Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05007236
Recruitment Status : Recruiting
First Posted : August 16, 2021
Last Update Posted : October 6, 2021
Sponsor:
Collaborator:
Incozen Therapeutics Pvt Ltd
Information provided by (Responsible Party):
Rhizen Pharmaceuticals SA

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.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Infection Drug: RP7214 + Standard of care (SOC) Drug: Placebo + Standard of care (SOC) Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : February 2022

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Proportion of patients requiring Covid-19 related hospitalization by Day 15. [ Time Frame: 15 days ]

Secondary Outcome Measures :
  1. Change from baseline in SARS-CoV-2 viral load at Days 3, 7 and 15 by quantitative RT-PCR test [ Time Frame: 15 days ]
  2. Time to symptom resolution in patients receiving RP7214 as compared to placebo [ Time Frame: 15 days ]
  3. Proportion of patients demonstrating symptom resolution [ Time Frame: 15 days ]
  4. Time to symptom improvement in patients receiving RP7214 as compared to placebo [ Time Frame: 15 days ]
  5. Proportion of patients demonstrating symptom improvement [ Time Frame: 15 days ]
  6. Adverse Events (AEs) as assessed by laboratory tests, vital signs and physical examination. [ Time Frame: 15 days ]
  7. 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 ]


Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Prajak Barde, MD +41325800175 pjb@rhizen.com

Locations
Layout table for location information
India
Panimalar medical college hospital and research institute Recruiting
Chennai, India
Contact: Satish Kumar         
Great Eastern medical school and hospital Recruiting
Srikakulam, India
Contact: K. Sudheer         
Sponsors and Collaborators
Rhizen Pharmaceuticals SA
Incozen Therapeutics Pvt Ltd
Layout table for additonal information
Responsible Party: Rhizen Pharmaceuticals SA
ClinicalTrials.gov Identifier: NCT05007236    
Other Study ID Numbers: RP7214-2101
First Posted: August 16, 2021    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Communicable Diseases
COVID-19
Disease Attributes
Pathologic Processes
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases