Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Umifenovir: Oral Umifenovir 800mg twice daily for 14 days + standard care of therapy.
Control Intervention1: Standard of care: Standard of care for COVID-19
Sponsors
Director CSIR Central Drug Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1. Asymptomatic persons WITH Nasopharyngeal swab positivity in RT-PCR tests for SARS-Cov-2 antigens. 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. 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 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. 4. Not participating in any other interventional drug clinical studies before completion of the present study.
Exclusion criteria
Exclusion criteria: • 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 • 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. o Known allergy or hypersensitivity to Umifenovir o Possibility of the subject being transferred to a non-study hospital within 72h o Pregnant or lactating women o Severe liver disease: underlying liver cirrhosis or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 5 times the ULN; o Known severe renal impairment [creatinine clearance (CcCl) O Known disease or comorbid condition like asthma, diabetes with second-and third-line medicines, insulin as defined in WHO guidance document.18 O The disease or condition which may affect the study as decided by physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from randomization to nasopharyngeal swab negativity by RT-PCR tests. 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time from randomization to clinical recovery or deterioration, on eight-category ordinal scale defined by WHO. Proportion of patients to clinical recovery or deterioration, on eight-category ordinal scale defined by WHO Proportion of patients hospitalized with Severe Covid-19 pnemonia (with respiratory rate =30/minute and/or SpO2 90% in room air) or ARDS or Septic shockas per Ministry of health, Govt of India guidelines. Adverse events in two groups. Timepoint: At 0, 7, 14, 21 and 28 days | — |
Countries
India
Contacts
Public ContactDr Vivek Bhosale MD
CSIR-Central Drug Research Institute
Outcome results
None listed