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A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of EIDD-2801 on SARS-CoV-2 Virus Shedding in Newly Hospitalized Adults With PCR-Confirmed COVID-19

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of EIDD-2801 on SARS-CoV-2 Virus Shedding in Newly Hospitalized Adults With PCR-Confirmed COVID-19

Status: Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 05 Jun 2020

At a glance

  • Drugs EIDD-2801 (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Ridgeback Biotherapeutics
  • Most Recent Events

    • 01 Jun 2020 Planned number of patients changed from 80 to 60.
    • 01 Jun 2020 Planned End Date changed from 13 Jul 2020 to 1 Sep 2020.
    • 01 Jun 2020 Planned primary completion date changed from 24 Jun 2020 to 1 Aug 2020.

Trial Overview

Purpose

Designed as a single center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of EIDD-2801 on SARS-CoV-2 Virus Shedding in Newly Hospitalized Adults with polymerase chain reaction (PCR)-Confirmed COVID-19.

Primary Endpoints

Number of Participants that achieve Virologic Clearance after oral administration of EIDD-2801

description: Achievement of undetectable SARS-CoV-2 RNA by Day 5 in nasopharyngeal (NP) swabs by quantitative reverse transcription polymerase chain reaction (qPCR) after administration with EIDD-2801
time_frame: 28 days

Number of Participants With any Serious Adverse Events(SAEs) as assessed by DAIDS

description: Incidence of Serious Adverse Events in subjects receiving EIDD-2801
time_frame: 28 days

Number of Participants With any Adverse Events(AEs) as assessed by DAIDS

description: Incidence of Adverse Events in subjects receiving EIDD-2801
time_frame: 28 days

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 60

  • Sex male & female
  • Age Group ≥ 18 years; adult

Patient Inclusion Criteria

1. Has COVID-19 disease, defined by having one or more of the following new symptoms and signs (within 7 days): - Fevers OR - At least one of the following symptoms: cough, shortness of breath, respiratory rate ≥ 20, radiographic evidence of pneumonia OR - Anosmia OR - other clinical symptoms or signs of COVID-19 that are not otherwise explained by comorbidities or co-diagnoses 2. PCR+ test for SARS-CoV-2. 3. Has new signs or symptoms of COVID-19 that began ≤7 days of anticipated first dose of study drug. 4. Persons ≥18 years old. 5. Prior to COVID-19 diagnosis was in good health and had controlled chronic conditions - defined by having stable dosing of medications for chronic medical conditions for at least 4 weeks prior to COVID-19 symptom onset. 6. Is admitted to the Johns Hopkins Medical Institutions and anticipated to remain in the hospital for ≥ 24 hours. 7. Is willing and able to comply with all study procedures including providing informed consent, collection of virology samples, and any safety tests that are not included as part of standard of care (SOC). 8. Is willing and able to take oral medications, and is anticipated to be able to take the full course of 5 days of study agent. Pregnancy and Contraception: No developmental or reproductive studies of EIDD-2801 have been conducted. Therefore, treatment with EIDD-2801 is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during the study and for 6 months after completion of EIDD 2801 dosing in female participants and in female partners of male participants who are taking EIDD 2801. 9. Female participants of childbearing potential must meet the the following criteria to be enrolled: 1. Have a negative pregnancy test at Screening 2. Must agree to undergo a follow-up pregnancy test on Study Day 28. 3. 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: i. 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 ii. 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. 10. Male participants must refrain from donating sperm during the study and for 100 days after dosing of the study drug is complete. 11. 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 - 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

Patient Exclusion Criteria

1. Has an illness within the past 30 days that requires mechanical ventilation or ICU admission prior to enrollment. 2. Is anticipated to require mechanical ventilation or ICU admission within 24 hours of enrollment. 3. Is not expected to survive longer than 24 hours. 4. Has a platelet count less than 125,000/µL, hemoglobin less than 10 g/dL, or has a disorder of the hematologic system including anemic disorder or other blood dyscrasia, cancer of the hematologic system, history of bone marrow transplant, or other significant hematologic disease. 5. Women who are pregnant or breastfeeding. 6. Is experiencing DAIDS AE grading scale grade 4 baseline medical conditions or laboratory abnormalities.. 7. Has received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 30 days for the treatment or prophylaxis of COVID-19 prior to the first dose of study drug. 8. Has received hydroxychloroquine or chloroquine within 30 days of study enrollment. 9. Is participating in another clinical study that involves pharmacologic intervention or has participated in another study within 30 days of 5 half-lives of the investigational agent (observational study participation is permitted). 10. In the opinion of the investigator, has end-organ disease as a result of relevant comorbidities: chronic kidney disease (reduced glomerular filtration rate (GFR) <60 mL/min by the Modification of Diet in Renal Disease (MDRD) study equation prior to COVID-19 symptom onset), decompensated chronic liver disease or cirrhosis, decompensated congestive heart failure, active peripheral vascular disease including active diabetic ulcers, chronic pulmonary disease requiring baseline supplemental oxygen, or bilevel positive airway pressure (BiPAP) prior to COVID-19 symptom onset. 11. Has a diagnosis of cancer that is not in remission. 12. Has received an organ transplantation. 13. Has received a bone marrow transplantation. 14. Has been on immunosuppressive medications within one month prior to enrollment. 15. Has any condition that would, in the opinion of the investigator, put the participant at increased risk for participation in a clinical trial. 16. Has known active hepatitis C (HCV RNA positive), active hepatitis B (hepatitis B surface antigen positive), or HIV (ELISA and confirmatory Western blotting). New screening tests not required. 17. Is currently taking nucleos(t)ide analogues, including remdesivir, for any indication within 30 days of study enrollment. 18. Is currently taking systemic corticosteroids other than replacement doses. 19. Nasal septal deviations, structural defects or corrective surgeries to prevent obtaining bilateral NP swabs in the posterior nasopharynx. 20. Has a Body Mass Index (BMI) >40 kg/m2. 21. Is anticipated to require surgery within 48 hours after hospital admission. 22. Is anticipated to have a nothing per mouth (NPO) order placed within 48 hours after hospital admission that is expected to last for > 24 hours.

