A Clinical Trial to study the safety and efficacy of a drug, DESREM TM in patients with Moderate to Severe Covid-19.

Phase 4

Not yet recruiting

• Conditions: Coronavirus as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2022/02/040649
• Lead Sponsor: Mylan Laboratories Limited

Brief Summary

This will be a postapproval for restricted use under emergency situation study,interventional, prospective, multi-center, open-label study to evaluate the safetyand efficacy of DESREMTM in Indian patients with moderate tosevere Covid-19 disease.

**Primary objective:**

To determine the efficacy of DESREMTMin patients with moderate to severe Covid-19, assessed by two-pointimprovement from baseline in clinical status on the 8-point ordinal scale atDay 14.

To determine the mortality rate in patientswith moderate to severe Covid-19 at Day 28 treated with DESREMTM

**Secondaryobjective:**

Keysecondary Objective: To assess the safety and tolerability of DESREMTMin patients with moderate to severe Covid-19.

Other secondary objectives: To assess efficacyof DESREMTM in patients with moderate to severe Covid-19, by viralclearance, fever normalization and time toSpO2 ≥ 94% on room air.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-03
• Last Update Posted: 2023-02-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Admitted to a hospital and has confirmed Covid-19 infection (Moderate to Severe 2.
• Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures, understand and agrees to comply with planned study procedures 3.
• Male and non-pregnant female subjects aged 18 years and above 4.
• 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 5.
• Illness of any duration, and at least one of the following: Meeting the updated MoHFW (Ministry of Health and Family welfare Directorate General of Health Services) Clinical Management Protocol COVID 19(Dated 03 Jul 2020): 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 7.
• Agrees to not participate in another clinical trial for the treatment of COVID-19 or any other indications through Day 28.

Exclusion Criteria

• 1.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 DESREMTM 8.Any other condition as per the physician’s discretion which would make the patient unsuitable for enrollment 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
Percentage of patients with at least two-point improvement from baseline in clinical status on the 8-point Ordinal scale	Day 14 | Day 28
Mortality rate	Day 14 | Day 28

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with viral clearance (SARS CoV-2 negativity)	Day 7, Day 14/ Time of Discharge
Time to first fever normalization	Day 14 & Day 28
Incidence of Treatment Emergent AEs	Day 1 to Day 28
Time to SpO2 94 % on room air	Day 14 & Day 28
Time to Recovery	Day 14
Mean Change from Baseline	Assessment day upto Day 28

Trial Locations

Locations (11)

DEC Health Care Center; 🇮🇳 Nellore, ANDHRA PRADESH, India

Government General Hospital; 🇮🇳 Guntur, ANDHRA PRADESH, India

Jubilee Mission Medical College & Research Institute; 🇮🇳 Thrissur, KERALA, India

King George Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Mahatma Gandhi Memorial Hospital; 🇮🇳 Warangal, TELANGANA, India

NIMS Medicity, Trivandrum; 🇮🇳 Thiruvananthapuram, KERALA, India

Noble Hospital Pvt. Ltd.; 🇮🇳 Pune, MAHARASHTRA, India

PCMC’s PGI Yashwantrao Chavan Memorial Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Saveetha Medical College and Hospital; 🇮🇳 Kancheepuram, TAMIL NADU, India

Sir Ganga Ram Hospital; 🇮🇳 Central, DELHI, India

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DEC Health Care Center

🇮🇳Nellore, ANDHRA PRADESH, India

Dr M Manoj Kumar

Principal investigator

9700487720

manojkumarmddec@gmail.com