A Clinical Trial to study the safety and efficacy of a drug, DESREM LQTM in patientswith Moderate to Severe Covid-19.
- Conditions
- Coronavirus as the cause of diseases classified elsewhere,
- Registration Number
- CTRI/2021/12/038637
- Lead Sponsor
- Mylan Laboratories Limited
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 202
- Confirmed Covid-19 infection 2.
- Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures 3.
- Subject (or legally authorized representative) understands and agrees to comply with planned study procedures 4.
- Male or non-pregnant female adult ≥ 18 years of age at time of enrollment 5.
- 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 6.
- 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 8.
- Agrees to not participate in another clinical trial for the treatment of COVID-19 or any other indications through Day 28.
- Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 3 times the upper limit of normal 2.
- Estimated glomerular filtration rate (eGFR) < 30 ml/min (including patients receiving hemodialysis or hemofiltration) 3.
- Pregnancy or breast feeding 4.
- Subjects with <40 kg body weight 5.
- Subjects who are on mechanical ventilation or ECMO (Extracorporeal membrane oxygenation) 6.
- Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours 7.
- Hypersensitivity to any ingredient of DESREM LQTM 8.
- Any other condition as per the physician’s discretion which would make the patient unsuitable for enrollment in the study 9.
- Patients who are on or would require any other investigational therapies/products for the treatment of Covid-19 disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of treatment emergent AEs and SAEs Day 1 to Day 28
- Secondary Outcome Measures
Name Time Method Mortality Percentage of patients with atleast Two point improvement from baseline in clinical status on the 8 Point ordinal scale
Trial Locations
- Locations (13)
Guntur Medical College and Government General Hospital,
🇮🇳Guntur, ANDHRA PRADESH, India
Jawahar Lal Nehru Medical College
🇮🇳Ajmer, RAJASTHAN, India
Jubilee Mission Medical College And Research Institute
🇮🇳Thrissur, KERALA, India
Lourdes Hospital
🇮🇳Ernakulam, KERALA, India
Mahatma Gandhi Memorial Hospital
🇮🇳Warangal, TELANGANA, India
Malabar Medical College Hospital And Research Centre
🇮🇳Kozhikode, KERALA, India
Mar Augustine Golden Jubilee Hospital
🇮🇳Ernakulam, KERALA, India
Noble Hospital Private Limited
🇮🇳Pune, MAHARASHTRA, India
PCMCs PGI Yashwantrao Chavan Memorial (YCM) Hospital
🇮🇳Pune, MAHARASHTRA, India
PDEA’S Ayurved Ruganalaya & Sterling Multispecialty Hospital
🇮🇳Pune, MAHARASHTRA, India
Scroll for more (3 remaining)Guntur Medical College and Government General Hospital,🇮🇳Guntur, ANDHRA PRADESH, IndiaDr K SudhakarPrincipal investigator9848233703sudhahealer@gmail.com