Efficacy and Safety Study of Antiviral Umifenovir 400mg Therapy in Mild COVID-19 Patients
Phase 3
Recruiting
- Conditions
- COVID 19 virus identified,
- Registration Number
- CTRI/2022/07/043948
- Lead Sponsor
- Medizest Pharmaceuticals Pvt Ltd India
- Brief Summary
A Randomized, Double Blind, Multicenter, Parallel, Placebo Controlled Clinical Trial to Assess the Efficacy, Safety and Tolerability of Antiviral drug Umifenovir with Standard Care vs. Standard Care Therapy in Mild COVID-19 Patients.
**Primary outcome measures**
Time from randomization to nasopharyngeal swab negativity by RT-PCR tests, for SARS-Cov-2 will be assessed at intervals for 28 days or till RT-PCR negativity whichever is earlier.
Prevention of Hospitalization among the two study treatments i.e. Test vs. Placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 735
Inclusion Criteria
- Mild COVID 19 patients aged 18-60 years (inclusive), at the time of signing the Informed Consent Form (ICF), with Nasopharyngeal swab positivity in RT-PCR tests for SARS-Cov-2 antigens detected (within 72.0 hrs before visit 02) during screening.
- Case categories according to severity as per Ministry of health & Family welfare, Govt.
- of India guidelines: ï‚· Mild/Uncomplicated illness: Patients with uncomplicated upper respiratory tract viral infection may have non-specific symptoms such as fever, cough, expectoration, shortness of breath, myalgia, fatigue, sore throat, nasal congestion, diarrhea, loss of taste with Nasopharyngeal swab positivity in RT-PCR tests for SARS-Cov-2 antigens.
- ï‚· Mild pneumonia with Nasopharyngeal swab positivity in RT-PCR tests for SARS-Cov-2 antigens.
- Additional Inclusion Criteria a) For mild cases: The interval between symptoms onset (or day of contact with a COVID-19 for asymptomatic patients detected during surveillance) and randomization is no more than 7 days.
- b) Eligible subjects of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period.
- c) Should not participate in any other interventional drug clinical studies before completion of the present study.
- Patients with or without hospitalization or patients in institutional quarantine.
- If the subject is hospitalized should fit in the working definitions of the mildly symptomatic category of severity of COVID 19.
Exclusion Criteria
- Sepsis, Septic shock as defined in MOH&FW guidelines.
- The cases as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support.
- Inability to intake or tolerate oral medications.
- Moderate and Severe COVID-19, as defined in (As per MOH, Govt.
- of India guidelines) 3.
- Known allergy or hypersensitivity to Umifenovir.
- Possibility of the subject being transferred to a non-study hospital within 72h.
- Pregnant or lactating women.
- Severe liver disease: underlying liver cirrhosis or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 5 times the ULN; 8.
- Known severe renal impairment [creatinine clearance (CcCl) <30 mL/min] or having received continuous renal replacement therapy, hemodialysis or peritoneal dialysis.
- Known disease or comorbid condition like asthma, diabetes with second-and third-line medicines, insulin as defined in WHO guidance document.18 10.
- The disease or condition which may affect the study as decided by physician.
- Where, in the opinion of the investigator, participation in this study will not be in the best interest of the patient, or any other circumstances that prevent the patient from participating in the study safely.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time from randomization to nasopharyngeal swab negativity by RT-PCR tests, for Intervals for 28 days or till RT-PCR negativity whichever is earlier. SARS-Cov-2 will be assessed at intervals for 28 days or till RT-PCR negativity Intervals for 28 days or till RT-PCR negativity whichever is earlier. whichever is earlier. Intervals for 28 days or till RT-PCR negativity whichever is earlier. Prevention of Hospitalization among the two study treatments i.e. Test vs. Placebo. Intervals for 28 days or till RT-PCR negativity whichever is earlier.
- Secondary Outcome Measures
Name Time Method Time from randomization to clinical recovery or deterioration, assessed at 00, 03, 05, 07, 10, 14, 21, 28 days or till RT-PCR negative and at last follow-up visit, on eight category ordinal scale defined by WHO 19 Intervals for 28 days or till RT-PCR negativity whichever is earlier.
Trial Locations
- Locations (8)
Chalasani Hospitals Pvt. Ltd.
🇮🇳Visakhapatnam, ANDHRA PRADESH, India
Ishwar Institute of Health Care
🇮🇳Aurangabad, MAHARASHTRA, India
King George Medical University, Lucknow
🇮🇳Lucknow, UTTAR PRADESH, India
Lifepoint Multispecialty Hospital
🇮🇳Pune, MAHARASHTRA, India
Medipoint Hospital Pvt. Ltd
🇮🇳Pune, MAHARASHTRA, India
Medstar Speciality Hospital
🇮🇳Bangalore, KARNATAKA, India
Orchid Specialty Hospital
🇮🇳Pune, MAHARASHTRA, India
ST. Georges Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Chalasani Hospitals Pvt. Ltd.🇮🇳Visakhapatnam, ANDHRA PRADESH, IndiaDr Surendra K MD PulmonologistPrincipal investigator020-67789100suren44konathala@gmail.com