Plant Formulation ATRICOV 452 in Improving the Level of COVID-19 Specific Inflammatory Markers in Patients

Due to the huge demand for health care facilities, there is a need for safe therapeutic intervention which can reduce the need for extensive health care support. In that regard, the current study was aimed at performing Phase 1 clinical trial to determine the safety of plant formulation in 24 healthy volunteers and Phase 2 trials in 100 COVID-19 patients to determine the tolerability and impact on the level of COVID 19 specific inflammatory markers. The outcomes of the Phase 1study have suggested the safe usage of plant formulation in humans and encouraged to conduct Phase 2 clinical trial. In the Phase 2 trial, the plant formulation was evaluated in 100 COVID-19 patients along with the standard of care. In Phase 1 single dose of 500 mg plant formulation capsule was used as an intervention, while 1gm thrice a day of plant formulation for 14 days was the testing dose for Phase 2. During the Phase 1 trial, no adverse event was observed and all organ systems were normal in function. During the Phase 2 trial, 100 patients underwent randomization, 50 were assigned to receive plant formulation, and 50 to receive placebo. Three patients in the placebo and two patients in the plant formulation group had dropped out from the study. Hence, the primary analysis population included 95 patients (48 allocated to plant formulation and 47 to placebo). The COVID 19 specific inflammatory markers improved faster and became normal in the plant formulation treatment group. In conclusion, the plant formulation (ATRICOV 452) has been found to be safe in phases 1 and 2. Trial Registration Phase 1: CTRI Registration number: CTRI/2020/09/027660 Phase 2: CTRI Registration number: CTRI/2021/01/030795