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A Safety, Tolerability and Efficacy of 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 : June 18, 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: 200 mg EIDD-2801 Drug: Placebo 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.

A total of 44 participants who start study treatment (approximately 22 in each treatment arm) will be followed on study for 5 days on treatment and an additional 23 days off treatment. Participants who do not start study treatment will be replaced . Participants will be randomized 1:1 to receive either EIDD-2801 at a dose of 200 mg twice daily for five days or matching placebo twice daily for five days.

Randomization will be stratified by time (days) from symptom onset - "early" versus "late" presentation, where "early" and "late" presentation are defined by:

  • Early presentation: enrollment 0 to ≤60 hours from symptom onset
  • Late presentation: enrollment >60 to ≤120 hours from symptom onset

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 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 : August 1, 2020
Estimated Study Completion Date : September 1, 2020

Arm Intervention/treatment
Experimental: 200 mg EIDD-2801
Participants will be randomized 1:1 to receive active/placebo study treatment as follows: EIDD-2801 200 mg twice daily (BID) for five days
Drug: 200 mg EIDD-2801
200 mg oral capsule EIDD-2801 (one capsule) or 100 mg oral capsule EIDD-2801 (two capsules)

Experimental: Placebo
Participants will be randomized 1:1 to receive active/placebo study treatment as follows: EIDD-2801 200 mg twice daily (BID) for five days
Drug: Placebo
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)

  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.
  3. ≤120 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 Screening

    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 kidney disease. 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 liver disease 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, and azithromycin, 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 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, 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         
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27157
Principal Investigator: Caryn Morse         
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: June 18, 2020
Last Verified: June 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