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.
Drug: RP7214 + Standard of care (SOC)
RP7214 tablets will be administered orally twice a day for 14 days
Drug: Placebo + Standard of care (SOC)
Placebo will be administered orally twice a for 14 days
Inclusion Criteria:
1. Willing and able to provide informed consent.
2. Males and females of ≥ 18 years of age
3. Patient with mild COVID-19 infection having ≥ 1 symptoms.
4. Laboratory confirmed Covid-19 infection by Reverse Transcription Polymerase Chain
Reaction (RT-PCR) in nasopharyngeal sample (within 72 hours prior to randomization).
5. Patient should have at least one pre-existing high-risk feature for developing severe
Covid-19 illness.
6. Ability to swallow and retain oral medication.
7. Male patient who is surgically sterile, or who is willing to agree to use a
contraceptive measure.
8. Women of childbearing potential should be willing to use a medically acceptable method
of contraception.
9. Willing to receive telephone calls or have videoconferences with study team personnel.
10. Willing and able to understand the nature of this study, comply with the study
procedures and follow-up procedures as per the study protocol.
Exclusion Criteria:
1. Patient with asymptomatic Covid-19 infection.
2. Patient who has experienced the onset of any of Covid-19 symptoms > 5 days at the time
of randomization.
3. Moderate to Severe COVID-19 infection
4. Patient with Covid-19 re-infection
5. Subjects who are severely immunocompromised
6. Subjects with autoimmune diseases
7. Patients with any bleeding disorder e.g., hemophilia and von Willebrand disease.
8. Current use of other DHODH inhibitors including teriflunomide or leflunomide.
9. Patients who are on or immediately require Covid-19 directed treatment such as
antivirals, immunomodulatory treatment, convalescent plasma, oral/ intravenous
steroids, or monoclonal antibodies at the time of screening.
10. Patients who have had received one or two doses of vaccine for Covid-19.
11. Patients participating in another clinical study or use of any investigational product
within 4 weeks or 5 half-lives of the drug, whichever is longer, before the date of
dosing
Citizen Hospital
Bangalore, India
Madhu Superspeciality Hospital & Research Center
Bangalore, India
Rajalakshmi Hospital & Research Center
Bangalore, India
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
Jivanrekha Multispeciality Hospital
Pune, India
PCMC'S PGI Yashwantrao Chavan Memorial Hospital
Pune, India
Sant Dnyaneshwar Hospital (Accord Multispeciality Hospital)
Pune, India
Govt General Hospital
Srikakulam, India
Great Eastern medical school and hospital
Srikakulam, India
King George Hospital
Visakhapatnam, India