Study to Evaluate the Efficacy and Safety of Oral RP7214 a DHODH Inhibitor in Patients With Symptomatic Mild COVID-19 Infection.

  • STATUS
    Recruiting
  • days left to enroll
    72
  • participants needed
    204
  • sponsor
    Rhizen Pharmaceuticals SA
Updated on 15 October 2021

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.

Details
Condition SARS CoV 2 Infection
Treatment RP7214 + Standard of care (SOC), Placebo + Standard of care (SOC)
Clinical Study IdentifierNCT05007236
SponsorRhizen Pharmaceuticals SA
Last Modified on15 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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