Study to Evaluate the Efficacy and Safety of Oral RP7214, a DHODH Inhibitor, in Patients With Symptomatic Mild COVID-19 Infection.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05007236|
Recruitment Status : Completed
First Posted : August 16, 2021
Last Update Posted : April 21, 2022
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|Condition or disease||Intervention/treatment||Phase|
|SARS-CoV-2 Infection||Drug: RP7214 + Standard of care (SOC) Drug: Placebo + Standard of care (SOC)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||163 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Oral RP7214, a DHODH Inhibitor, in Patients With Symptomatic Mild SARS-CoV-2 Infection.|
|Actual Study Start Date :||September 20, 2021|
|Actual Primary Completion Date :||March 25, 2022|
|Actual Study Completion Date :||March 25, 2022|
|Experimental: RP7214 + Standard of care (SOC)||
Drug: RP7214 + Standard of care (SOC)
RP7214 tablets will be administered orally twice a day for 14 days
|Placebo Comparator: Placebo + Standard of care (SOC)||
Drug: Placebo + Standard of care (SOC)
Placebo will be administered orally twice a for 14 days
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Willing and able to provide informed consent.
- Males and females of ≥ 18 years of age
- Patient with mild COVID-19 infection having ≥ 1 symptoms.
- Laboratory confirmed Covid-19 infection by Reverse Transcription Polymerase Chain Reaction (RT-PCR) in nasopharyngeal sample (within 72 hours prior to randomization).
- Patient should have at least one pre-existing high-risk feature for developing severe Covid-19 illness.
- Ability to swallow and retain oral medication.
- Male patient who is surgically sterile, or who is willing to agree to use a contraceptive measure.
- Women of childbearing potential should be willing to use a medically acceptable method of contraception.
- Willing to receive telephone calls or have videoconferences with study team personnel.
- Willing and able to understand the nature of this study, comply with the study procedures and follow-up procedures as per the study protocol.
- Patient with asymptomatic Covid-19 infection.
- Patient who has experienced the onset of any of Covid-19 symptoms > 5 days at the time of randomization.
- Moderate to Severe COVID-19 infection
- Patient with Covid-19 re-infection
- Subjects who are severely immunocompromised
- Subjects with autoimmune diseases
- Patients with any bleeding disorder e.g., hemophilia and von Willebrand disease.
- Current use of other DHODH inhibitors including teriflunomide or leflunomide.
- 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.
- Patients who have had received one or two doses of vaccine for Covid-19.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05007236
|Madhu Superspeciality Hospital & Research Center|
|Rajalakshmi Hospital & Research Center|
|Panimalar medical college hospital and research institute|
|Maharaja Agrasen Superspeciality Hospital|
|Nil Ratan Sircar Medical College and Hospital|
|Malabar Medical College|
|BAJ RR Hospital & Research center|
|DEC Healthcare Hospital|
|Vijaya Super specialty Hospital|
|Jivanrekha Multispeciality Hospital|
|PCMC'S PGI Yashwantrao Chavan Memorial Hospital|
|Sant Dnyaneshwar Hospital (Accord Multispeciality Hospital)|
|Govt General Hospital|
|Great Eastern medical school and hospital|
|King George Hospital|
|Responsible Party:||Rhizen Pharmaceuticals SA|
|Other Study ID Numbers:||
|First Posted:||August 16, 2021 Key Record Dates|
|Last Update Posted:||April 21, 2022|
|Last Verified:||April 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases