72 hours prior to enrollment, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking >24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection
- •Illness of any duration, and at least one of the following: Meeting the updated MoHFW (Ministry of Health and Family welfare, Government of India) Clinical Guidance For Management of Adult COVID-19 Patients (Dated 22 Apr 2021): Clinical severity of moderate to severe.
- •Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 28
- •Agrees to not participate in another clinical trial for the treatment of COVID-19 or any other indications through Day 28.
Exclusion Criteria
- •Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 3 times the upper limit of normal
- •Estimated glomerular filtration rate (eGFR) < 30 ml/min (including patients receiving hemodialysis or hemofiltration)
- •Pregnancy or breast feeding
- •Subjects with <40 kg body weight
- •Subjects who are on mechanical ventilation or ECMO (Extracorporeal membrane oxygenation)
- •Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours
- •Hypersensitivity to any ingredient of DESREM LQTM
- •Any other condition as per the physician’s discretion which would make the patient unsuitable for enrollment in the study
- •Patients who are on or would require any other investigational therapies/products for the treatment of Covid-19 disease.
Outcomes
Primary Outcomes
Incidence of treatment emergent AEs and SAEs
Time Frame: Day 1 to Day 28
Secondary Outcomes
- Mortality(Percentage of patients with atleast Two point improvement from baseline in clinical status on the 8 Point ordinal scale)
Investigators
Study Sites (13)
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