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

  • STATUS
    Recruiting
  • participants needed
    44
  • sponsor
    Ridgeback Biotherapeutics, LP
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Updated on 1 February 2023
See if I qualify
estrogen
hysterectomy
fever
vasectomy
congestion
dyspnea
antiviral drugs
follicle stimulating hormone
cough
bilateral oophorectomy
pharyngitis
chills
SARS
sore throat
anosmia
oral contraceptives
throat
acute respiratory syndrome (sars)

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

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 168 hours from symptom onset

Details
Condition SARS-CoV 2
Age 18years - 100years
Treatment Placebo, 200 mg EIDD-2801
Clinical Study IdentifierNCT04405570
SponsorRidgeback Biotherapeutics, LP
Last Modified on1 February 2023

Eligibility

 Yes No Not Sure

Inclusion Criteria

Able to provide informed consent prior to initiation of any study procedures
18 years of age at Screening
Study treatment is expected to begin within 168 hours from first symptom onset
Ability to swallow pills
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
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)
Agrees to not participate in another interventional clinical trial for the treatment of SARS-CoV-2 during the study period (28 days) unless hospitalized
Agrees to not obtain investigational medications outside of the EIDD-2801 study
Agrees to the sampling detailed in the schedule of evaluations (SOE) and to comply with study requirements including contraception requirements
Female participants of childbearing potential must meet the following criteria to be
enrolled
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
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
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
Male participants must refrain from donating sperm during the study and for 100 days after dosing of the study drug is complete
Male participants with female partners must have either
Surgical sterilization (vasectomy 1 month before screening) OR
Female partner must be of not be of childbearing potential OR
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

Need for hospitalization or immediate medical attention in the clinical opinion of the study investigator
Hemoglobin <10 g/dL in men and <9 g/dL in women
Platelet count <125,000/L
Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73m2
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) 3x upper limit normal (ULN)
History of or current hospitalization for COVID-19. Note: Individuals hospitalized and then discharged, even if only hospitalized for 1 day, are excluded
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
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
History of known blood dyscrasia
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
Receipt of a SARS-CoV-2 vaccination prior to study entry
Known allergy/sensitivity or any hypersensitivity to components of EIDD-2801, or its formulation
Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
History of recent hemorrhagic cerebrovascular accident (CVA) or major bleed
Presence of a condition, that in the opinion of the investigator, would place the subject at increased risk from study participation
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estrogen
hysterectomy
fever
vasectomy
congestion
dyspnea
antiviral drugs
follicle stimulating hormone
cough
bilateral oophorectomy
pharyngitis
chills
SARS
sore throat
anosmia
oral contraceptives
throat
acute respiratory syndrome (sars)

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