COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45236

Dr Vivek Bhosale MD

drvivekbhosale@cdri.res.in

2020-09-01

Recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

1. Asymptomatic persons WITH Nasopharyngeal swab positivity in RT-PCR tests for SARS-Cov-2 antigens. <br/ >2. Case categories as uncomplicated illness, Mild pneumonia, Moderate pneumonia according to severity WITH Nasopharyngeal swab positivity in RT-PCR tests for SARS-Cov-2 antigens as per Ministry of health & Family welfare, Govt of India guidelines. 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. <br/ >Mild pneumonia WITH Nasopharyngeal swab positivity in RT-PCR tests for SARS-Cov-2 antigens. Moderate pneumonia is defined as Adults with presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 <94% (range 90-94%) on room air, Respiratory Rate more or equal to 24 per minute. <br/ >3. 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. <br/ >4. Not participating in any other interventional drug clinical studies before completion of the present study. <br/ > <br/ >

â?¢ Severe COVID-19, as defined in Ministry of Health, Govt of India guidelines. Adolescent or adult: fever or suspected respiratory infection, plus one of the following, respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90% on room air, Cases of Acute respiratory distress syndrome (ARDS). <br/ >â?¢ 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. <br/ >o Known allergy or hypersensitivity to Umifenovir <br/ >o Possibility of the subject being transferred to a non-study hospital within 72h <br/ >o Pregnant or lactating women <br/ >o Severe liver disease: underlying liver cirrhosis or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 5 times the ULN, <br/ >o Known severe renal impairment [creatinine clearance (CcCl) <30 mL/min] or having received continuous renal replacement therapy, hemodialysis or peritoneal dialysis. <br/ >O Known disease or comorbid condition like asthma, diabetes with second-and third-line medicines, insulin as defined in WHO guidance document.18 <br/ >O The disease or condition which may affect the study as decided by physician. <br/ >

2

Director CSIR Central Drug Research Institute

18

100

India

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

132

Time from randomization to nasopharyngeal swab negativity by RT-PCR tests. <br/ >For moderate patients; the end point will be time to improvement by one category from randomisation on the eight-category ordinal scale defined by WHO & average change in the ordinal scale from baseline.Timepoint: For examination and other tests; the time points are baseline; 7; 14; 21; 28 days. The nasopharyngeal swab testing will be done at baseline; fifth day and subsequently every 48 hours upto 21 days and then on 28 day or till it becomes negative whichever is earlier.

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "", "treatment_id": 1336, "treatment_name": "Umifenovir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]