Trial Details

Identifiers

Identifier Owner
NCT04405739 ClinicalTrials.gov: US National Institutes of Health
EIDD2801-2004 -

Organisations

  • Sponsors Ridgeback Biotherapeutics
  • Affiliations Ridgeback Biotherapeutics

Trial Dates

  • Initiation Dates

    Planned : 01 Jun 2020

  • Primary Completion Dates

    Planned : 01 Aug 2020

  • End Dates

    Planned : 01 Sep 2020

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • Phase of Trial Phase II
  • Location USA
  • Focus Adverse reactions; Therapeutic Use

Interventions

Drugs Route Formulation
EIDD-2801Primary Drug Oral Capsule

200 mg EIDD-2801

Drug: 200 mg EIDD-2801 (Two 100 mg oral capsule of EIDD-2801)

300 mg EIDD-2801

Drug: 300 mg EIDD-2801 (Three 100 mg oral capsule of EIDD-2801)

placebo (PBO)

Drug: Placebo (PBO) (Placebo oral capsule)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Ashwan Balagopal Johns Hopkins Bayview Medical Center USA
Ashwin Balagopal Howard County General Hospital, John Hopkins Hospital, Suburban Hospital USA
Laura Szewczyk
786-687-2495 EIDD2801@ridgebackbio.com
show details
-
Stephanie Swords
sswords1@jhmi.edu
show details
Howard County General Hospital, John Hopkins Hospital, Johns Hopkins Bayview Medical Center, Suburban Hospital USA

Centres

Centre Name Location Trial Centre Country
-
-
-
Howard County General Hospital Columbia, Maryland USA
John Hopkins Hospital Baltimore, Maryland USA
Johns Hopkins Bayview Medical Center Baltimore, Maryland USA
Ridgeback Biotherapeutics
-
-
Suburban Hospital Bethesda, Maryland USA

Trial History

Event Date Event Type Comment
05 Jun 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 05 Jun 2020
01 Jun 2020 Other trial event Planned number of patients changed from 80 to 60. Updated 05 Jun 2020
01 Jun 2020 Completion date Planned End Date changed from 13 Jul 2020 to 1 Sep 2020. Updated 05 Jun 2020
01 Jun 2020 Other trial event Planned primary completion date changed from 24 Jun 2020 to 1 Aug 2020. Updated 05 Jun 2020
01 Jun 2020 Other trial event Planned initiation date changed from 26 May 2020 to 1 Jun 2020. Updated 05 Jun 2020
29 May 2020 Other trial event New source identified and integrated ClinicalTrials.gov: (US National Institutes of Health: NCT04405739). Updated 29 May 2020
26 May 2020 Status change - not yet recruiting Status changed from planning to not yet recruiting. Updated 29 May 2020
07 Apr 2020 Other trial event According to a Ridgeback Biotherapeutics media release, U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug application for EIDD-2801 Updated 08 Apr 2020
02 Apr 2020 Other trial event According to a Ridgeback Biotherapeutics media release, the company expects to begin this human trial for EIDD-2801 in April 2020. Updated 03 Apr 2020
24 Mar 2020 New trial record New trial record Updated 24 Mar 2020
19 Mar 2020 Other trial event According to a Ridgeback Biotherapeutics media release, this trial is expected to begin in second half of 2020. Updated 24 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. Ridgeback Biotherapeutics. Ridgeback Biotherapeutics and Drug Innovations Ventures at Emory Partner to Develop Clinical Stage Coronavirus Treatment. Media-Rel 2020;.

    Media Release
  3. Ridgeback Biotherapeutics. Breakthrough Ebola Treatment Receives Contract from U.S. Government. Media-Rel 2020;.

    Media Release
  4. Ridgeback Biotherapeutics. FDA Clears the Way for Ridgeback Biotherapeutics to begin Human Testing of a Promising Potential Treatment for COVID-19. Media-Rel 2020;.

    Media Release
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