This is a randomized, double-blind, placebo-controlled study of RP7214 in patients with symptomatic mild SARS-CoV-2 infection, having at least one high-risk feature (e.g., age \> 60 years, hypertension, diabetes mellitus, chronic lung disease, chronic kidney disease, liver disease, cerebrovascular disease, obesity, cancer) for developing severe Covid-19 illness.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
163
RP7214 tablets will be administered orally twice a day for 14 days
Placebo will be administered orally twice a for 14 days
Citizen Hospital
Bangalore, India
Madhu Superspeciality Hospital & Research Center
Bangalore, India
Rajalakshmi Hospital & Research Center
Bangalore, India
Proportion of patients requiring Covid-19 related hospitalization by Day 15.
Time frame: 15 days
Change from baseline in SARS-CoV-2 viral load at Days 3, 7 and 15 by quantitative RT-PCR test
Time frame: 15 days
Time to symptom resolution in patients receiving RP7214 as compared to placebo
Time frame: 15 days
Proportion of patients demonstrating symptom resolution
Time frame: 15 days
Time to symptom improvement in patients receiving RP7214 as compared to placebo
Time frame: 15 days
Proportion of patients demonstrating symptom improvement
Time frame: 15 days
Adverse Events (AEs) as assessed by laboratory tests, vital signs and physical examination.
Time frame: 15 days
Change in the disease-specific inflammatory markers (Ferritin, C-reactive protein (CRP), D-dimer, neutrophil to lymphocyte/CD8+ ratio, LDH, IL-6) as compared to baseline.
Time frame: 15 days
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Panimalar medical college hospital and research institute
Chennai, India
Maharaja Agrasen Superspeciality Hospital
Jaipur, India
Nil Ratan Sircar Medical College and Hospital
Kolkata, India
Malabar Medical College
Kozhikode, India
BAJ RR Hospital & Research center
Mumbai, India
DEC Healthcare Hospital
Nellore, India
Vijaya Super specialty Hospital
Nellore, India
...and 6 more locations