Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: ATRICOV 452: ATRICOV 452 (500mg) 2 capsules TID for 14 days + standard of care
Control Intervention1: Placebo of ATRICOV 452: Placebo of ATRICOV 452 (500mg) 2 capsules TID for 14 days +
Sponsors
Atrimed Pharmaceutical Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Both male and female adult populations aged from 18 to 60 years will be included in the study. 2.Confirmed RT-PCR positive for SARS CoV-2 and IgG â??ve symptomatic patients as determined by the principal investigator/ Physician. 3.Controlled Diabetes (Type 2 DM (Hb1Ac 4.Patient with BMI from >=18 to 5.Patient is willing and able to comply with all trial requirements. All the patients obtained written informed consent form in English as well as native language, according to national regulations.
Exclusion criteria
Exclusion criteria: 1.If the physician finds vulnerability based on the history, nutritional status, physical appearance, or any other reason. 2.Judgment of the physician on likely need of ICU admission. 3.Known hepatic & kidney disease. 4.Known hypersensitivity to usual standard of care drug. 5.Known patient of cardiovascular disease, including congenital and ischemic heart disease, congestive cardiac failure. 6.Uncontrolled Type 2 DM (Hb1Ac >7), Insulin dependent DM & Uncontrolled HTN (systolic BP>=140 mm Hg or diastolic BP>=90 mm Hg. 7.Patients with BMI 30 (Obese) are not included in the study. 8.Hemoglobin 9.Known patient of HIV or on any other anti-viral medication for a disease other than Covid-19. 10.Pregnant and lactating women. 11.Presence of debilitating diseases like Tuberculosis, Rheumatoid arthritis, Carcinoma, Known case of inflammatory autoimmune diseases of any kind, neurodemyelinating diseases like Multiple sclerosis, Transverse myelitis, Thyroid, adrenal, pituitary endocrine disorders, Renal failure, Inflammatory bowel disease. 12.Patients who had participated in another clinical trial with in the previous 30 days. 13.Patients under immune suppressants and steroid (steroid for any other disease than Covid-19). 14.Signs and symptoms, haematological, imaging investigations show signs of severe COVID will be excluded. 15.Any other medical conditions that is considered as unsuitable for the study by investigator. 16.Patient is not willing to give inform consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Time taken for clinical resolution of signs and symptom 2.Time taken for the conversion of COVID +ve to COVID -ve of throat swabs 3. Change in Disease progress markersTimepoint: From screening to 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Frequency of requirement for supplemental oxygen or non-invasive ventilation. 2.Frequency of requirement for mechanical ventilation. 3.Decrement of symptoms like headache, myalgia, rhinorrhea, loss of taste, loss of smell, diarrhoea, fatigue. 4.Number of people who needed ICU admission & number of days in ICU 5.Number of days in the hospital stay Timepoint: From screening to 14 days | — |
Countries
India
Contacts
Public ContactDr Harish S
ICBio Clinical Research Pvt. Ltd.
Outcome results
None listed