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A Safety, Tolerability and Efficacy of Molnupiravir (EIDD-2801) to Eliminate Infectious Virus Detection in Persons With COVID-19

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: NCT04405570
Recruitment Status : Recruiting
First Posted : May 28, 2020
Last Update Posted : November 16, 2020
Sponsor:
Information provided by (Responsible Party):
Ridgeback Biotherapeutics, LP

Brief Summary:
This is a phase IIa, double-blind, placebo-controlled, randomized trial, designed to compare the safety, tolerability, and antiviral activity of EIDD-2801 versus placebo as measured by infectious virus detection in symptomatic adult outpatients with COVID-19

Condition or disease Intervention/treatment Phase
SARS-CoV 2 Drug: EIDD-2801 Drug: Placebo (PBO) Phase 2

Detailed Description:

This is a phase IIa, double-blind, placebo-controlled, randomized trial, designed to compare the safety, tolerability, and antiviral activity of EIDD-2801 versus placebo as measured by infectious virus detection in symptomatic adult outpatients with COVID-19. The study is a multicenter trial that will be conducted in the United States.

In this study up to approximately 108 participants will be randomized to receive EIDD-2801 or Placebo orally twice a day (BID) for 5 days. The study may enroll up to 5 parts with subsequent doses that may be higher or lower than doses studied in previous cohorts, and will be doses that have been studied for safety in a Phase 1 study. Doses will be chosen based on emerging virology and safety data from this and ongoing studies.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability and Efficacy of EIDD-2801 to Eliminate Infectious Virus Detection in Persons With COVID-19
Actual Study Start Date : June 16, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 30, 2020

Arm Intervention/treatment
Experimental: EIDD-2801 twice daily (BID) for 5 days
Dose A, Dose B, Dose C, Dose D, Dose E
Drug: EIDD-2801
Oral capsule of EIDD-2801

Placebo Comparator: placebo (PBO) twice daily (BID for five days Drug: Placebo (PBO)
Placebo oral capsule




Primary Outcome Measures :
  1. Virologic Efficacy [ Time Frame: 28 days ]

    The distribution of days until first non-detectable SARS-CoV-2 in nasopharyngeal (NP) swabs will be estimated for each randomized arm (drug versus placebo), using Kaplan-Meier methods with a corresponding stratified log-rank test (to account for the "early" versus "late" time from symptom onset randomization strata).

    Non detectable defined as "a viral load below the limit of quantification


  2. Number of Participants with any Adverse Events (AEs) as Assessed by Kaplan Meier Approach [ Time Frame: 28 days ]
    Measure the safety and tolerability of EIDD-2801 by estimating in the randomization arm the probability of 1) any adverse events (AEs) leading to early discontinuation of blinded treatment (active or placebo), 2) study drug-related discontinuation of treatment, 3) new grade 3 or higher AE (not already present at baseline), and 4) study drug-related new grade 3 or higher AE. The cumulative probability of each safety and each tolerability endpoint (4 endpoints) by using the Kaplan-Meier approach and stratified log-rank test.


Secondary Outcome Measures :
  1. Number of Participants With any Adverse Events (AEs), Grade 2 or higher as Assessed by Kaplan Meier Approach [ Time Frame: 28 days ]
    Measure the safety and tolerability of EIDD-2801 by estimating the occurrence of Grade 2 or higher AE and drug related AEs by using the Kaplan-Meier approach and stratified log-rank test.



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.


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

Inclusion Criteria:

  1. Able to provide informed consent prior to initiation of any study procedures.
  2. ≥18 years of age at Screening.
  3. Study treatment is expected to begin within ≤168 hours from first symptom onset.
  4. Ability to swallow pills.
  5. Documentation of confirmed active SARS-CoV-2 infection, as determined by a molecular test conducted at any US clinic or laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent from an NP swab collected ≤96 hours prior to study entry.
  6. Experiencing at least one of the following SARS-CoV-2 infection symptoms: fever (can be subjective including feeling feverish or having chills) OR signs/symptoms of respiratory illness (including but not limited to upper respiratory congestion, loss of sense of smell or taste, sore throat OR lower respiratory illness - cough, shortness of breath).
  7. Agrees to not participate in another interventional clinical trial for the treatment of SARS-CoV-2 during the study period (28 days) unless hospitalized.
  8. Agrees to not obtain investigational medications outside of the EIDD-2801 study.
  9. Agrees to the sampling detailed in the schedule of evaluations (SOE) and to comply with study requirements including contraception requirements.
  10. Female participants of childbearing potential must meet the following criteria to be enrolled:

    i. Have a negative pregnancy test at Day 1, prior to randomization.

    ii. Must agree to undergo a follow-up pregnancy test on Study Day 28.

    iii. Must agree to use at least 2 forms of contraception during the study and for at least 50 days after dosing of the study drug is complete, as discussed with and approved by the investigator.

    OR Must have an azoospermic partner (vasectomized or due to a to medical cause). Note: azoospermic partner is acceptable provided that the partner is the sole sexual partner of the woman of childbearing potential and the absence of sperm has been confirmed.

