SARS-CoV-2 Infection
Conditions
Brief summary
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.
Interventions
DRUGRP7214 + Standard of care (SOC)
RP7214 tablets will be administered orally twice a day for 14 days
DRUGPlacebo + Standard of care (SOC)
Placebo will be administered orally twice a for 14 days
Sponsors
Incozen Therapeutics Pvt Ltd
Rhizen Pharmaceuticals SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients requiring Covid-19 related hospitalization by Day 15. | 15 days |
Secondary
| Measure | Time frame |
|---|---|
| Time to symptom resolution in patients receiving RP7214 as compared to placebo | 15 days |
| Proportion of patients demonstrating symptom resolution | 15 days |
| Time to symptom improvement in patients receiving RP7214 as compared to placebo | 15 days |
| Change from baseline in SARS-CoV-2 viral load at Days 3, 7 and 15 by quantitative RT-PCR test | 15 days |
| Adverse Events (AEs) as assessed by laboratory tests, vital signs and physical examination. | 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. | 15 days |
| Proportion of patients demonstrating symptom improvement | 15 days |
Countries
India
Outcome results
None listed