A clinical study to estimate the efficacy and safety of oral RP7214 in patients with Mild COVID-19 infection.
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/09/036317
- Lead Sponsor
- Incozen Therapeutics Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 163
1.Willing and able to provide informed consent.
2.Males and females of = 18 years of age, at the time of signing the informed consent.
3.Patient with mild COVID-19 infection having = 1 symptoms. Mild infection is defined as presence of any one of the signs and symptoms of COVID-19 such as fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and/or smell, without shortness of breath or hypoxia. The respiratory rate should be < 24/min and SpO2 = 94% on room air. Patients should have one or more of these symptoms on the day of start of treatment.
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 (e.g., age > 60 years, hypertension, diabetes mellitus, chronic lung disease, chronic kidney disease, liver disease, cerebrovascular disease, obesity (Body mass index (BMI) > 30.0 kg/m2), cancer) 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 remain completely abstinent or will agree to use barrier contraceptive measures and agrees to refrain from donating sperm during the entire study treatment period and for 3 months after the last dose of study drug.
8. Women of childbearing potential who should be willing to use a medically acceptable method of contraception as defined in Appendix B while participating in the study and for 30 days after the last dose of study drug AND must have a negative pregnancy test within 3 days prior to dosing on Day 1.
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.
Individuals who meet any of the following criteria will be considered ineligible to participate in the study:
1. Patient with asymptomatic Covid-19 infection.
2. Patient who has experienced onset of any of Covid-19 symptoms > 5 days at the time of randomization.
3. Moderate to Severe COVID-19 infection.
-Moderate infection is defined as patients with pneumonia with no signs of severe disease. Clinical features suggestive of presence of dyspnea and/or hypoxia, fever, cough, including SpO2 = 93% (range 90-93%) on room air OR respiratory rate = 24 per minute.
-Severe infection is defined as patients with either severe pneumonia, acute respiratory distress syndrome, sepsis or septic shock. Clinical features suggestive of clinical signs of pneumonia plus one of the following parameters such as respiratory rate > 30 breaths/min, severe respiratory distress and SpO2 < 90% on room air; or signs of acute respiratory distress syndrome or sepsis or septic shock.
4. Subjects who are severely immunocompromised (e.g., subjects with HIV infection, subjects with solid organ transplantation or bone marrow transplantation, subjects receiving chemotherapy/ radiotherapy, subjects with primary immunodeficiency).
5. Autoimmune diseases such as multiple sclerosis (MS), systemic lupus erythematosus (SLE), rheumatoid arthritis (RA).
6. Patients with any bleeding disorder e.g., hemophilia and von Willebrand disease.
7. Current use of other DHODH inhibitors including teriflunomide or leflunomide.
8. Patients who are on or immediately require Covid-19 directed treatment such as antivirals (e.g., remdesivir, favipiravir), immunomodulatory treatment (e.g., tocilizumab, itolizumab, baricitinib or JAK inhibitors), convalescent plasma, oral/ intravenous steroids, or monoclonal antibodies at the time of screening.
9. 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.
10. Patient with history of heart failure, Class 2 or greater using the New York Heart Association (NYHA) functional class.
11. Patients on medication that is associated with prolonged QT such as antipsychotic medications or antidepressants (e.g., citalopram, venlafaxine, and bupropion) and unable to stop the same during the trial.
12. Pregnant or lactating females.
13. Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient.
14. Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.
15. Concurrent condition that in the investigator’s opinion would jeopardize compliance with the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients requiring Covid-19 related hospitalization by Day 15Timepoint: 15 Days
- Secondary Outcome Measures
Name Time Method Adverse Events (AEs) as assessed by laboratory tests, vital signs and physical examination.Timepoint: Day 1 to 30;Change from baseline in SARS-CoV-2 viral loadTimepoint: Days 3, 7 and 15;Change in the disease specific inflammatory markersTimepoint: <br/ ><br>Days 3, 7 and 15 as compared to baseline <br/ ><br>;Effect of RP7214 on SARS-CoV-2 viral load and clearance in patients with mild SARS-CoV-2 infection as compared to placebo. <br/ ><br> <br/ ><br>Effect of RP7214 on clinical symptoms <br/ ><br> <br/ ><br>Safety of RP7214. <br/ ><br> <br/ ><br>Immuno-modulatory effect of RP7214 <br/ ><br>Timepoint: 15 days;Proportion of patients demonstrating symptom resolution <br/ ><br> <br/ ><br>Timepoint: Days 3, 7 and 15;Time to symptom resolution and improvement in patients receiving RP7214 as compared to placebo.Timepoint: Day 1 to Day 15