    Note that female not of childbearing potential is defined as either:

    1. Surgically sterile: females who are permanently sterile via hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy by reported medical history and/or medical records. Surgical sterilization to have occurred a minimum of 6 weeks, or at the Investigator's discretion, prior to Screening. OR
    2. Postmenopausal: Females at least 60 years of age with amenorrhea for ≥12 months (by history) or 45 years of age with amenorrhea for 12 months without an alternative medical reason with confirmatory follicle stimulating hormone levels of ≥40 mIU/mL. The amenorrhea should not be induced by a medical condition such as anorexia nervosa, hypothyroid disease or polycystic ovarian disease, or by extreme exercise. It should not be due to concomitant medications that may have induced the amenorrhea such as oral contraceptives, hormones, gonadotropin releasing hormones, anti-estrogens, or selective estrogen receptor modulators.
  11. Male participants must refrain from donating sperm during the study and for 100 days after dosing of the study drug is complete.
  12. Male participants with female partners must have either

    1. Surgical sterilization (vasectomy ≥1 month before screening) OR
    2. Female partner must be of not be of childbearing potential OR
    3. Agree to use 2 forms of contraception during the study and for 100 days after dosing of the study drug is complete, as discussed with and approved by the investigator

Exclusion Criteria:

  1. Need for hospitalization or immediate medical attention in the clinical opinion of the study investigator.
  2. Hemoglobin <10 g/dL in men and <9 g/dL in women.
  3. Platelet count <125,000/L.
  4. Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73m2
  5. Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≥3x upper limit normal (ULN).
  6. History of or current hospitalization for COVID-19. Note: Individuals hospitalized and then discharged, even if only hospitalized for 1 day, are excluded.
  7. History of significant kidney disease in the opinion of the site investigator. Note: If the individual responds "yes" but can provide a creatinine clearance value ≥60 mL/min by Cockcroft Gault equation within 1 year prior to study entry, the individual may participate.
  8. History of significant liver disease in the opinion of the site investigator or active Hepatitis B or active Hepatitis C. Human immunodeficiency virus (HIV) that is advanced (CD4<200/mm3) and/or on treatment with nucleoside analogues.
  9. History of known blood dyscrasia
  10. Use of therapeutic interventions with possible anti-SARS-CoV-2 activity within 30 days prior to study entry, e.g., remdesivir, lopinavir/ritonavir fixed dose combination, ribavirin, chloroquine, hydroxychloroquine, convalescent plasma, or participation in a clinical trial involving any of these drugs whether for treatment or prophylaxis.
  11. Receipt of a SARS-CoV-2 vaccination prior to study entry.
  12. Known allergy/sensitivity or any hypersensitivity to components of EIDD-2801, or its formulation.
  13. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  14. History of recent hemorrhagic cerebrovascular accident (CVA) or major bleed.
  15. Presence of a condition, that in the opinion of the investigator, would place the subject at increased risk from study participation.

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): NCT04405570


Contacts
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Contact: Laura Szewczyk 786-687-2495 EIDD2801@ridgebackbio.com

Locations
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United States, California
Benchmark Research Recruiting
Colton, California, United States, 92324
Contact: Brian Bearie, MD         
Contact: Cynthia Dukes       cynthiadukes@benchmarkresearch.net   
Valley Clinical Trials, Inc. Recruiting
Northridge, California, United States, 91325-4138
Contact: Haydee Gutierrez    818-671-2221    haydee@valleyclinicaltrials.com   
Principal Investigator: Masoud Azizad, MD         
FOMAT Medical Research Recruiting
Oxnard, California, United States, 93030
Contact: Anthony Sana    805-483-1185    asana@fomatmedical.com   
Principal Investigator: Augusto Focil, MD         
United States, Florida
Indago Research and Health Center, Inc. Recruiting
Hialeah, Florida, United States, 33012-4170
Contact: Duniel Cruz    305-825-6588 ext 335    ducruz@indagoresearch.org   
Principal Investigator: Jose Cardona, MD         
United States, Louisiana
NOLA Research Recruiting
New Orleans, Louisiana, United States, 70125
Contact: Corey Herbert, MD         
Contact: Kaye Doiron       kaye@research.works   
United States, North Carolina
University of North Carolina School of Medicine Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Susan Pedersen    919-966-6713    spederse@med.unc.edu   
Principal Investigator: William Fischer         
Duke Recruiting
Durham, North Carolina, United States, 27710
Contact: Cameron Wolfe, MD         
Contact: Maria Manson       maria.manson@duke.edu   
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Elizabeth Zieser-Misenheimer       ezieserm@wakehealth.edu   
Principal Investigator: Caryn Morse, MD         
United States, Texas
Care United Research, LLC Recruiting
Forney, Texas, United States, 75126
Contact: Jennifer Jasso    972-564-0044    jennifer.jasso@dhat.com   
Principal Investigator: Shilpi Mittal, MD         
Laguna Clinical Research Not yet recruiting
Laredo, Texas, United States, 78041
Contact: Milton Haber         
Contact: Maria Candelario       maria.candelario@elligodirect.com   
United States, Washington
Fred Hutch Recruiting
Seattle, Washington, United States, 98109
Contact: Elizabeth Duke, MD    206-667-6958    eduke@fredhutch.org   
Principal Investigator: Michael Boeckh, MD         
Sponsors and Collaborators
Ridgeback Biotherapeutics, LP
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Responsible Party: Ridgeback Biotherapeutics, LP
ClinicalTrials.gov Identifier: NCT04405570    
Other Study ID Numbers: EIDD-2801-2003
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infection