Clinical study to evaluate the safety and efficacy of ATRICOV 452 for the treatment of COVID-19 along with the standard of care

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2021
INTERVENTION: 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 + standard of care CONDITION: Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere PRIMARY OUTCOME: 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 OUTCOME: 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 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 < 7) and Hypertension (Systolic BP <140 mm Hg or diastolic BP <90 mm Hg). 4.Patient with BMI from â?¥18 to â?¤ 30 are included. 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.
Epistemonikos ID: 1cf405c285b17d4e6f34203bfcb628510ce549ec
First added on: Jul 08, 2021